No declaratory relief in BPCIA milestone

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Sandoz filed a complaint for declaratory judgement of invalidity and non-infringement of the two newly granted patents in the US District Court for the Northern District of California on 24 June.

In the complaint, Sandoz claimed that Amgen hopes to use the patents to stop competitors from entering the market with their generic versions and to extend Enbrel’s monopoly until 2029.

Sandoz also stated in its complaint that it is seeking to gain FDA approval for its etanercept product in the future.

“Sandoz took significant steps in preparation for com-mercialising etanercept in reliance on the expectation it would be able to begin marketing immediately upon FDA approval and without the cloud of potential infringement claims,” the complaint said.

In August, Amgen moved to dismiss Sandoz’s allega-tions, and stated that Sandoz’s action was premature, “as it is just starting the determinative phase of the clinical trial process”.

A US district judge dismissed Sandoz’s motion for declaratory judgement that its etanercept product does not infringe patents protecting Amgen’s Enbrel drug.

It is the first time the patent litigation provision from the 2010 Biologics Price Competition and Innovation Act (BPCIA) has been interpreted in court.

The BPCIA was an amendment made to the Public Health Service Act to create an approval pathway for biological products that are demonstrated to be highly similar to a Food and Drug Administration (FDA)-approved biological product.

Amgen was awarded two patents, in 2011 and 2012, for formulations of the pharmaceutical compound etanercept. Earlier patent protection covering the au-toimmune disease treatment was about to expire, or already had.

Hoffman-La Roche licenses the two patents to Am-gen, and Amgen markets and co-promotes Enbrel in the US with Pfizer.

Global Patent Prosecution Highway launches in January Starting in January 2014, 13 countries wil l begin offering faster patent prosecution.

South Korea is the latest addition to the Global Patent Prosecution High-way (GPPH), joining this month. The GPPH is an initiative between national intellectual property offices with the aim of reducing patent backlogs and work duplication.

The pilot scheme now boasts patent office members from the US, Japan, Australia, Canada, Russia, the UK, Spain, Denmark, Finland, and Northern Europe.

Forest settles Bystoli dispute with Actavis

US drug company Forest Laborato-ries and Actavis have settled a patent infringement dispute over the blood pressure drug Bystoli.

Actavis and other companies filed Abbre-viated New Drug Applications (ANDA) in order to market their own versions of Forest’s Bystolic, a hypertension (high blood pressure) treatment.

Forest sued seven companies in the US District Court for the Northern District of Illinois earlier this year for infringing its patent (US6545040).

Under the settlements, Forest will pro-vide licences to Actavis, Alkem, Amer-igen, Glenmark, Hetero, Indchemie, and Torrent.

Actavis the last company is to settle with Forest since the ANDAs were filed last year.

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No declaratory relief in BPCIA milestoneContinued from page 1

It also argued that the district court had no sub-ject matter jurisdiction, because Sandoz had not yet submitted an FDA filing.

Ruling on 11 November, district Judge Maxine Chesney said that the court had no subject matter jurisdiction and so could not declare Am-gen’s patents invalid.

Under the BPCIA, an applicant cannot file a lawsuit until it has engaged in a series of statutorily mandated exchanges of drug and patent information. Sandoz, in not yet seek-ing FDA approval for its generic version of En-brel, had failed to meet this requirement, ruled Judge Chesney.

It also failed to prove a threat of future injury and provide commercial marketing notice to Amgen.

Sandoz and Amgen did not respond to requests for comment.

Global Patent Prosecution Highway launches in JanuaryContinued from page 1

PPHs between single offices, such as those between IP Australia and the US Patent and Trademark Office (USPTO) since 2008, and the European Patent Office and USPTO since September 2008, have created a quick and efficient network through which filers can use to obtain protection for their inventions.

Forest settles Bystoli dispute with ActavisContinued from page 1

Under the agreements, the companies can launch their own generic versions of the treat-ment either three months before the drug pat-ent expires in 2023 or on the date each com-

pany’s ANDA receives final approval from the US Food and Drug Administration (FDA).

The agreements are also subject to FDA ap-proval. Financial details were not disclosed.

Judges: Innovation Act could damage rather than repairNew legislation aimed at addressing abusive patent litigation in the US could undermine the development of sound court rules and practices, two judges have warned.

House Judiciary Committee chairman Bob Goodlatte introduced the Innovation Act into US Congress on 23 October. The legislation, which has bipartisan support, aims to reduce abusive ‘patent troll’ litigation.

If adopted, the act would introduce height-ened pleading standards and transparency provisions into patent litigation, as well as a modernised version of fee shifting.

Section 6 of the Innovation Act sets out procedures and practices to implement, and makes recommendations to the Judi-cial Conference, the principal policy making body concerned with the administration of US courts.

Two members of the Committee on Rules of Practice and Procedure of the Judicial Con-ference wrote to Goodlatte on 6 November.

US circuit Judge Jeffrey Sutton and district Judge David Campbell “greatly appreciate, and share, the desire to improve the civil justice system in our federal courts, includ-ing by reducing abusive procedural tactics in patent litigation”.

But, they warned, “legislation that mandates the contents of the federal rules contravenes the longstanding Judicial Conference policy opposing direct amendment of the federal rules by legislation instead of through the deliberative process Congress established in the Rules Enabling Act...”

Genetic patentsDespite the US Supreme Court’s ruling in Association for Molecular Pathology v Myr-iad, the genetics company is still enforcing patents for the disputed technology

p8Panel discussionExperts reveal what should be done when key patents are about to expire

p10Country focusSpoor & Fisher lawyers discuss sports supplement labelling in South Africa

p16Italy insightIP Law Galli’s senior partner explains how new patent laws are affecting ge-neric drug companies in the country

p18SME supportUsing GrowthAccelerator can aid SME growth, say two of its proponents

p20Patent BoxDr Adam HIll on what UKTI is doing to draw investment into the UK’s life science industry p21

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Among its other provisions, Section 6 of the Innovation Act would require the Judicial Con-ference to promulgate rules and procedures on core document discovery.

It would also provide procedures to en-sure initial disclosure and early case man-agement conference practices in district courts, to help identify any potentially case-dispositive issues.

Under the Rules Enabling Act, Congress cre-ated a “thorough and inclusive process” for addressing procedural problems in federal courts that is “multi-layered” and ensures a re-duction of the “ever-present risk of unintended consequences”, wrote the judges.

Dictating the outcome of the Rules Enabling Act process with Section 6 of the Innovation Act “runs counter to that process”.

“We worry that this kind of approach more often will undermine, rather than further, the development of sound rules and practices.”

The judges recommended to Congress that it should let the Judicial Conference study whether certain rules should be amended to address abusive patent litigation tactics, and whether the provisions of the Innovation Act should be implemented at all.

WIPO: brands cost half a trillion in 2011

Companies around the world have spent al-most half a trillion dollars on branding, ac-cording to a report published by the World Intellectual Property Organization (WIPO).

The report, entitled Brands: Reputation and Image in the Global Marketplace and pub-lished on 14 November, offers data, analysis and insight into how companies use brands to differentiate their products from their competitors, and what developing brands mean for consumers, market competition and innovation.

According to the report, companies spent nearly $466 billion dollars in 2011, exceeding outlays on research and development and design while accounting in some countries for up to a quarter of firms’ overall investments in intangible assets.

WIPO director general Francis Gurry said: “A brand incarnates an enterprise’s reputation and image and so is one of an enterprise’s most valuable assets. As markets have become more distributed and virtual, the protection provided by trademarks for reputation and image has also become increasingly important.”

The report stated that while branding invest-ments correlate closely with economic de-velopment around the world, rapidly growing middle-income countries such as India and China are investing more in branding than

Dr. Reddy’s wins trademark caseIndia’s Intellectual Property Appellate Board (IPAB) has ordered the country’s IP office to invali-date Reddy Pharmaceutical’s ‘Reddy’ trademark, ruling in favour of Dr. Reddy’s Laboratories.

Dr. Reddy’s Laboratories, which Anji Reddy es-tablished in 1984, registered a trademark for its name in 2001.

But India’s IP office granted a ‘Reddy’ trademark to Reddy Pharmaceutical in 2005 for ‘medicinal and pharmaceutical preparations’.

Dr. Reddy’s Laboratories sought to cancel the opposing trademark because it would cause market confusion, but Reddy Pharmaceutical asserted that its mark was based on the name of its founder Konda Raghu Rami Reddi.

high-income countries like the US when they were at comparable stage.

The report also went into detail about the role of the trademark system in supporting the branding activities of companies.

Many low to middle-income economies are registering trademarks more intensively even if they make comparatively less from other forms of IP.

Trademark demand quadrupled between 1985 and 2011, from just fewer than 1 million applications per year in 1985 to 4.2 million by 2011, according to the report.

In 2001, China’s trademark office became the top recipient of trademark filings—a position China gained in patent filings 10 years later.

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It also argued that it has been present in the pharmaceutical market since 1996.

Ruling in favour of Dr. Reddy’s Laboratories, the IPAB said: “Reddy Pharmaceutical Ltd deliber-ately adopted the impugned mark, ‘Reddy’, to deceive the public, and is in every way a wilful misrepresentation to the customer.”

Avedro licenses corneal biome-chanical device from universityAvedro has obtained an exclusive licence to commercialise patented invention created at the University of Rostock in Germany.

The devices that are in part based on these patents allow Avedro to enter the market with a diagnostic device that accurately assesses cor-neal biomechanical strength.

The device will also be capable of measuring the biomechanical parameters of the retina and crystalline lens.

“Avedro is the world leader in the science and research of therapeutic cross-linking for a va-riety of corneal treatments,” said David Muller, CEO of Avedro. “Through this agreement, we are now able to deliver a device that will de-finitively measure the results of our advanced cross-linking treatments.”

“University of Rostock researchers have

spent years adopting the concept of Brillouin scattering for biological and medical pur-poses,” said Oliver Stachs of the University of Rostock. “We are thrilled to have found the best commercial partner to translate our work into a clinically much-needed product.”

The new device will be released in 2014.

Natco triumphs over Teva Natco could launch a generic version of the multiple sclerosis drug Copaxone after win-ning a patent battle against Israel based Teva Pharmaceuticals.

On 13 October, the US Supreme Court turned down a request from Teva to stay a lower court order that denied patent protection to Copaxone from next year instead of 2015.

Teva sued Natco in the US District Court for the Southern District of New York Natco after the company filed an Abbreviated New Drug Ap-plication (ANDA) with the US Food and Drug Administration for marketing a generic version of Copaxone in the US in 2008.

The court ruled that Natco’s ANDA for the ge-neric version of Copaxone infringed all of the asserted claims of Teva’s patent.

But the US Court of Appeals for the Federal Circuit reversed the decision made by the lower court, resulting in the drug’s patent

protection being shortened to 2014 rather than 2015.

In July, Teva asked the Supreme Court to impose a stay while it prepares an appeal against the July ruling. It rejected the request and did not provide further explanation.

In 2009, Natco successfully blocked Teva’s patent application for the same drug in India.

