NESCIClifford Chance Regenerative Medicine

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NESCI/Clifford ChanceRegenerative Medicine
Stem Cell Conference Workshop, Feb 2009

• Developments in biological method patents
• Professor Alison Firth
• Newcastle University / Surrey University

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What type of claim was used in WARF?

• Some reports of WARF describe the invention as a
  method, but
• main claim
• 1 A cell culture comprising primate embryonic
  stem cells which (i)
• To a product, cf US machine, article of
  manufacture, composition of matter
• Not a process claim

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Different!

• How different?
• Europe
• European Patent Convention as amended in 2000
• Draft Community Patent Convention text found its
  way into national laws
• USA
• Recent petition to Supreme Court process claims
  not second class

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Process claims - less or more rewarding for
patentee than product claims?

• Scientific feasibility/sufficiency
• Methods of medical treatment
• analogies from other areas
• infringement rights
• doctrine of equivalents/ purposive construction
• exhaustion of rights

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scientific feasibility

• Genentech (TPA) 1989
• Lundbeck ( enantiomer, SSRI) 2008

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Methods of medical treatment

• EPC Art 53(c) and national equivalents
• surgery, therapy, diagnosis, practised on the
  human or animal body
• Articles 54(4) and (5) EPC 2000
• Actavis UK v Merck 2008
• Not excluded US and many other countries

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analogies

• USPTO also more generous m,ethods of doing
  business, computer related inventions
• Signs of restriction may have implications for
  bio
• Bilski 2008 CAFC, petition Supremen Court 2009
  - method of hedging risk in financial
  transactions

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Bilski test

• not claim a fundamental principle in its entirety
  
• only a particular application of the fundamental
  principle
• Method patentable if
• i. tied to a particular machine or apparatus (not
  the case in with the Bilski claims under appeal),
  or
• ii transforms a particular article into a
  different state or thing

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Is Bilski relevant to biological patents?

• Classen Immunotherapies, Inc. v. Biogen 2008
• Petition to SC
• Classen, Cominsky etc demonstrate trend against
  process inventions

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Infringement rights (direct)

• Contrast
• 35 U.S.C. 271 Infringement of patent appears
  even-handed as to the nature of the claimed
  invention
• (a) Except as otherwise provided in this title,
  whoever without authority makes, uses, offers to
  sell, or sells any patented invention, within the
  United States, or imports into the United States
  any patented invention during the term of the
  patent therefor, infringes the patent.
• With
• S 60(1) of Patents Act 1977 and
• Also other European national provisions based on
  CPC, eg German s9

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S 60(1) emphasis, parentheses added

• 60.-(1) Subject to the provisions of this
  section, a person infringes a patent for an
  invention if, but only if, while the patent is in
  force, he does any of the following things in the
  United Kingdom strict Plastus Kreativ cf Menashe
  under s 60(2) in relation to the invention
  without the consent of the proprietor of the
  patent, that is to say -
• (a) where the invention is a product, he makes,
  disposes of, offers to dispose of, uses or
  imports the product or keeps it whether for
  disposal or otherwise
• (b) where the invention is a process, he uses the
  process or
• he offers it for use in the United Kingdom when
  he knows, or it is obvious to a reasonable person
  in the circumstances, that its use there without
  the consent of the proprietor would be an
  infringement of the patent double territorial
  requirement the German courts seem to have
  found ways of circumventing this difficulty
  actual or constructive knowledge

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S 60(1)(c)

• where the invention is a process, he disposes of,
  offers to dispose of, uses or imports any product
  obtained directly this has been narrowly
  construed in Pioneer v Warner 1997 by means of
  that process or keeps any such product whether
  for disposal or otherwise.
• Similar concept in 35 USC 271(g), which spares
  the product of a patented process from
  infringement if
• (1) it is materially changed by subsequent
  processes or
• (2) it becomes a trivial and nonessential
  component of another product.
• TRIPs Art 28

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Process claims difficult to litigate?

• Astron Clinica, Inrotis et al 2008
• Re infringing activities
• 800 Adept v Murex Securities 2008, US CAFC
• Strict interpretation of claims
• Muniauction v Thomson 2008
• Multiple actors, strict vicarious liability test

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exhaustion of rights

• Quanta v L.G. Electronics 2008 US SC
• US doctrine applies to process patents
• Murphy v Media Protection Services Ltd 2008
• Ref to ECJ on freedom of services in context of
  TV decoders

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Conclusion

• process claims confer lesser rights than product
  claims
• Europe and US, but
• Await SC in Bilski