Recent Developments In Patent Law: Update On Federal Circuit Cases

1
Recent Developments In Patent Law Update
OnFederal Circuit Cases
Brian V. Slater, Esq. Partner

• FITZPATRICK, CELLA, HARPER SCINTO
• 30 Rockefeller Plaza
• New York, NY

2
Standards for Patentability

• A valid patent must be
• Useful
• Novel
• Nonobvious
• Fully and appropriately described

3
Overview

• Written description
• Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d
  1316 (Fed. Cir. 2002)
• Enzo Biochem, Inc. v. Gen-Probe Inc., 42 Fed.
  Appx. 439 (Fed. Cir. 2002)
• U. of Rochester v. G.D. Searle Co., 2003 U.S.
  Dist. LEXIS 3030 (W.D.N.Y. 2003)
• Best mode
• Bayer AG v. Schein Pharmaceuticals, Inc., 301
  F.3d 1306 (Fed. Cir. 2002)

4
Written Description Statute

• The specification shall contain a written
  description of the invention, and of the manner
  and process of making and using it, in such full,
  clear, concise, and exact terms as to enable any
  person skilled in the art to which it pertains,
  or with which it is most nearly connected, to
  make and use the same, and shall set forth the
  best mode contemplated by the inventor of
  carrying out his invention

35 U.S.C. 112, 1
5
Written Description Basics

• Fact question
• Meaningful disclosure is quid pro quo to public
  for being excluded from practicing the invention
  for limited period
• An application itself must describe an
  invention, and do so in sufficient detail that
  one skilled in the art can clearly conclude that
  the inventor invented the claimed invention as of
  the filing date sought.

Lockwood v. American Airlines, Inc., 107 F.3d
1565, 1572, 1966 (Fed. Cir. 1997)
6
Written Description v. Enablement

• Written description means describing the
  invention in sufficient detail that one skilled
  in the art can conclude that the inventor
  invented the claimed invention
• Enablement means one skilled in the art is taught
  by the patent how to make and use the invention,
  without undue experimentation

7
Written Description Basics

• Most often applied to priority situation, e.g.,
  new matter added
• Does WD requirement apply to original claims?
• YES The Regents of the University of
  California v. Eli Lilly and Co., 119 F.3d 1559
  (Fed. Cir. 1997)

8
Lilly Facts

• Patent specification disclosed
• rat insulin cDNA sequences
• method for obtaining them
• amino acid sequences of human insulin
• Claims in dispute were to vertebrate, mammalian
  and human insulin cDNA

9
Lilly Holdings I
Court affirmed judgment that both human cDNA and
genus cDNA patent claims were invalid for lack of
WD

• Human cDNA claims
• patent describes only general method for
  obtaining human-insulin encoding cDNA, but not
  cDNAs relevant structural or physical
  characteristics
• description of human insulin amino acid sequences
  does not describe cDNA that encodes them (because
  of redundancy of genetic code)

10
Lilly Holdings II

• Genus cDNA claims
• disclosure of rat cDNA sequences does not
  describe structure of sufficient members of broad
  functional classes of vertebrate or
  mammalian insulin cDNA
• A definition by function . . . does not
  suffice to define the genus because it is only an
  indication of what the gene does, rather than
  what it is

Lilly, 119 F.3d at 1568
11
Lilly Consequences

• How should one properly describe cDNA genus?
• According to Lilly
• One way is to recite the nucleotide sequences of
  a representative number of cDNAs (silent as to
  what is representative)
• Another way is to recite structural features
  common to genus members, which features
  constitute a substantial portion of genus

Lilly, 119 F.3d at 1569
12
Enzo Facts I

• Detection of bacteria that causes gonorrhoeae
  difficult because of high degree of homology
  between N. gonorrhoeae and N. meningitidis
• Specification referred to ATCC deposit of three
  sequences that preferentially hybridize to six
  common strains of N. gonorrhoeae over six common
  strains of N. meningitidis (also deposited)

Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d
1316 (Fed. Cir. 2002)
13
Enzo Facts II

