We are pleased to publish the first edition of our London IP Group Patent Newsletter. We do hope you find it a good read. All comments and feedback will be most gratefully received.

Patent News

September 2011London

Europe’s Unified Patent Litigation System Inches Nearer .................................................................................. 2

As Spain and Italy try to place a spanner in the machine that is the EU patent enhanced cooperation procedure, we review the latest developments in the single EU patents court.

UK 2010 Patents Court Statistics .............................................................................................................................. 3

We review the trends arising from the decisions in London at trial on patent cases and in the Court of Appeal.

Will Ireland Outstrip UK’s Reputation as a Patent “Graveyard”? ...................................................................... 5

We review the latest patent trial judgment.

Northern Ireland ........................................................................................................................................................ 6

Yes, it has its own patent jurisdiction! But you need patience if you are waiting for a judgment. We review the first judgment for years.

Mr Justice Arnold on Experts ................................................................................................................................... 6

Lawyers now have further guidance on how to choose and instruct experts in patent litigation.

New English Judicial Appointments ....................................................................................................................... 7

As the Courts’ summer term ended, news came of a number of changes amongst the judges who hear patent cases in London.

The Patents County Court Reborn Again .............................................................................................................. 8

We review this judicial Phoenix.

Pharma Focus .............................................................................................................................................................. 8

There has much recent activity in the English and EU Courts concerning patents and SPCs relating to pharmaceutical products. These include:

» decisions affecting SPCs on combination products and “old products”;

» how to infringe Swiss form claims;

» a preview of the first Supreme Court patents case; and

» further highlights from the pharma world.

London IP Practice Group ........................................................................................................................................ 11

2 | September 2011

Europe’s Unified Patent Litigation System Inches Nearer

The European Unitary Patent / Unified Patent Court

After years of relatively little progress, there appears to be momentum building up behind the two building blocks underlying the European Union’s goal of a unified patent system:

• the creation of a unitary patent right covering the EU; and

• the creation of a unified patent court for litigating both “classic” European patents and the (proposed) unitary EU patent.

In this note, we take stock of where we are.

The creation of unitary EU patent protectionIn March of this year the EU’s Competitiveness Council1 adopted a decision authorising “enhanced cooperation,” paving the way for all willing Member States to work towards a unitary patent for the EU. This would break the stalemate over, in particular, the language regime of such a patent. As matters currently stand, the only non-participating Member States are Italy and Spain: so any unitary patent for the EU would not extend to those two countries.

On 27 June 2011, the Competitiveness Council agreed to general approaches on two draft Regulations – the first relating to the creation and substance of the unitary patent itself 2, the second to the language arrangements. Accordingly, the essential elements of these legal acts have now been agreed, pending the opinion of the European Parliament.

So, are we nearly there? One potential stumbling block is that on 30 May 2011, Italy and Spain started proceedings at the Court of Justice, challenging the Council’s decision to authorise enhanced cooperation. The proceedings are at an early stage, and it is likely to be many months before the Court of Justice considers the Spanish and Italian complaints.

In the meantime, the Competitiveness Council and the Commission remain optimistic:

“We are now entering the home straight. Working closely with the European Parliament, the final objective–the creation of unitary patent protection–is within reach....a unitary patent in Europe could be a reality within the next two years.”

(Commissioner Michel Barnier, 27 June 2011).

It is worth noting here that the current proposed Regulation on the unitary patent states it will not apply until the entry into force of the instrument creating a unified patent litigation system and the setting up of such a system. Which brings us to the proposed unified patent court.

The creation of a unified patent court for the EUA draft agreement on a unified patent court having exclusive jurisdiction in respect of litigation relating to the infringement and validity of both “classic” European patents and the (proposed) unitary EU patent was in effect agreed back in December 2009. The 2009 draft agreement was to be entered into by the EU, its component Member States and certain third party countries to the European Patent Convention.

