What is a patent ?

A patent is a legal title granting its holder the exclusive right to make use of an invention for a limited area and time by stopping others from, amongst other things, making, using or selling it without authorisation.

http://www.european-patent-office.org

Why filing a patent ?

• The exclusive right to exploit an invention commercially makes it easier for companies to finance research and development.

• As exclusive rights, patents strengthen a company's market position.

• Patent inventions encourage research into alternative solutions.

• The licensing of patents promotes the dissemination of new technologies.

Intellectual PropertyIntellectual Property

• Intellectual Property – Intangible property– Ideas and innovations

• Copyrights-key to software industry• Trademarks-Key to all industries• Patents-key to biotechnology and high

technology– Inventions

Large Patent Infringement Damage AwardsThe largest Amount of money paid for a single Patent

Hoffman LaRoche paid Cetus 300 million dollars for the Polymeruse Chain Reaction patent, invented by Kary Mullis.

The 10 largest damage awards for the 10 years ending in 1993

Lawsuit Award

Polaroid v. Eastman Kodak $873,200,000Smith v. Hughes $204,800,0003M v. Johnson & Johnson $107,300,000Pfizer v. International Rectifier $35,800,000Shirley v. Bentley $44,200,000Studiengesellschaft Kohle v. Dart $36,100,000TWM Manufacturing v. Durn Corp. $31,300,000Deere & Co. v. International Harvester $28,500,000Micro Motion, Inc. v. Exac Corp. $26,200,000 From From IPC, Intellectual IPC, Intellectual

Property CreatorsProperty Creators

Genentech Slapped With $500M In Intellectual Property Dispute

Verdict: $500,164,030.00

Case: City of Hope National Medical Center, Arthur Riggs and Keiichi Itakura v. Genentech, Inc., No. BC 215 152 Verdict Date: 06-24-2002

Genentech Inc., the South San Francisco-based biotechnology giant, was ordered to pay research hospital City of Hope National Medical Center $200 million in punitive damages on top of $300 million in compensatory damages … Genentech failed to pay royalties on certain drugs arising out of technology invented by City of Hope's scientists … which would pay a royalty to City of Hope for the sales of products by Genentech that were covered by the patent.

City of Hope contended that Genentech concealed licensed sales of protein products, such as hepatitis vaccines, over a 15-year period that were worth about $16.7 billion.

Note what the statutory power of exclusion provided the City of Note what the statutory power of exclusion provided the City of Hope in terms of Damage awards, royalties owed, and market Hope in terms of Damage awards, royalties owed, and market size.size.

Biotechnology InventionsBiotechnology Inventions• Product Claims

– Compositions of Matter

• Pharmaceutical agents (small molecules), antibodies, peptides, transgenic animals, cell lines, knock out/in mice, RNA, DNA

– Improvements and new uses

–– Articles of ManufactureArticles of Manufacture

–– MachinesMachines

• Product claims covers the product claimed regardless of the method by which it is made; gives the patentee the right to restrict use and sale of product

– claimed by characterizing its properties

– Claimed by characterizing product function

– Comprising a component part or parts

Article 52 - Patentable inventions

(1) European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step.

(2) The following in particular shall not be regarded as inventions within the meaning of paragraph 1:

(a) discoveries, scientific theories and mathematical methods; (b) aesthetic creations; (c) schemes, rules and methods for performing mental acts,

playing games or doing business, and programs for computers; (d) presentations of information (not true in reality).

Article 52 - Patentable inventions II

...(4) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the humanor animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

Article 53 - Exceptions to patentability

European patents shall not be granted in respect of:

(a) inventions the publication or exploitation of which would be contrary to "ordre public" or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;

(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.

Article 54 - Novelety

(1) An invention shall be considered to be new if it does not form part of the state of the art.

(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.

Article 56 – Inventive Step

An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art. If the state of the art also includes documents within the meaning of Article 54, paragraph 3, these documents are not to be considered in deciding whether there has been an inventive step.

Article 57 – Industrial application

An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture.

