1. A claimed antiviral
drug was held to be obvious, despite the antiviral drug being a new chemical
entity.
2. A once-monthly oral dosing regimen was
found to be obvious despite evidence that it had higher efficacy compared to
prior art dosage regimens.
3. Pharma patent
was
unenforceable due to inequitable conduct before the USPTO.
4. A district court’s
ruling of non-enablement was overturned because the defendant provided no
evidence of undue experimentation.
5. A biosimilar
lawsuit was dismissed for lack of standing since the biosimilar product was in
a clinical trial.
6. Disputes prior to issuance of a patent
were held to be justiciable controversies as the basis for a declaratory
judgment lawsuit.
7. The Federal Circuit did not find any
clear error in the district court’s conclusion that the infringer failed to
prove by clear and convincing evidence that a food effect for the micronized
formulation was known in the art, but found an error in the district court’s
reliance on the doctrine of inherency to disclose the food effect limitation.
8. A primer was held to be ineligible
matter for patent based on the Supreme Court’s holding in Myriad. Claims
of the patent that require comparing a patient’s gene with the wild-type and
identifying any differences are patent ineligible subject matter in view of Alice.
9.
Patent
claims were held to be nonobvious because the prior art failed to meet the
claimed strength, dissolution limitations, and claimed amounts of modified
release polymers.
10. Claims to a
diagnostic test using cell-free fetal DNA (cffDNA) were held to be not patent
eligible under 35 U.S.C. § 101.
11. Patent claims
directed to sequencing deoxyribonucleic acid (DNA) are invalid as obvious.
12. A subsection (k) applicant
(biosimilar) may only give effective notice of commercial marketing after the
FDA has licensed its product, effectively delaying launch of a biosimilar
product by six months.
1.
Bristol-Myers Squibb Co. v. Teva Pharmaceuticals
USA, Inc., 769 F.3d 1339 (Fed. Cir. 2014).
The Federal Circuit affirmed the district
court’s ruling that the claimed antiviral drug was obvious, despite the
antiviral drug being a new chemical entity.
Bristol-Myers Squibb (BMS) modified
the natural nucleoside 2′-deoxyguanosine (deoxyguanosine), which resulted in
the product Entecavir. The product is structurally identical to deoxyguanosine
except for one difference: it has a carbon-carbon double bond (also known as an
exocyclic methylene group) at the 5’ position of the carbocyclic ring, while
deoxyguanosine has an oxygen atom.
The district court held that one of
ordinary skill in the art would have been motivated to select 2’-CDG as a lead
compound and to modify it to obtain the claimed compound. Expert testimony
revealed that in choosing whether to modify 2′-CDG’s carbocyclic ring or its
guanine base, the carbocyclic portion of 2’-CDG would be retained. However,
testimony also showed that other chemists were making changes to the
carbocyclic portion. Teva’s expert also testified that changing the carbocyclic
portion resulted in greater activity than changes to the guanine ring.
Accordingly, this was a natural decision because the goal was to develop antivirals
with improved activity. Unrefuted expert testimony also explained how the next
obvious choice for modification would have been either the 2’ or 5’ position on
the carbocyclic ring, because those were the only two locations where small
changes could easily be made to the molecule. A skilled artisan would focus on
the smallest elements on the top row of the periodic table, including carbon
and fluorine. In addition to expert testimony, the court stated that toxicity
concerns did not prevent BMS from using 2’-CDG as a starting point.
Although
BMS argued that a new chemical entity, as a matter of law, cannot be obvious
when the claimed invention possesses unexpected properties, the Federal Circuit
explained that an unexpected result or property does not by itself support a
finding of nonobviousness.
District
court holding affirmed.
2.
Hoffmann-La Roche Inc. v. Apotex
Inc., 748 F. 3d 1326 (Fed. Cir. 2014).
A
once-monthly oral dosing regimen was found to be obvious despite evidence that
it had higher efficacy compared to prior art dosages.
The
issue in this case is whether it would have been obvious at the time of
invention to select a once-monthly oral dosing regimen of ibandronate to treat
osteoporosis and to set that dose at 150 mg, as claimed in the asserted patent.
A representative claim on appeal reads as follows:
1.
