Transcript research.unc.edu

Recent Developments
in Patent Law
W. Murray Spruill
Question …
• Allowance rates have drastically
dropped at USPTO … WHY???
75.0
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1975 1978 1981 1984
1987 1990 1993 1996 1999 2002 2005 2008*
From: “Trust and Faith: The Credibility of a Patent System Depends on
the Output” John Doll, Commissioner for Patents, October 8, 2008.
Patentability
• What is a patent?
– A grant (from US or other govt. to patent owner) to
exclude others from:
•
•
•
•
•
making;
using;
selling;
offering for sale; or
importing claimed invention
Patentability
• An invention must meet the following
patentability requirements:
–
–
–
–
–
Statutory subject matter** (§ 101)
Utility (§ 101)
Novelty** (§ 102)
Obviousness** (§ 103)
Written Description, Enablement
and Best Mode (§ 112)
** Areas of focus for presentation
Patentability – Subject Matter
• 35 U.S.C. § 101: Patentable subject matter
includes any new and useful process (i.e.,
method), machine, manufacture or composition of
matter, or any new and useful improvement
thereof.
• Unpatentable subject matter includes laws of
nature, natural phenomena and abstract ideas.
• First requirement that the USPTO assesses for
patentability.
Patentability – Subject Matter
• In re Bilski, 545 F.3d 943 (Fed. Cir., October 30,
2008).
– About patenting business methods.
• Methods of hedging risks in commodities trading.
• For example, intermediate buys coal and sells to consumers at a
fixed price.
Patentability – Subject Matter
– Court noted that patentable methods do not include
“laws of nature, natural phenomena, [or] abstract ideas.”
– Court re-established a “machine-or-transformation test”
as the test for all patent-eligible methods.
Patentability – Subject Matter
• Court noted:
– “A claimed process is surely patent-eligible under § 101
if: (1) it is tied to a particular machine or apparatus, or
(2) it transforms a particular article into a different state
or thing.”
– Use of specific machine or transformation of article must
impose meaningful limits.
– An application of a law of nature or math formula to a
known structure or process may be patentable (ex.
curing rubber)
Patentability – Subject Matter
• The purpose of the machine or transformation test is to
prevent the preemption of fundamental principles.
• Fundamental principles = laws of nature, natural
phenomena, and abstract ideas.
• Adding data gathering step to algorithm – not enough to
make it patent eligible.
• Merely displaying on a machine not enough.
Patentability – Subject Matter
• Any method claims should either recite a nexus between
the method and a machine, or emphasize a
transformation step leading to a useful, concrete and
tangible result.
• Bilski has been rigorously applied by the USPTO and
courts. Fate of Bilski uncertain as the Supreme Court
granted certiorari on June 1, 2009. The case is set for
oral argument on November 9, 2009.
Patentability – Subject Matter
• Classen Immunotherapies, Inc. v. Biogen IDEC,
No. 2006-1634, -1649 (Fed. Cir., December 8,
2008).
– A method of determining whether an immunization
schedule affects incidence or severity of a chronic
immune-related disorder comprising immunizing
mammals with one or more doses of one or more
immunogens according to the immunization schedule,
and comparing prevalence, frequency or severity of
disorder in treatment group and control group.
Patentability – Subject Matter
– Interestingly, the court’s decision was shorter than the
claim at issue: “In light of our decision in In re Bilski, 545
F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district
court’s grant of summary judgment that these claims are
invalid under 35 U.S.C. § 101. Dr. Classen’s claims are
neither ‘tied to a particular machine or apparatus’ nor do
they ‘transform[] a particular article into a different state
or thing.’ Bilski, 545 F.3d at 954. Therefore we affirm.”
Patentability – Subject Matter
• Prometheus Laboratories, Inc. v. Mayo Collaborative
Services, No. 2008-1403 (Fed. Cir., September 16,
2009).
– Method claims for calibrating the proper dosage of
thiopurine drugs used to treat various gastrointestinal
disorders such as Crohn’s disease and ulcerative colitis.
Patentability – Subject Matter
– “A method of optimizing therapeutic efficacy for treatment of
an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a
subject; and
(b) determining the level of 6-thioguanine in said subject,
wherein the level of 6-thioguanine less than about 230 pmol
per 8 x 108 red blood cells indicates a need to increase the
amount of said drug subsequently administered to said
subject and wherein the level of 6-thioguanine greater than
about 400 pmol per 8 x 108 red blood cells indicates a need to
decrease the amount of said drug subsequently administered
to said subject.”
Patentability – Subject Matter
• Invention offers an iterative approach to dosing:
– Administer drug.
