GENERAL

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GENERAL

• Definition
• A product by process claim defines a product in
  terms of the method used to obtain the product
  and not by its elements and structure.
• Relevance
• Biological productse.g. a macromolecule is
  secreted by a micro-organism
• Semiconductorse.g. a wafer prepared by a process
• Chemicale.g. a zeolite (catalyst) manufactured
  by a process
• and other fields, especially biotech.

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• Rule of Necessity
• Can be used only where the product cannot be
  described by its physical characteristics.
• Issue
• Product-by-Process claims only cover a product.
  However, is the product limited by the process,
  or does the claim cover the product, not limited
  by the process, even if made by another process?

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UNITED STATES

• Re Rule of Necessity
• Originally USPTO required the Rule of Necessity.
  
• Since about 1952 no longer a requirement.
• Now a days used whenever applicants wants.
• Typically used to be able to charge user of
  product with direct infringement rather than just
  manufacturer, e.g. to charge the computer company
  using the chip, not just the chip manufacturer.

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• During Prosecution
• MPEP 2133
• even though product-by-process claims are
  limited by and defined by the process,
  determination of patentability is based on the
  product itself if the product in the
  product-by-process claim is the same as or
  obvious from a product of the prior art, the
  claim is unpatentable even though the prior
  product was made by a different process. Citing
  In re Thorpe 777 F.2d 695 (Fed. Cir. 1985). (J.
  Newman decision)

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• The burden then shifts to the applicant to come
  forward with evidence establishing an unobvious
  difference between the claimed product and the
  prior art product.
• Typically this can be presented in a Declaration
  under 37 C.F.R. 1.132.

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• Alleging Infringement
• Scripps Clinic Research Foundation v. Genentech
  (927 F.2d 1565 (Fed. Cir. 1991) (J. Newman
  opinion)
• Held claims are not limited by the method steps.
  They are product claims, independent of how the
  product was made.
• Found that this product was distinguished over
  prior art products by product characteristics
  (e.g. potency and purity), and patentable
  independent of the process used to make the
  product.
• Product-by-process claims must be considered the
  same way for patentability and for infringement.

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• Atlantic Thermoplastic Corp. v. Faytex Corp. (970
  F.2d 834 (Fed. Cir. 1992) (different panel, not
  including J. Newman)
• Held claims are limited in an infringement
  question by the process terms.
• Declined to follow the Scripps case because that
  case did not consider Supreme Court precedent,
  and indicated that the Scripps Court would have
  reached a different result if it had considered
  such controlling precedent. But did not overrule
  Scripps.
• Fed. Cir. Rejected a petition to rehear the case
  en banc. Provoked heated debate.
• Judge Rich Court ignored precedential rules.
  The panel in Atlantic was not only insulting to
  the Scripps panel, it is mutany. It is heresy.
  It is illegal.

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• Judge Newman suggested differences between the
  2 cases.Scripps the product is newAtlantic
  the product is old or obvious, but the process is
  new
• District Courts
• Confused by the 2 cases
• Some followed Scripps, some followed Atlantic

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• Smithkline Beecham Corp. v. Apotex Corp. (439 F.
  3d 1312 (Fed. Cir. 2006 (J. Newman)
• Recognized that the District Court perceived a
  conflict between Scripps and Atlantic and the
  District Court concluded that it was bound to
  follow Scripps because it was the earlier
  decision, and therefore read the product claims
  not limited by the process and found the claims
  anticipated by a prior art product.
• Fed. Cir. Indicated that we need not address the
  controversy here between Scripps and Atlantic.
  The issue does not turn on how broadly or
  narrowly we construe the patents claims, for it
  is undisputed that the product is known in the
  prior art.

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• The Fed. Cir. refused to hear arguments that this
  product has physical characteristics different
  from the prior art, because those arguments were
  not presented timely.
• J. Newman dissented. She indicated that this
  claimed product was different and the case should
  have been remanded to investigate the
  differences.
• Fed. Cir. rejected a petition to rehear en banc,
  in a heated debate.
• J. Rader should clarify conflicting decisions
• J. Newman should clarify that there is no
  conflict.
• Scripps novel product
• Atlantic novel process.

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• Comment
• Perhaps Smithkline was really an issue of
  patentability, and the Fed. Cir. agrees with
  USPTO, not to limit claims during prosecution to
  the process, but will consider only the product
  unless patent can show different product
  characteristics.
• In infringement issues, applicant should be
  concerned that Court will limit infringement to
  performances of the process limitation, only.
• Therefore, claim interpretation will be different
  for prosecution and for infringement.