However, on 8 March 2011, the Court of Justice held the draft agreement, in its (then) current form, was incompatible with the EU treaties. In short, the Court of Justice observed that the envisaged unified patent court would be outside the judicial and institutional framework of the EU, yet would be called upon to interpret and apply provisions of EU law. The concern was the national courts of the Member States would be giving up, on matters within the exclusive jurisdiction of the unified court, the obligation to refer questions on the interpretation and application of EU law to the Court of Justice. The Court also observed that, if the unified patent court was in breach of EU law, the Member States could not be held to account.

The (then) Hungarian Presidency of the EU Council, in May 2011, suggested a solution to the Court of Justice’s concerns. This was quickly followed by the publication, dated 14 June 2011, of a revised draft agreement on a unified patent court. The draft appears to take the path of least resistance in the face of the Court of Justice’s decision:

1. The participation of third (non-EU) countries has now been excluded, and the EU as an institution itself is no longer a contracting party. Accordingly, the draft agreement now provides for a court common to the contracting Member States such that, it is hoped, it would fall squarely within the judicial framework of the EU.

2. The main features of the functioning of the court (set-up, language régime, etc) as prescribed in the 2009 draft agreement are maintained.

3. There is a chapter dedicated to the “Primacy and Interpretation of Union Law” addressing:

• the recognition of the primacy of EU law and the Member States’ obligation to ensure the unified patent court complies with EU law;

1 A division of the Council of the European Union (this being, along with the European Parliament, part of the legislature of the EU). 2 Now termed a “European patent with unitary effect.”

Winston & Strawn London Patent News | 3

• the referral of questions of interpretation of EU law to the Court of Justice3; and

• the accountability of Member States in cases of breaches of EU law by the unified patent court, and their liability for damages resulting from such breaches.

SummaryThe determination of the EU institutions to press on with European patent reform is palpable–the use of enhanced cooperation on the creation of a unitary patent right to the exclusion of (and continued opposition from) Italy and Spain, along with the swift excision of non-EU states from the draft agreement on the unified patent court, are cases in point. Indeed, the (current) Polish Presidency of the EU Council has signalled its determination to push forward the patent reforms, “with a view to reaching overall political agreement by the end of this year.”

Whether or not continued progress will be quite so serene, particularly in the face of the Italian and Spanish challenges to enhanced cooperation, remains to be seen.

We understand the Competitiveness Council is scheduled to discuss progress towards the unified patent court (and the unitary patent) on 29/30 September and 5/6 December 2011.

Phil Carey +44 (0)20 7011 8728 pcarey@winston.com

UK 2010 Patents Court Statistics

Patent Dispute Statistics 2010

Winston & Strawn London has compiled data on the patents cases heard in the English Courts in 2010. A selection of statistics derived from that data is set out in the table at the end of this article.

In 2010 patentees were largely unsuccessful in patent disputes. From the data alone, one might assume that the English Courts are rather hostile towards patentees, but this is not really the case. In situations where the patent is strong and/or its interpretation is clear cut, disputes often settle. The patent disputes that make it all the way to trial tend to be those where the patent’s validity is vulnerable or the patent is difficult to construe for infringement purposes. Sometimes the exceptional commercial importance of a patent to the patentee makes it worth litigating even if the chances of success are not high. It can lead to a satisfactory settlement, and especially so if the economic strength of the patentee is more than the other party. Another factor is the high level of scrutiny that a patent is subject to in an English Court. The cases are heard by specialist judges, who usually have a scientific background, and evidence from technical experts also plays a prominent role in the proceedings. Each patent is “put under the microscope” and any weaknesses are likely to be exposed.

Some interesting facts can be derived from the data:

• The number of cases in the Patents Court was lower than normal1. This may partly be explained by the fact that nearly all the cases that were fixed for trial in the autumn of 2010–many of which were telecoms cases–settled shortly before they were due to be heard.

• Patents for medical devices were the most common type of patent litigated to trial in 2010.

• Relatively few pharmaceutical patents were litigated to trial in 2010 compared to recent years.

• Telecoms technology again featured prominently as the subject of patent disputes. Although many of the telecoms cases scheduled to be heard in 2010 settled, three telecoms cases covering four patents did make it to a hearing.

