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Patentability of inventions in the field of biotechnology

Patentability of inventions in the field of biotechnology. Dr. Peter Burkhardt EPO Munich, Dir 2.4.03. April 8, 2010. The European Patent Organisation. European Patent Organisation. European Patent Office. Administrative Council. The legislative body Important functions:

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Patentability of inventions in the field of biotechnology

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  1. Patentability of inventions in the field of biotechnology Dr. Peter Burkhardt EPO Munich, Dir 2.4.03 April 8, 2010

  2. The European Patent Organisation European Patent Organisation European Patent Office Administrative Council The legislative body Important functions: • to adopt the budget • to approve the President's actions in implementing the budget • to amend the Implementing Regulations and Rules relating to Fees The Administrative Council consists of delegates from the member states. The executive body The Office's task is to examine European patent applications.  The European Patent Office European Patent Organisation

  3. 36 member states Austria • Belgium • Bulgaria • Croatia • Cyprus • Czech Republic • Denmark • Estonia • Finland • France • Germany •Greece • Hungary • Iceland • Ireland • Italy • Latvia • Liechtenstein • Lithuania •Luxembourg • Former Yugoslav Republic of Macedonia • Malta • Monaco • Netherlands • Norway • Poland • Portugal • Romania • San Marino •Slovakia • Slovenia • Spain • Sweden • Switzerland • Turkey • United Kingdom European patent applications and patents can also be extended at the applicant's request to the following states: Albania • Bosnia-Herzegovina • Montenegro•Serbia

  4. Locations The Hague Munich PschorrHöfe Headquarters Munich Isar building Brussels Bureau Vienna Berlin  The European Patent Office Location

  5. Patentability in Biotechnology • General patentability criteria (Articles 52 and 53 EPC) • Rules 23b-e EPC • EU Directive 98/44/EC as supplementary means for interpretation of the EPC

  6. Main criteria for patentability • Novelty • not previously made available to the public • Inventive step • not obvious • Industrial application • use, function • Sufficiency of disclosure • invention must be repeatably described • Clarity of claims

  7. Patentable subject-matter • Isolated biological material even if it previously occurred in nature (EU biotech directive/EPC) • proteins (e.g. natural human proteins, enzymes), DNA (e.g. human gene sequences), chemicals from microorganisms (e.g. antibiotics) • living organisms and cells: (stem) cells, bacteria, viruses; animals, plants

  8. Patentable subject-matter • Methods and uses of biotech-related products: • producing a protein, PCR, in vitro diagnosis, in silico screening, preparation of plants and animals • making foods, medicines

  9. Exceptions to patentability - Art. 53(b): European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants and animals. - Reason: Avoid double protection in field of plant breeding. - Extension to animal breeding and "varieties" by analogy

  10. Exceptions to patentability - Art. 53(c): European patents shall not be granted in respect of therapeutic or surgical methods practiced (by doctors) on humans or animals. - Reason: Allow doctors to practice without restrictions by patents

  11. Patentable medical-type claims • Interferon for use as a medicine • Use of interferon for the manufacture of a medicament for treating cancer • A method for diagnosing cancer comprising measuring the concentration of interferon

  12. EP-B-0 436 257 - “Neem” (insecticide) patent : Revoked in opposition in 2001- Lack of novelty Appealed by proprietor Revocation confirmed (T416/01) Traditional knowledge

  13. EP-A-0 973 534 - „Hoodia“application(appetite suppressants): Refused in examination during oral proceedings Appealed by applicant Order to grant „use claims“ (T543/04) Traditional knowledge

  14. EP-B-0 744 888 - “Oil Maize” patent: Opposition filed by Government of Mexico, Misereor, Greenpeace Revoked in opposition – Novel (yes) Not appealed Traditional knowledge

  15. Can plants be patented ? • Yes. If the technical feasibility of the invention is not confined to a particular plant variety. Rule 27(b) EPC Also • Microbiological or other technical process, or a product obtained by means of such a process other than a plant variety. Rule 27(c) EPC An example: • Not allowable: A plant variety such as durum wheat type wh222 deposited at a seed depository. • Allowable: A transgenic plant and its seeds containing an exogenous bacterial gene encoding Bt toxin.

  16. What is a plant variety? • In analogy with the UPOV convention, Rule 26(4) EPC defines "plant variety" as any plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be: •  defined by the expression of the characteristics that results from a given genotype or combination of genotypes, •  distinguished from any other plant grouping by the expression of at least one of the said characteristics, and •  considered as a unit with regard to its suitability for being propagated unchanged.

