#19708 - 20. Biotech And Contemporary Issues - Intellectual Property Law

Reading - Bently and Sherman 6^th Ed: 511-550

Harvard/Oncomouse [1992] O.J. EPO 589

Novartis/Transgenic Plant [1999] EPOR303

WEEK 20

BIOTECH AND CONTEMPORARY ISSUES

Biological subject matter

Legal, social, economic issues within IP law!

1. Increasing recognition of the commercial importance of biological material

2. Commercial value vs. Public interest

   1. What should be kept in a public interest? Allows future research

3. Protecting investment and market position

4. The elimination of trade obstacles

   1. EU and international –

   2. If not allowing patenting over lifeforms – the UK will be affected as a trading partner.

5. Consumer vs. environmental

   1. Genetically modified foods/plants – as consumers do we want to be eating GMF/P? do they have a negative impact on the environment?

6. Access to new products and processes?

   1. Without patent drug will not exist in the first place – huge cost to create all these inventions

   2. With patent, facilitating access to medicine.

   3. How do we regulate the science?

7. Relationship between science, law, society and economics

   1. How do we feel about the science being carried out?

   2. How do we feel about the awarding system?

   3. Are companies benefitting and thriving within the law?

   4. Are companies staying within the socially acceptable line?

European Patent Convention (EPC) came into force 1973 – revised 2000. UK patent law 1977 is implementation of the EPC. There are 39 members of the EPC, all EU-27 and more! Not a body of the EU. It is an intergovernmental organisation

• How is the EPC interpreting the issues discussed above?

Exclusions to patentability under the EPC

EPC decisions –

Art.53(A) –Harvard/Oncomouse [1990] OJ EPO 476; Plant Genetic Systems v Greenpeace [1995] EPOR; Howard Florey/Relaxin [1995] EPOR

• Unforeseeable and unpredictable environmental damage argument dismissed by the EPOR, need to establish real harm, not speculative harm (Plant Genetic Systems)

• Pregnant women hormone (Relaxin) is supposed to help childbirth; against human dignity argument failed. Argued that patenting DNA would be enslaving pregnant women (unsuccessful argument)

Art.53(B) – plant and animal varieties

Ciba-Geigy/propagating material [1984] OJEPO 112

Plant genetic systems [1995] EPOR

Novartis/transgenic plant [1999] EPOR

Harvard/Oncomouse [1990] OJ EPO

Directive on the Legal Protection of Biotechnological Inventions

• EU cannot revise the EPC

  • Need to stick to the core policy and practice of the EPC but can ‘interpret’ and ‘clarify’

• Clarify and influence EPC decisions

• The objective of the directive = eliminate uncertainty and to promote bioscience research

  • to direct policy and practise

• has been adopted by the EPO in the form of a supplementary means of interpretation

  • rules intending to help patent examiners understand the EPC for biotech

Article 4 – Biotech Directive

• plant and animal varieties are not patenable (art.4(1))

• ‘technical feasibility’ (art.4(2))

Art.5 – Biotech Directive

• Relaxin – the human body is never going to be patentable.

• “The human body at various stages of its formation and development and the simple discovery of one of its elements, including the sequence/partial sequence of a gene cannot constitute patentable inventions…”

• However, genes are patentable BUT it is needed to know what the gene does

  • Relaxin isolated the hormone, found out the function – so the justification is they sequenced it, they know what it does and isolated the hormone

Art. 6 – contrary to ordre public or morality

• Eg. use of human embryos for industrial or commercial purposes

• ‘substantial medical benefit’

Supplementary means of interpretation

Rule 29 (Art. 5(1) BD) – the human body and its elements

Rule 28 (Art.6(2)(C) – the use of human embryos for industrial/commercial purposes.

**upon analysis, the Biotech directive is incorporated within the EPC.

Art.7— The Commission’s Group of Ethics in Science and New Technologies will evaluate all ethical aspects of biotechnology.

• Assists the European Patent Office (EPO)

  • They can ask for a comment or feedback

• Acts as a forum // do not have to be a bioethicists and patent attorney.

  • Can ask this Commission for guidance.

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EPO decisions post-BD on Art. 53(A) EPC

1. Harvard/oncomouse [2005]

• Use the biotech directive as a way of guidance – carried a detriment/utilitarian test in the interpretation of the biotech directive

• Need to look at suffering of the animal and potential medical benefit to humans. (medical benefit outweighs?)

