Reach Through RT Claims Are research tools, and associated patents and licences, a good thing for in

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Reach Through (RT) Claims Are research tools,
and associated patents and licences, a good thing
for industrial research?

• J C Gaal PhD RPA EPA
• Head of Biotech Patents, Syngenta Limited
• M T Flattery BS JD
• Global Head IP Licensing, Syngenta Group

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Disclaimer

• The views expressed here do not necessarily
  reflect those of our present or former (or
  possible future) employers.
• Views, however, are dictated by the needs of the
  client!

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Patents solely to keep the competitor out

• Patents are commercial weapons used to deter a
  competitor from entering the same
  market/territory.
• The principal entities precluded by the patent
  are unlikely to be the Patentees customers.
• No need (desire) for Patentee to licence to
  survive

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Research Tool Patents

• Patents are the principal means by which to
  generate revenue by licence.
• The principal entities precluded by the patent
  are likely to be the Patentees customers
• Need to licence to survive.

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RT Claims

• Potentially offensive RT claims may be present
  in-
• Licences - invoices, etc for receipt of goods
• Patents

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Anxiety level as a function of time in respect of
research tool patents containing RT claims
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Anxiety level as a function of time in respect RT
claims in licences (invoices, etc for receipt
of goods)
Blind panic
Mild Hysteria
Hot Neck Syndrome
Anxiety Level
Agitated
X
X
X
X
X
X
X
X
X
X
Relaxed
Moribund
1996
2000
2004
2008
Time
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Licences with RT provisions

• The Patentee may seek to enforce RT claims
  through licence agreements.
• i.e. licences to use screening techniques/material
  which contain high royalty rates based on
  commercialisation of a product obtained by use of
  the technique.
• If the licence is imposed by contract per se the
  validity of the patent claim is irrelevant
  because the cause of action will be for breach of
  contract and will operate outside the terms of
  the patent.

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RT Claims

• Sadly, just as in purely academic research,
  most industrial research does not lead to any
  commercial product or process.
• The majority of contracts which contain RT
  provisions, based on sales of products, the
  development of which involved early use of the
  research tool, are unlikely to generate revenue
  for the Patentee/Licensor.

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RT Claims

• We need to be wary of licences containing RT
  provisions in small print on the back of an
  invoice or acceptance of order form for the
  supply of a screening agent which is signed
  innocently in routine manner by a purchasing
  officer.

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RT Claims

• Possible unfair competition law issues
  depending on the form and substance of the
  licence and the length and scope of the
  intended reach.
• We expect the sympathy of the court if the
  licence terms are oppressive or operate to
  stifle research.

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When are patents for research tools
infringed?(S60 UKPA)

• Infringement requires some
• Making
• Using
• Disposing of
• Offering to dispose of
• Importation
• Keeping
• Of the claimed invention within the jurisdiction
  of the court, or
• Some supply (or offer to supply) of essential
  means for carrying out the claimed invention,
  except that when the supply is of a staple
  commercial product the supply must have been
  intended to induce the purchaser to work the
  claimed invention
• And provided that the act does not fall within
  permitted exceptions.

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Permitted exceptions to patent infringement in UK

• S60(5)a. private acts, (experimental or
  otherwise) performed for non-commercial
  purposes
• S60(5)b. private or public acts performed for
  experimental purposes relating to the
  subject matter of the invention
• S60(6) a supplier to someone who per se is
  exempted under S60(5) is not himself
  exempted.

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Research Tool patents with RT Claims during each
stage research

• RT claims of the form Compounds having a
  function, obtainable/obtained by use of the assay
  . are unlikely to be infringed during early
  stage research
• Success is a possible infringing act
• Failure is not.

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Research Phase

• During the research phase Industry can, usually,
  relatively easily-
• Move research to a patent-free territory
• Probably avail itself of statutory exemptions to
  patent infringement for truly experimental and/or
  private and non (immediately) commercial acts
• possibly including clinical and field trials,
  depending on the territory

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Production

• But what about production?

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Production

• Functionally equivalent, non patented, non
  licensed alternatives may be available/could be
  made
• Licences may be obtained where the terms are
  objectively equitable or the upfront costs
  and RT royalties are less than the likely costs
  of litigation taking stacking into account
  and the need to return a reasonable profit margin.

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Production

• 3. Patent/licence impediments may have to be
  removed by litigation/opposition.
• 4. Big Industry is not averse to law suits and
  has the financial clout to carry them through to
  a successful conclusion.

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Validity

• Granted patents have a presumption of validity
• Noble sentiment
• Is that presumption now greater for some
  technology areas than others?
• Biotech patents have a poor record in terms of
  being held to be valid (and infringed).

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Patentable Invention

• A patent is granted in respect of an invention
  i.e. a
• Novel
• Non-obvious
• Industrially applicable
• Non-excluded
• Technical solution to a problem.