3 While the 2009 draft agreement had provisions on referrals, the context is now very different in light of the reconstitution (in the current draft) of the unified patent court as a court common to the Member States of the EU, rather than an international court outside the framework of the EU.

1 Over the past few years, on average there have been 16 patents cases heard in the Patents Court per year, and in 2009 there were 27 first instance patents trials.

4 | September 2011

2 Reflecting the large number of trials in 2009.

• A wide variety of different technologies, including oil exploration, food packaging, cement additives and machinery for separating potatoes, were also the subject of patent disputes in 2010, illustrating that the patents litigated in the English courts continue to cover diverse inventions.

• The majority of the cases heard in the Patents Court in 2010 were brought against patentees by claimants seeking revocation of one or more patents and/or a declaration of non-infringement.

• In the Court of Appeal, in most cases, it was the patentee that appealed the decision of the lower court.

• On the whole, patentees were less successful in the Patents Court than in the Court of Appeal.

• The high proportion of cases where at least one of the parties is not based in the UK indicates that the English Courts continue to be an attractive forum for foreign litigants.

• The English Courts continue to produce judgments quicker than any other major European court. The Patents Court hands usually down its judgment less than one month after the hearing and the Court of Appeal, on average, produces its judgment in patent cases within two months.

Number of patent trials/appeal hearings 2010 21Patents Court trials 2010 10Court of Appeal hearings 2010 112

Field of technology of patents Medical Devices: 7 cases / 12 patents

Pharmaceuticals:3 cases / 3 patents

Telecoms:3 cases / 4 patents

Other:8 cases / 12 patents

Claimant in Patents Court trials Patentee: 30%Non-Pantentee: 70%

Appellant in Court of Appeal hearings

Patentee: 82%Non-Pantentee: 18%

Percentage of cases where at least one of the parties was not based in the UK

90%

Patents Court trials in which the patentee was successful (at least one claim valid or infringed or both where both were an issue)

1 out of 1 patent where validity only in issue

3 out of 14 patents where both in issue

(there was no infringement only cases)

Court of Appeal hearings in which the patentee was successful (at least one claim valid or infringed or both where both were an issue)

2 out of 8 patents where validity only in issue

0 out of 3 patents where infringement in issue

3 out of 5 patents where both in issue

Average time from close of hearing to judgment – Patents Court

Less than 4 weeks

Average time from close of hearing to judgment – Court of Appeal

8 weeks

Sarah Innes +44 (0)20 7011 8709 sinnes@winston.com

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Will Ireland Outstrip UK’s Reputation as A Patent “Graveyard”?

Abbott Laboratories and Medinol

Coronary Stents and InvalidityIn November 2010, Mr Justice Arnold, one of the three specialist judges in the Patents Court in London, held three Medinol patents not to be infringed by Abbott Laboratories’ coronary stents.

It might be thought this would have been good enough for Abbott, but Abbott had also applied to have all three patents revoked for invalidity. Abbott relied on novelty over two separate references, obviousness over one of those, plus Common General Knowledge and added matter.

Arnold J. was not wholly convinced. Abbott had run a perfect squeeze argument between non infringement and anticipation on the main patent. As the Abbott stents did not infringe, the anticipation arguments did not succeed in invalidating the patent. The result was that one of those patents had to be amended by the patentee but was then declared valid, as was the second one. The third, the Judge found to be invalid based on a different argument for lack of novelty over one of the two citations.

On added matter, Abbott ran the argument that the scope of the claims had been extended between application and grant, an extension that was not supported by the disclosure of the specification. Indeed the specification itself had altered to, Abbott argued, better support that extension of the claim. By following the EPO approach to determining whether matter had been added when the change concerns the deletion or replacement of a feature from a claim, Abbott said that such changes meant that the patent must be declared invalid.