Article 62 – Right of the inventor to be mentioned

The inventor shall have the right, vis-à-vis the applicant for or proprietor of a European patent, to be mentioned as such before the European Patent Office.

The seven deadly sins of the inventor

1. The invention is more complex than the problem merits

The seven deadly sins of the inventor

2. The invention is not kept secret until the date of filing.

The seven deadly sins of the inventor

3. The invention isn't new.

The seven deadly sins of the inventor

4. The inventor hasn't fully considered the problem.

The seven deadly sins of the inventor

5. No-one wants it.

The seven deadly sins of the inventor

6. An invention is safer if it's kept secret.

The seven deadly sins of the inventor

7. The inventor has an unrealistic idea of the value of his invention.

Types of Patents

• Utility Patent• Design Patent• Plant Patent• Reissue Patent

Types of PatentsUtility Patent - Issued for the invention of a new and useful process, machine, manufacture, or composition of matter, or a new and useful improvement thereof, it generally permits its owner to exclude others from making, using, or selling the invention for a period of up to twenty years from the date of patent application filing

Cloned genes, monoclonal antibodies, natural product, transgenic animals, lab tools

What is filed in reality?

According to US-PTO:

• plant extract or microbiological culture • isolated virus• selective, pure proteins (e.g. erythropoetin)• selective, pure nucleic acids (e.g. isolated genes, plasmids)

Gene without function can not be filed as apatent• all organic molecules, natural products from all sources

Patent Cases

Aplication: Biogen, EP-B-0 321 134Patent: DNA-Insertion in mikrorgansims for production of IFN-alpha

objection: not novel, because already published by Lawn et al. (1978) Cell, 1157

Judgement: novel, because DNA-Sequence was only known from Gene library

Consequence: Gene library does not inhibit novelety, because libraries are like books without index

Harvard Mouse

Harvard Mouse

objection: no patents on animals or living organisms

Inventor: Harvard UniversityPatent: Transgenic mice, EP-0169 172

?

Patent or not ?

• German: …Tierarten…

• English: …animal variaties…

• French: …races animales…

Harvard Mouse

objection: no patents on animals or living organisms

Judgement: novel, because no new animal race has been created

Consequence: Transgenic mice can be patented because only single animalsare genetically modified

Inventor: Harvard UniversityPatent: Transgenic mice, EP-0169 172

Patents on genes

DNA Sequence

Biotechnology directive says...

Protein Sequence

Homepages of international Patent Offices

EPO: http://www.european-patent-office.org

Japanese Patent Office: http://www.jpo-miti.go.jp

World Intellectual Property Organization: http://www.wipo.int

US-Patent Office: http://www.uspto.gov

Drug Regulation

Drug Regulation Authorities of interest:

USA: FDAEuropa: EMEAJapan: Ministery of Welfare and Health

Biopiracy

37

Structure

• history about patents in general• the value of biodiversity• examples of biopiracy• international agreements• persons and NGOs involved in the counter-

movement

38

History1474 – the senate of Venice enacts a law for the protection of inventors

1500 1600 1700 1800 1900

2000

1988 – US-patent office grants the first patent on a mammal (cancer mouse)

1873 –Louis Pasteur receives the first patent on a living organism in the USA (purified yeast)

1623/24 – first law for the protection of intellectual property rights in England

1973 – signing of the European Patent Agreement

19901980197019601950

Until 2001 the EPO granted267 patents on plants,69 on animals and962 on human genes.

1997 –introduction of resowing-fees in Germany

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Requirements and power of patents

• criteria of patentability – novelty– inventiveness and – usefulness

• deadline for raising an objection lasts 9 months• valid for 20 years• second registration of the same kind is impossible in another country

• costs for a patent are about 30000 €, the EPO gets 5000 €, plus annual fees, the profit in 1999 was 125 mio. €

40

Cupuaçu

Basmati

Hoodia

41

Origin of the word “biopiracy”• for the first time introduced by the RAFI in 1993

• Definition of the ETC Group: "the appropriation of the knowledge and genetic resources of farming and indigenous communities by individuals or institutions seeking exclusive monopoly control (usually patents or plant breeders' rights) over these resources and knowledge.”

