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REMBRANDT DIAGNOSTICS, LP v. ALERE, INC. (April 10, 2020)
The plain claim language suggests a
broader meaning of “equivalent to” than “equal to.” Claim 1 recites, in
relevant part, that the “entry of fluid into the flow control channel creates
an ambient pressure within the flow control channel equivalent to the ambient
pressure outside of the flow control channel, thereby eliminating a pressure
gradient along which excess sample fluid could flow into the flow control
channel.” Similar to the oft-used claim term “substantially,” we consider
“equivalent,” as used in claim 1, to be a term of degree that does not require
mathematical precision. (“[T]he term ‘substantially’ is a descriptive
term commonly used in patent claims to ‘avoid a strict numerical boundary to
the specified parameter.’” Indeed, as Rembrandt correctly observes, the
patent law doctrine of equivalents refers to the legal comparison of two
elements that are, in fact, different, which supports that “equivalent” is not
limited to “equal.” If the applicants meant “equal,” they would have used the
word “equal” rather than the broader word “equivalent.” Claim 1 neither uses
the term “equal” nor refers to a numerical measurement, numerical comparison
between pressures, or even the pressure unit of measurement—pascals.
BASF CORPORATION v. SNF HOLDING
COMPANY (April 8, 2020)
In Shimadzu, the Supreme Court
explained that the public-use bar applies to uses of the invention “not
purposely hidden” and held that the use of a process in the ordinary course of
business—where the process was “well known to the employees” and no “efforts
were made to conceal” it from anyone else—is a public use. In our public-use
cases, we have applied the rule of Shimadzu to assess whether a use was
successfully concealed or hidden and therefore inaccessible to the public. If
the use identified by the defendant was not successfully concealed or hidden
from those who lack any “limitation or restriction, or injunction of secrecy,”
then it is a public use within the meaning of § 102(b). (experimental use is
not public use). The parties disagree whether Celanese’s use of the Sanwet®
Process meets this standard. The district court cited evidence that Celanese
had given tours of the Portsmouth plant to local officials, potential
customers, and members of the public and that newspaper articles and a
commemoration video depicted the interior of the plant. BASF principally
contends that, while certain elements of the claimed process were
unquestionably made public—such as the shape of the conical taper—the rest were
not, precluding a finding of public use. SNF responds that Celanese failed to
fully conceal the process, which qualifies as public use as a matter of law. We
conclude that the district court erred in finding, on summary judgment, that
the claimed process was publicly accessible. As an initial matter, we disagree
with BASF that public use under § 102(b) requires a finding that the public was
made aware of every limitation of the claimed process. Our precedent is
clear that a factfinder should consider whether certain elements of the claimed
invention were already in the public domain at the time of the alleged
public-use or on-sale activity. Thus, we have held that § 102(b) “does not
require a strict identity between the claimed invention and the device involved
in the public use or on sale activities;” it only requires that “the
differences between the claimed invention and the device used or sold would
have been obvious to one skilled in the art.” In re Smith, 714 F.2d 1127,
1137 n.13 (Fed. Cir. 1983) (citing In re Corcoran, 640 F.2d 1331, 1333 (CCPA
1981)); see also In re Blaisdell, 242 F.2d 779, 783 (CCPA 1957) (finding public
use even where some elements of the invention are by their nature concealed
from view) (citing Hall v. Macneale, 107 U.S. (17 Otto) 90, 96–97 (1883)).
VALEANT PHARMACEUTICALS INTL. v.
MYLAN PHARMACEUTICALS INC. (April 8, 2020)
Claim 1: A stable pharmaceutical
preparation comprising a solution of methylnaltrexone or a salt thereof,
wherein the preparation comprises a pH between about 3.0 and about 4.0.
Claim 8 recites “[t]he
pharmaceutical preparation of claim 1, wherein the preparation is stable to
storage for 24 months at about room temperature.”. Notably, claim 8 recites the
same preparation as claim 1, but with a newly stated result: 24-month stability.
Mylan cites three prior art
references involving different compounds, but each discloses formulations with
pH ranges that overlap with the range recited in claim 8, pH between about 3
and about 4. Specifically, Bahal teaches a naloxone composition with a pH of 3
to 3.5, Oshlack teaches a naltrexone composition with a pH of about 3 to about
5 and about 4, and Fawcett discloses a naltrexone formulation with a pH of 3.5
that fell to 3.2 over 90 days. In Mylan’s view, these references establish a
prima facie case of obviousness because the pH ranges they teach overlap with
those in claim 8. While no reference contemplates methylnaltrexone
specifically, Mylan submits that methylnaltrexone bears significant structural
and functional similarity to both naloxone and naltrexone such that a person of
skill in the art would seek to use prior disclosed pHs for naloxone and
naltrexone when formulating solutions of methylnaltrexone.