Medinol however, argued that the EPO test was inconsistent with the test for added matter set out by Jacob LJ in Napp v Ratiopharm ([2009] EWCA Civ 252 at para 98) and that, by applying this Court of Appeal authority, there could not be added matter. Arnold J pointed out that the EPO test was not put forward in that case so was not considered. Although he rejected the notion that the tests were inconsistent, he nevertheless accepted that he was bound by the Court of Appeal and found the patent valid.

At the same time all this was going on, Medinol had sued Abbott for infringement of the main patent in the Republic of Ireland, where Abbott manufactured these market-leading stents. Proceedings were also continuing on this patent in the courts of Germany and the Netherlands where Abbott has also been found not to infringe this patent, although for slightly differing reasons in each jurisdiction. It had become accepted wisdom, on both sides of the Irish Sea, that an Irish trial would be likely to follow the earlier outcome on the same patent in London.

When the trial came on in Dublin in January 2011, most of the English issues were re-run, and with the same expert witnesses as had given evidence in London. In March, Judge McGovern gave judgment on infringement, duly in favour of Abbott, the defendant. He also found that, on the construction of the claims proposed by Medinol, the patent would be invalid for anticipation. However, it was not until three months later that the Judge handed down a further judgment, this time on Abbott’s argument that the patent should be invalidated for added matter.

So far as Abbott was concerned, it was worth waiting for. With the Court of Appeal decision only persuasive authority in Ireland, Judge McGovern ignored the decision and preferred to show comity with the EPO approach on added matter, in line with the approach suggested by Lord Neuberger in Dr. Reddy’s v. Eli Lilly ([2010] R.P.C. 9 at paragraph 92). As such, he found, in robust and clear terms, that the patent was invalid. Whereas the patent application had disclosed a so-called “out-of-phase arrangement” of what the patentee had creatively described as “first meander patterns,” he held the patentee should not have tried to extend the claims of the granted patent so as to cover in-phase arrangements. So revoked for added matter.

Few patent cases have been decided in Ireland and as such, it is difficult to draw statistical conclusions from them. It has long been thought that the Irish court, faced with similar evidence, would be likely to follow any earlier English decision. However, after this case, it appears that Dublin is inclined to fit in with its continental brethren and be more independent of its bigger immediate neighbour.

Richard Price +44 (0)20 7011 8735 rcprice@winston.com

Tim Robinson +44 (0)20 7011 8730 trobinson@winston.com

6 | September 2011

Northern Ireland

Patent Litigation in Northern Ireland

June saw the decision of the High Court of Northern Ireland in Siemens AG v Seagate Technology (Ireland) handed down a year after the hearing of the case. Mr Justice Deeny expressed his regret that the shortage of judicial manpower and greatly increased workload had prevented the judgment from being handed down earlier. Patent litigation is a great rarity in Northern Ireland.

The case concerned a patent for magnoresistive sensors owned by Siemens. Siemens sought a declaration of infringement in respect of “wafers” manufactured by Seagate at their factory in Springtown, just outside Derry, and an injunction restraining further manufacture. The wafers manufactured at the Springtown factory are sent to another of Seagate’s factories in the Far East and incorporated into hard drives there. The fundamental question was whether the wafers manufactured by Seagate were magnoresistive sensors and so constituted an infringement of the patent. Seagate claimed that the patent should be revoked for obviousness or insufficiency.

Why did Siemens choose to bring proceedings in the High Court of Northern Ireland? The Judge noted in his judgment that Siemens could have chosen to plead infringement of the finished hard drive products rather than the wafers alone which, he hinted might have been easier to show, and could have been brought in the Patents Court in London. Deeny J. stated that, despite this point being made repeatedly, Siemens chose not to answer it and so its reasons for bringing the case in Northern Ireland remain unclear. Perhaps Siemens was of the view that its patent was more likely to survive a case in Northern Ireland than one in London?

In any event, the Judge found that the wafers manufactured by Seagate did not infringe the patent. Having made this finding, the judge declined making a final finding on validity and merely expressed his provisional view. He was reluctant to make a decision on validity where courts in two other jurisdictions (the United States and Germany) had taken opposite views on the matter. His provisional view, however, was that the patent was invalid for obviousness.