Copaxone is the largest branded drug sold by Teva, which accounted for almost 20 percent of its revenue in 2012 and 40 percent of the multiple sclerosis market.

Federal Circuit affirms invalidity of Ohio Willow patent

The US Court of Appeals for the Federal Cir-cuit struck a blow to Ohio Willow Wood’s am-putee sheath patent when it affirmed a lower court’s decision on its invalidity.

At issue was the patent for gel and cushioning devices for amputees employing prosthesis.

Ohio Willow sued Alps South for patent in-fringement in the US District Court for the District of Southern Ohio in December 2004. But Alps South requested a re-examination of the patent and it was later found to be invalid.

Ohio Willow later amended the claims of the

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patent at the US Patents and Trademark Office, but Alps South requested a second re-examina-tion of the patent in November 2011.

The Federal Circuit agreed with the US District Court for Southern District of Ohio that Ohio Willow’s attempt to claim an amputee sheath that kept the interior coating gel from bleeding through the sheath’s fabric was obvious based on prior art shown in both the Ohio Willow Wood Co v Thermo-Ply and Ohio Willow Wood Co v Alps South cases.

Ohio Willow argued that the lower court failed in examining the patent, and didn’t account for the product’s success in the marketplace.

However, the Federal Circuit found that even as a whole the patent remained obvious, and the secondary evidence of sales figures was inadequate to overcome that finding.

The Federal Circuit also requested that the case be sent back to the district court to find whether Ohio Willow had committed inequitable conduct during re-examination proceedings.

The Federal Circuit stated in its decision: “We affirm the district court grant of summary judgement on the issues of collateral estoppel and obviousness.”

“However, we hold that there are genuine is-sues of material fact regarding whether Ohio Willow’s counsel committed inequitable con-duct during the re-examinations of the patent.”

Both parties must pay their own legal costs.

Horizon Pharma acquires AstraZeneca’s VimovoHorizon Pharma will acquire the US rights to make and sell AstraZeneca’s Vimovo for an up-front payment of $35 million.

Under the terms of the deal, Horizon will pay a 10 percent royalty on net sales to Vimovo co-developer Pozen. The annual minimum royal-ties will be $5 million in 2014, increasing to $7.5 million in 2015.

Vimovo treats three forms of arthritis and reduc-es the risk of stomach ulcers in patients taking certain arthritis drugs.

Horizon said it would begin selling the drug in early 2014.

“The acquisition of Vimovo is a major step forward in our strategy to leverage our busi-ness model and maximise our commercial in-frastructure, and we expect it to create significant value for our shareholders,” said Timothy Walbert, Horizon’s chairman, president, and CEO, in a statement.

Since 2011, AstraZeneca has accused rival companies Mylan Pharmaceuticals, Lupin, Avtavis and Dr. Reddy’s Laboratories of infring-ing its patent for the arthritis medication.

In all cases, AstraZeneca has sought an injunc-tion and damages.

Cadence prevails against Exela Pharma in patent case

A federal judge has ruled that Exela Pharma did in-fringe patents owned by Cadence Pharmaceuticals.

Cadence, which is a biopharmaceutical company that acquires, licenses, develops and markets hospital drugs, sued Exela Pharma in the US District Court for the District of Delaware in 2011, claiming that Exela infringed two patents covering its Ofirmev pain reliever.

The district court rejected Exela’s claims that the patents are invalid and also ruled that Exela’s Abbreviated New Drug Application for a generic version of Ofirmev infringes both of the patents.

Ofirmev is an injection that is used to treat mild to moderate pain and to manage moderate to severe pain with adjunctive opioid analgesics, and to reduce fever.

The US Food and Drug Administration (FDA) approved it in 2010.

“We are very pleased with the court’s decision, as it confirms our belief in the strength and va-

lidity of the patents covering Ofirmev,” said Ted Schroeder, president and CEO of Cadence.

USPTO to open permanent office in Silicon ValleyThe US Patent and Trademark Office (USPTO) is planning to open a permanent office in Silicon Valley.

The USPTO has selected the San Jose City Hall building, located at 200 East Santa Clara Street, as the permanent location. The agency plans to occupy the new space by the end of 2014.

The selection of a permanent USPTO office in the Silicon Valley is a key part of the Depart-ment of Commerce and Obama administration’s efforts to boost America’s innovation economy.

“A permanent USPTO office in Silicon Valley will help grow the regional innovation ecosystem by empowering entrepreneurs to more readily nav-igate the nation’s intellectual property system,” said US secretary of commerce Penny Pritzker.

“The USPTO plays a crucial role in helping protect the cutting-edge ideas that drive our economy and keep the US globally competitive. The permanent satellite offices help advance the commerce department’s innovation agenda by helping entrepreneurs get their products to market more quickly, provide resources tailored to the needs of local start-ups, and create good paying, high-skilled jobs.”

According to a statement from the USPTO, a permanent West Coast office will enable the agency to help more entrepreneurs learn about its services, meet with examiners and access its comprehensive search databases.

The space will also provide public access to search equipment and teleconference capabili-ties to incorporate in-person and virtual meet-ings with examiners.

The USPTO hopes to staff the new Silicon Val-ley office with at least 60 patent examiners and approximately 20 Patent Trial and Appeal Board judges within a year.

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“The USPTO never faltered in its commitment to opening a permanent Silicon Valley satellite office, despite the setback caused by seques-tration,” said USPTO deputy director Teresa Stanek Rea.

“A permanent office will allow us to attract ad-ditional intellectual property professionals who will work closely with regional entrepreneurs to process patent applications, reduce the backlog of unexamined patents, and speed up the over-all process—creating good jobs and promoting American innovation.”

The USPTO was forced to suspend its search for permanent office space in Silicon Valley in July due to budget cuts.

In September 2011, US President Barack Oba-ma called for the USPTO to establish three or more satellite offices.

The USPTO opened its first permanent satellite office in Detroit in July 2012.

Health activists challenge hepatitis C patentHealth activists are challenging an attempt to patent a hepatitis C treatment in India.

US-based Initiative for Medicines, Access & Knowledge is arguing that US biotechnology company Gilead Sciences’s bid to patent the treatment would prevent affordable access to medicine for the liver-destroying disease.

Initiative for Medicines, Access & Knowledge filed the challenge at the Kolkata branch of the Indian Patent Office, to prevent the biotechnol-ogy company from monopolising Sofosbuvir’s production and pricing.

The activist group, which works to ensure afforda-ble access to drugs, said it opposed the patent for Sofosbuvir on the ground that it is “old science”.

Sofobuvir is an oral drug for the treatment and cure of hepatitis C that was discovered by Phar-masset and then acquired for development by Gilead Sciences.

“Sofosbuvir is not innovative enough at the molecular level to warrant a patent,” said Els Torreele, director of the Open Society Founda-tions’s Access to Essential Medicines Initiative, which is backing the challenge.

“This is a battle over whether profits or the lives of patients will drive the Hepatitis C response.”

Andrew Hill, a pharmacologist at Britain’s Liver-pool University, said: “Sofosbuvir is the first of several oral hepatitis C drugs expected to come to market soon but they are compounds that are relatively simple and cheap to make.”

There are currently 12 million people in India living with hepatitis C and could cost around $80,000 for a course of treatment. The patent

opposition is an attempt to ensure generic ver-sions of the drug can be developed that will be affordable for people in developing countries infected with chronic hepatitis C.

India’s patent laws have had major setbacks for Western drug makers such as Hoffman-La Roche and Pfizer, both companies having pat-ents recently revoked.

Roy Waldron, CEO of Pfizer, recently accused India of unnecessarily denying intellectual prop-erty rights to foreign filers.

EU citizens support IP rights,reveals OHIMMost European citizens believe that it is vital to protect intellectual property for economic growth, a new survey from the Office of Harmonization in the Internal Market (OHIM) has revealed.

The survey interviewed 26,500 people aged 15 and over about their perceptions of the impor-tance of IP.

The subsequent report, European Citizens and Intellectual Property: Perception, Awareness and Behaviour, revealed that almost 96 percent of Europeans believe that IP is important to sup-port innovation and creativity.

Although the survey showed positive support for IP rights, it also revealed that 34 percent of Eu-ropeans believe that buying counterfeit goods can be justified in order to save money and 42 percent think it is acceptable for personal use.

Many of the respondents believed that the IP system does not meet their expectations for price, availability, diversity and quality.

This figure was especially high in people aged between 15 and 24.

According to the report, 26 percent of citizens between 15 and 24 have downloaded or ac-cessed copyright-protected content illegally over the last 12 months.

This drops to 17 percent of those aged between 25 and 34, 9 percent between 35 and 44, 5 per-cent between 45 and 54, and below 2 percent of those who are 55 or older.

Age seemed to be the most important variable: “52 percent of EU citizens between 15 and 24 ... agree that the purchase of counterfeit allows the consumer to make ‘a smart purchase’.”

Level of education did not influence the results, but the report found that perceptions varied sig-nificantly depending on the occupations of the respondents, with “50 percent of EU citizens seeking a job [agreeing] that buying counterfeit could be seen ‘an act of protest’ versus 38 per-cent of EU citizens on average”.

However, the survey concluded with awareness

of legal alternatives, finding that 80 percent of Europeans agree with the statement:

“Whenever there is an affordable legal option I pre-fer to access/download/stream content through authorised platforms and not do it illegally.”

António Campinos, president of OHIM, said the results revealed that the research provided “independent and reliable” data on perceptions and behaviour regarding IP and infringement.

The survey will serve as a baseline for future ac-tions and policy making. The research covered all 28 member states of the EU.

BakerHosteler and IP boutique to merge in 2014BakerHosteler and Woodcock Washburn LLP will merge pending a partner vote in December.

If the vote is successful, then the merge will be-come effective on 1 January 2014.

Woodcock Washburn will provide an additional 68 lawyers to BakerHostetler’s current IP prac-tice, making a total of 140 practitioners.

BakerHostetler has more than 800 attorneys and has 11 offices in the US. By merging with Woodcock Washburn, the firm will gain pres-ences in Atlanta, Philadelphia and Seattle.

“Woodcock Washburn’s nationally known and highly regarded intellectual property practice strengthens our IP position, particularly for clients in the technology sector,” BakerHo-stetler executive partner Steven Kestner said in a statement.

“This is another significant step in our mis-sion to help our clients grow and protect their businesses in today’s complex business and regulatory environment.”

Steven Rocci of Woodcock Washburn will join BakerHostetler’s policy committee and Joseph Lucci will become managing partner of the Phil-adelphia office.

Additional Woodcock Washburn partners will have leadership roles in the combined firm’s IP practice.

Lucci noted that Woodcock Washburn has been approached by a number of firms over the years, but it preferred to remain a standalone boutique.

“However, the opportunity brought about by the potential combination of the resources of Wood-cock Washburn and BakerHostetler was too good to pass up.”

“Finding a partner with the same culture and values—a dedication to outstanding client ser-vice above all in a collegial and collaborative work environment—was an added bonus that we found with BakerHostetler.”

8 www.ipprolifesciences.com

GeneticPatents

The war has been a long one for Myriad Genet-ics. Many in the biotechnology industry awaited the decision that saw the US Supreme Court unanimously rule that genes that are isolated from the human body cannot be patented.