– Determine level of drug in subject.
– Decide whether next dose should be the same, higher, or
lower.
Patentability – Subject Matter
• Invention involves a mental step.
– The claim identifies the threshold that is important.
– Process of comparing the drug level to threshold is in mind of
physician.
Patentability – Subject Matter
– District court found that the administering and
determining steps were merely necessary “datagathering” steps for any use of the correlations.
Patentability – Subject Matter
– Federal Circuit reversed and held that the administering
and determining steps were transformative and thus
satisfy the transformation prong of the machine-ortransformation test.
– Court was clear to distinguish Prometheus claims from
diagnosis claims that merely require data gathering and
correlation.
– Claims are transformative when a drug is administered.
Patentability – Subject Matter
• Petition for cert filed with Supreme Court.
• Supreme Court granted cert in Laboratory Corp. of
America Holdings v. Metabolite.
Patentability – Subject Matter
• Metabolite’s claims
– A method for detecting a deficiency of cobalamin or folate in
warm-blooded animals comprising the steps of:
• assaying a body fluid for an elevated level of total
homocysteine; and
• Correlating an elevated level of total homocystein in said
body fluid with a deficiency of cobalamin or folate.
Patentability – Subject Matter
• See U.S. Pat. No. 5,443,036:
– 1. A method of inducing aerobic exercise in an unrestrained
cat comprising the steps of:
• (a) directing an intense coherent beam of invisible light
produced by a hand-held laser apparatus to produce a
bright highly-focused pattern of light at the intersection of
the beam and an opaque surface, said pattern being of
visual interest to a cat; and
• (b) selectively redirecting said beam out of the cat’s
immediate reach to induce said cat to run and chase said
beam and pattern of light around an exercise area.
Patentability – Subject Matter
– What can you do to minimize non-statutory subject
matter rejections in view of these cases when claiming
and describing an invention in an application?
Patentability – Novelty
• Governed by 35 U.S.C. § 102: An invention is not
patentable if it was disclosed before the date of
filing, or before the date of priority if a priority is
claimed, of a patent application, or if statutorily
barred.
Patentability – Novelty
• Under US patent law, an invention lacks novelty
when one prior art reference or event discloses all
the elements or limitations of a claim and enables
one of skill in the art to make and use the claimed
invention.
Patentability – Novelty
• Sanofi-Synthelabo v. Apotex, Inc., No. 2007-1438
(Fed. Cir., December 12, 2008).
– About a denial of a validity challenge by generic
pharmaceutical company Apotex of Sanofi’s patent for
the dextrorotary isomer of methyl alpha-5(4,5,6,7tetrahydro-(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate
(i.e., Plavix®; US Patent No. 4,847,265).
Patentability – Novelty
Claim:
– “Hydrogen sulfate of the dextro-rotatory isomer of methyl
alpha-5(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)(2chlorophenyl)-acetate
methyl
alpha-5(4,5,6,7tetrahydro(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate
substantially separated from the levo-rotatory isomer.”
Patentability – Novelty
– Sanofi separated the enantiomers of MATTPCA and
found that L-form had virtually all the neurotoxicity and
that the R-form had the biological activity (anti-platelet
activity) and filed the application that became the ‘256
patent.
• Parties agreed that generally known in the art that
enantiomers can have different biological activities,
but that it was rare to have such polar activities in
enantiomers.
• Sanofi earlier patent to racemic mixture cited as prior
art.
Patentability – Novelty
• Sanofi presented evidence:
– Hundreds of derivatives that were synthesized and tested.
– First compound approved had serious side effect.
– Second series of compounds synthesized still with serious side
effects (21 examples in patent).
– Plavix enantiomer displayed absolute stereoselectivity.
Patentability – Novelty
• Additional considerations:
– Separating enantiomers difficult and unpredictable both in
terms of the process of separation and the properties.
– Absolute stereoselectivity displayed by Plavix rare,
unexpected, and unpredictable.
Patentability – Novelty
– Apotex argued that separation of enantiomers routine
and that properties of enantiomers inherent and
necessarily present in the racemate.
– Count found that “the knowledge that enantiomers may
be separated is not ‘anticipation’ of a specific enantiomer
that has not been separated, identified and
characterized.”
– Court also found that the prior art did not enable one of
skill in the art to make the claimed enantiomer.
Patentability – Novelty
• In re Gleave, No. 2008-1453 (Fed. Cir., March 26,
2009).
– About USPTO rejection of claims directed toward
antisense oligonucleotides for Insulin-Dependent Growth
Factor Binding Proteins (“IGFBP”).
– Looked at whether a prior art document disclosing sense
nucleic acid molecules with unknown utility can
anticipate antisense nucleic acid molecules.