• Patent claimed nucleotide sequence that
  preferentially hybridizes to N. gonorrhoeae over
  N. meningitidis by a ratio of greater than 51
• Dependent claims were drawn to the three
  deposited probe sequences and discrete
  subsequences, mutations, and mixtures

14
Enzo Procedural Background

• Original panel decision (Lourie Prost Dyk,
  dissenting) affirmed judgment claims were invalid
  for failure to meet WD requirement of 35 U.S.C.
  112
• rejected argument that deposit inherently
  disclosed inventors were in possession of claimed
  sequences
• On rehearing, panel unanimously vacated that
  decision and reversed and remanded

15
Enzo Holdings I

• On rehearing, Court faced with two main
  questions
• Whether Enzos deposits of claimed sequences of
  dependent claims constituted an adequate WD?
• Issue of first impression
• Reference in specification to a deposit in a
  public depository, when it is not otherwise
  available in written form, constitutes an
  adequate WD
• Remanded fact issue of whether subsequences,
  mutations, and mixtures were described by
  reference to the deposited sequences

Enzo, 296 F.3d at 1325
16
Enzo Holdings II

• Whether WD requirement is met for all claims on
  basis of functional ability of three deposited
  probe sequences to hybridize to deposited strains
  of N. gonorrhoeae?
• Depends on whether three deposited sequences are
  representative of the genus under Lilly
• PTO WD Training Example 9 provide that nucleic
  acid genus claims may be adequately described if
  nucleic acids hybridize under highly stringent
  conditions to known sequences
• Remanded issue to be decided consistent with
  Lilly and PTOs WD Guidelines

Enzo, 296 F.3d at 1324, 1327-28
17
Enzo Additional Issues

• Whether reference to deposit of six strains of N.
  gonorrhoeae inherently describes claimed
  sequences that hybridize to them (i.e., by
  showing function/structure correlation) is a fact
  issue
• Ipsis verbis inclusion of claim words in
  specification does not necessarily satisfy the WD
  requirement, e.g., an anti-inflammatory steroid
  or an antibiotic penicillin

18
Enzo Additional Issues

• Even if three deposited probe sequences indicated
  Enzo possessed invention, possession may not
  be sufficient to describe invention
• compare Lockwood, One shows that one is in
  possession of the invention by describing the
  invention, with all its claimed limitations, not
  that which makes it obvious.
• Reduction to practice without adequate
  description is insufficient to describe invention
  

Lockwood 107 F.3d at 1572, emphasis omitted
19
Enzo En Banc Rehearing Denial

• Only Rader, Gajarsa and Linn voted for rehearing
  (PTO filed brief as amicus in favor of rehearing)
• Dyk, who voted against rehearing, nevertheless
  said Court would benefit from further
  percolation of the issues

Enzo Biochem, Inc. v. Gen-Probe Inc., 42 Fed.
Appx. 439 (Fed. Cir. 2002)
20
Enzo En Banc Rehearing Denial

• Those for en banc rehearing
• based on statute, there is no separate WD
  requirement only an enablement requirement
• separate WD requirement introduced by CCPA in
  1967 only for determining priority
• Lilly was first CAFC case to apply WD outside of
  a priority context
• Lilly and Enzo result in heightened disclosure
  requirement making enablement irrelevant

21
Enzo En Banc Rehearing Denial

• Those against en banc rehearing
• WD is separate requirement from enablement
• Statute says and between mentions of WD and
  enablement
• Supreme Court in Festo said patent application
  must describe, enable and set forth the best mode
  of carrying out the invention
• Fact that prior WD cases may have dealt only with
  priority is circumstantial

22
Post-Enzo WD Decisions

• Does Enzo and Lilly WD requirement apply to
  pharmaceutical method of treatment claims?
• YES U. of Rochester v. G.D. Searle Co., 2003
  U.S. Dist. LEXIS (W.D.N.Y. 2003).