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EUROPE

• Rule of Necessity
• EPO strictly follows the Rule of Necessity. Only
  if you can not claim it otherwise will
  product-by-process claims be allowed.
• Issue
• In United States
• for prosecution Construe it to cover All
  products
• for infringement Construe it to cover
  Identical Method
• In Europe (EPO)
• for prosecution Construe it to cover Identical
  Product i.e. the process steps place a
  limitation on the product scope of the product
  claim, even though, the scope of the limitation
  may be indeterminate. However, if is not limited
  to only the claimed process.

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Regarding Infringement

• Infringement decisions are on a country basis
• By way of example
• UK House of Lords Case Kirin-Amgen Inc. v
  Hoechst (Oct. 2004)
• The UK must apply the same law as the EPO in
  deciding novelty. Product-by-process claims
  where the product itself is not new, are not
  allowable.
• A new process is not enough to make the product
  new, the product itself must be distinguishable
  in some way from the prior art product in order
  to be new.
• Note in US, in a parallel case, the patent was
  found valed and infringed by a District Court and
  affirmed by the CAFC.

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• The UK Patent Office amended its Examination
  Guidelines to conform to this decision stating
  that product-by-process claims will now be
  treated in the UK as product per se claims. The
  process feature limiting the claim only to the
  extent that a detectable fingerprint is left on
  the product by the process steps.
• In Europe same claim interpretation for
  Patentability and for Infringement.

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• Comment
• Problem with European Approach if there must be
  detectable differences in the product that makes
  it recognizably different from prior art
  products, then claim those differences. The only
  reason for using product-by-process claims in
  Europe is because you cant define the structural
  or physical differences.
• Another problem If you have a patent to a
  process, under European Law (EPC Art 64(2) this
  patent will extend to products directly obtained
  by such a process, even though that product is no
  different than the prior art products.

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JAPAN

• Rule of Necessity
• Only where an object cannot be adequately
  specified by the chemical name or chemical
  structure formula or its properties (1975
  Substance Patent Standards).
• Claim Interpretation

JPO construes a product-by-process claim to
define a final Product, and is not limited to
only a product that is produced by the process
defined in the claim i.e. the process identifies
the claimed product (Identical Product Approach),
not an indispensable element of the claim
(Identical Method Approach
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• Court Cases
• 1997 Tokyo High Court Case No. Hei 6 (Ne) 2857
  Hoffman La Roche Case
• If the product is novel, it is not limited by the
  claimed process but includes other processes for
  producing the identical product.
• 2000 Tokyo District Court Case No. Case No. Hei
  11 (Wa) 8434
• In general not limited to the specific process.
• However, if there are valid reasons for limiting
  the scope of a product-by-process claim to the
  claimed process, the scope of the claim may be
  construed as only limited to that process.
• In this case, during prosecution the patent was
  granted only due to assertions that the process
  was vital to the claimed invention (Prosecution
  History Estoppel?)

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• 2001 Tokyo District Court Case No. Hei (Wa) 27714
• In general must include every limitation and
  therefore cant disregard the process limitation.
  However if there are reasons not to limit it
  just to this process, the claims can be
  considered to cover the identical product.
• In this case, there were appropriate methods of
  claiming the product other than by the process
  and therefore in this case it was intended by the
  patent owner to limit it to the specified
  process.
• Also during examination, assertions that the
  process was vital to the claimed invention.

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• Conclusion
• Product-by-process claims not limited to the
  process, but must be an identical product
  (Identical Product Theory as in Europe)
• However, in litigation, there may be valid
  reasons for limiting the claim to the specific
  process (Identical Process Theory)

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SUMMARY

• United Sates
• Prosecution All products
• Infringement Identical Process (possibly)
• Europe
• Identical Product
• Japan
• Identical Product, but where exception, only
  Identical Process.

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RECOMMENDATIONS

• Try to avoid product-by-process claims, wherever
  possible.
• If must be used, be sure to point out some
  novelty of the product produced.
• Do not argue that the process is vital to the
  invention if you want to try for broader
  coverage.
• Be sure to include Process claims to at least
  cover the novel process.

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Contact Information for Samson Helfgott Director
of Patents Katten Muchin Rosenman LLP 575 Madison
Ave. New York, N.Y., 10022 (212)
940-8683 Samson.Helfgott_at_kattenlaw.com Disclaimer
This presentation does not constitute any
specific legal or business advice.