Patentability – Novelty
Claim:
– “A bispecific antisense oligodeoxynucleotide, wherein
substantially all of the oligodeoxynucleotide is
complementary to a portion of a gene encoding human
IGFBP-2 and substantially all of the
oligodeoxynucleotide is also complementary to a gene
encoding human IGFBP-5, and wherein the
oligodeoxynucleotide is of sufficient length to act as an
antisense inhibitor of human IGFBP-2 and human
IGFBP-5.”
Patentability – Novelty
– Prior art reference disclosed a list of all 15-mer sense
oligonucleotides (>1400 sequences) from a (publiclyavailable) full-length IGFBP-2 sequence.
– Disclosed that antisense oligonucleotides could
comprise any oligonucleotides that specifically bind to
(i.e., hybridize with) any of the disclosed 15-mer sense
oligonucleotides.
Patentability – Novelty
– For a reference to anticipate under § 102, it needs to
satisfy two (2) requirements: (1) it must disclose each
and every element of the claimed invention (explicitly or
implicitly as “arranged or combined in the same way as
in the claim”); and (2) it must enable one of skill in the art
to make and use the invention without undue
experimentation.
Patentability – Novelty
– The court held that anticipation required merely that the
oligonucleotide sequence was in the prior art.
Anticipation found even though no antisense
oligonucleotide disclosed.
– Court suggested that method of using the antisense
compounds may be patentable.
Patentability – Obviousness
• Governed by 35 U.S.C. § 103: An invention is not
patentable if it would have been obvious to one of
ordinary skill in the art.
– Distinguished from novelty in that each and every
element or limitation of the claimed invention does not
need to be contained in a single reference or event.
Patentability – Obviousness
• KSR Intl v. Teleflex, Inc., 550 U.S. 398 (2007).
– About patent infringement of an adjustable vehicle
control pedal connected to an electronic throttle control.
– Supreme Court case addressing obviousness.
Patentability – Obviousness
• Sensors
– Car engines without computer-controlled throttles – the
accelerator interacts with throttle via mechanical link/cable.
– ’90’s computers installed in cars to control engine operation –
open and close valves in response to electronic signals.
– Computer-control throttle uses electronic sensor.
Patentability – Obviousness
• Pedals
– Traditionally a pedal could not have its position in footwell
adjusted by sliding pedal back and forth.
– 70’s – pedals designed that could be adjusted to change their
location in footwell.
Patentability – Obviousness
• Prior art also disclosed placement of sensors on
adjustable pedals.
• Sensor located in pedal footpad – suffered from wire
chafing.
Patentability – Obviousness
• KSR patent
– Adjustable pedal with an electronic sensor attached to support
member allowing sensor to remain in a fixed position while
driver adjusts pedal.
– Prior art showed a support structure for an adjustable pedal
where one of the pedal’s pivot points remains fixed.
Patentability – Obviousness
• District Court – obvious
• Federal Circuit – not obvious
– Obvious to try does not constitute obviousness.
– Teaching, motivation, suggestion test.
Patentability – Obviousness
• Supreme Court – obvious
– The combination of familiar elements according to known
methods – obvious – when it yields predictable results
– Rejected TMS test.
– Relied on 1966 Graham v. John Deere Co.
Patentability – Obviousness
• Graham Factors:
– Determine the scope and content of the prior art;
– Determine the level of ordinary skill in the art;
– Determine the differences between the claimed invention
and the prior art; and
– Consider objective evidence of nonobviousness.
• e.g., commercial success, long-felt but unsolved needs and/or
failure of others.
Patentability – Obviousness
• When there is a design need or market pressure to solve
a problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has a
good reason to pursue known options.
• In that instance, the fact that a combination was obvious
to try → obvious.
Patentability – Obviousness
• A person of ordinary skill often will be able to fit
teachings of multiple patents together like pieces of a
puzzle.
Patentability – Obviousness
• Mechanical invention → application to chemistry and
biotechnology (unpredictable arts).
Patentability – Obviousness
• Impax Laboratories, Inc. v. Aventis Pharmaceuticals,
Inc.
– Prior art reference must be enabling Aventis patent to the use
of riluzole to treat ALS.
Patentability – Obviousness
– Previous patent by Aventis disclosed class of compounds and
indicated that they were useful for treatment of variety of
diseases including ALS.
– Some dosage information provided.
Patentability – Obviousness
The court reasoned:
• Not an enabling reference since
– Riluzole is one of hundreds of compounds.
– Did not teach that riluzole per se could be used to treat ALS.
– Dosage information was broad and not specific to any
particular compound.