Sarah Innes +44 (0)20 7011 8709 sinnes@winston.com

Mr Justice Arnold on Experts

All IP practitioners are aware of the importance of expert evidence in patent proceedings in the English courts. Lengthy cross examination requires a party to select witnesses with the relevant knowledge, but also with the ability to express their own views even under the most rigorous questioning. Care must, of course, be taken when instructing an expert how to prepare his evidence. The importance of this topic has been highlighted by Mr Justice Arnold in his recent decision in the MedImmune v Novartis1 case. It was of such importance that Arnold J. devoted no fewer than 58 paragraphs of his judgment to expert evidence.

A key feature of English litigation is that experts have a primary duty to the Court, not to the party by whom they are retained. Arnold J. was keen to emphasise that the opinion given by an expert must be independent and impartial and the responsibility for the impartiality of the report is shared between the expert himself and the lawyers instructing him. Lawyers instructing experts have a duty to explain the expert’s responsibilities, which extends beyond merely drawing the expert’s attention to the relevant sections of the Civil Procedure Rules. Whilst Arnold J. did not criticise the practice of lawyers drafting expert reports on the basis of what the expert has told them, he did note that the responsibility to ensure that the report is objective falls squarely upon the shoulders of the lawyer. To ensure impartiality, the expert report should not focus solely on the aspects of documents supporting one party’s case, but should give a balanced interpretation of the documents. Similarly, if the expert has given evidence on the same or similar subject matter before other courts or patent offices, this should be explained in his evidence, together with any publications the expert has authored in the field. As the Judge explained, the party’s opponent will, of course, scour the expert’s publication history and, if these matters are not dealt with in evidence, the lawyers run the risk that the evidence is discredited, harming both the expert, and their client’s case.

Another fundamental issue identified by the Judge as he commenced analysis of the experts giving evidence in this case was that those selected should reflect the averagely skilled man in the art or, as it may be, the skilled team. The role of the expert is to assist the court in the identification of the common general knowledge of the skilled man or team at the priority date. For the court to attach any weight to the evidence of the expert on these matters it would be most beneficial if the expert himself was typical of the skilled man in the art. Ideally, he should have knowledge of, and preferably experience in, the relevant field at the relevant date (he may thus have first-hand knowledge of some of the papers to which he is directed). In this particular case, Arnold J. concluded that the experts relied upon by MedImmune were not reflective of those in the skilled

1 MedImmune Limited v (1) Novartis Pharmaceuticals UK Limited (2) Medical Research Council [2011] EWHC 1669 (Pat).

Winston & Strawn London Patent News | 7

team and thus could offer limited assistance in relation to the common general knowledge in the field at the priority date. In contrast one Novartis expert was too skilled, leading the Judge to view his evidence in the context that he was acknowledged to be inventive, something which the hypothetical skilled man is not.

Arnold J. also raised concerns as to how one of the experts in the MedImmune case was instructed. Whilst in fact the expert was first provided with the relevant documents, asked for his views and only then allowed to see the patent in suit, his report was drafted in a way that did not reflect this, leading the judge to have some concerns as to the instruction process. Where experts have previously given evidence on the same matter in other jurisdictions there is of course the very real risk that any views expressed in the English case are tainted by hindsight, (especially if the UK instruction process as required was not followed).

And finally, the Judge was critical of the instruction of an expert whose first language was not English. Some readers may feel this is rather unfair, especially as in some cases this is very difficult to avoid. However in order to do right by the parties it is essential that the judge can understand all witnesses, and indeed make the most of their knowledge and experience. Of course Arnold J. was not advocating for only English experts to be instructed. Nevertheless we should be alive to the fact that any expert will be under pressure when giving evidence, and in order to do his best it is essential that he understands the questions completely and that what he says can be clearly understood.

This is not the first time these views have been expressed from the Bench. Experience shows however that lessons regularly need to be re-learned.