A
method for treating or inhibiting postmenopausal osteoporosis in a
postmenopausal woman in need of treatment or inhibition of postmenopausal
osteoporosis by administration of a pharmaceutically acceptable salt of
ibandronic acid, comprising:
(a) commencing
the administration of the pharmaceutically acceptable salt of ibandronic acid
by orally administering to the postmenopausal woman, on a single day, a first
dose in the form of a tablet, wherein the tablet comprises an amount of the
pharmaceutically acceptable salt of ibandronic acid that is equivalent to about
150 mg of ibandronic acid; and
(b) continuing the administration by orally
administering, once monthly on a single day, a tablet comprising an amount of
the pharmaceutically acceptable salt of ibandronic acid that is equivalent to
about 150 mg of ibandronic acid.
With
regard to monthly dosing, prior art disclosed a preferred embodiment in which
“a dosage form of the invention is administered to a patient . . .
preferably once a month.” With respect to the selection of a specific 150 mg
monthly dose, the Federal Circuit relied on a prior art reference that
disclosed 2.5 and 5 mg daily doses “showed positive outcome in all regions.” Additionally,
another prior art reference disclosed weekly doses of ibandronate “from the
group consisting of 35 mg, 40 mg, 45 mg, or 50 mg.” The 35 mg weekly dose of
ibandronate is equivalent to a 5 mg daily dose, which appears in the
aforementioned prior art references. This suggested that there was a reasonable
expectation of success with the total-dose equivalents of the 5 mg daily dose.
Based on the daily and weekly dosage disclosed in the prior art, the Federal
Circuit held that it would be obvious to extrapolate a monthly dose of 150 mg
(5 mg/day x 30 days = 150 mg/month).
The
Federal Circuit found the claim obvious despite conceding that the 150 mg
resulted in greater efficacy:
“While the
evidence would support a finding of superior efficacy of the 150 mg monthly
dose in raising BMD levels, as compared to a 2.5 mg daily dose, that improved
efficacy does not rebut the strong showing that the prior art disclosed monthly
dosing and that there was a reason to set that dose at 150 mg. . . . The
evidence of superior efficacy does nothing to undercut the showing that there
was a reasonable expectation of success with the 150 mg monthly dose, even if
the level of success may have turned out to be somewhat greater than would have
been expected. For the same reasons, the nonlinear bioavailability of
ibandronate does not rebut the prima facie showing of obviousness of a once
monthly dose of 150 mg.”
The
dissent believed the claim to be nonobvious because the once-a-month dose
approach “required twelve years of research and clinical testing and evaluation
to demonstrate its efficacy when dosed once a month and its safety at this high
monthly dosage.” Without the “extensive exploration,” the successful method of
a monthly dose would not have been successful. Furthermore, prior art does not
show or suggest the single dose of 150 mg in addition to once-a-month
administration. The dissent also expressed concern over the court’s ruling,
stating that improvements will be discouraged, and relied on the following data
which illustrates the 150mg dose resulting in unexpectedly high amount of
ibandronate in serum.
3.
Apotex Inc. v. UCB, Inc., 763 F.3d 1354 (Fed. Cir.
2014).
The Federal Circuit affirmed the
district court holding that U.S. Patent No. 6,767,556 (the ‘556 patent) was unenforceable
due to inequitable conduct before the USPTO.
The ‘556 patent is directed to the
manufacture of moexipril tablets. Moexipril is an angiotension-converting
(“ACE”) inhibitor and is susceptible to degradation and instability. Claim 1,
the only independent claim which relates to the improved stability of the
compound, reads as follows:
1. A
process of making a solid pharmaceutical composition comprising moexipril
magnesium, said process comprising the step of reacting moexipril or an acid
addition salt thereof with an alkaline magnesium compound in a controlled
manner in the presence of a sufficient amount of solvent for a predetermined amount
of time so as to convert greater than 80% of the moexipril or moexipril acid
addition salt to moexipril magnesium.
The explanation for need of a solvent
as noted in claim 1 is known as “wet granulation” and has been known in the
industry since the 1980s. To overcome a prior art reference, U.S. Patent No.