Patentability – Obviousness
• Procter & Gamble Co. v. Teva Pharmaceuticals USA,
Inc.
– In addition to structural similarity, prima facie obviousness
requires some reason or motivation for making the changes to
a known compound: unpredictability of the art must be
considered.
– Patent drawn to risedronate, the active ingredient in Actonel.
– Teva asserted P&G’s patent claims were invalid as having
been obvious in light of an expired P&G patent disclosing
structural similar compounds.
• Background
– Risedronate was a member of a group of compounds known as
biphosphonates which were active in inhibiting bone
resorption.
– The ‘406 patent listed thirty-six polyphosphonate molecules as
treatment candidates for intermittent dosing, including 2-pyr
etidronate (EHDP).
– Risedronate (3-pyr EHDP) and 2-pyr EHDP were positional
isomers.
Patentability – Obviousness
– In finding claims not obvious, court considered:
• P&G experts testified that as of the filing date, a person of ordinary
skill in the art would have understood that the properties of
bisphosphonates could not be anticipated based on their structure.
• In 1984 – every bisphosphonate compound exhibits its own physicalchemical, biological and therapeutic characteristics, that each
bisphosphonate has to be considered on its own.
• P&G had synthesized and tested 2-pyr EHDP, risedronate (3-pyr
EHDP) and 4-pyr EHDP, and had confirmed that unpredictability of
bisphosphonates – test results for 4-pyr EHDP indicated that it was not
active in inhibiting bone resportion.
Patentability – Obviousness
• Ritchie v. Vast Resources, Inc.
– Sex aid made from Borosilicate glass obvious where
properties are known and borosilicate glass used to make
Pyrex glassware.
– Patent claimed a “sexual aid *** fabricated of a generally
lubricious glass-based material containing an appreciable
amount of an oxide of boron to render it lubricious and
resistant to heat, chemicals, electricity and bacterial
absorptions.”
Patentability - Obviousness
– Glass that contains boron oxide is called “borosilicate glass.”
– In prior art, glass sexual devices were made out of soda-lime
glass.
– Federal Circuit fund that the claimed invention would have
been obvious under § 103.
Patentability – Obviousness
• The court noted that “lubricious” in the context of the
patent-in-suit meant “slippery” (although adding the
primary meaning of the word was “lecherous”).
Patentability – Obviousness
• Factors:
– Pyrex glassware was originally made from borosilicate glass
by Corning, Inc.
– Borosilicate glass was known to be “lubricious.”
Patentability – Obviousness
• The Court reasoned that since borosilicate glass is a
standard product with well-known properties –
including the properties listed in the patent – to
experiment with substituting borosilicate glass for
ordinary glass in a sexual device was not a venture into
the unknown.
Patentability – Obviousness
– In re Bell and In re Deuel, two Federal Circuit decisions
from the 1990's, established an early standard for
obviousness with respect to biotechnological inventions.
Natural Killer Cell Activation Inducing Ligand (“NAIL”).
Patentability - Obviousness
• In re Bell, 991 F.2d 781 (Fed. Cir. 1993)
– Claim 15. Purified nucleic acid molecules containing a human
sequence encoding insulin-like growth factors I and II
(“IGF”).
Patentability – Obviousness
• Bell: Prior Art
– Amino acid sequences for IGF-I and -II;
– General method for isolating a gene that encodes a particular
protein where at least a short amino acid sequence of the
encoded protein is known; and
– General method employing a probe specifically corresponding
to the known amino acid sequence for the protein.
– Discloses that it is advantageous to design the probe based on
amino acids specified by unique codons.
Patentability - Obviousness
• Bell: Board Decision
– Board found that the claimed sequences would have been
obvious because the DNA and protein are linked via the
genetic code, even though they are not structurally similar,
given:
• Disclosure of the partial structure for the protein; and
• General cloning methods.
Patentability - Obviousness
• Bell: CAFC
– CAFC acknowledged one could hypothesize the possible structures for a
gene if the structure of the protein is known based on the genetic code.
– But CAFC observed that a vast number of nucleotide sequences might
code for a specific protein given the degeneracy of the genetic code.
• Undisputed that 1036 different nucleotide sequences could code for IGF amino
acid sequence.
– CAFC thus concluded that the claimed nucleic acid molecules would not
have been obvious in light of:
• Nearly infinite number of possible nucleotide sequences; and
• Failure of prior art to suggest which of these possibilities is the claimed human
sequence.
Patentability - Obviousness
• Bell: Limitations
– CAFC limited Bell’s reach:
“This is not to say that a gene is never rendered obvious
when the amino acid sequence of its coded protein is
known. Bell concedes that in a case in which a known
amino acid sequence is specified exclusively by unique
codons, the gene might have been obvious.”