  17. What is an "Essentially biological process"? What is an essentially biological process? • Can be thought of as those processes traditionally done by breeders. • Article 2(1) UPOV Convention 1961 simultaneous protection for the same botanical genus or species by plant breeders' right and patent not allowed. • Rule 26(5) EPC: • "A process is essentially biological if it consists entirely of natural phenomena such as crossing and selection."

  18. But crossing and selection are not necessarily natural phenomena... T320/87 (an older decision) • "Essentially biological" has to be judged on the basis of the essence of the invention taking into account the totality of human intervention and its impact on the result achieved. • The necessity for human intervention alone is not yet a sufficient criterion for its not being "essentially biological". • Human interference may only mean that the process is not a "purely biological" process, without contributing anything beyond a trivial level. • Claims found not to concern "essentially biological process".

  19. But crossing and selection are not necessarily natural phenomena... • EP 0 044 723 (T320/87) claimed (paraphrased): A process for [---] producing hybrid seeds, comprising: (a) selecting parent plants and selecting a second parent plant; (b) crossing parent plants to obtain phenotypically uniform hybrids; (c) cloning said first parent plant to produce a first cloned parental line; (d) crossing cloned parental line with second parent plant to obtain [---] phenotypically uniform hybrids [---]; and (e) repeating steps (c) and (d) as required to obtain hybrid seed that yields phenotypically uniform hybrid plants.

  20. How much human intervention? • EP 0 572 412 Method of producing corn grain with enhanced quality grain traits, comprising randomly interplanting two specified types of corn seed, permitting pollination, and harvesting the corn grain. Revoked in opposition (Article 53(b) - essentially biological process) Appeal filed, but later withdrawn • Questions to be answered: Is interplanting a sufficient intervention? Is "corn grain" a plant? Can further use as a "commodity" exit the exemption?

  21. Human intervention continued..... • EP 1 069 819 Method for production of Brassica oleracea, comprising steps of crossing and selection, wherein molecular markers used to identify desired hybrids Opposition division: not an essentially biological process of producing plants Appeal pending (T83/05) Referred to Enlarged Board as G2/07

  22. Human intervention continued..... • EP 1 211 926 Method for breeding tomatoes having reduced water content and product of the method Opposition division: method claims of main request related to an essentially biological process of producing plants maintained in amended form encompassing only product claims Appeal pending (T1242/06) Referred to Enlarged Board as G1/08

  23. How can I claim the products of plant breeding? • Excepted from patentability as a plant variety: • A plant obtained from seed deposited as Brassica napus olifera 975N-1650 with the accession number 97838 • Allowable (e.g. EP-0 891 130, T0788/07): • A hybrid plant comprising an inheritable and stable fertility restorer gene for ogura coplasmic male sterility, produced by a cross between a plant obtained from seed deposited as Brassica napus olifera 975N-1650 with the accession number 97838 as a male parent, and a second Brassica plant as a female parent.....

  24. Hybrids • In line with T320/87: "Hybrid seed and plants from such seed, lacking stability in some trait of the whole generation population, cannot be classified as plant varieties within the meaning of Article 53(b) EPC ." • Also T788/07 (Reasons 3) "Hybrid seed or plants thereof according to claims 1 to 5 are not considered as units with regard to their "suitability for being propagated unchanged" (Rule 26(4)(c) EPC) and are therefore not regarded as plant varieties which are excluded from patentability (Article 53(b) EPC). • In line with Rule 26(4): "Plant variety" - DUS, irrespective of whether the conditions for the grant of a plant variety right are fully met.....Hybrid varieties?

  25. How can the results of a successful breeding scheme be claimed? • Plant breeding may be done with the aim of achieving a particular fatty acid profile. • Types of claim: WO03/064576 - Refused in examination. - Claim 1: A flax seed having a linolenic acid content of greater than 65% of the total fatty acid content of said seed. WO95/22598 - Revoked in opposition. - Claim 1: Corn grain having a total oil content of at least 6.0% of the total seed weight measured at zero percent moisture wherein the oleic acid content is not Iess than 55% of the total oil content. - Claim 2: A corn oil obtainable from grain of claim 1.

  26. What's wrong with these claims? • Claims lack a link to the underlying genotype. Not characterised. • Claims express a "result to be achieved" • Particular examples are plant varieties • Repeatability may rely on availability of particular plants/seeds; need for deposit (Rule 28) - chance event... • Oil can be made by other means: mixing, separation • Breeding methods excepted from patentability

  27. Solutions • Include a clear non-natural step, e.g. chemical mutagenesis, molecular screen (depending on the outcome of G2/07 and G1/08). • Ensure materials are publicly available: deposit - R.31 EPC. • Include genetic features in definition of plant material.

  28. Where to Get More Information • www.epo.org - Learning

  29. Where to Get More Information • e-learning modules

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