The June 2013 decision stripped Myriad of patents for the BRCA1 and BRCA2 human genes associated with hereditary breast and ovarian cancer. The Association for Molecular Pathology, along with several other medical associations, doctors and patients, as well as the Public Patent Foundation, brought the case against Myriad, seeking a declaration that

claims from the three patents-at-dispute were invalid under 35 USC §101.

Specifically, the Supreme Court had to decide whether a naturally occurring segment of de-oxyribonucleic acid (DNA) was patent eligible under 35 USC §101 by virtue of its isolation from the rest of the human genome.

Following the ruling, Myriad began suing its competitors in Utah (Gene by Gene, Ambry Ge-netics, GeneDX and Quest Diagnostics) that re-leased their own, cheaper BRCA1 and BRCA2 cancer tests.

In the Gene by Gene and Ambry case, Myriad is in the process of arguing that their low-cost BRCA1 and BRCA2 tests should be banned from sale in the US.

In its response to Ambry’s and Gene by Gene’s opposition to its permanent injunction request, Myriad contended that their belief that its as-serted patents should be found invalid “turns upon two vastly different views of the nature and scope of the Supreme Court’s holding”.

“As a result, it is worth setting aside characteri-sations of that holding, and instead engage in

Myriad returnsIPPro revisits the US Supreme Court’s ruling in Association for Molecular Pathology v Myriad following the genetics company’s recent enforcement of patents protecting its BRACAnalysis test against rivals offering cheaper alternatives FRANKI WEBB REPORTS

9 www.ipprolifesciences.com

GeneticPatentsGeneticPatents

a careful examination of the language of the decision itself.”

In the Supreme Court’s decision, “[it] expressly recognised that there are several ways of creat-ing synthetic DNA of which the creation of cDNA was only” a particular one, concluding that “[t]he court thus at least implicitly ruled that other forms of synthetic DNA are also patentable”. cDNA is made in a laboratory with an enzyme that creates DNA using an RNA template.

As a result of this, Myriad is enforcing up to 10 patents against Ambry and Gene by Gene, none of which were subject to the Supreme Court’s ruling in June.

Say what?

After the location and sequence of the BRCA1 and BRCA2 genes were discovered, Myriad claimed for an invention that isolates the genes and tests for a risk of breast and ovarian can-cer. It filed and was granted multiple patents to protect the invention.

Once the original case had headed to and been heard in court, the petitioners were granted summary judgement. The three pat-ents were invalidated because they covered products of nature, but this confused patent holders such as Myriad, which argued that the simple act of isolating a piece of DNA from a genome is enough modification to ful-fill a patent claim.

Myriad took to case to the US Court of Ap-peals for the Federal Circuit and argued that although a naturally occurring DNA segment is a product of nature and not patent eligible be-cause it has merely been isolated, complemen-tary DNA (cDNA) is patent eligible because it is not naturally occurring.

But according to the Supreme Court’s June 2013 decision: “[Myriad] found an important and useful gene, but groundbreaking, innova-tive, or even brilliant discovery does not by it-self satisfy the §101 inquiry.”

The Supreme Court majority stressed that its hearing of the case was not about policy con-siderations but “solely whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics, meet the thresh-old test for patent-eligible subject matter in light of various court holdings, including Mayo.”

Case chore

In Mayo v Prometheus, the Supreme Court held that claims directed to a method of giving a drug to a patient, measuring metabolites of that drug, and with a known threshold for ef-ficacy in mind, deciding whether to increase or decrease the dosage of the drug, were not pat-ent eligible subject matter.

Tom Engellenner, partner at Pepper Hamilton

LLP, states: “In this case, the Supreme Court held that Prometheus’s patents claiming di-agnostic methods (for optimising therapies for certain gastrointestinal disorders) were in-eligible for patent protection because the diag-nostic methods claims pre-empted the use of a law of nature.”

“Diagnostic patents are almost always based on a discovery of a correlation that allows one to make a prediction with some degree of cer-tainty. If these correlations are deemed ‘laws of nature’, it will be hard to see how any di-agnostic method patent can survive the patent eligibility test.”

Another key case, which was used by the Supreme Court when it issued its decision on Myriad, was that of Diamond v Chakrabarty.

Genetic engineer Ananda Chakrabarty devel-oped a bacterium that is capable of breaking down crude oil, but the then commissioner of patents and trademarks, denied to grant a patent for the invention, because living things were not patentable in the US.

However, on hearing the case, the Supreme Court ruled: “A live, human-made micro-organ-ism is patentable subject matter under 35 USC §101 [because Chakrabarty’s] micro-organism constitutes a ‘manufacture’ or ‘composition of matter’ within that statute.”

In the Myriad case, the Supreme Court said that the act of isolating DNA from the human body is not sufficient human intervention to warrant patentability, unlike the Federal Cir-cuit before it, which held that the process was patentable because the inventors isolated and purified the genes.

Of course, as Myriad is now making its compet-itors aware, cDNA molecules were left outside the scope of the Supreme Court’s ruling.

“The Supreme Court’s Myriad ruling specifi-cally left untouched cDNA, DNA with non-nat-urally occurring sequences or applications of knowledge concerning genes,” explains Col-leen Tracy, partner of Fitzpatrick, Cella, Harper & Scinto.

Make it all not true

The scope of the Myriad decision extends be-yond the genetics company’s business. Kevin Hooper, partner at Bryan Cave LLP, says: “There is no question that the breadth of patent eligible subject matter has been narrowed by the Myriad decision. With the human genome project and other similar whole genome se-quencing programs completed or well under-way, the height of genomic sequence claiming has long since passed.”

“Thus, I see the Myriad decision having a ma-jor impact on those already issued patents claiming isolated genomic sequences.”

Tracy agrees, adding that the Supreme Court’s Myriad decision was narrowly tailored to natu-rally occurring DNA sequences, but is not lim-ited to only human DNA.

“We cannot patent mouse, bacteria or vi-ral genes if the sequence is the same as the naturally occurring sequence. Although some investors may be scared off, anyone who takes a few minutes to understand the ruling will un-derstand that it narrowly addressed the patent-ability of natural DNA sequences.”

Hooper argues that the decision could also spur on innovation, as scientists no longer need to worry about infringing patent claims for DNA sequences.

But according to Engellenner, the decision could reduce incentives for investors in these fields: “Without capital, most inventors have difficulty in bringing their ideas to fruition. This is especially true in biotechnology, where lengthy clinical trials are often needed to bring a product to market.”

For now, it is up to district courts and the Fed-eral Circuit to develop case law that will clarify the scope of the Myriad decision.

“Interestingly, the Supreme Court appeared to view ‘naturally occurring DNA’, particularly the genomic DNA recited in Myriad’s claims, as having both a structural and an informational component. The Supreme Court appears to have de-emphasised the structural nature of the claimed sequences and focused on the in-formation contained in the genetic sequence,” states Hooper.

The Myriad decision also had repercussions for the US Patent and Trademark Office (USPTO), which advised examiners in a memo shortly after the Supreme Court delivered its ruling: “[N]atural-ly occurring nucleic acids are not patent eligible merely because they have been isolated. Exam-iners should now reject product claims drawn solely to naturally occurring nucleic acids or frag-ments thereof, whether isolated or not, as being ineligible subject matter under 35 USC §101.”

Despite the memo, Engellener says that there is little likelihood that the USPTO will find new applications with isolated DNA claims to be patentable, as the human genome and the genomes of hundreds of other species have already been sequenced.

Tracy adds: “There may be attempts to apply the Myriad ruling to natural products, antibiotics, antibodies, stem cells, vectors, etc. The question will be whether the claimed invention is different enough from the naturally occurring product.”

Whether Myriad’s attempts to enforce its other BRACAnalysis patents will ultimately prove successful or not remains to be seen, but the Supreme Court’s controversial and complicated June 2013 decision has created new questions that lower courts must ponder, and Myriad is making sure that they do just that. IPPro

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Pharmaceutical giants such as Mer-ck & Co are seeing key patents in their portfolios expire, giving rise to generics. Their sales are taking a hit—what can they do to prolong their rights?

Liz Cohen: The EU Commission sector inqui-ry into the pharmaceutical sector resulted in a number of findings by the commission, in which it suggested that certain conduct by originator

pharmaceutical companies contributes to the delay in entry of generic medicines. As a re-sult, the behaviour of originator pharmaceutical companies is under even greater scrutiny from the competition authorities than ever before, and pharmaceutical companies will need to be careful to ensure that they apply for and enforce their legitimate intellectual property rights in a manner that is compliant with both national and EU competition law.

The development of safe, effective and high-quality pharmaceutical products usually in-

volves technical advances in a number of fields, including but not limited to the discovery and testing of a novel active pharmaceutical ingredi-ent (API). Patent law recognises this, and the legislation (as interpreted by the UK courts and the European Patent Office, or EPO) allows for patents to a number of features of a medicinal product, where the technical contribution of that feature is both novel and involves an inventive step. Patent protection is therefore available for, among other things, APIs, combinations of APIs, processes of manufacture, formula-tions and second medical uses. In the case of

Nothing lasts foreverWhat do pharmaceutical companies do when their key patents are about to expire? IPPro asks the experts

Liz CohenPartnerBristows LLP

Robert WatsonPartnerMewburn Ellis LLP

Cesare GalliSenior partnerIP Law Galli

Helen Jones PartnerGill Jennings & Every LLP

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the latter, the second medical use can include treatment of a new indication, treatment of new patient group or a new dosage regime.

Pharmaceutical companies should not there-fore overlook patents in their portfolio that protect aspects of a medicinal product beyond the API, which are often the result of lengthy and expensive research on the part of the company. Good preparation can assist in en-forcing each of these patent rights until expiry, including applying for interim relief pending trial where appropriate.

For existing patents, patent term extensions (PTEs) in the form of supplementary protec-tion certificates (SPCs) are available in the EU. SPCs of up to five years are available, depend-ing on the date of first marketing authorisation in the European economic area (and a further six month paediatric extension to the SPC is also available). SPCs have the same effect as the basic patent that they extend, but are limited to the use of the active ingredient(s) that are the subject matter of the marketing authorisation on which the SPC is sought in medicinal products.

SPCs are only available where the “product”, as defined in the SPC legislation (Regulation (EC) No 469/2009) as the active ingredient or combination of active ingredients, has not previ-ously been the subject of an SPC and the term of the SPC will be calculated by reference to the first marketing authorisation in the EEA. The first marketing authorisation had been thought to mean the first for that API with the practical effect that SPCs would not be available for sec-ond medical uses of that API.

However, in a notable development in 2012, the Court of Justice of the EU (CJEU) made it clear that SPCs are available for second medical use patents since their term should be calculated by reference to the first marketing authorisation for that second medical use in the Neurim case (Case C-130/11).

The CJEU specifically referred to the need for the SPC system to encourage and foster inno-vation in the pharmaceutical sector.