Catherine Drew +44 (0)20 7011 8727 cmdrew@winston.com

New English Judicial Appointments

Following the retirement of Lord Justice Robin Jacob in April, the Lord Chancellor did not arrange an immediate replacement from within the ranks of the judges of the Chancery Division, and particularly from those who have served on the Patents Court.

As expected however, it has now been announced that Mr Justice David Kitchin is to be promoted in October. In addition, Mr Justice Kim Lewison, a general Chancery Judge who has heard patent cases, is going up as well. This will make the Court of Appeal as strong in judges with patent experience as it probably has ever been, because Lord David Neuberger is also there. Lord Neuberger heard patent cases when he was a First Instance Judge (notably Amgen v Boehringer Mannheim), and in the Court of Appeal, and also during the time he was in the House of Lords. Even now, as Master of the Rolls – the President of the Court of Appeal – he was back in the Supreme Court (as it now is) in July as a member of the panel which heard Human Genome Sciences Inc v Eli Lilly and Company.

There is no news as to who may be appointed to join Mr Justices Floyd and Arnold in the Patents Court. Judge Colin Birss, appointed to the Patents County Court in October 2010, has been brought over to sit as a Patents Court Judge when neither of the other two Judges has been available. It must be at least a possibility that, if he continues to do well, he will be promoted earlier than was originally thought to be a specialist patents member of the Chancery Division of the High Court.

Richard Price +44 (0)20 7011 8735 rcprice@winston.com

8 | September 2011

The Patents County Court Reborn Again

The Patents County Court

After its ‘re-launch’ in the Autumn of 2010, the restyled Patents County Court (PCC) has been roundly hailed. The energetic Judge Birss has been racing through his work. Following a promotional blitzkrieg upon his appointment, he has delivered particularly detailed judgments at both case management conferences and at trials. Such helpful guidance is clearly aimed at those weighing up whether to bring proceedings in the PCC and appears to have been successful in drumming up further business, although not of the main kind originally envisaged.

To date his judgments have included decisions in trade marks, passing off, copyright and design rights but, as yet, no cases of alleged patent infringement or invalidity. We are told that the Judge’s diary is chock-a-block through the Autumn of 2011, but that patent cases are still rare exceptions.

With the recent imposition of a recoverable damages cap of £500,000, and with costs awards limited to £50,000, it may be that patent cases do not find a natural home in the PCC. As the Court beds down, it may become a better forum for smaller design right, copyright and trade mark disputes. As such it is notable that Judge Birss has suggested that the court be renamed the Intellectual Property County Court, a change of name the government has recently indicated it approves.

Following the recent Hargreaves recommendations, the government has expressed keenness for a small claims track for intellectual property cases for sums of £5,000 or less, so long as the move satisfies a ‘value for money’ test. Such cases would find a natural home at the PCC. There is an argument that such disputes may be better handled outside the court system, but ministers said “access to the courts at a proportionate cost should act as an incentive to settle or arbitrate as well as being a means of resolving less tractable but straightforward disputes.”

On this basis it may not be long before the court’s diary is full to bursting point, something that will no doubt please Judge Birss so soon after the re-launch. Such success will surely be noticed. With at least one slot opening for a High Court patent specialist following the recent promotion of Kitchin J to the Court of Appeal, it may be not be that long before Judge Birss is offered the chance to bring his case management skills to bear on larger, more complicated disputes.

Phil Carey +44 (0)20 7011 8728 pcarey@winston.com

Pharma Focus

How to Infringe Swiss Form Claims

Mr Justice Kitchin recently considered the scope of Swiss form claims in the context of the proton pump inhibitor esomeprazole. The patent in suit (EP1,020,461), held by AstraZeneca, seeks to protect the magnesium salt of the S enantiomer of omeprazole (magnesium esomeprazole) with an optical purity of 99.8% enantiomeric excess1 and the use of that salt for the manufacture of a medicament for inhibition of gastric acid secretion. The patent comprises claims in various forms, including product per se claims and “Swiss form” claims. For the purposes of the English action the case turned on the construction of claim 1 only.