42

Cupuaçu

• similar to cocoa• traditionally used for juice, ice-

cream, marmelade and gateaus• the japanese corporation Asahi

registered the name and applied for a patent for its use

• protest: chocolate made of Cupuaçu is sold by third-world-stores

• not successful yet

43

Hoodia-Cactus

• growing in the Kalahari desert

• used as an appetite suppressant by the San tribe

• was patented in order to sell diet pills

• Benefit Sharing: Pfizer and Phytopharm will pay 6 % of all royalties (only 0.003% of netto sales)

44

Basmati• 27 varieties grown in India

• patent by RiceTec. Inc. in Alvin, Texas, USAwith support by the IRRI

(International Rice Research Institute)

• India won the trial

45

• ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture)

• CBD (Convention on Biological Diversity)

• WIPO (World Intellectual Property Organization)

• UPOV (International Union for the Protection of New Varieties of Plants)

• TRIPS (Trade Related Aspects of Intellectual Property rights)

• DIRECTIVE 98/44/EC on the legal protection of biotechnological inventions

International agreementsbe-tt-e-r

w-o-r-s-e

46

Vandana Shiva

• “Biopiracy deprives us in three ways:1. It creates a false claim to novelty and

invention, even though the knowledge has evolved since ancient times as part of the collective and intellectual heritage of India.

2. It divests scarce biological resources to monopoly control of corporations thus depriving local communities the benefits of its use.

3. It creates market monopolies and excludes the original innovators (farmers) from their rightful share to local, national and global markets.”

X

T

C

B

A

Herbal medicinal product for... (treatment, prevention ...)

New productsserious diseases

major claims

minor claims

Traditional medicinal product

Fraudulent or misleadingclaims

Traditionally usedwithout supportive scientific evidence

Grading of Recommendationsw

ell-e

stab

lishe

d Future minimum for WEU ?Requirements HMP > Chemicals?

EMEA – Drug Regulation

EMEA: European Medicines Evaluation AgencyLocation: LondonFounded: 1993, operational 1995Duty: Drug regulation „Central Procedure“

Supervise safe and effective use of medicinal products in EUTwo comittees: CPMP and CVMPCo-ordinate GLP, GMP and GCP inspections

Mandate of the HMPWPEMEA Management Board, December 18, 2001

B) Working documents not adopted by CPMP / CVMP

Publication on the EMEA website in a specific HMPWP folder

Note added for clarification:

“The views presented in this document are those of the HMPWP, which has been created as a forum for exchange of experience in the field of herbal medicinal products. This document is released for the purpose of transparency and has no legal force with respect to CD 2001/83 EEC”

Examples: Guidelines on safety, efficacy, regulatory questions, core-data on herbal drugs

Work Programme of the HMPWG2003-2004

Quality

• Concept Paper for a NfG on biopharmaceutical characterisation of herbal medicinal products

• Compilation of general quality questions answered by the HMPWP

• Implementation of WHO Good Agricultural and Collection Practises

Work Programme of the HMPWG2003-2004

Safety

• NfG on non-clinical testing:Implementation of the final CPMP/SWP NfG

• Position papers related to HMP containingEstragoleMethyleugenoleα- and β –AsaroneSassafras / SafroleCapsaicinQuassin / Quassia amaraPulegone / MenthofuranHypericine / Hypericum

Impact of EU Scientific Committee on Food

Common Technical Document (CTD)

Annex 1 to CD 2001/83 (final rev. 2003)

General Concept

Herbal medicinal products differ from conventional medicinal products.

They are intrinsically associated with the particular notion of herbal substances and herbal preparations.

Additional specific requirements dealing with Module 3 must be identified to take into account their nomenclature, structure, the characteristics of their manufacturers and the manufacturing process employed.

Modules 1, 2, 4 and 5 are applicable.