Helen Jones: In the aftermath of the recent European Commission pharmaceutical sector inquiry, it is clear that pharma companies must avoid anti-competitive agreements and abuse of dominance to maintain market exclusivity. In this environment of increased scrutiny under competition law, the patent cliff presents a more significant problem, and while pharmaceutical companies continue to rely heavily on product patents, an increas-ing importance is placed on maximising regulatory data exclusivity and securing SPC protection to extend exclusivity.

With respect to SPCs, it is clear that these rights are becoming increasingly important, and pat-ent drafting and prosecution should now take place with an eye to the developing case law and the likely commercial need to support SPC

applications. This developing commercial real-ity increases the importance of coordination be-tween patent and regulatory departments within pharmaceutical companies.

Product-based protection can be supplement-ed by supporting or ancillary inventions made during the product development process and throughout the product lifecycle. While such developments are typically less valuable than rights in the product itself, they can prove ex-tremely valuable in a sector that is as lucrative and as tightly regulated as pharmaceuticals. Examples of such ancillary developments include improvements in formulations, synthetic methods, manufacturing processes, drug deliv-ery devices, dosage regimes, packaging and drug combinations.

It is essential to take a strategic approach to patent portfolio development with a view to the big picture and a willingness to diversify so as to provide as many means of protection as possible.

Cesare Galli: In Italy, a rule introduced in Sep-tember 2012 abolished the main problem for originators arising from the marketing of the generic drug—namely, the reduction of the drug redemption price by the National Health Ser-vice. It now states that drugs equivalent to those whose patent or SPC is near to expiry cannot qualify as drugs paid by the Italian National Health Service before the expiry of the patent or SPC.

Apart from this provision (that is unlikely to re-main in force for long, as it seems to be contrary to EU law), any activity carried out by the gener-ic drug manufacturers before the expiry of the patent/SPC, which are not strictly linked to the obtainment of a market authorisation, may be prohibited and made illicit, including the market-ing of the generic drug made after the expiry of the patent/SPC, entitling the originators to ask for preliminary injunctions and seizures.

Robert Watson: The best patents are those to true innovations. Therefore, for protection for existing drugs to be extended, continued research into those products needs to continue such that innovations can be brought to the market. Such innovations can then be protected providing extended protection.

How can IP attorneys and R&D departments work together better to get products to market quicker, so that gaps in revenue can be plugged?

Galli: A strict cooperation among patent attor-neys, patent lawyers and R&D departments is necessary at every stage of the life of the pat-ent, including the drafting of the relevant applica-tion (and divisional ones, if it is the case). Not only do patent laws and regulatory rules have to be carefully considered, but also competition/anti-trust rules and the procedural rules aimed at

enforcing the relevant rights. This is particularly true for Italy, where not only granted patents, but also patent applications may be enforced in courts. Both preliminary injunction/seizures (in urgency proceedings) and full damages/disgorgement of profits (in cases on the merits) can be sought.

Cohen: The key driver in determining the time taken to bring new medicinal products to market is the length of time required to conduct pre-clinical and clinical trials and the application for approval before the relevant regulatory author-ity. The traditional IP attorney will have a limited role in this process, as it proceeds according to the regulatory framework.

The role of the IP attorney in the early stages of a product’s development should therefore focus on working closely with the R&D department, as well as litigation specialists where appropriate, to determine patent filing strategies to protect as many of the technical advances that are made in developing a novel medicinal product or use of an existing product. Early consideration of the prior art with the R&D department can also assist with choosing the right clinical develop-ment programme and ensure that sufficient evidence is available at the time of patent filing to support the claimed invention. This should maximise the chances of obtaining valid patent protection of sufficiently wide scope to recoup the significant investment that will be required in order ultimately to bring the medicinal product to market. Involving litigation specialists in these early discussions can also assist in assessing whether the envisaged patent protection can be effectively enforced.

Certain jurisdictions, such as the US, also require applicants for patents to disclose all relevant pri-or art that they are aware of to the national patent granting office, so careful discussion and record-keeping needs to occur to avoid subsequent challenges to the enforceability of patents on the grounds of non-disclosure.

Jones: In seeking to protect a company’s IP, it is essential that documents are drafted well and with the company’s commercial needs in mind. Quick and easy passage through the patent of-fice can prove very valuable in securing early market exclusivity as well as maximising the protection available under an SPC.

However, the IP attorney can also have a big impact in the commercialisation process by helping technical and business teams to navi-gate third party rights and to secure freedom to operate. In doing so, the IP attorney can steer licensing efforts in the most cost-effective direc-tion and help avoid costly and disruptive product redesigns late in the development cycle.

It is clear that a close working relationship between business and technical teams and the IP attorney can prove extremely valuable for pharmaceutical companies that operate in crowded technical fields and rely heavily on market exclusivity.

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Watson: The main obstacles to bringing a new drug product to market lie in the regulatory are-na, and not in the IP system. Although IP protec-tion can play a key role in protecting the huge amount of investment that goes into bringing a product to market, this is a supporting role to the scientific and clinical work needed.

IP rights may also be critical when large phar-maceutical companies license in or acquire early stage products from small research-based companies—in such situations, the key IP work is carried out by the small companies. Such companies need to be well advised so that they have adequate protection for their lead com-pounds, which can dovetail into the IP strate-gies of the large pharmaceutical companies. Although IP will also be secondary to the sci-ence in these situations, a well thought through IP strategy can assist in a drugs path to market, which will inevitably involve a large pharmaceu-tical company with the necessary resources to carry out the clinical studies needed.

How can in-house IP counsel forestall competitors’ invalidity accusations?

Watson: As with all patents, they need to be drafted well—the narrower the patent scope, the less likely they can be attacked for invalidity. Patents directed to novel chemical entities that are well supported in terms of chemical scope and contain comprehensive biological data will fare much better than excessively broad cases with limited biological data.

Novel chemical entity cases are likely to be stronger than cases directed to further medical uses, alternative forms or pharma-ceutical formulations—for these types of cases, it is even more important that the scope of the claims is justified by experi-mental data supporting the innovative nature of the development being claimed.

Jones: Competitors will always claim patents are invalid—there is a need to clear the way, and the expense is justified where markets are large as in the pharmaceutical sector.

The advice to any IP attorney is the same—build the strongest possible portfolio of patents. The early stages of searching and drafting are particularly important in building an apprecia-tion of the prior art and claiming the invention accordingly. It is essential to always claim strategically with sufficient fall back positions to secure commercially relevant protection, and never put all your eggs in one basket.

There is an element of uncertainty as to the en-forceability of any individual patent, but where a patent is part of a well-constructed portfolio there is a greater likelihood of effective exclusivity.

Cohen: A key consideration in enforcing patent rights is an analysis of their susceptibility to re-vocation. Careful filing strategies are essential to ensure that a pharmaceutical company does not inadvertently disclose material damaging to

its subsequent patent applications, for example, through public disclosure of the innovation by researchers prior to filing of the patent (or prior-ity application). In the UK, all prior public dis-closures, even by the inventors, are considered prior art when determining the validity of a pat-ent, unless the disclosure was made in breach of confidence.

Ultimately, there is little that patents holders can do before revocation proceedings have con-cluded to prevent third parties from suggesting that the patents are invalid. As set out above, obtaining prior art and keeping records for the purposes of disclosure to national patent au-thorities can be of assistance in defending sub-sequent unenforceability challenges based on lack of disclosure.

Patents granted by the EPO already carry a prima facie assumption of validity due to the fairly rigorous examination procedure at the EPO, particularly when compared to the ex-amination conducted by some national patent offices of member states to the European Pat-ent Convention (EPC).

Furthermore, European patents are subject to central opposition proceedings at the EPO if any opposition is filed within a nine-month period af-ter grant. A successful opposition will result in revocation of the European patent in all the EPC countries in which protection was sought, and is final subject to an internal appeal to the Techni-cal Board of Appeal (TBA). On the other hand, an unsuccessful opposition (including appeal) is not final, in the sense that any party (including the opponent) may still apply to revoke each na-tional patent deriving from the European patent before the respective national courts.

However, a European patent that has success-fully navigated an opposition, particularly an appeal before the TBA, carries with it an even greater presumption of validity. There are many reasons to file patents through the European phase rather than the national phase, the most obvious being the reduced costs to obtain pan-European protection. However, the benefit of the presumption of validity provides additional incentive to pursue this route.

The UK Intellectual Property Office (IPO) will also issue non-binding opinions on validity if re-quested (only concerning novelty and inventive step). However, these are relatively rare and it is unlikely that a patent will therefore already be subject to a favourable opinion from the UK IPO.

Galli: Since the EPO problem and solution ap-proach is widely recognised not only before the EPO Board of Appeal, but also in courts (includ-ing the Italian courts. See for instance: Sandoz/Astrazeneca Court of Trieste, Order, 29 March 2011; Pharmaland/L’Oréal, Court of Turin, Sent, 23 February 2009; and IBSA/Pfizer, Court of Milan, Sent, 26 May 2009), a full scenario of the real problems tackled by the researchers for reaching the patented invention, and of the obstacle and technical prejudices overcome, is

necessary. In many cases, experimental data showing the surprising effect of the patented in-vention prove to be very helpful, as secondary indicators of inventive step.

Where do brands come in?

Jones: Brand development is a critical compo-nent of the pharmaceutical commercial devel-opment path—the most successful pharmaceu-tical products have all been well branded and become instantly recognisable based on brand names, for example, Prozac or Viagra.

Successful brand development builds a relation-ship with the most important of constituents—the consumer. Commercial impact and mainte-nance of market share relies heavily on strong branding, and a sufficiently strong presence can help to maintain market share and pricing levels after patent expiry.

Accordingly, brand development should form part of an integrated IP strategy to support product launch, and this requires early investment just like development of a strong patent portfolio.

Cohen: Brand protection, whether of the reg-istered (trademarks) or unregistered (claims for passing off) variety, provides significant ad-ditional value to medicinal products over and above patents. However, they do not generally protect inventions. Trademarks are not avail-able, for example, for shapes where that shape is necessary to achieve a technical result.

Most trademarks in relation to pharmaceuti-cal products will constitute a word mark under which the product is sold. However, slogans, the shape of goods and colours are also capable of registration as trademarks. In addition to the originator’s trademark for a pharmaceutical product, an international non-proprietary name (INN) will be assigned to the API by the World Health Organization (WHO) or similar national body. Unlike trademarks, INNs can be used without restriction.

Unlike many other industries, the regulatory authorities strictly regulate brands that may be used to promote medicinal products. The scruti-ny of the marketing authorisation application by the national or EU regulatory authority before a medicinal product can be authorised will include an examination of the name proposed to be giv-en to the product. The choice of trademark must be: (i) an invented name that is not liable to con-fusion with the INN or other common name for the API, or with any other invented names used for medicinal products; or (ii) the INN/common name accompanied by a trademark or name of the proprietor. The product packaging must also be approved by the regulatory authority.

Trademarks do play an important role in the pharmaceutical sector, in that they can provide greater differentiation between products in the same class than INNs (which use a similar stem for all compounds sharing similar and/or

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Gill Jennings & Every LLP is a long-established leading fi rm of European patent and trade mark attorneys based in London and Munich. We specialise in the medical technologies and life sciences sectors and represent a broad range of clients including global corporations, SMEs, universities and individual inventors.