4,743,450 (the ‘450 patent), the patentee argued that its product contained
moexipril hydrochloride and magnesium oxide is therefore “capable of an
acid-base reaction that is difficult to control and results in uncertainty
regarding the final composition of the product.” The patentee further submitted
an expert declaration which stated that the alkaline magnesium compound in the
prior art ‘450 patent behaved as a stabilizer and did not react. The
declaration further stated that a person of ordinary skill in the art would not
expect a reaction to occur between the moexipril and the alkaline stabilizer. The
patentee then amended the claim to state at least an 80% conversion, as opposed
to the claimed “greater than 80%,” to distinguish the prior art in which there
was no reaction.
Prior to a
jury trial for the infringement of the ‘556 patent, a bench trial was held
pertaining to claim construction and equitable defenses. The district court
held that the patentee committed inequitable conduct during prosecution because
the patentee was aware of a reaction in the prior art between the moexipril and
the alkaline magnesium compound. The inventor conceded during trial that he had
a “strong suspicion” and a “belief” that the prior art was made according to
his claimed process. Additionally, the inventor conducted tests that compared
the prior art to a moexipril product with no alkaline stabilizer. In his
handwritten notes, the inventor concluded that the Apotex product was “much
less stable than the magnesium salt,” which implied at least a suspicion that
the prior art consisted of moexipril magnesium. Approximately one month later,
the inventor’s suspicion was confirmed by two Apotex scientists who produced a
detailed mass spectrometry report on the prior art and concluded that moexipril
in the prior art is “mainly present” as moexipril magnesium. Based on these
facts, the Federal Circuit affirmed the district dourt’s finding of inequitable
conduct.
4.
Alcon Research Ltd. v. Barr Laboratories, Inc., 745 F.
3d 1180 (Fed. Cir. 2014).
The Federal
Circuit overturned the district court’s ruling of non-enablement because the
defendant provided no evidence of undue experimentation.
The claim at
issue pertains to the addition of an amount of polyethoxylated castor oil
(PECO) to enhance the stability of a composition comprising prostaglandin:
1. A
method of enhancing the chemical stability of an aqueous composition comprising
a therapeutically-effective amount of a prostaglandin, wherein the method
comprises adding a chemically stabilizing amount of a polyethoxylated castor
oil [(“PECO”)] to the composition.
The district
court found that the claim was not enabled because of many “variables,”
including the number of prostaglandins and the range of PECOs encompassed by
the claims. Additionally, the claim was not enabled because there were “[v]arious
parameters including pH, buffer, buffer concentration, preservatives, chelating
agents, and other excipients which may affect the chemical stability of
prostaglandins in ophthalmic formulations.”
The Federal
Circuit reversed the district court’s finding of non-enablement, stating that
the defendant’s evidence that addressed non-enablement was based on
unsubstantiated conclusory statements, “which was not sufficient.”
Barr adduced no evidence at trial that changing
any of the “variables” or “[v]arious parameters” identified by the district
court would render Alcon’s claimed invention inoperable, nor was there any
evidence that experimenting with those variables was required for an ordinarily
skilled artisan to be capable of increasing the chemical stability of a
prostaglandin by adding PECO. Adjusting variables may be relevant to optimizing
the stability of a given prostaglandin composition, but Barr proffered no
evidence that any experimentation, let alone undue experimentation, with those
variables would be necessary in order to practice the claimed invention. Without
that evidence, there is no foundation for the district court’s nonenablement
ruling.
The Federal
Circuit also held that the particular claims of the patent were enabling, based
on the disclosure of exemplary formulations, various classes of prostaglandins,
various types of PECOs, and stability data. The district court’s nonenablement
ruling was reversed.
5.
Sandoz Inc. v. Amgen Inc., 773 F.3d 1274 (Fed. Cir.
2014).
The Federal
Circuit affirmed dismissal of a declaratory judgment claim because plaintiff
had no standing to initiate a biosimilar lawsuit since the biosimilar product
was in a clinical trial.