Common Technical Document (CTD)

Annex 1 to CD 2001/83 (final rev. 2003)

Presentation and format of the dossier

Special guidance on herbal medicinal products

For the purposes of this NTA the terms "herbal substances and herbal preparations" shall be considered equivalent to the terms "herbal drugs and herbal drug preparations", as defined in the Eur. Pharm.

For herbal medicinal products applications, applicants should take into account below referred to guidance in addition to what is already explained in the core-Structure of the Modules 2 and 3.

Levels of EvidenceWell-established use CD 1999/83 EC and

Annex 1 to CD 2001/83 EC (final rev. 2003)

… The documentation … should cover all aspects of the safety and/or efficacy assessment and must include or refer to a review of the relevant literature, taking into account pre- and post-marketing studies and published scientific literature concerning experience in the form of epidemiological studies and in particular of comparative epidemiological studies. … With respect to the provisions on “well-established medicinal use” it is in particular necessary to clarify that “bibliographic reference” to other sources of evidence(postmarketing studies, epidemiological studies, etc.) and not just data related to tests and trials may serve as a valid proof of safety and efficacy of a product if an application explains and justifies the use of these sources of information satisfactorily. …

What are Biopharmaceuticals?

• Derived from genetic expression of a living organism• Frequently have complex structure• Most importantly, they require special quality control regulations:

• Biological nature of starting material• Biological basis of manufacturing process• Biological test methods needed to characterise batches of

the manufacturing process to ensure the level of purity andactivity

Definition of Biopharmaceuticals

EMEA: Council Regulation (EEC) Council Regulation (EEC) Nr 2309/93 Nr 2309/93 -- ANNEXANNEX (List A)

Biopharmaceuticals are:

-Vaccines, genetically derived (incl. Gene deletion)- monoclonal antibodies- Recombinant proteins or nucleic acids

Germany: Drug Act §§ 1 und 21

Other legal requirements

• National lawGentechnology actBiotechnology Directive

• EMEA und FDA - Notes of GuidelinesTSESeeding systemsInternational Units (I.U.)

• National and European PharmacopeaeEndotoxinsSterilityPharmaceutical Quality (purity, activity, identity

Clock Stop for questions and commentsClock Stop for questions and comments

Pre-application(4 month before application)

Application and validationDecission about

Rapporteuer and Co-Rapporteur

File Review and assessment repor

Consolidated list of questionsScientific evaluation

(210 days)

Transfer by EMEA to CommissionDraft Commitee decission

Qualified majority: Decission adopted and published in O J

EMEA – Drug Regulation Process

Registration dossier

Part I administrative data summary of product characteristics (SPC) packaging, leaflet Expert reports Part II Technical, biological pharmaceutical data Part IIIToxicopharmalogical data Part IV Clinical data, Pharmacovigilance identical in the 15 EU countries

Operating times

Drug Time for approval

Gonal F 107 daysNovoseven 138 daysHumalog 210 daysTritanrix-HB 180 daysAvonex 216 daysTwinrix 197 daysRapilysin 204 daysEcokinase 204 days

11 13

5948 45

46 43

1812 3 1 2

0

10

20

30

40

50

60

70

80

GB NL S D DK F

Countries

Drug

s GenericsNDI

RMS = Reference Member State

RMS-approvals in 2000

Time for approval(2000)

15,8

11,6

8 7,4

02468

1012141618

BfArM FDA MCA EMEA

ICH

Have common requirements

quality, safety, efficacy of new medicines acceptedwherever in the world

The ICH Topics

Scope : harmonization of requirements

Q : Quality (technical) S : Safety (toxicology) E : Efficacy (clinical)

These three criteria are those considered by RegulatoryAuthorities for granting a Marketing Authorization toa new medicinal product

STANDARDS FOR LICENSURE • Safe • Pure • Potent • Effective • Consistent• Characterization of Products • Manufacturing Process • Stability • Preclinical Testing • Clinical Trials • Specification & Testing Methods

PRODUCTION PROCESSES FOR BIOTECHNOLOGY DERIVED

PRODUCTS

• Cloning/preparation of seed stock Prokaryotes Eukaryotes Hybridomas

• Fermentation • Conversion, if necessary, from primary to final product • Purification • Formulation

Biological Tests for Identity & Potency

•in vivo Bioassays •in vitro Bioassays •Bioassays

QUALITY TOPICS, Biotechnology products.