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pharmacological properties). This can be of as-sistance in reducing medication errors by health practitioners, and in adverse event reporting where different medicinal products with the same INNs may have different adverse effect profiles due to the choice of excipients.

With prescription-only medicines, the role of brands is necessarily less important when dis-tinguishing an originator’s product from that of a generic product with the same INN as prescrib-ing is now predominantly done by INN. Indeed, prescribing physicians are usually encouraged to prescribe by INN, and pharmacists are often required to substitute branded original products for the cheaper generic product, in the drive to decrease costs and switch patients to cheaper generic medicines where available.

However, for over-the-counter medicines, or in countries where direct-to-consumer advertising of prescription medicines is permitted, brands can create greater brand identity in the minds of consumers, who are less accustomed to think-ing of medicinal products by way of INN.

Trademarks do have other roles in the phar-maceutical industry, in that they can prevent generic companies from free-riding the goodwill generated in the medicinal product and associ-ated advertising, ensuring that generic products do not take unfair advantage of the reputation of the originator and its products when the generic product comes to market.

Furthermore, trademarks can also play a role in the fight against counterfeit medicines, which pose significant risk to public health, particu-larly where customs authorities are involved, as these make it easy to distinguish between genuine and counterfeit product.

Galli: Brands may be even more important than patents, in the pharmaceutical field. Even when drug manufacturers cannot advertise directly their products to the consumers (like it is in Italy, for drugs other from OTC products), the manu-facturer’s general brand, if appropriately used and advertised, may help to build confidence

and improve customer retention. Product trade-marks too, especially when clearly linked to the manufacturer’s brand, may benefit from this re-lationship, in such a way to prolong at least par-tially the possibility of leading the market even after the expiry of patent rights. Furthermore, in appropriate cases, they can be useful for mak-ing the parallel importers toe the line.

Watson: In my opinion, brand awareness is quite high for pharmaceuticals. Much will de-pend on the sales route, with brands playing a larger role for over the counter medicines. Many direct consumers are distrustful of ge-neric products, even when they have exactly the same formulation. Therefore, a well-thought through branding strategy can be valuable for OTC medicines. In the UK, I think that branding is much less important for prescription medi-cines, as the choice of drug is left to qualified individuals with a greater awareness of the ac-tives and formulations.

Would trade secrets be another option for pharmaceutical companies over patents?

Watson: Although trade secrets can play a role in any IP strategy, their use needs to be bal-anced with the inevitable public disclosures that occur during testing, approval and sale of phar-maceutical products.

Cohen: In many industries, a choice lies be-tween protecting an innovation as a trade secret under the law of confidential information (or the national equivalent such as unfair competition) and applying for a patent that claims the inno-vation. With pharmaceutical products, however, the product is made available to the public in sufficient quantities so that it will usually be pos-sible to reverse engineer most innovations that would otherwise be protectable through confi-dential information.

Moreover, many of the innovations, for example, the APIs, combinations of API, dosage regimes and medical uses, must clearly be stated in the

publicly available regulatory documents. There is therefore only limited scope for use of trade secrets by pharmaceutical companies instead of patents, even though the period of protection for confidential information can sometimes sig-nificantly outlast the limited patent term.

The main area in which a pharmaceutical company might choose to protect innovations through trade secrets is in the process of manu-facture of the API, including the specific process parameters. With traditional small chemical compounds, there are usually many processes of manufacture that could be developed, al-though it is usually worth applying for patents for novel processes of manufacture where these can be described at a sufficiently general level.

However, for detailed process parameters that confer a technical advantage to the process, such as increased yields or purity, it is often more appropriate to protect these as trade se-crets, as patent protection may be difficult to obtain and/or easy to circumvent.

Furthermore, the modern pharmaceutical in-dustry has made great strides since the advent of the biotechnology age, and today’s leading pharmaceutical products are as likely to be biological as chemical in origin. The process of manufacture for biological pharmaceutical products is in most cases manifestly more com-plicated than that for small chemical products, involving as it does biological systems. The technical know-how developed in manufactur-ing a biological medicinal product that can sat-isfy the requirements of the regulatory authori-ties constitutes a significant proportion of the value in such products. The detailed processes of manufacture are therefore even more condu-cive to protection as trade secrets.

It should always be borne in mind, however, that a patent grants an absolute monopoly for the term of the patent, regardless of the origin or nature of the process or product, whereas a claim for misuse of will need to establish that confidential information was used and that the information was acquired

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in breach of confidence. Rigorous internal pro-cedures will also be required to maintain confi-dentiality of trade secrets as once a disclosure is made public, even inadvertently, it is usually impossible to retrieve the situation. Breach of confidential information claims are also usually very expensive to conduct, and it is therefore easier to maintain and assert a patent monopoly in most cases.

Jones: Trade secrets, or confidential informa-tion, can be very important in the pharmaceuti-cal sector. However, reliance on them to protect IP is not always appropriate. Pharmaceutical companies needs to be assured that strong pro-tection will exist for a term sufficient to recover the vast investment made in bringing their prod-ucts to market. While trade secrets are not term limited, they are less strong and likely more dif-ficult to enforce than patent rights.

Trade secret protection may be appropriate where the objective is to maintain secrecy, but this is not likely to be the case for most phar-maceutical products, methods or devices. The value in trade secrets lies in maintaining their confidentiality. Should a competitor discover the secret by legitimate means then it is free to use it. Accordingly, the proprietor must take steps to maintain confidentiality. This approach might prove useful for protection of improvements to processes that are not subject to regulatory re-view, but such cases are not common.

Additionally, excessive reliance on trade secrets may not be in a company’s commercial best in-terest. A balance must be struck between the desire to maintain secrecy (commercial advan-tage) and the need to develop public trust and confidence (eg, regulatory approval), and open engagement with the public via the patent office may prove a worthwhile for this reason in addi-tion to providing robust protection.

Galli: Even if it is hard to believe that trade se-crets can play a really significant role in the phar-maceutical filed, since they are more relevant for method patents than for products ones, and only when reverse engineering is not easily available, we should consider the technology concerning specific pharmaceutical forms, where often the know-how is much more important than the pat-ents themselves, as reverse engineering may not supply all the relevant information.

A case presently pending before the IP Special-ized Division of the Court of Milan deals with this issue, as it was brought in a case of stolen know-how regarding just the formulation of con-trolled release drugs.

What are pharmaceutical com-panies and their lobbyists doing to convince legislators to extend patent terms?

Galli: Information perhaps is the keyword in all branches of IP law making. This is particularly true for the pharmaceutical industry, since the

real investments and the time frame for market-ing drugs seem to become even more challeng-ing and require extended patent terms for being recovered. Also, data concerning savings for the national health services, which may derive from the use of more effective drugs, may be helpful in this perspective.

Cohen: The EU SPC regime, first introduced in 1992, was extended by the introduction of pae-diatric extensions in 2007. Where a paediatric investigation plan (PIP) is approved and the studies conducted, SPCs can be extended by a further six months. Both extensions were intro-duced by the EU to recognise the hurdles faced by pharmaceutical companies as a result of the EU’s regulatory legislative framework.

In the case of SPCs, the legislation is designed to partially compensate the patent holder for the significant regulatory delay in bringing a product to market that results in significantly reduced term of effective patent protection. The six-month SPC extensions under the Paediatric Regula-tion can be thought of as compensation for the introduction under that Regulation of compulsory additional research into the authorised medicinal product in the paediatric population.

Further patent term extensions are not on the agenda in the EU at present, although following the Neurim decision, further extensions of the SPC system may result from a broader interpre-tation of the SPC Regulation than from amend-ments to the regulation itself. A number of non-EU countries throughout the world have also introduced PTEs for the pharmaceutical sector.

However, there are ongoing discussions in a number of countries with a view to introducing a similar regime to compensate pharmaceutical companies for regulatory delays. For example, the leaked contents of the Trans-Pacific Partner-ship (TPP) trade negotiations between a num-ber of Pacific Rim countries suggest that patent protection measures were tabled by the US, including requirements for all countries to in-clude compensatory PTEs. These amendments apparently faced severe opposition from some other members of the TPP and were withdrawn, although it appears the issue remains live. The TPP countries that currently do not have a PTE system are Canada, Malaysia, Mexico, New Zealand, Peru and Vietnam, although Canada will now introduce a PTE system of up to two years’ duration as a result of the Comprehen-sive Economic and Trade Agreement entered into with the EU.

Developments are also afoot in Australia, al-though in this case in the other direction. Aus-tralia’s PTE system currently extends patents by up to five years, but the previous government published a pharmaceutical patents review in April 2013 that proposes either reducing the length of extensions as across the board or en-suring that expiry is no later than the equivalent patent/PTE/SPC expiry in major trading part-ners, including the US and the EU. Furthermore, PTEs would no longer be available for patents to methods of use and manufacture. Whether

the new Australian government will take forward the recommendations in the report remains to be seen.

Watson: The current regimes of term exten-sions for pharmaceutical patents appear to be accepted in both professional and political circles. I can’t imagine any longer term ex-tensions being acceptable. However, there are upcoming changes to the patent regime in the UK, with the planned extension of the ‘Bolar’ exemptions—the extended exemptions should make it easier to carry out clinical tri-als in the UK without worrying about patent infringement issues. The UK government is also planning to extend the exemptions to cover the studies necessary for Health Tech-nology Assessments. When coupled with the recent introduction of Patent Box provisions to the UK, it can be seen that the government is keen for pharmaceutical companies to remain in the UK.

Jones: Firstly, it is important to note that pat-ent term is fixed at 20 years from first filing. Im-mense efforts have been made to extend this standard globally, and it is very unlikely that any amount of lobbying will change that. However, a well-executed IP strategy can have the effect of extending market exclusivity through maximisa-tion of SPC and regulatory data protection.

Given the importance of SPCs to the pharma-ceutical sector, it is worthwhile making efforts to have the law regarding SPCs clarified. Given re-cent case law developments, this may be most efficiently achieved by redrafting of the EU regu-lations, but whatever the mechanism, there is a need for clarity.

Harmonisation and clarification of the law on research use and Bolar-type exemptions from patent infringement would also be beneficial to pharmaceutical companies. This need was recently acknowledged by the UK IPO, which carried out extensive consultations and concluded that the UK legislation required amendment to achieve harmony with our EU partners. Uncertainty over the scope of the Bolar exemption remains and grows with the imminent arrival of the Unitary Patent Court, which will necessarily apply a standard that is significantly different from that currently in place in at least some major European phar-maceutical markets.