Sandoz
sought declaratory judgment, arguing that that use of the biological product
would not constitute infringement of any valid claim of two Amgen patents
because both patents were “unenforceable due to prosecution laches, and
. . . both patents [were] invalid.” Although Sandoz conducted Phase
III clinical trials of the drug product in dispute, it had not filed an
application with the Food and Drug Administration (FDA). In response to the
declaratory judgment, Amgen moved for complaint dismissal arguing that the
court did not have jurisdiction due to a lack of “real and immediate injury or
threat of future injury” caused by Amgen. The district court dismissed the
infringement case:
“Any dispute
about patent infringement is at present subject to significant
uncertainties--concerning whether it will actually arise and if so, what
specific issues will require decision. Sandoz’s Phase III trial may fail in
material ways. If so, perhaps Sandoz will not file for approval, thereby
eliminating altogether the patent dispute it has asked the district court to
adjudicate. Perhaps, if the trial materially fails, i.e., uncovers significant
problems, Sandoz will instead modify its proposed product and ultimately file
for FDA approval of the modified product. At a minimum, that scenario could
alter the content of any patent dispute: notably, infringement of the specific
claims of the specific patents . . .could present different questions
depending on the precise product.”
Sandoz
did not show an immediate harm from the inability to seek or secure patent
adjudication prior to filling an application for FDA approval. Because Sandoz
did not meet the Article III requirements of immediacy and reality, the
district court’s declaratory judgment dismissal was affirmed.
6.
Danisco 2 US Inc. v. Novozymes A/S, 744 F.3d 1325 (Fed.
Cir. 2014).
The Federal Circuit held that disputes
prior to issuance of a patent can be the basis of a justiciable controversy for
a declaratory judgment.
Danisco U.S. Patent No. 8,084,240 (the
‘240 patent) issued on December 27, 2011, claiming priority from a June 6, 2009
provisional application. The active ingredient is a claimed α-amylase variant
polypeptide enzyme with a substitution from glutamic acid to proline. After
receiving its Notice of Allowance, Novozymes amended a pending application
(later issued as U.S. Patent No. 8,252,573, [the ‘573 patent]) to claim Danisco’s
claimed enzyme with the same substitution.
After Novozymes’s ‘573 patent was
issued, Danisco sought declaratory judgment. In response, Novozymes moved for
complaint dismissal and claimed lack of jurisdiction, which was granted. The
court reasoned that a justiciable controversy did not exist because Danisco
challenged Novozymes’s ‘573 patent the day that it was issued. Therefore,
Novozymes could not have taken any affirmative action to enforce its patent
rights. Although there was prior litigation history between the two parties,
the district court held that the history did not support a conclusion that an
actual controversy existed. The district court ruled that the presence of
“pre-issuance conduct” between the parties was not enough to constitute an
affirmative act. The Federal Circuit dismissed the district court’s reasoning,
stating that “[t]he district court’s categorical distinction between pre- and
post-issuance conduct is . . . irreconcilable with the Supreme Court’s
insistence on applying a flexible totality of the circumstances test, its
rejection of technical bright line rules in the context of justiciability, and
our own precedent.”
The pre-issuance activity in this case
which demonstrated that the two parties have “been at war” over patent
involving the claimed enzyme included:
Novozymes’s
sole enzyme claimed in its ‘573 patent was the same claim as Danisco’s ‘240
patent; the record indicates that Novozymes sought its patent due to the belief
that Danisco would infringe once their claim issued; Novozymes asserted on two
occasions that Danisco’s ‘240 patent was invalid and should not be entitled to
a patent on the claimed enzyme; Novozymes sued Danisco or its predecessors
twice for infringement of related liquefaction products.
The Federal Circuit held that
Novozymes’s activities demonstrate a “preparedness and a willingness to enforce
its patent rights,” which is enough to support a conclusion that subject matter
jurisdiction existed. The totality of the circumstances in the instant case
established a justiciable controversy and the dismissal of Danisco’s complaint
for subject matter jurisdiction was reversed and remanded for further
proceedings.
7.
Par Pharmaceutical, Inc. v. TWi Pharmaceuticals,
Inc., 773 F.3d 1186 (Fed. Cir. 2014).
The Federal Circuit did not find any
clear error in the district court’s conclusion that the infringer failed to
prove by clear and convincing evidence that a food effect for the micronized
formulation was known in the art, but found an error in the district court’s
reliance on the doctrine of inherency to disclose the food effect limitation.
The patent claimed a method of using a
nanosized megestrol formulation to “increase the body mass in a human suffering
from . . . loss of body mass.” Par Pharmaceuticals (Par) was approved
to market the generic version of micronized megestrol, and through
reformulation, reduced the particle size to the nanometer range. Although the
nanosized formulation showed a reduced food effect, the U.S. Patent and
Trademark Office (USPTO) rejected Par’s method of using the nanosized
formulation as obvious in light of the micronized prior art formulation.