Before the English High Court2 Ranbaxy sought a declaration of non-infringement to enable it to import product into the UK which had been manufactured in India. AstraZeneca counterclaimed for infringement. There was no dispute between the parties that the manufacturing process utilised by Ranbaxy started with magnesium esomeprazole with an optical purity of 99.8% e.e. During the manufacturing process a quantity of omeprazole racemate is added; thus the finished product does not have the same optical purity.

According to AstraZeneca this was irrelevant, as the product to be imported by Ranbaxy was a direct product of a process in which magnesium esomeprazole with the requisite optical purity was used to manufacture a medicament. The use of the claimed compound to make any product, regardless of its final optical purity, was protected.

Ranbaxy on the other hand argued that their product did not infringe the claim as the medicament was not formulated using, and did not contain, magnesium esomeprazole with the required optical purity. Ranbaxy contended that the claim required the final medicament also to contain magnesium esomeprazole with an optical purity of 99.8% e.e.

Kitchin J. was persuaded by the arguments of Ranbaxy, finding that the skilled man would believe the patent to be directed to the production of optically pure magnesium esomeprazole and its use in particular therapies. Recognising that magnesium esomeprazole with an optical purity of 99.8% e.e. was new, he would understand the teaching of the claim to be towards the use of this new compound for manufacture of a medicament containing that compound. This, he said, would be reinforced by the skilled man’s understanding of patent claims and in particular claim 9 of the patent which claimed the compound

1 Enantiomeric excess refers to the ratio of the most prominent enantiomer in a mixture to the least prominent enantiomer. In this case to fall within the scope of the claim there must be in excess of 99.9% of the S enantiomer and less than 0.1% of the R enantiomer, giving an enantiomeric excess of at least 99.8% i.e. the compound has an optical purity of at least 99.8% e.e.

2 Ranbaxy (UK) Limited v AstraZeneca AB [2011] EWCA 1831(Pat).

Winston & Strawn London Patent News | 9

itself and was thus not asserted against Ranbaxy (as it was not importing a product containing the esomeprazole salt of sufficient purity). Thus in the Judge’s view the Swiss form claim 1 was directed to a medicament which contained magnesium esomeprazole with an optical purity of 99.8% e.e.

Such a construction of the claim does appear to read a limitation into the claim, which is not otherwise present on a strict literal interpretation. After all, the claim specifies only the use of the esomeprazole salt for the manufacture of a medicament for a specific purpose, there is no limitation in the claim regarding the composition of the final medicament. Conversely Astra– Zeneca accepted there was no infringement of the product claim, and logically there should be no broadening of the claimed invention simply because the claim is framed in a Swiss form as opposed to direct form.

This is not the last we will hear of this patent. It is likely this decision will be appealed; the outcome of that appeal will no doubt affect whether the validity side of the case is put before a judge at the trial scheduled for early 20123. In the meantime the KRKA action concerning infringement and validity comes before the High Court later this year.

In a further twist the Opposition Division at the EPO earlier this summer held the patent to be invalid for lack of inventive step. AstraZeneca have already lodged an appeal against this decision. Furthermore in July the District Court of the Hague in the Netherlands gave its judgment on the validity of the ‘461 patent, finding the patent to be valid. This decision was given after the OD had made its pronouncement, though the OD decision was not brought to the Court’s attention as the case had been heard and closed prior to the OD hearing.

We are thus left with a complex picture throughout Europe. Given the value of the product, it is certain that there will be many more chapters in the coming months and even years.

Catherine Drew +44 (0)20 7011 8727 cmdrew@winston.com

Further Highlights from the Pharma World

Below we run through some other recent significant patent/SPC and regulatory developments relating to pharmaceutical products.