Q5A: Viral safety evaluation Q5B: Genetic stability Q5C: Stability testing Q5D: Cell substrates Q6B: Specifications, biotech. products

Q5A: Viral safety

Scope: • Biotech./biologicals derived from characterized cell • banks of human or animal origin; r-DNA products • concerned; classical vaccines excluded.

Highlights: • Potential contamination (master Cell Bank, adventitious) • Cell line testing, virus (MCB, WCB, cells, age limit, • retroviruses, antibody, in vivo, in vitro ) • Bulk testing, viral clearance procedures (choice of • viruses, design, inactivation, removal,…)

Q5B: Genetic stability

Scope: • Characterisation of expression constructs for • the production of r-DNA protein productions in • eukaryotic / prokaryotic cells.

Highlights: • Rationale for analysis of expression construct. • Characterisation of expression system, MCB, WCB. • Limit for cell age production • Aim: Consistent production through analysis of • DNA and purified protein.

Q5D: Cell substrates

Scope: Standards for animal / human cell lines, primary cells, microbes, used to prepare biotech. / biologicals.

Highlights: Source, history, generation of cells. Cell banking. Characterization of cell banks: identity, purity, stability. Primary cell substrates.

Specification

• A list of tests • References to Analytical Procedures • Acceptance Criteria • One part of a total control strategy

designed to ensure product quality and consistency

Specification

• Characterization • GMP • Validated Manufacturing Process • Raw Material Testing • In-Process Testing • Stability Testing

Drug Product Specification

• Appearance and description • Identity • Purity and impurities • - Process-related impurities • Cell culture media • Host cell proteins, DNA • Monoclonal Ab or Chromatographic media • Solvent • - Product-related impurities • Molecular variant • Potency • Quantity

Drug Product Specification

• Appearance and description • Identity • Purity and Impurities • Potency • Quantity • General Tests • Additional Testing for Unique Dosage Forms

GMO Patents and Seed legislation

Impact on farmers and breeders by Patents and PVP

•Patents on genes

and processes (GMO‘s)

Plant VarietyProtection for seed varieties

Breeders•Access to

genetic resources

for breeding; •Income

Farmers•Farmers rights

(the use of saved seeds)•Cost of Seed

Biodiversity•Creation and

conservation of plant varieties for agriculture

Plant Variety Protection

• UPOV (International Union for the Protection of New Varieties of Plants)

• UPOV 1961, 1972 (3 member states), 1978 (24 member states), 1991(31 member states).

• Obligation by the WTO TRIPS Agreement to protect seed varieties by PVP or Patents.

UPOV 78 was a monopoly for the sale of seeds

• UPOV 78, Article 5 : The effect to the right granted to the breeder is that his prior authorisation shall be required for

- The production for purposes of commercial marketing

- The offering for sale- The marketing

UPOV 91 is much broader

• UPOV, Article 14: The following acts ... shall require the the authorization of the breeder:

- Production or reproduction (multiplication)- Conditioning for the purpose of propagation- Offering for sale; selling or other marketing- Exporting, importing, stocking for any of the

mentioned purposes.

Breeders Exemption

• In all acts of UPOV there is a strong breeders exemption.

• UPOV 91, Article 15: The breeders right shall not extend to acts done for the purpose of breeding other varieties.

• Exemption: Essentially derived varieties (GMOs, selection, mutants)

Farmers Rights (farmers privilege)

• No problem under UPOV 78• Only optional exception under UPOV 91:• Article 15: Each contracting Party may, within

the reasonable limits and subject to the safeguarding of the legitimate interest of the breeder, restrict the breeder‘s right in relation to any variety in order to permit farmers to use for propagating purposes, on their own holdings the product of the harvest which they have obtained by planting, on their own holdings the protected variety.