23
Searle Facts I

• Cox-1 enzyme helps protect stomach lining
• Cox-2 enzyme associated with inflammation stimuli
• Prior art drugs (NSAIDs) inhibited both Cox-1
  and Cox-2
• U. Rochester scientists discovered existence of
  Cox-2 and its separate function from Cox-1

24
Searle Facts II

• Patent describes screening assays useful for
  development of drugs that selectively inhibit
  inflammation without producing side effects due
  to inhibition of Cox-1
• Patent says assays are for screening compounds
  including peptides, polynucleotides and small
  organic molecules
• Patent claims method of administering to humans a
  non-steroidal compound that selectively inhibits
  Cox-2 activity and has minimal effect on Cox-1
  activity

25
Searle Holding

• Court held (Larimer, J.) patent failed to
  provide WD of claimed invention
• patent only describes the function of compound
  called for but no showing of correlation between
  function and structure (relying on PTO WD
  Guidelines)
• inventors did not identify even one suitable
  compound
• patent is merely research plan that describes
  tests to run on wide spectrum of compounds in
  hope at least one will work

26
Searle Additional Issues

• Court rejected plaintiffs contention that Enzo
  and Lilly limited to claims directed to nucleic
  acid sequences
• Lillys holding that the inventors must describe
  invention is not limited to genetic material
• Enzo gave specific non-DNA examples of
  descriptions that would not meet the WD
  requirement, i.e., anti-inflammatory steroid
  and antibiotic penicillin

27
Searle Additional Issues

• Court rejected plaintiffs argument that WD
  requirement doesnt apply to method of treatment
  claims
• claimed method depends upon finding a compound
  that selectively inhibits Cox-2
• It means little to invent a method if one does
  not have possession of a substance that is
  essential to practicing that method

University of Rochester, 2003 U.S. Dist. LEXIS
3030 at 31
28
Status of WD Requirement

• Insufficient votes to overturn Lilly/Enzo
  application of WD to original claims
• Genus can be described by identifying sufficient
  number of species or structural features common
  to substantial portion of genus (Lilly)
• Functional descriptions not enough unless clear
  correlation between function and structure (Enzo)
• WD requirement applies to pharmaceuticals,
  nucleic acids, methods of treatment, and
  compositions (Searle)
• PTO WD Guidelines important reference for
  prosecutors, opinion givers and litigators
  (Enzo/Searle)

29
Best Mode Statute

• The specification . . . shall set forth the best
  mode contemplated by the inventor for carrying
  out his invention.

35 U.S.C. 112, 1
30
Best Mode Basics

• Fact question based on two part test
• 1. Subjective test Did inventor at time of
  filing application possess best mode for
  practicing invention?
• 2. Objective test Is inventor's disclosure
  adequate to enable one of ordinary skill in art
  to practice the best mode?
• Best mode violation need not be intentional

Bayer AG v. Schein Pharmaceuticals, Inc., 301
F.3d 1306, 1320 (Fed. Cir. 2002)
31
Best Mode Basics

• The purpose of the best mode requirement is to
  ensure that the public, in exchange for the
  rights given the inventor under the patent laws,
  obtains from the inventor a full disclosure of
  the preferred embodiment of the invention.

Dana Corp. v. IPC Ltd. Partnership, 860 F.2d 415,
418 (Fed. Cir. 1988)
32
Best Mode v. Enablement

• Best mode is separate and distinct from
  enablement
• Enablement under 112 requires specification to
  disclose an invention in such a manner as will
  teach one of skill in the art how to make and use
  it
• Because of subjective nature of best mode
  inquiry, unlike enablement, it cannot be met by
  mute reference to the knowledge of one of
  ordinary skill in the art and requires actual
  disclosure

Bayer AG, 301 F.3d at 1314
33
Barr Case

• Claims to antidepressant drug Prozac
• Applicant did not disclose (a) cheaper/better
  method for making starting material or (b)
  preferred solvent for recrystallizing and
  purifying end product
• No best mode violation
• Neither starting material nor method to make it
  were claimed, and starting material commercially
  available, not novel
• Recrystallization with a solvent disclosed and
  not claimed selection of particular solvent
  routine to person of skill in the art

Eli Lilly Co. v. Barr Labs., Inc., 251 F.3d 955
(Fed. Cir. 2001)
34
Bayer Case

• Bayer AG v. Schein Pharmaceuticals, Inc., 301
  F.3d 1306 (Fed. Cir. 2002)
• What is the proper legal test for meeting the
  best mode requirement?
• Is the best mode requirement limited to subject
  matter within the scope of the claims?
• Is best mode a trap only for unwary or for
  wary too?