A clear understanding of reimbursement issues in each major market is critical to pharmaceutical companies, and this is aided by developing a close working relationship with those national bodies that coordinate drug purchasing. Providing value for money is clearly an aim of most companies, but it is critical for the continued existence of the pharmaceutical sector that such agencies ap-preciate the true cost of innovative drugs. A healthy innovation engine is required to con-tinue to maintain a pipeline of new medicines to improve on existing treatments and develop solutions to the yet unknown challenges of the future. IPPro

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CountryFocus

Although many consumers are unaware, over the counter sports supplements could be le-thal. The supplements market in South Africa is worth hundreds of millions of rand every year, an income which is generated through sales to both professional athletes and the average consumer. As a result of the vastly competitive market, and the fact that consumers are look-ing to be bigger, stronger and faster, there has been much speculation that supplement com-

panies add ‘a little extra’ to their off-the-shelf-supplements in order to give the consumer the results they want. This situation is not unique to South Africa, but because of the legisla-tive lacuna in which sports supplements found themselves, there appeared to be nothing act-ing against the problem. Thankfully, this is set to change with the heralding of new regulations that bring sports supplements into the domain of strict regulatory controls.

Until now, supplement companies have been able to act with relative impunity in an industry absent of any regulation. This has led to a rather unfortunate situation whereby consumers have been duped into believing that they are buying safe products in situations where they were po-tentially putting their lives at risk.

Substances such as Methylhexanamine, com-monly known as 1,3-dimethyl or DMAA, which

A new era for sports supplements in South AfricaUntil now, a lack of information on sport supplement labels posed serious health risks, say Bryce Matthewson and Dirk Hanekom of Spoor & Fisher

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has been linked to a number of deaths interna-tionally, is being widely used in over the coun-ter supplements without any warning to con-sumers. The serious health concerns relating to DMAA are not merely speculative and have been acted on in many foreign jurisdictions, in-cluding Canada, New Zealand, parts of Sweden and Australia, all of which have banned DMAA. In the UK, the Medicines and Healthcare prod-ucts Regulatory Agency called for the removal of popular supplement Jack 3D and other sup-plements containing DMAA, while in US, the Food and Drug Administration issued warning letters to manufacturers of DMAA products on the basis that they have failed to submit the nec-essary documentation relating to the safety of the products.

The failure to properly and accurately label sup-plements introduces the additional problem that professional athletes are often not aware of the true ingredients in the supplements, which can lead to positive tests for banned substances. The South African Institute for Drug Free Sport (SAIDS) stated in 2011 that it believed that the increase in positive results that it had experi-enced during the course of 2011 was as a result of the impunity with which supplement compa-nies acted. SAIDS went on to state that it was working together with the South African Sports Medicine Association (SASMA) to develop a framework around the regulation of the indus-try, but to date nothing appears to have come of this.

The regulations

On 22 July 2011, South Africa’s minister of health, Dr Aaron Motsoaledi, published draft amendments to the general regulations in terms of the Medicines and Related Substances Act, with the aim of bringing complementary medi-cines, arguably including sport supplements, into the ambit of the act. Shortly afterwards, the Medicines Control Council (MCC) published draft guidelines “to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines”.

On 15 November 2013, two years after the draft was published, the regulations were finally ga-zetted. Any doubt as to whether the regulations

would cover sports supplements was laid to rest in the gazetted regulations, which define a ‘complementary medicines’ as:

“[A]ny substance or mixture of substances that –(a) originates from plants, minerals or animals;(b) is used or intended to be used for, or manu-factured or sold for use in assisting the innate healing power of a human being or animal to mitigate, modify, alleviate or prevent illness or the symptoms thereof or abnormal physical or mental state; and (c) is used in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982).”

Furthermore, they make specific reference to sports supplements in the section dealing with the implementation of the regulations.

As a result of the amendment, sports supple-ments will in future be scrutinised by the Med-icines Control Council of South Africa (MCC) for safety, efficacy, and quality. Furthermore, all manufacturers, distributors, importers, and exporters of these products will now re-quire licences for these activities, while the products will in future have to comply with the prescribed requirements including those relating to labelling, package inserts, and pa-tient information leaflets. In addition, and un-til such time as the products have been reg-istered with the MCC, the product will have to carry the following notice:

“This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.”

In essence, sports supplements will now be dealt with no differently from any other medi-cine. This change bodes well for both the av-erage consumer and professional athletes who make use of sports supplements. The labelling requirements will place professional athletes in a better position to consider the use of the specific supplement in light of possibly banned substances. Furthermore, this will now enable manufacturers to mark products as being “pro-fessional athlete friendly”, and athletes will be able to trust this.

The implementation of the regulations will come in a phased approach. Requirements relating to labelling and inserts with come into effect three months after the publication of the regulations and the remainder of the require-ments will, in the case of sports supplements, take effect 30 months after publication.

Some supplements, such as those purporting to be suitable for weight loss, will be effected as from 24 months.

In essence, this will mean that, depending on the category, sports supplements will have to be submitted to the MCC for approval by either the 24 or 30 month deadline. There is little doubt that unsafe products will continue to be avail-able on the black market, and this is a practice that will require strict enforcement to eradicate, but this is certainly a step towards safer prod-ucts for consumers.

We are yet to see how the MCC will deal with the influx of applications that it will now receive, or how and indeed if these regulations will be properly enforced, but there is little doubt that this long awaited move by the Department of Health should be welcomed as a step in the right direction. IPPro

As recently as February of this year, South African lightweight champion boxer Viwe Md-letyeni was stripped of his title having tested positive for DMAA. Mdletyeni denies that he was aware that it was contained in the supplements he was using.

The 2012 winner of the Comrades Marathon, Ludwick Mamabolo, also tested positive for DMAA, as did Springbok rugby players Bjorn Basson and Chilliboy Ralepele. Like Mdletyeni, Mamabolo has maintained his innocence, saying that he was using the same supplements as he has always been using. If this is accurate, then the products may have been cross-contaminated during manufacture, or the formulation of the products changed without a corresponding label change. These scenarios are equally problematic.

Despite all of these concerns, supplements containing potentially dangerous substances, DMAA included, are still readily available in the South African marketplace. This is largely because supplements have previously fallen into a legislative lacuna, a situation which is about to change.

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ItalyInsight

How did the Italian Decree Law 158/2012 change the country’s patent law?

Decree Law 158/2012, later transformed in Law 8 November 2012 No 189, is a comprehensive public health reform act, including rules on many different aspects of the matter, which do not directly affect the patent law.

However, among other rules, it stated that generic drugs cannot be reimbursed by the National Health Service (thus making them uncompetitive) until the relevant patent or supplementary protection certificate (SPC) ex-pires, regardless of whether the generic drug falls or not within the scope of protection of the patent or SPC, and whether the patent or SPC is valid or not. Although this rule has been heavily criticised—including by the Competi-tion Authority—nonetheless parliament gave its final approval and it is currently in force.

The new law abolished the main problem for originators arising from the marketing of the generic drug—namely, the reduction of the drug redemption price by the National Health Service—as it now states that drugs equivalent to those whose patent or SPC is near to expiry cannot qualify as drugs paid by the Italian Na-tional Health Service before the expiry of the patent or SPC.

However this rule clearly conflicts with the principles derived from Article 10 of EU Direc-tive 83/2001/EC, as amended by EU Directive 27/2004/EC (which transposed the Bolar clause into EU law), and is constitutionally illegitimate because of its inequality of treatment. There-fore, Italy may once again face infringement proceedings from the EU.

Does the enforcement of the new law mean less generic drugs will entering the Italian market?

Yes, of course. Since in Italy all people benefit from the reimbursement of drugs by the National Health Service, the new law in practice means that generic drugs are more expensive than the corresponding original drugs, until the relevant patent expires, even if they do not amount to an infringement thereof or the patent is null. Hence, this new law in practice reinstated pat-ent linkage for generic drugs.

Italy has been accused of pat-ent linkage in the past. What has the country done to defend itself against these allegations?

In 2005, the Italian Code of Industrial Proper-ty (ie, the law that put together all the existing rules on patents, designs and trademarks) was adopted. It included a rule excluding from patentability any “studies and testing aimed at getting, even abroad, an authori-sation for launching/selling a drug and the consequent practical fulfillments, including preparation and use of pharmacologically active raw materials strictly necessary to it/the purpose”.

This rule was intended to exploit the cor-responding EU law provision (Article 10 of Directive 83/2001/EC, as amended by Di-rective 27/2004/EC). However, a further rule was also included whereby the marketing authorisation application for generic drugs might be filed “one year before” the patent or SPC expiration date. But Italian courts did not interpret the law consistently, since the Court of Milan found that the reference to the period of “one year before” the expiry of the patent or SPC was not limiting, while other courts considered the filing of a marketing authorisation application more than one year before the patent or SPC expiry date to be illegal, in case the generic drug fell within its scope of protection.

That led to an EU infringement procedure and finally to a change in the law, in Janu-ary 2012, through Decree Law 1/2012, which aligned Italian law with EU legislation, stating that a marketing authorisation application for a generic drug protected by a patent or an SPC can be filed more than one year before the expiry date of the patent or SPC, since only the manufacture, import or sale of the product could be considered an infringement.

Why is patent linkage for generic drugs such as a sensitive issue within the EU?

At the EU level, it is undisputed that not only testing but also the requesting and granting of marketing authorisations must be considered to be non-infringing activities. This must be es-tablished all over Europe. The issue has been disputed outside of Italy. Two recent German and Polish decisions held that only the activity directly carried out by the subject asking for a market authorisation may be held licit.

On the contrary this limitation (which seems contrary to the rationale underlying the EC directive) clearly does not hold in Italy, where the law makes no distinction between the activity of generic drug manufacturers and bulk manufacturers.

Which strategies may be advisable in Italy for originators and generic drug manufacturers, respectively?

The clear illegitimacy of the provision introduced in September 2012 means that it is unlikely to remain in force for long. Thus, it is even more advisable to take timely action using the means offered by Italian IP law, which has now reached a significant level of efficiency.

Actually, Article 131 of the Code of Industrial Property allows an IP rights holder to obtain a preliminary injunction in case of “any imminent infringement” of the asserted right. Therefore, the early filing of an marketing authorisation ap-plication, even if it does not represent a prepa-ratory act aimed at the marketing of an equiva-lent drug before the expiry of the relevant patent or SPC, is a significant clue in that direction, particularly when taken together with other ele-ments that can be assumed by the applicant’s previous behaviour or lack of response to a request not to manufacture, import and sell the equivalent drug before the expiry of the relevant patent or SPC.