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Patent Description

• The invention must be described in the patent in
  a manner sufficiently clear and complete to
  enable the skilled man to make/use it and
• Materials for use in a process must be adequately
  described in the patent or obtainable without
  undue burden and
• Some evidence in the patent (file) that the
  patentee was truly in possession of the invention
  at the effective filing date of the patent.

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Claims

• RT claims almost by definition attempt to
  cover things not specifically disclosed in the
  patent otherwise they would not reach.
• Each case needs to be considered on its own
  merits but ..

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Claims

• RT claims normally fail (somewhere in the
  process) on at least one of the following
• Lack of written description of the RT products,
  or materials for use in a process i.e. no
  evidence that the patentee was in possession of
  the invention
• Lack of enablement over the effective scope of
  the claim
• Lack of novelty
• Lack of inventive step
• Lack of utility.

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University of Rochester vs G.D. Searle, Pfizer
Pharmacia

• Assay and method of treatment claims which RT to
  Cox 2 inhibitors not known to the patentee
• Claim 1
• A method for selectively inhibiting PGHS-2
  activity in a human host, comprising
  administering a non-steroidal compound that
  selectively inhibits activity of the PGHS-2 gene
  product to a human host in need of such treatment.

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University of Rochester vs G.D. Searle, Pfizer
Pharmacia

• No written description/sufficient disclosure of
  the inhibitors for use in the claimed methods
  the essential technical limitations of the claims
• Fell at the first objective hurdle (A
  description of what a material does rather than
  what it is usually does not suffice)
• But might have been revoked for lack of
  enablement assuming written description had not
  been contemplated?

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Bayer AG Bayer Corporation vs Housey
Pharmaceuticals Inc.

• US patent for drug screening assay
• Claim 1 of USP4,980,281
• A method of determining whether a substance is
  an inhibitor or activator of a protein whose
  production by a cell evokes a responsive change
  in a phenotypic characteristic other than the
  level of said protein in said cell per se, which
  comprises
• a. Providing a first cell line which produces
  said protein and exhibits said phenotypic
  response to the protein
• b. Providing second cell line which produces the
  protein at a lower level than the first cell
  line, or does not produces the protein at all,
  and which exhibits said phenotypic response to
  the protein to a lesser degree or not at all
• c. Incubating the substance with the first and
  second cell lines and
• d. Comparing the phenotypic response of the first
  cell line to the substance with the phenotypic
  response of the second cell line to the substance.

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Bayer AG Bayer Corporation vs Housey
Pharmaceuticals Inc.

• Bayer allegedly used the assay in Europe to
  develop drugs sold in the US.
• 35USC 271(g)
• Whoever without authority imports into the United
  States or offers to sell, sells, or uses within
  the Untied States a product which is made by a
  process patented in the United States shall be
  liable as an infringer, if the importation, offer
  to sell, sale, or use of the product occurs
  during the term of such process patent A
  product which is made by a patented process will,
  for purposes of this title, not be considered to
  be so made after-
• 1. It is materially changed by subsequent
  processes or
• 2. It becomes a trivial and nonessential
  component of another product.

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• CAFL held that 271(g) only applies to
  manufactured products, or methods used directly
  in making a final product not information which
  is the product of the Housey claim.

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Chiron Corporation vs Genentech Inc

• Chiron patent (USP6,054,561) granted with claim
  to MAb that specifically binds a human breast
  cancer Ag.
• Claim 1
• A monoclonal antibody that binds to a human
  breast cancer antigen that is also bound by
  monoclonal antibody 454C11 which is produced by
  the hybridoma deposited with the American Type
  Culture Collection having Accession No. HB8484.

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Chiron Corporation vs Genentech Inc

• None of the priority applications satisfied the
  written description requires for the Ag
• CAFC decided that the 561 patent was not
  entitled to priority
• Interfering prior art deprived the claimed
  invention of novelty
• The patent was thus held invalid.

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Amendments

• Wordsmithing the claim, whilst useful to
  overcome novelty and inventive step objections,
  may not overcome written description and/or
  enablement deficiencies.
• A fundamentally deficient disclosure is very
  difficult to repair after the application has
  been filed without changing the basic nature of
  the claimed invention.

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Patent System

• The object of the patent system is to reward and
  encourage innovation.
• An attempt to inhibit scientific progress by
  using research tools and/or patents or licences
  with RT claims, in a monopolistic manner, will
  likely bias the court in favour of the alleged
  infringer.

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Patent System

• In an area of uncertain law as exists in
  relation to research tool patents the courts
  have little difficulty in finding a way of
  reaching a decision in conformity with what they
  see as the over-riding public interest which is
  likely to favour scientific progress, whether
  industrial or not, rather than stifle it.

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Conclusion

• Whatever the value of Research Tool patents and
  covetous RT claims to the Patentee in terms
  of affecting industrial RD, generally they are a
  nuisance rather than serious impediment.