• Degree of certainty

2. Leland Stanford/Modified Mouse [2002]

3. Edinburgh Patent (EP 069531)

• Embryonic stem cells. When patent came back, it removed the term ‘animal’ embryo

• Animal encompasses humans

4. WARF Patent Application [2003]

• Products derived from embryonic stem cells. Used to make various products.

• Embryonic stem cells =

  • Removing the embryonic cell before it becomes a foetus – is this ethically / morally wrong?

  • Rule 28 (Art. 6(2)(C) BD) – uses of human embryos for industrial or commercial purposes

  • Rule 29 (Art. 5(1) BD) – the human body at various stage of human life

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2003 United Kingdom IPO (UKIPO)

• Practice Notice regarding inventions involving human embryonic stem cells.

• Huge potential benefits if this research is allowed

  • They’ve had a debate!

  • The potential benefits outweigh

• The embryos which get tested on come from IVF

  • Wasteful to throw away spare eggs !

• University of Edinburgh and WARF – appeal outcome

  • No claim on human embryonic cells or related products; human embryonic stem cells can only be obtained from a method which involved the destruction of human embryos

CJEU – 2011

• The human embryo involve the destruction at one point in time

• Always against public morality

What is a human embryo?

• Brustle – any human ovum, as soon as fertilised; a non-fertilised human ovum with the inherent capacity of developing into a human being

• International Stem Cell Corporation v CJEU [2014]

Novartis/Transgenic Plant

• Clarified what is meant by plant and plant variety

• If there is some form of technical innovation that can be shown, it is patentable.

• Subject matter and scope are two different issues

• Read with the BD – helps us define and narrow the scope of exclusion

Thoughts

CAN WE REALLY HAVE A EUROPEAN MORALITY STANDARD?

IS THE BROAD EXCLUSION OF HUMAN EMBRYOS (PUBLIC MORALITY) PREVENTING SCIENTIFIC RESEARCH WHICH MAY POTENTIALLY HAVE MEDICAL BENEFITS?

SHOULD THE UK MOVE AWAY FROM THESE DECISIONS POST- BREXIT?

• Plant and animals are patentable. But embryos remains strongly held to a moral standard.

  • GMP and GMAs can be patented as long as it produces human benefit?

Textbook reading

Biological subject matter

A patent shall not be granted for ‘any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a microbiological process or other technical process or the product of such a process’ (paragraph 3(f) of Schedule A2 to the Patents Act 1977 and 53(b) of the EPC)

• The second part of paragraph 3(f)/Article 53(b) goes on to qualify and limit the subject matter that is excluded from patentability. As an exception to the exception, it provides that if an invention is ‘a microbiological process or other technical process or the product of such a process’, the invention may be patented.

PA 1977, Sch. A2, para. 4; EPC Regs, reg. 27; Biotech. Dir., Art. 4(2)

• The EPC and the 1977 Act explicitly state that it is possible to patent inventions for plants and animals, so long as they comply with the general requirements of patentability

Animal varieties

When Article 53(b) of the EPC 1973 was first drafted, the potential scope of the animal variety exclusion was straightforward and uncontroversial. This has changed, however, as patent law has been forced to confront the developments in biotechnology that have taken place since then.

OncoMouse - genetically modified non-human mammal (in particular a mouse), which had been modified so that it would be susceptible to cancer- used in cancer research.

• At first instance, the Examining Division (ED) held the invention covered an unpatentable animal variety

• On appeal – ED had misconstrued the exclusion which, being an exception to patentability, ought to be construed narrowly. Article 53(b) did not exclude animals in general. On this basis, the TBA remitted the matter to the Examining Division for reconsideration.

• The Examining Division said that animal variety either meant a species or a subunit of a species. ED acknowledged while the terms of the EPC was not consistent, it was not necessary to decide which was the authoritative meaning for the purpose of the Convention

  • Rationale - the claims in question related to non-human mammals, a category that was neither a species nor a subunit of a species (taxonomy of a higher classification than species)

The meaning of ‘animal variety’ was considered by the TBA in its 2006 decision in Harvard/Transgenic animals (re-run of Oncomouse decision)

• Noted - the reasoning of the Enlarged Board of Appeal (EBA) in relation to plant varieties in Novartis was applicable to the decision as to whether an invention fell within the animal variety exclusion

Novartis - the EBA held that where a specific plant variety is not individually claimed, the claim will not be excluded from patentability under Article 53(b).

• The TBA said that a ‘definition by reference to taxonomical rank would be consistent with the position in relation to plant varieties and in the interests of legal certainty’. Unnecessary to pursue the matter further

• Transgenic rodents would not have been caught by either the...