How to read Article 15?

• Seed exchange farmer to farmer is forbidden.

• Product of the harvest is not the same as propagating material. Therefore the multiplication of fruits, berries and vegetables is forbidden.

• Where the re-use of seeds is allowed a payment is (sometimes) required.

Implementation in Europe – EC Regulation 2100/94 / Art. 14

• Farmers‘ rights only apply to listedagricultural plant species of: fodder plants, cereals, potatoes, oil and fibre plants.

• small farmers shall not be required to pay any remuneration to the holder.

• other farmers shall be required to pay an equitable remuneration to the holder, which shall be sensibly lower than the amount charged for the licensed production of propagating material of the same variety in the same area;

• the actual level of this equitable remuneration may be subject to variation over time, taking into account the extent to which use will be made of the derogation provided for in paragraph1 in respect of the variety concerned

Implementation on country level

• The payment of the remuneration differs between European countries.

• No payment in Italy and Austria (and Switzerland).

• Payment only for soft wheat in France –when selling the crop

• Payment for all listed species in Germany –on farm level

Tasks on PVP in Europe• Do not ratify UPOV 91• Do not strengthen PVP on European or national levels• Use all flexibilities possible under the European

regulation• Do not allow private contracts to override the farmers

rights still in place.• ... do not pay (German example)• Keep non-protected varieties on the market

Patent law related to seeds • TRIPS, Article 27.3:

Members may also exclude from patentability:(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.

European Directive on the legal protection of biotechnological

inventions - 98/44/EC• Article 4

1. The following shall not be patentable:(a) plant and animal varieties; (b) essentially biological processes for the production of plants or animals.2. Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety

Broad coverage• Article 8

The protection conferred by a patent on a biological material possessing specific characteristics (or on a process that enables a biological material to be produced possessing specific characteristics) as a result of the invention shall extend to any biological material derived from that biological material (or directly obtained through that process) through propagation or multiplication in an identical or divergent form and possessing those same characteristics.

Patents on genes

• Article 9 The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material in which the product is incorporated and in which the genetic information is contained and performs its function.

Farmers Rights• Article 11

1. By way of derogation from Articles 8 and 9, the sale or other form of commercialisation of plant propagating material to a farmer by the holder of the patent or with his consent for agricultural use implies authorisation for the farmer to use the product of his harvest for propagation or multiplication by him on his own farm, the extent and conditions of this derogation corresponding to those under Article 14 of Regulation (EC) No 2100/94.

• Farmers right for patented seeds = farmers right for protected seeds by plant variety protection

but• There is only one pvp for one variety, but maybe

several patents on this plant.• Therefore a farmer could be confronted with

higher payments for GMOs than for conventional seeds.

• Possibility to exempt seeds which are unintentionally contaminated with GM traits from patent protection (Swiss proposal)

Breeders Exemption• There is no breeders exemption in patent law (best

case: a research exemption). • Article 12

1. Where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he may apply for a compulsory licence for non-exclusive use of the invention protected by the patent inasmuch as the licence is necessary for the exploitation of the plant variety to be protected, subject to payment of an appropriate royalty.

but• Applicants for the licences must demonstrate

that:(a) they have applied unsuccessfully to the holder of the patent or of the plant variety right to obtain a contractual licence; (b) the plant variety or the invention constitutes significant technical progress of considerable economic interest compared with the invention claimed in the patent or the protected plant variety.

• Easy for GMOs – very hard for conventional breeding

Patents impede breeding

• The access to genetic resources for breeding was always free. With patents on genes and processes this time is over.

• This could have a severe impact on food security.

Tasks on patents in Europe

• The flexibility under the patent directive is quite small (scope of the protection for genes).

• The directive has to be changed (Input from Germany?).

Further work .....

• If we want to protect farmers rights, we have to work on plant variety protection.

• If we want to safeguard the access to genetic resources for breeders we have to work on patent law.(including the FAO Seed-Treaty)

• ......and not forget the threat of „biological protection“(new hybrids, terminator, traitor).