Subsequent to the rejection, Par amended its independent claims by adding two
“wherein” clauses that addressed food effect limitations as follows:
“. . .
wherein after a single administration in a human subject of the formulation
there is no substantial difference in the Cmax of megestrol when the
formulation is administered to the subject in a fed versus a fasted state,
wherein fasted
state is defined as the subject having no food within at least the previous 10
hours, and wherein fed state is defined as the subject having a high-calorie
meal within approximately 30 minutes of dosing.”
The
USPTO granted the patent with the above amended claims and the Food and Drug
Administration (FDA) approved the nanoparticle formulation.
TWi
Pharmaceuticals (TWi) filed an ANDA and sought approval to market a generic
form of Par’s nanosized formula and Par filed suit claiming infringement. TWi
stated that Par’s claims were obvious under 35 U.S.C. § 103, did not
contain patentable subject matter under § 101, and were not enabling under
§ 112.
The
Federal Circuit did not find any clear error in the district court’s conclusion
that the infringer failed to prove by clear and convincing evidence that a food
effect for the micronized formulation was known in the art. The Federal Circuit
did, however, find error in the district court’s reliance on the doctrine of
inherency to disclose the food effect limitation. Inherent teachings are a
question of fact and in order to rely on inherency, the limitation at issue
“necessarily must be present, or [must be] the natural result of the
combination of elements explicitly disclosed by the prior art.” Because there
were no findings of fact regarding these limitations, the Federal Circuit vacated
the district court’s inherency analysis and remanded to determine if TWi
presented evidence that the claimed food effect is necessarily present in the
prior art combination.
The
district court also found motivation to combine prior art referenced, and the
Federal Circuit agreed. Par argued that there was no motivation to combine
because a person of ordinary skill in the art at the time of the invention
“would not have been motivated to combine nanoparticle technology with
micronized megestrol to abrogate a food effect.” Because the food effect was
unknown at the time of invention, it is unclear how the inventors were
motivated to nanosize the formulation. The Federal Circuit found that the
district court’s examination of alternate motivations was not done in error.
The alternate motivation analyzed by the district court was the viscosity of
the micronized formulation. Due to its highly viscous properties, AIDS patients
had difficulty swallowing the micronized formulation. Because it was known in
the art that NanoCrystal technology could reduce viscosity, one in ordinary
skill in the art would know that reduced particle size could lead to improved
bioavailability. Therefore, motivation to create a nanosized formulation was
present and the district court did not err in their conclusion that motivation
to combine megestrol with nanoparticle technology was present.
Additionally,
the district court held that there was a likelihood of success in combining
megestrol with nanoparticle technology. The court held that a person of
ordinary skill in the art would believe making nanoparticles was not difficult,
could be successfully implemented, and could reduce viscosity. Prior art
disclosed that the use of nanoparticle technology had evolved to be reliable
and showed consistency regarding properties such as viscosity.
While
the Federal Circuit agreed with the district court’s conclusions regarding
motivation to combine references, expectations of success from combining, and
that the ‘576 patent was nonobvious, the district court’s judgment was vacated
and remanded for further analysis regarding the inherency on the food effect
limitation.
8.
In re BRCA1- & BRCA2-Based Hereditary Cancer
Test Patent Litigation, 774 F.3d 755 (Fed. Cir. 2014).
A primer, which is a strand of short
nucleic acid sequences that serves as a starting point for DNA synthesis, held
to be patent ineligible matter based on the Supreme Court’s holding in Myriad. The Federal Circuit also applied
the Supreme Court’s decision in Alice
to invalidate two claims of the patent that require comparing a patient’s gene
with the wild-type and identifying any differences.
The issue in this case was whether a
primer, which is a strand of short nucleic acid sequences that serves as a
starting point for DNA synthesis, is patent ineligible matter based on the
Supreme Court’s holding in Myriad. (In Association for Molecular
Pathology v. Myriad, 133 S. Ct. 2107 (2013)), the Supreme Court held that
isolated DNA claims were patent ineligible because the location and order of
the nucleotides existed in nature before Myriad found them.” and ‘‘Myriad’s
principal contribution was uncovering the precise location and genetic sequence
of the BRCA[ genes].” However, in Myriad the Supreme Court found the cDNA
claims to be patent eligible under § 101because cDNA is an exon-only
sequence, with no introns, that does not occur in nature.