Patentability – Obviousness
• In re Deuel
51 F.3d 1552 (Fed. Cir. 1995)
• Claimed invention directed to isolated and purified
DNA and cDNA molecules encoding heparin-binding
growth factors (“HBGF”)
– Claim 4. All possible isolated/purified DNAs
encoding HBGF
– Claim 5. Specific DNA encoding HBGF
Patentability - Obviousness
• Deuel: CAFC
– CAFC rejected the use of a prior art method as a basis for
finding a claimed composition obvious:
• “We today reaffirm the principle, stated in Bell, that the existence of a
general method of isolating cDNA or DNA molecules is essentially
irrelevant to the question of whether the specific molecules themselves
would have been obvious, in the absence of other art that suggests the
claimed DNAs.
Patentability - Obviousness
– CAFC emphasized that a prima facie case of unpatentability
of a chemical compound is based on the structural similarity of
the claimed compound to a prior art compound (“Structural
Similarity Test”)
– CAFC reasoned that the structural relationship between the
claimed compound and the prior art compound may provide
the requisite motivation or suggestion to modify known
compounds to obtain new compounds
Patentability - Obviousness
• Deuel: CAFC
– Even if disclosure of a protein structure and general cloning
techniques might have given a skilled artisan the motivation to
make a cDNA, that does not render the claimed cDNA
obvious.
Patentability - Obviousness
• In re Kubin Effectively Overturned by KSR: Nucleic
acid sequence obvious where protein is known and
technique for cloning is known
– Claim
• An isolated nucleic acid molecule comprising a polynucleotide
encoding a polypeptide at least 80% identical to amino acids 22-221 of
SEQ ID NO:2, wherein the polypeptide binds CD48.
• Claims were drawn to polynucleotides that encoded a polypeptide
known as the Natural Killer Cell Activation Inducing Ligand
(“NAIL”).
• NAIL is a specific receptor protein on the cell surface that plays a role
in activating NK cells.
Patentability - Obviousness
• Rejection:
– The primary reference was a patent to Valiante that disclosed a
receptor protein called “p38”, which was the same protein as
NAIL.
– Valiante also disclosed:
• A monoclonal antibody specific for p38
• The DNA and protein sequences for the receptor p38 may be obtained
by resort to conventional methodologies
– Sambrook et al., Molecular Cloning, A Laboratory Manual,
was the second reference the board had relied upon.
Patentability - Obviousness
• Valiante did not disclose either the amino acid sequence
for p38 or the sequence for the DNA molecule that
encodes p38.
• Sambrook disclosed method for molecular cloning, but
did not discuss how to clone any particular gene.
Patentability - Obviousness
• The board reasoned that Valiante’s disclosure of the
existence of p38 and a method of isolating its DNA,
including disclosure of a monoclonal antibody to do so,
established that Valiante had possession of the amino
acid sequence for p38 and that there was a reasonable
expectation of success in obtaining a polynucleotide.
• Because of the importance of NAIL in the human
immune response system, one of ordinary skill in the art
would have been motivated to use conventional
techniques, such as disclosed in Sambrook and used by
Valiante, to obtain such a polynucleotide
Patentability - Obviousness
• On appeal, the Federal Circuit affirmed.
• KSR had cast doubt on the continued viability of Deuel.
• The court relied on the Supreme Court’s statement in
KSR that where a skilled artisan merely pursues “known
options” from a “finite number of identified, predictable
solutions”, obviousness under §103 arises.
• The Federal Circuit also refused to limit KSR to
“predictable arts”.
– What can you do to minimize obviousness rejections for
molecular biology-related inventions in view of these cases
when claiming an invention:
• Importance of building record
– Note the variety of attempts to perform what may be considered a simple
experiment
– Keep track of your successes as well as the failures (not only the failures
of others)
– Shift of focus to the predictability of the prior art methods rather than
predictability of a claimed structure (although predictability of the
structure is still important)
– Note improvements to unsuccessful prior art methods
– Avoid characterizing methods as standard
Patentability - Obviousness
• Balance with Enablement
– Beware of building too strong a case for
enablement.
» The Court seized on the fact that Sambrook was
incorporated by reference in Kubin’s application as well
as the prior art Valiante patent.
» The likely reason Sambrook was incorporated by
reference in both instances was to support the case for
enablement of the respective inventions.
» Of course, this is easier said than done. The Examiner
rejected Kubin’s application for lack of enablement as
well as lack of adequate written description, and
obviousness.
Questions
Thank you!