Problems for biotechnology patent applications in Europe

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Problems for biotechnology patent applications in
Europe

• Chris Denison, Partner
• Mewburn Ellis LLP, London
• chris.denison_at_mewburn.com

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A fundamental problem

• How to obtain adequate protection for inventions
  in an unpredictable field
• For most biotechnological inventions, it is easy
  to predict in general terms how the same effect
  or result could be achieved in a different way
• But detail is unpredictable

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A fundamental problem

• Two key legal principles apply
• Contribution to the art
• Clarity
• and one serious legal obstacle
• Added matter

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Principle 1

• The scope of protection of a patent should
  reflect the contribution to the art
• Reflects bargain inherent in the patent system
• Disclosure of invention promotes knowledge and
  stimulates further research
• In return, patent gives monopoly of limited
  duration to prevent 3rd parties from immediately
  copying the invention

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Principle 2

• Scope of protection of a patent should be clear
• 3rd parties must be able to determine whether or
  not their activities infringe a patent

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Serious obstacle

• Prohibition on added subject matter
• Common to all patent systems, but very strictly
  applied by the EPO
• Cannot increase the information content of the
  application in any way (e.g. by addition,
  deletion or clarification) after the application
  is filed
• Severe restriction on the way the claims can be
  amended in light of objections
• Essentially, all possible future amendments must
  be envisaged when the application is filed

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Serious obstacle

• If the European application relies on the filing
  date of an earlier application, the claims of the
  European application must not contain any new
  information compared to the earlier application

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Example 1

• Applicant has newly discovered a protein with a
  useful property
• Predictable that many variants of the protein
  will have the same useful property
• But unpredictable exactly which variants

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Example 1

• A claim that protects only the specific protein
  is too narrow
• 3rd parties can easily avoid infringement by
  making mutations that do not affect the useful
  property
• This is still making use of the applicants
  invention
• Unfair to the applicant

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Example 1

• A claim that protects any protein with the useful
  property is probably too broad
• May cover completely unrelated proteins, which
  owe nothing to the applicants invention
• Unfair to 3rd parties

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Example 2

• Using an anti-ligand antibody, applicant
  discovers that inhibiting a ligand-receptor
  interaction is useful to treat a disease
• In principle, it is predictable that other
  mechanisms of inhibiting the interaction will
  also work
• But these require different amounts of luck
  and/or increasing amounts of time and effort to
  identify

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Example 2

• Antagonist anti-receptor antibodies and soluble
  receptors
• Aptamers, antisense, RNAi, gene therapy
• Small molecule inhibitors of ligand-receptor
  binding or receptor signalling

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Example 2

• Claim limited to antagonist anti-ligand
  antibodies may be too narrow
• 3rd parties could make use of the invention but
  avoid infringement by straightforwardly
  developing other inhibitors (e.g. soluble
  receptors)

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Example 2

• Claim to any antagonist may be too broad
• Small molecules may be identified in ways which
  owe nothing to the invention
• May be difficult to determine whether a small
  molecule is an antagonist of the receptor and/or
  interaction

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The law Contribution to the art

• 2 aspects
• Inventive step
• Sufficiency of disclosure

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Inventive step

• Art 52(1) EPC
• European patents shall be granted for any
  inventions which involve an inventive step.
• Art 56 EPC
• 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.

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Inventive step

• To be inventive, a claim must define something
  which represents the solution to a technical
  problem
• Substantially all embodiments within a claim must
  solve the problem
• Decision of the Boards of Appeal of the EPO
  illustrates this
• T939/92 (Herbicides/AgrEvo)

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T939/92

• Claim was to a broadly defined class of chemicals
• Not credible that activity would be obtained
  across the class
• So the only technical problem solved across the
  scope of the claim was the mere provision of
  alternative chemical compounds
• Claim was obvious as a solution to that problem

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T939/92

• Could have avoided objection by stating herbicide
  activity in the claim (so claim limited to active
  compounds)
• BUT this would have caused an objection of
  insufficiency

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Sufficiency of disclosure

• Art 83 EPC
• The European patent application must disclose
  the invention in a manner sufficiently clear and
  complete for it to be carried out by a person
  skilled in the art.
• Without undue burden and without exercising
  inventive activity
• T187/93 (Vaccines/Genentech) is complementary to
  T939/92

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T187/93

• Claims contained a functional limitation (in vivo
  protection by vaccine)
• Board held that not possible to reproduce
  function across the whole range of the claim
  (viral pathogens in general)
• Claims insufficient

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T187/93

• Allowed narrower claims closely based on
  exemplified viral proteins
• Inventive step was acknowledged on the basis that
  it was unpredictable that the invention would
  work
• The Board applied the same uncertainty to the
  question of whether the generalised claims were
  sufficiently disclosed

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The law - Clarity

• Art 84 EPC
• The claims shall define the matter for which
  protection is sought. They shall be clear .
• 3rd parties must be able to determine whether
  their activities fall within the scope of the
  claim
• EPO is extremely strict

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Clarity common problems

• On their own, variant, mutant, derivative,
  etc. will provoke objection
• How much variation is permitted?
• Provide structural limits on variation, e.g.
  sequence identity (as determined by a defined
  algorithm) and functional definition

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Clarity common problems

• Structurally undefined analogues, mimetics,
  agonists, antagonists, etc. will provoke
  objection (clarity and other grounds)
• Specific, structurally defined classes may be
  allowable, e.g. retroenantiomers, antisense
  oligos

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Clarity common problems

• Functional definitions
• Ensure application describes how the function is
  determined, e.g. by activity in assay.
• Must be reproducible give precise descriptions
  of assay conditions, activity thresholds, etc.

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Take-home messages

• What is the contribution to the art?
• What is the technical effect that makes the
  exemplified work inventive over the prior art?
• To what extent can this be generalised with
  reasonable predictability and without undue
  burden?
• If the applicant exemplifies various ways of
  performing the invention, the chances of
  obtaining broad claims are greatly increased

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Take-home messages

• Draft claims that correspond to that extent of
  generalisation (even if there are more ambitious
  claims as well!)
• Ensure that 3rd parties can determine whether
  their activities fall within the claims.
• If the clarity of a claim term is arguable,
  ensure that there is basis in the application for
  defining it more clearly.

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Take-home messages

• Content of prior art may change over time as more
  documents are found
• Include a series of progressively narrower
  generalisations of the invention
• Include these when the application is drafted
• Dont expect to be able to put anything new into
  the application after it is filed
• Also applies to priority application

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Thank you for listening

• chris.denison_at_mewburn.com
• www.mewburn.com