The
Federal Circuit held that primers are not distinguishable from the isolated DNA
found patent-ineligible in Myriad and are not similar to the cDNA found to be
patent-eligible. Primers necessarily contain the identical sequence of the gene
sequence directly opposite to the strand to which they are designed to bind.
They are structurally identical to the ends of DNA strands found in nature, and
are patent ineligible. The Federal Circuit also dismissed the notion that
primers are in fact not naturally occurring because single-stranded DNA cannot
be found in the human body, noting that the Supreme Court made clear, “separating
[DNA] from its surrounding genetic material is not an act of invention.” See Alice
Corp. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) (“Alice”).
The
Federal Circuit also applied the Supreme Court’s decision in Alice to invalidate two claims of the
patent that require comparing a patient’s gene with the wild-type and
identifying any differences. In Alice, the Supreme Court reiterated its
two-step test to determine patent eligibility for any claims that allegedly
encompass abstract ideas. First, “we determine whether the claims at issue are
directed to [a] patent-ineligible concept[ ]. If so, we then ask, ‘what else is
there in the claims before us?’ Based on the test set out in Alice, the
comparisons described in the claims are directed to the patent-ineligible
abstract idea of comparing BRCA sequences and determining the existence of
alterations. The methods, directed to identification of alterations of the
gene, require merely comparing the patient’s gene with the wild-type and
identifying any differences that arise. The claim thus recites nothing more
than the abstract mental steps necessary to compare two different nucleotide
sequences: one looks at the first position in a first sequence; determines the
nucleotide sequence at that first position; looks at the first position in a
second sequence; determines the nucleotide sequence at that first position;
determines if the nucleotide at the first position in the first sequence and
the first position in the second sequence are the same or different, wherein
the latter indicates an alteration; and repeats the process for the next position.
Having determined that the comparison steps of the method claims are abstract
ideas, the Federal Circuit moves to the second step of Alice and considered
whether the particular mechanism for the comparisons added by claims renders
the claims patent-eligible. The Federal Circuit then held that set forth
well-understood, routine and conventional activity engaged in by scientists at
the time of Myriad’s patent application.
The
district court’s denial of Myriad’s injunctive relief was affirmed.
9.
Ferring B.V. v. Watson Laboratories, Inc., 764 F.3d
1401 (Fed. Cir. 2014).
The Federal
Circuit affirmed the district court ruling that the patent claims are not
obvious for failing to meet the claimed strength, dissolution limitations, and
claimed amounts of modified release polymers.
Ferring B.V.
(Ferring) owns U.S. Patent Nos. 7,947,739 (the ‘739 patent), 8,022,106 (the ‘106
patent), and 8.273.795 (the ‘795 patent), which are modified release
formulations of tranexamic acid under the brand name Lysteda® for
the treatment of heavy menstrual bleeding known as menorrhagia. The patent
claims have three essential elements, one of which requires about 650 mg of
tranexamic acid. Almost one year prior to Ferring’s patents issued, Watson
filed an ANDA and sought the FDA’s approval to market generic versions of
Lysteda®.
The court held
that prior art did not set forth limitations nor provide reason to motivate the
combination of teachings to “derive the claimed formulation with specific
dissolution profiles.” Watson contended that each of Ferring’s claim
limitations were disclosed or suggested in prior art. To support this
contention, Watson presented a 2007 report that evaluated the safety and
efficacy of a 500 mg tranexamic acid product. According to Watson, it would
have been obvious to increase the dosage to 650 mg and to modify the drug in
packaging suitable for oral dosage. Although Ferring argued that prior art
taught away from using a dosage as high as 650 mg, the court agreed with Watson
for the following four reasons:
1. Prior art references disclose 500 mg
tranexamic acid formulations without indicating higher tablet strengths. The
report upon which Watson relies specifically notes that an increased dose of
tranexamic acid results in increased in gastrointestinal side effects.
2.
