Transcript Recent Developments In Patent Law: Update On Federal

Recent Developments In
Patent Law: Update On
Federal Circuit Cases
Brian V. Slater, Esq.
Partner
FITZPATRICK, CELLA, HARPER & SCINTO
30 Rockefeller Plaza
New York, NY
www.fitzpatrickcella.com
Standards for Patentability
A valid patent must be:
•Useful
•Novel
•Nonobvious
•Fully and appropriately described
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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)
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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
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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)
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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
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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)
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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
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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 cDNA’s
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)
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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
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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
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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)
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Enzo Facts II
•Patent claimed nucleotide sequence that preferentially
hybridizes to N. gonorrhoeae over N. meningitidis by a
ratio of greater than 5:1
•Dependent claims were drawn to the three deposited
probe sequences and discrete subsequences, mutations,
and mixtures
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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
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Enzo Holdings I
On rehearing, Court faced with two main questions:
1. Whether Enzo’s 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
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Enzo Holdings II
2. 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 PTO’s WD Guidelines
Enzo, 296 F.3d at 1324, 1327-28
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Enzo Additional Issues
1. 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
2. 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”
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Enzo Additional Issues
3. 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.”
Lockwood 107 F.3d at 1572, emphasis omitted
4. Reduction to practice without adequate description is
insufficient to describe invention
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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)
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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
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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
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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).
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Searle Facts I
•Cox-1 enzyme helps protect stomach lining
•Cox-2 enzyme associated with inflammation stimuli
•Prior art drugs (NSAID’s) inhibited both Cox-1 and
Cox-2
•U. Rochester scientists discovered existence of Cox-2
and its separate function from Cox-1
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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
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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
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Searle Additional Issues
Court rejected plaintiff’s contention that Enzo and Lilly
limited to claims directed to nucleic acid sequences:
• Lilly’s 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”
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Searle Additional Issues
Court rejected plaintiff’s argument that WD requirement
doesn’t 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
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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)
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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
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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)
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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)
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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
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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)
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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?
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Bayer Facts
•Patent directed to class of antibiotics including CIPRO
•Patent disclosed way to make CIPRO:
6-FQA + piperazine = CIPRO
•Patent did not disclose inventor’s preferred way of
making 6-FQA, using “Klauke” compound
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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
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Bayer Holding
CAFC affirmed district court’s finding of no best
mode violation
•Must first construe claims
•Claims are to CIPRO end product, not the intermediate
•Schein conceded inventor’s preferred way of making
intermediate had no material effect on properties of
claimed CIPRO end product
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Bayer Comments On “Novelty” Test
•Court rejected Schein’s 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
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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
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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”?
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Example Of Best Mode Affecting Invention’s
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)
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Example of Best Mode Affecting Invention’s
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
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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
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Thank You
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