35
Bayer Facts

• Patent directed to class of antibiotics including
  CIPRO
• Patent disclosed way to make CIPRO
• 6-FQA piperazine CIPRO
• Patent did not disclose inventors preferred way
  of making 6-FQA, using Klauke compound

36
Bayer Discussion Of Law

• Focus is on carrying out the invention, i.e., as
  defined by the claims
• CAFC only ever invalidated claims for failure to
  satisfy best mode requirement seven times
• Two categories of best mode violation
• 1. Failure to disclose a preferred embodiment
• 2. Failure to disclose aspects of making or
  using the claimed invention and the undisclosed
  matter materially affected the properties of the
  claimed invention

Bayer AG, 301 F.3d at 1319
37
Bayer Holding

• CAFC affirmed district courts finding of no best
  mode violation
• Must first construe claims
• Claims are to CIPRO end product, not the
  intermediate
• Schein conceded inventors preferred way of
  making intermediate had no material effect on
  properties of claimed CIPRO end product

38
Bayer Comments On Novelty Test

• Court rejected Scheins argument (based on Barr)
  that disclosure of preferred synthetic route to
  intermediate is mandatory because intermediate is
  novel
• According to Court, Barr merely acknowledged
  that when a novel compound is necessary to
  practice the best mode, one of skill in the art
  must be able to obtain that compound, i.e., the
  best mode must be enabled

Bayer AG, 301 F.3d at 1322
39
Bayer Rader Concurrence I

• Judge Rader issued concurring opinion
• District Court correctly applied law in
  concluding best mode was an intermediate, not the
  claimed invention, and its disclosure was not
  compelled
• Majority should have halted its analysis there
• There is no support in statute or case law for
  widening best mode net to include properties of
  invention far less any material effect or impact
  on those properties

Bayer AG, 301 F.3d at 1324
40
Bayer Rader Concurrence II

• Applicants have commercial incentive to disclose
  best mode because otherwise trade secret status
  may be lost to competitor who obtains blocking
  patents
• Best mode historically was trap only for
  uninformed applicant because it was limited to a
  clear scope of claimed invention approach
• Extending best mode requirement to unclaimed
  uses and properties makes it also a trap for
  the wary
• - what is a property?
• - what is a material effect?
• - how material is material?

41
Example Of Best Mode Affecting Inventions
Properties

• Patent on valve stem seal for use in engine
• Seal included portion of elastomeric material
• Inventor concluded fluoride surface treatment was
  necessary to satisfactory performance of seal
  otherwise it leaked
• Specification did not disclose fluoride treatment
• Held best mode violation

Dana Corp. v. IPC Ltd. Partnership, 860 F.2d 415,
420 (Fed. Cir. 1988)
42
Example of Best Mode Affecting Inventions
Properties

• Bayer majority In Dana . . .the inventors
  failed to disclose subjective preferences that
  related to the use of the claimed inventions, and
  the undisclosed information materially affected
  the properties of the claimed inventions.
• Rader concurrence Having invented a unique seal
  apparatus, the inventor could not have guessed
  that the best mode would reach out to encompass a
  process to increase the useful life of one
  component of the invention a process that was
  already well known in the prior art to boot.

Bayer AG, 301 F.3d at 1319, 1325
43
Status of Best Mode Requirement

• Lack of predictability in law
• Materially affect and properties are
  undefined
• Need for en banc clarification by CAFC
• In meantime, applicants need to carefully
  consider not only claimed invention but (1) way
  it is made and used and (2) whether these affect
  its properties (Bayer/Dana)
• If in doubt -- disclose

44
Thank You