The
references do not disclose the claimed amounts of modified release polymers.
While the report does list species of excipients, there is no specified amount
present in the formulation of the polymer or any other active ingredient.
3. Watson did not identify any prior art
references that disclose the critical dissolution limitations of the patented
claims. Rather, Watson merely asserted in a conclusory manner that those
limitations would have been obvious and failed to address why one of ordinary
skill in the art would choose the specific release profiles claimed.
4. Supporting evidence demonstrated that
there was a long-felt and unmet need for a treatment for menorrhagia that
avoided adverse events. This was demonstrated by the FDA’s “fast track” status
grant to Ferring in order to expedite product review of Lysteda®.
The district
court holding that Watson did not provide clear and convincing evidence that
Ferring’s patents were invalid as obvious under § 103 was affirmed.
10.
Ariosa Diagnostics, Inc. v. Sequenom, Inc. 788 F. 3d
1371 (Fed. Cir. 2015).
Claims to a diagnostic
test using cell-free fetal DNA (cffDNA) were held to be not patent eligible
under 35 U.S.C. § 101.
U.S.
Patent No. 6,258,540 (the ‘540 patent) is owned by Sequenom and claims methods
of using cell-free fetal DNA (cffDNA), a non-cellular fetal DNA that circulates
freely in the blood stream of a pregnant woman. The use of cffDNA could be used
to detect the “small fraction of paternally inherited cffDNA in maternal plasma
or serum to determine fetal characteristics, such as gender.” Appellee Ariosa Diagnostics
Inc. (Ariosa) makes and sells another non-invasive test used to determine
prenatal diagnosis of fetal characteristics. Ariosa and its licensee sought
declaratory judgment after receiving infringement threats on behalf of
Sequenom, who then filed a counterclaim of infringement of the ‘540 patent.
Both Ariosa and Sequenom filed cross motions for summary judgment regarding
invalidity under 35 U.S.C § 101.
The
district court held that the claims of the ‘540 patent did not add enough to
the natural phenomenon of paternally inherited cffDNA to make the claims
patentable under § 101. The ‘540 patent merely applied “well-understood,
routine processes to paternally inherited cffDNA, a natural phenomenon.”
Additionally, the district court found that the claimed process “posed a risk
of preempting a natural phenomenon.” To determine whether the exception is
applicable, the court first addressed whether the concept was patent
ineligible. Because the method begins and ends with the taking and location
nucleic acids within cffDNA, the claims related to matter that occurs naturally
therefore rendering the concept patent ineligible The court then moved to the
second prong of the test and considered whether the additional elements of each
claim transformed the nature of the claim into a patent-eligible application.
The court found that method steps of the preparation and amplification of DNA
sequences in plasma or serum were well-understood, conventional and routine as
stated in the specification, and therefore not new and useful.
Although
Sequenom argued that there are other uses for cffDNA aside from uses claimed in
the ‘540 patent and that the application of the natural phenomenon embodied
narrow and specific claims, the court held that “the only subject matter new
and useful as of the date of the application was the discovery of the presence
of cffDNA in maternal plasma or serum.”
The
district court’s summary judgment ruling was affirmed.
11.
Trustees of Columbia Univ. v. Illumina, Inc., Case
No. 2014-1547, 2015 U.S. App. LEXIS 12343 (Fed. Cir. July 17, 2015)
The Federal
Circuit affirmed the Patent Trial and Appeal Board (PTAB) decision that patents
directed to sequencing deoxyribonucleic acid (DNA) are invalid as obvious.
DNA is
composed of double-stranded molecules called nucleotides, and each nucleotide
consists of three distinct parts: a sugar, a base, and one or more phosphate
groups. Frederick Sanger and Alan Coulson invented a sequencing method that
relied on dideoxynucleotides (ddNTPs), which have a hydrogen atom (H) rather
than OH at the 3’ position. An electrophoresis step caused Sanger’s sequencing
to be to slow in order to effectively sequence entire genomes. Thereafter, a
new type of process called sequencing by synthesis (SBS) avoided the need for
electrophoresis by placing removable “caps” at the 3’-OH group. However, this
process interfered with its operation because the “caps” were located in close
proximity to the active site of the polymerase. According to Columbia
University, Dr. Jingyue Ju and his colleagues avoided this problem by placing
an unlabeled removable cap on the 3’-OH group and attaching the label to a
cleavable linker attached to deazapurine base.