There has been much activity in the European courts concerning supplementary protection certificates (SPCs) in the last few years. Two new developments came in the shape of the Advocate-General’s opinion in the Medeva4 case and the ruling of the Court of Justice in the Synthon and Generics [UK] cases. The first of these related to when SPCs could be granted on combination products if the basic patent on which the applicant was founding the claim to an SPC did not have a specific claim to a combination product. The solution suggested by the Advocate-General is complex. She has suggested abandoning a literal interpretation of the SPC Regulation and instead creating a new definition of the term “product” within the Regulation, in order better to reflect the purpose of the legislation. Unfortunately, the change to the definition runs through the Regulation, and has the, possibly unintended, consequence of restricting the number of SPCs likely to be granted from each basic patent. If the Court of Justice follows this opinion it could lead to numerous revocation actions being brought on current combination product SPCs and also encourage patentees to file additional, divisional patents to circumvent the suggested restrictions on the number of SPCs that can be granted from one basic patent.

The Synthon and Generics [UK] cases5 focussed on whether or not products authorised in the EU before the implementation of the EU medicines legislation (in the shape of Directive 65/65/EEC) could fall within the SPC regime and/or whether the duration of the SPC certificates of such products should be set from the date of the first marketing authorisation in the EU, whether this was an authorisation compliant with Directive 65/65/EEC or not. The Court of Justice followed the opinion of the Advocate-General in this case in stating that such products should not be considered for SPCs in any event. Their status as “older” products meant that they fell outside the scope of legislation that was designed to encourage innovation in bringing “new” products to the market. After deciding the Synthon case on this point, the Court of Justice stated it did not need to consider the questions on duration (on which the legal argument in the Generics [UK] case turned) as they were irrelevant if these “old” products did not qualify for SPCs in any event.

In the biotechnology field a lengthy judgment was handed down in the case of Novartis v Medimmune6. This case concerned Medimmune attempts to claim that Novartis had infringed

3 Interestingly this is one of the rare occasions on which a patent trial has been bifurcated before the English courts.

4 Case C-322/105 Cases C-195/09 and C-427/096 [2001] EWHC 1669 (Pat)

10 | September 2011

its early phage display technology patents by employing this technique in the production of an antibody that became the marketed product Lucentis. Many invalidity arguments were ranged against the Medimmune patents but one that stuck was that, in so far as the patents related in general to a method of displaying antibody fragments on the surface of phage, the patents were obvious over a lecture given at a conference in Banbury in 1990. This was ironic since it was a conference co-organised by Professor Greg Winter, one of the key inventors working in the field of antibody gene library and phage display at the time with the MRC and Cambridge Antibody Technology (which became Medimmune). The judge also found the patents not infringed, largely because Novartis persuaded him that its construction of the relevant technical terms found in the patents’ claims was correct.

Other points to note from the decision were that the judge thought that, if the claims had been infringed, then the antibody within the Lucentis product would have been a product “directly obtained” from the patented process, and that an interesting non-infringement argument based on Article 8(2) Biotechnology Directive7 was not engaged because the antibodies produced were not “biological material” within the definitions found in the Biotechnology Directive and so this legislation did not apply. The case is also noteworthy for the extensive review of the technical specialisms and language skills of the expert witnesses chosen (see earlier article on this topic).

We are also anticipating soon a first patents judgment from the newly formed Supreme Court (it replaced the House of Lords last year). In the case of Eli Lilly v Human Genome Sciences, the parties are battling it out over the validity of a patent directed at neutrokine-a. This molecule is now known to be important in the immune system and both GSK (working with Human Genome Sciences) and Eli Lilly have products either approved or about to be approved that target this molecule. Eli Lilly’s main invalidity arguments centred around the lack of information in the Human Genome Sciences patent relating to the function of the neutrokine-a protein. This, say Eli Lilly, means that the invention either lacks industrial applicability as required under the section 1(1)(c) Patents Act 1977 or renders the invention obvious contrary to sections 1(1)(b) and 3 of this Act because the patent, in effect, only discloses a gene of no known function hence makes no contribution to the art. The case was heard in mid-July with the judgment expected in the next month or so.

Gareth Morgan +44 (0)20 7011 8726 gmorgan@winston.com

7 Directive 98/44/EC

Winston & Strawn London Patent News | 11

Intellectual Property Practice

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