All of this can support the issue of a prelimi-nary injunction or at least a description order (ie, a protective measure intended to check whether the manufacturer has already started manufacturing or importing the generic drug). In turn, if the patent is deemed to be invalid or not infringed, the generic drug manufacturer may resort to a preliminary declaration of non-infringement, as provided by the amended code. The manufacturer can use this mecha-nism if there are elements indicating that the originator wants to take legal action against it (eg, warnings or legal actions taken abroad against other manufacturers of the same generic drug). IPPro

The Italian jobIPPro talks to Cesare Galli of IP Law Galli about the generic drug market in ItalyFRANKI WEBB REPORTS

u EPO OPPOSITIONS AND APPEALS - THE CASE LAW 23 January 2014 - London - Ref. H1-3014

u EUROPEAN PATENTS - THE CASE LAW 24 January 2014 - London - Ref. H1-3114

u AVOIDING PITFALLS IN PATENT / KNOW-HOW LICENSES AND R&D COLLABORATIONS 22 January 2014 - London - Ref. L1-5214

u STRATEGIC IP PLANNING 27-29 January 2014 – London - Ref. H1-5014

u MAXIMISING RETURNS ON RESEARCH 3 February 2014 – London - Ref. H2-5614

u IP COMMERCIALISATION FUNDAMENTALS, PLANNING AND EXECUTION 19-20 February 2014 – London - Ref. H2-5014

u INSTITUTE FOR PATENT PROSECUTION 24-25 February 2014 – London - Ref. H2-5514

u BECOME A CERTIFIED PATENT VALUATION ANALYST 6-7 March 2014 – Copenhagen - Ref. H3-5814 11-12 March 2014 – London - Ref. H3-5714

u PATENTING MEDICAL TECHNOLOGY 14 March 2014 – London - Ref. H3-3214

u BIOTECHNOLOGY FOR THE NON-BIOTECHNOLOGIST 9-11 April 2014 – Nice - Ref. B4-5014

e-mail: josephine.leak@management-forum.co.uk Tel. +44 (0)1483 730071 Fax. +44 (0)1483 730008www.management-forum.co.uk

ItalyInsight

20 www.ipprolifesciences.com

GrowthAccelerator

What is GrowthAcelerator and how does it work?

Susan Ingham: GrowthAccelerator is a UK De-partment of Business, Innovation and Skills Busi-ness Support Service aimed at ambitious small and medium-sized enterprises (SMEs). It’s a part-nership between BIS and a consortium of proven growth experts, Winning Pitch, Grant Thornton, Pera Consulting and Oxford Innovation.

Growth Accelerator is all about expert coaching tailored to your business and high-level con-nectivity. There are four elements to GrowthAc-celerator: access to finance, which deals with funding; growth through innovation; and busi-ness development, coaching and leadership and management training.

It’s heavily subsidised. The company would be expected to invest a certain amount in GrowthAc-celerator, and that would depend on how many employees the company has (zero to four: £600; five to 49: 1500; and 50 to 250: £3000).

Who does it target and why?

Ingham: SMEs overall. They must be growing, and have the ambition and capacity to grow, along with a willingness to invest time and a small amount of cash. They can be in any sector.

Two thirds of UK economy growth in the last 20 years has been down to innovation and it obvi-ously has huge impact on growth. If you want to grow the overall economy, then investing in and encouraging innovative companies has to be a focus and a way forward. Life sciences is a sector that would account for a fair amount of innovative companies.

Stephen Carter: As patent attorneys, we do a lot of work with innovative companies, and a lot of those are in the life sciences industry. We’ve been involved with a number of SMEs in GrowthAccelerator and they have all been in the life science sector. Medical device companies are a good example.

Ingham: With GrowthAccelerator’s growth through innovation stream, we talk to SMEs about not only creating new products and generating new ideas, but also innovating in their overall business processes: A company is identified as high growth quite simply by ambi-tion. Senior management having real ambition is mainly what we look for. Clients will have an assessment interview with a growth manager, who will work with the business and take it through eligibility.

The client will also be invited to complete an online diagnostic survey across 10 business areas, which identifies areas for attention.

How important is IP to growth? Or is the point of GrowthAccelerator to help businesses generate IP?

Carter: GrowthAccelerator has not been set up to stimulate a generation of intellectual prop-erty. It has been set up to support businesses that want to grow. I think that, inevitably, a lot of companies that are looking to grow will gener-ate IP. In a lot of cases, protecting that IP will be a factor that contributes to the success of the company’s growth.

There is a lot more to growing a successful business than generating IP, but I think IP can be one of the foundations that helps to sup-port that. A company can do that in a num-ber of ways. Patents can act as a barrier to competitors, which can give you some sort of monopoly that’ll allow quicker growth. IP can also be a source of revenue for a company if it intends to license, whether it’s trademarks or patents. IP can contribute to growth when a company is looking for external investment. Investors often want evidence of IP and the steps of protection for that IP.

Ingham: I would say that part of the GrowthAc-celerator coaching process might be to create an environment for innovation that will generate new, protectable ideas. There is a strong link between growth and IP.

How can GrowthAccelerator help businesses to do this?

Carter: GrowthAccelerator has given access to patent office funding for IP audits, which is not necessarily about helping the business develop new IP, but it’s just helping them to understand what IP they have already and how it relates to their business.

Ingham: It’s a £3000 grant that you can tender for and that’s to help companies to look what they already have, perhaps where they might want to go with IP and develop an IP strategy and identify areas to focus on.

Carter: Some of our clients have used that fund-ing to understand their competitors’ IP positions. Rather than looking at their own IP and what they are going to do with it, they have looked at others’ IP and whether there is anything out there that’s going to act as a barrier.

What can businesses do to attract investment and funding without IP in their locker?

Carter: I think you’ll be hard pushed to find a company without IP. You might find a lot of com-panies that tell you they don’t have IP. In fact, a lot of companies do. IP, in a broad generic sense, is about what the company offers that customers want, and which the competition can’t offer. I think that if a company does not have that to offer then it won’t get any customers and so will quickly fail.

Ingham: There’s a need to raise awareness around that particular issue. I’ve come across a lot of companies that think they don’t have IP, because they don’t make anything. If you are looking for investment in your company, wheth-er it’s grants or equity finance, IP is a big asset to have. IPPro

Growth to greatnessIPPro talks to Susan Ingham of GrowthAccelerator and Stephen Carter of Mewburn Ellis LLP about how the programme can help SMEs FRANKI WEBB REPORTS

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GrowthAccelerator PatentBox

What is UKTI’s mandate in terms of the life science industry?

UK Trade & Investment (UKTI) has for a number of years worked with trade organisa-tions in order to drive foreign investments into the life science industry in the UK. It has also supported trade from the life science in-dustry and the ecosystem within the UK to countries abroad.

On the investment side, that activity is now under the umbrella of the UK Life Science In-vestment Organisation, which is the result of the life science strategy published in Decem-ber 2011.

The idea behind that initiative was to bring the industry to work hand-in-hand with the civil service to drive foreign direct investments into the life science industry in the UK.

The policy driver behind the life science strat-egy was very simple. There was a relentless market for technology, a rise in patient vol-ume, and a drop in the healthcare and life sci-ence budgets.

For those reasons, George Freeman MP was asked to become the architect of the strategy from which the Life Science Investment Or-ganisation was born.

On the trade side, UKTI works in support of the 3500-medical technology companies and the 800-biotechnolgy companies from the UK. UKTI is working on two initiatives. Firstly, it sup-ports home-grown industry to develop business abroad through partnership and market access.

Secondly, UKTI has an initiative called Healthcare UK. It looks to exercise the UK’s healthcare system, which is one of the big-gest in the world, treating over a million pa-tients every single day, to turn it into an asset rather than the liability it has been over the last couple of decades.

How does the Patent Box work?

The Patent Box enables companies to apply a lower rate of Corporation Tax—10 percent compared to the main rate of 23 percent—to profits earned after 1 April 2013 from pat-ented inventions and certain other innova-tions. As the scheme is available to all who meet the qualifying criteria, it stands to ben-efit companies across all sectors, but par-ticularly those in life science industry that are research-intensive.

Companies can benefit from the Patent Box if they are liable to pay Corporation Tax and make a profit from exploiting patented inven-tions. The patent must have been granted by the UK Intellectual Property Office, the Europe-an Patent Office, or by the following countries in the European economic area: Austria, Bul-garia, the Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Poland, Portugal, Romania, Slovakia, and Sweden.

The company, or another company in the same group, must also own or exclusively license-in the patents and must have made a significant contribution to the creation or de-velopment of the patented invention, or to a product incorporating the patented invention.

If the company is a member of a group, it must also actively own the patented invention by taking a significant role in managing its whole portfolio of eligible patents. The company does not have to make all of the decisions re-garding the portfolio, but it must undertake a significant amount of the management.

Aside from patents per se, companies can also benefit from the Patent Box if they hold certain medicinal or botanic innovation rights.

This also builds up the required minimum distribution tax credit. Broadly speaking, this scheme is the type of tax incentive that is uti-lised by companies before revenue is earned.

It allows you to offset the costs of labour against your tax liability. However, once you start paying corporation tax, that is really when the patent box scheme kicks in.

What are the expectations for a scheme like this?

The Patent Box has created a highly competitive tax environment for companies, which encour-ages them to locate high-value jobs and activity associated with the development, manufacture and exploitation of patents in the UK.

The life science industry has been a major ben-eficiary of the scheme. Smaller companies have benefited, as patents developed collaboratively are included. Profits from the sale of patents are eligible for the reduced tax rate, allowing easier realisation of investment in a company.

Foreign direct investment in UK R&D has grown to a record 298 projects for 2012/13, an increase of 84 percent on 2011/12 figures,

creating almost 10,000 new high-value jobs for the UK economy and reflecting the country’s attractiveness as a global centre for innovation.

What other schemes are UKTI launch-ing to promote trade and investment within the UK in terms of IP?

In terms of IP as it relates to the life scienc-es, the government recognises that stimulus investments and tax measures are very important for fostering collaboration between industry and academia.

Smaller high-risk early-stage companies have been assisted via the introduction of a Seed Enterprise Investment Scheme (SEIS), offer-ing a 50 percent income tax relief on invest-ments. To kick-start the scheme, the govern-ment offered a capital gains tax exemption on gains realised from the disposal of an asset in 2012/13 that was invested in SEIS in the same year.

Furthermore, the government recently intro-duced an above-the-line R&D tax credit, to improve the visibility and certainty of R&D tax relief to attract large-scale investment in innovation.

In addition, significant investments have al-ready been made in cross-cutting initiatives such as stratified medicines and emerging technologies, for example synthetic biology, informatics and regenerative medicine, and the government is addressing funding rules that stifle partnership working. IPPro

Gift-wrapped opportunitiesDr Adam Hill tells IPPro how UK Trade & Investment is drawing investment into the life science industry through the new Patent Box scheme FRANKI WEBB REPORTS

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IndustryEvents

Pan European IP Summit Paris 2013

Location: ParisDate: 09-11 December 2013www.premiercercle.com

This year, for its first time ever, the IP Summit comes to Paris. Indeed, according to the deal signed in June 2012 by the European Council, Paris should soon host the main seat of the Unitary Patent Court. Furthermore, where else would be the best place to speak about luxury and consumer goods from big brands?

With a mix of keynote speeches, plenary sessions and workshops, this three-day-conference aims at discussing, with high-level speakers from the industry and representatives of international public authorities, major recent evolu-tions, actions, and ongoing reforms.

World Pharma Licensing Congress

Location: LondonDate: 17-18 February 2014www.iprconnections.com

The pharmaceutical industry is facing a precipice. As patents on existing blockbuster drugs expire, big pharma companies are forced to parachute off the proverbial patent cliff. This legal escarpment means the end of pat-ent protection on various blockbuster drug products, opening the market to generic substitutes.

The World Pharma Licensing Congress is the platform to exchange ideas and establish creative partnerships.

http://www.iprconnections.com

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Industry appointments

PeopleMoves

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Brooks Kushamn PC has expanded its medical device and trademark practice groups with four new attorneys.