Columbia
University asserted that it would not be obvious at the time of invention to
use a “reversible chain-terminating nucleotide with a label attached to the
base, rather than to the cap on the 3’-OH group of the sugar.” While Columbia
University conceded there was interest in the lease-labeled nucleotide
analogues, it argued that the most relevant reference, Tsien, contained a
preference of labeling the 3’-OH caps rather than the base. However, Tsien
noted that the label could be attached to the base, noting that it should not
be implied that the base is the only place where labeling can occur. Therefore,
the PTAB concluded that Columbia understated the interest level of base-labeled
nucleotide analogues within the prior art. The PTAB also noted to other
references that recognized base-labeled nucleotides containing removable 3’-OH
moieties to be useful and effective methods.
Regarding
motivation to combine, Columbia University argued that the PTAB “never
identified any affirmative motivation that would have led a skilled artisan to
abandon the ‘ideal,’ natural C-8 possession taught by Tsien.” Although this
position was ideal, the court had previously explained that better alternatives
described in prior art does not mean that “an inferior combination is an apt
for obviousness purposes.”
With respect
to the reasonable expectation of success, Illumina argued that a person having
ordinary skill in the art could have reasonably expected that the combination
of available references to synthesize a 3’-OH-capped nucleotide with a label
attached to a deazapurine base would be successful. The court held that other
patent disclosures were substantial evidence to support the PTAB’s finding that
there was a reasonable expectation of success in achieving the claimed
invention.
While both
parties presented arguments with respect to secondary considerations, the court
held that they did not weigh strongly in favor of nonobviousness.
12.
Amgen Inc. v. Sandoz, Inc., 794 F.3d 1347 (Fed. Cir.
2015).
A
subsection (k) applicant (biosimilar) may only give effective notice of
commercial marketing after the FDA has licensed its product, effectively
delaying launch of a biosimilar product by six months.
Traditionally,
and applicant who files a biologics license application (BLA) will provide
clinical data to demonstrate product safety and efficacy. As an alternative,
applicants may file an abbreviated biologics license application (aBLA)
pursuant to 42 U.S.C. § 262(k) by submitting information to demonstrate
that the product is “biosimilar” or “interchangeable” with a previously
approved reference product. Additionally, the applicant may submit public
information regarding the safety and effectiveness of the reference product.
Since
1991, Amgen marketed Neupogen® (filgrastim), and in May 2014, Sandoz
sought FDA approval of a biosimilar filgrastim product and filed an aBLA. On
July 8, 2014, Sandoz notified Amgen of the filing and its intention to launch
the product upon FDA approval. Traditionally, the Food and Drug Administration
(FDA) approves biological products by granting a license under 42 U.S.C. § 262(a).
Amgen sued Sandoz, and amongst other matters, alleged that the Biologics Price
Competition and Innovation Act of 2009 (BPCIA) was violated when Sandoz did not
disclose required information and by giving a “premature, ineffective, notice
of commercial marketing prior to FDA
approval of the biosimilar product. The district court held that subsection (k)
allows an applicant not to satisfy the obligation to give notice of commercial
marketing under § 262(l)(8)(A) prior to FDA approval.
According
to paragraph (l)(8)(A), “the subsection (k) applicant shall provide notice to
the reference product sponsor not later than 180 days before the date of the
first commercial marketing of the biological product license under subsection
(k).” Amgen argued that the statute’s purpose of providing time to seek
preliminary injunction and resolve patent disputes is not satisfied when notice
is provided after FDA licensure. The court agreed with Amgen, stating that a
subsection (k) applicant may only give effective notice of commercial marketing
after the FDA has licensed its product. Although a licensed product may be
marketed, it does not necessarily follow that “whenever the future commercial
marketing of a yet-to-be licensed product is discussed, it is the ‘licensed’
product.” The court believed that Congress intended notice to follow licensing
because it is after licensing that therapeutic uses and manufacturing processes
are fixed. Once the scope of the approved license is known and marketing of the
biosimilar product is determined, the reference product sponsor (RPS) may
effectively choose whether to seek a preliminary
injunction from the court.
No comments:
Post a Comment