The firm has hired Kristin Murphy, Linda Mettes, Rachel Smith and Dorne McKinnon-Rybicki for its Southfield office.

Murphy’s practice at Brooks Kushman focuses on domestic and foreign patent prosecution. She will join its medical device team to further expand the practice area.

Before joining Brooks Kushman, Murphy was a managing partner at Rader, Fishman & Grauer in Bloomfield Hills.

Mettes has nearly 20 years of litigation experi-ence in a variety of technologies in the mechani-cal, electrical and life science industries.

In the medical device and life science arena, Mettes has experience with neurosurgical devices, stents, ophthalmic surgical equip-ment, implants, medical imaging contrast agents, robotic catheters, vaccines, stimu-lants, analgesics, hormone replacement and birth control pills.

Smith also previously practiced at Rader, Fish-man & Grauer. Her experience is in patent pros-ecution and includes patent litigation, licensing and negotiations, as well as freedom to operate and opinion work.

Smith’s practice is primarily focused in the auto-motive, electronics and medical device industries.

McKinnon-Rybicki will join the firm’s trademark practice on foreign and domestic clearance, prosecution, opposition and cancellation pro-ceedings, and enforcement.

Ropes and Gray LLP has bolstered its IP prac-tice with three new attorneys.

Melissa Rones joins as partner. Stuart Yoth-ers and Louis Fogel join as counsel.

Rones counsels clients in the biotechnology and biopharmaceutical industries on a wide range of IP issues, including patent portfolio development and lifecycle management, patent prosecution, and freedom-to-operate.

She works with clients to develop and execute patent strategies focused on obtaining robust and enforceable patent protection in the US and around the world. In addition, she advises cli-ents on patent issues in connection with a range of transactions.

Fogel counsels clients in all aspects of patent litigation to help businesses achieve their strate-gic and scientific goals. His experience covers a variety of industries, including pharmaceuticals, biotechnology, medical devices, chemicals, and electronic products.

He also has experience advising clients on Hatch-Waxman Act litigation.

Yothers represents clients across a broad technical spectrum, including wireless com-munications, semiconductor manufacturing and pharmaceuticals.

Honigman Miller Schwarts and Cohn LLP has added Jamal Edwards to its IP litigation practice group.

Edwards joins as partner to the firm’s Detroit office.

Edwards focuses his IP litigation practice on health care, technology and financial services.

Prior to joining, he was a partner at Kirkland & Ellis LLP in Chicago for several years, fo-cusing his practice on IP, particularly in pat-ent and trade secret litigation and counselling private equity investors and their technology holding companies.

He previously was regional counsel for the IBM Corporation in Chicago.

Hiscock & Barclay LLP has recruited John Gut-koski to its IP litigation group.

Gutkoski joins the firm as partner to its Boston office.

Gutkoski’s practice has included serving as lead counsel for clients in matters spanning life sci-ences, technology, and financial services.

He has tried cases involving the use of lasers to treat skin conditions and stimulate collagen pro-duction, the use of computer networks among banking institutions to process and store check images, and the design of high-speed digital converter semiconductors, among others.

Gutkoski previously served as the chairman of Foley & Lardner LLP’s IP practice in Boston and most recently was a partner with Holland & Knight, LLP.

Rader, Fishman & Grauer PLLC has hired Barbara Mandell to its Bloomfield Hills office.

Mandell joins the firm as partner.

She is an IP litigator and commercial arbitrator. Who started her career as a staff attorney at the Federal Trade Commission in Washington, DC, investigating, litigating and trying anti-trust cases of national significance.

She has more than 30 years in complex litiga-tion, including years spent as general coun-sel. In addition to anti-trust, her experience includes disputes involving patent, trademark, computer and Internet law, theft of trade se-crets, breach of licence agreements and fran-chise agreements, trade dress and copyright infringement claims, and counterfeiting, unfair competition and false advertising claims.

Holland & Hart LLP has signed up Tyson Wilde as an associate in its Salt Lake City office.

Wilde focuses on patent prosecution, particu-larly drafting and prosecuting mechanical and electrical patent applications.

He works in a variety of technology areas, in-cluding networks, computers, software, print-ing, circuits, photography, memory and medical devices. Wilde also represents clients with me-chanical, electrical and chemical technology in the industries of oil and gas, mining, construc-tion and clean tech.

Additionally, Wilde assists clients with patent portfolio management.

He is admitted to practice in Utah and before the US Patent and Trademark Office. Prior to becoming an attorney, Wilde was a patent agent for more than seven years. IPPro

Pr oIPLIFESCIENCES

Antonina Nijran is senior associate at Fasken Martineau DuMoulin LLP and a member of the technology and intellectual property and life science practice groups. She advises on a wide range of commercial, IP and transactional matters and undertakes com-mercial work for a variety of corporate clients, including advising on agency, distribution and franchise arrangements, licensing deals, services agreements, including consultancy arrange-ments, sale and purchase terms, website terms of use, assignment and novation agreements and confidentiality agreements. Antonina works with a variety of pharmaceutical and biotech companies in the life sciences sec-tor including advising on negotiating and drafting licensing arrangements, development deals, research and development collaborations, manufacture and supply arrangements, distribution agreements, material transfer agreements and quality and pharmacovigilance agreements.

She also has experience in advising on a variety of matters in the technology sector, including, website and software development projects, software licensing and maintenance agreements, master services agreements, reseller agreements and escrow agreements. Antonina also advises clients in different industry sectors on privacy and data protection issues, including transfer of personal data outside the EEA, data transfer agreements, preparation of data protection registrations and questionnaires for data protection audits and drafting data pro-tection sections of staff handbooks and privacy policies.

Take with...

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IndustryPeople

IPPro takes five with Antoni-na Nijran, an up-and-coming senior associate at Fasken Martineau DuMoulin LLP

How did you get into intellectual property law?

I have always considered intellectual property to be one of the more dynamic and attractive areas of law and an area that I felt would en-able me to work in a variety of sectors. At the end of my training contract I was lucky enough to be given the opportunity to qualify into com-mercial IP and the rest, as they say, is history.

What do you specialise in and why?

I advise on a wide range of commercial, IP and transactional matters, and undertake com-mercial work for a variety of corporate clients, including advising on agency, distribution and franchise arrangements, licensing deals, and services agreements. These include consul-tancy arrangements, sale and purchase terms, website terms of use, assignment and novation agreements, and confidentiality agreements.

As a member of the life sciences team, I ad-vise a variety of pharmaceutical and biotech companies in the life sciences sector on ne-gotiating and drafting licensing arrangements, development deals, research and development collaborations, manufacture and supply ar-rangements, distribution agreements, material transfer agreements, and quality and pharma-covigilance agreements.

What is a typical day for you?

The varied and sometimes unpredictable na-ture of my work is something that I really en-joy—no two days are the same.

How do you get ready for an espe-cially difficult case?

Preparation for a matter or a meeting will gen-erally take a similar form—reading papers, considering the law and advising the client accordingly. All matters are important and the same processes will generally apply.

Is there a case you are most proud of, and why?

I was very involved on a significant part of the project that launched the London Bike Scheme. It is great to see how well-received and suc-cessful the scheme has been and to have been a part of that. I also love using the bikes!

What are your ambitions?

To continue to develop my knowledge and experience.

Do you have any advice for students thinking of getting into IP law?

Get an understanding of what IP law actually consists of and what practicing IP law will en-tail to avoid early disappointment. It is not all high profile branding, copyright disputes and record licensing deals, although there is that too! IPPro

....Antonina Nijran

26 www.ipprotheinternet.com

IndustryPeople

Tanvi Shah is an intellectual property specialist at Fasken Martineau DuMoulin LLP who has assisted with several contentious IP matters both in the High Court of Justice for England and Wales and Patents County Court.

In addition to her contentious and advisory IP work, Tanvi has advised on regulatory matters specific to the life sciences industry. These include regulation of medicinal products and medical devices, and the rules on promotion of medicines. She has also carried out commercial and IP due diligence relating to corporate transactions in the life sciences and information technology sectors and has advised on data protection and freedom of information matters.

Take with...

working in IP law as a solicitor would be the ideal career path for me.

Before that, for my undergraduate degree I studied Chemistry with Research Abroad (Ger-many) at Imperial College London. In my third year (of four), having decided against pursuing a career in research, I was looking for other op-tions of what to do once I graduated.

What do you specialise in and why?

While my main area of specialism is IP law, this of-ten overlaps with the other areas I advise on when dealing with commercial considerations, and so it is important to keep abreast of these areas. I find the variety both interesting and enjoyable.

I advise on the full spectrum of IP rights (pat-ents, trademarks, design rights, copyright, passing off and related matters) across a va-riety of industries, focusing particularly on the life sciences and technology sectors. I have also advised on regulatory matters specific to the life sciences industry, including regulation of medicinal products and medical devices, and the rules on promotion of medicines.

Finally, I have also carried out commercial and IP due diligence relating to corporate transac-tions in the life science and information technol-ogy sectors and have advised on data protec-tion and freedom of information matters.

What is a typical day for you?

A cliché, but there is no such thing—the range of matters I assist with and types of work that involves mean no two days are the same.

How do you get ready for an especially difficult case?

Preparing for an especially difficult case is gen-erally no different from preparing for any other case—save that the usual preparation steps may take longer. Preparing for a case will usu-ally involve considering the factual background and the available evidence (in discussion with

the client), the client’s commercial concerns and looking at the particular issues of law relevant to that case. What other preparation is needed will always be very dependent on the details of the case.

Is there a case you are most proud of, and why?

What I am most proud of is the variety of cases that I have been able to work on and the differ-ent industries these have covered, such as phar-maceuticals, veterinary pharmaceuticals, optics, baby buggies, cosmetics and beer glasses.

However, if I had to pick one particular case it would be a passing off case for a small cosmet-ics company in which we brought an interim injunction application and negotiated on the client’s behalf to stop the infringements of the client’s rights by two other companies.

Although a relatively small case, the successful outcome had a significant impact for the client (had we not succeeded, it appeared at risk of going out of business), and due to the client’s budget constraints, I was personally able to play a greater role than in some of the larger cases I have worked on.

What are your ambitions?

To further develop my knowledge and experi-ence in IP law and hopefully continue to have the opportunity to work on interesting cases.

Do you have any advice for students thinking of getting into IP law?

To be a good IP lawyer, you have to have a fairly logical but creative mind and enjoy applying black letter law and case law in a very practical and commercial manner. More than that though, I think it is important to have a natural curiosity about the world and how things work. One of my favourite aspects of being an IP lawyer is learning about the different technologies that are critical to our clients’ businesses and also having to understand the in-dustries that the clients operate in. IPPro

....Tanvi ShahIPPro takes five with Tanvi Shah, an up-and-coming associate at Fasken Martineau DuMoulin LLP

How did you get into intellectual property law?

I attended a presentation by chemists that had gone into the law—the speakers were an intel-lectual property solicitor, an IP barrister and a patent attorney. This presentation, and the work experience I did after it, made me realise that

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