Valeant responds that overlapping ranges for different chemical compounds that
fail to meet claim 8’s stability requirement do not establish obviousness.
According to Valeant, the structural and functional similarities of the
compounds are not relevant because claim 8 recites a solution of
methylnaltrexone with a stability profile unrecognized and unattained in the
prior art. Nevertheless, Valeant submits, methylnaltrexone, naloxone, and
naltrexone function differently because of their structural differences, and
nothing about the shared function of the drugs is relevant to their stability
in solution.
We agree with Mylan that the record supports a prima facie case of obviousness
here. In Peterson, this court recognized that “[a] prima facie case of
obviousness typically exists when the ranges of a claimed composition overlap
the ranges disclosed in the prior art.” In re Peterson, 315 F.3d 1325, 1329
(Fed. Cir. 2003) (citing In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997));
In re Woodruff, 919 F.2d 1575, 1578 (CCPA 1990); In re Malagari, 499 F.2d 1297,
1303 (CCPA 1974)). At issue in Peterson was a claim to a nickel-base
single-crystal superalloy used in the manufacture of turbine engines. The
claimed composition included a relatively small amount of rhenium—about 1 to 3
percent. The prior art of record taught compositions with 0 to 7 percent
rhenium, an overlapping range within which the narrower, claimed range fell. We
explained that “[s]electing a narrow range from within a somewhat broader range
disclosed in a prior art reference is no less obvious than identifying a range
that simply overlaps a disclosed range.” Peterson, 315 F.3d at 1329–30. We thus
held that the overlapping ranges were sufficient to establish a prima facie
case of obviousness, shifting the burden to the patentee to show that the
invention would not have been obvious. Here, the pH range recited in claim 8
clearly overlaps with the pH range in the record art, but none of the
references disclose the same drug as the one claimed. We are thus
presented with the question whether prior art ranges for solutions of
structurally and functionally similar compounds that overlap with a claimed
range can establish a prima facie case of obviousness. We conclude that they
can and, in this case, do.
GENENTECH, INC. v. IANCU (March
30, 2020)
Claim 1. A method for the treatment
of a human patient with breast cancer that overexpresses ErbB2 receptor,
comprising administering a combination of an antibody that binds ErbB2, a
taxoid, and a further growth inhibitory agent to the human patient in an amount
effective to extend the time to disease progression in the human patient,
wherein the antibody binds to epitope 4D5 within the ErbB2 extracellular domain
sequence.
Claim 5. A method for the treatment
of a human patient with breast cancer characterized by overexpression of ErbB2
receptor, comprising administering an effective amount of a combination of an
anti-ErbB2 antibody which binds epitope 4D5 within the ErbB2 extracellular
domain sequence, a taxoid, and a further therapeutic agent, to the human
patient.
The claims and specifications of
the ’441 and ’549 patents do not clearly define what comparison is required by
the disputed claim terms. The examiner recognized as much during prosecution of
the ’441 patent, rejecting as indefinite the claim term “extend the time to
disease progression.” The examiner found the term to be a relative term
undefined by the claim, without “a standard for ascertaining the requisite degree,”
and that “one of ordinary skill would not be reasonably apprised of the scope
of the invention.”
The examiner inquired:
Specifically, it is never set forth what the extension
of time to disease progress is relative to, for example, is the extension of
time to disease progress relative to untreated patients? Patients who received
antibody or taxoid alone? Patients who received antibody and an anthracycline?
Genentech responded:
[T]he expressions “extend the time to
disease progression” and “response rate” are clear from the specification and
would be readily understood by a skilled oncologist. Clearly, the combination
of an anti-ErbB2 antibody and a taxoid is administered in an amount effective
to extend the time to disease progression relative to an untreated patient.
The Board determined that
Genentech’s response to the examiner was an express choice, which defined the
claim term and led to the issuance of the Genentech argues that the Board
erred in its reliance on this exchange by using it “to override the meaning
evident from the specification.” The specification does not, however, expressly
define the disputed terms. And Genentech did not view this choice as
inconsistent with the specification during prosecution. Instead, Genentech interpreted
its own claim language, based on its own specification’s disclosure, as
referring to a comparison to untreated patients. The examiner even provided
Genentech with the very alternative option (“taxoid alone”) for which Genentech
now advocates. Genentech expressly rejected this comparator during prosecution
and instead clearly stated that it was effectiveness relative to an untreated
patient. Genentech provided an unequivocal, direct response to the examiner’s
inquiry—that the term “extend the time to disease progression” was compared to
an untreated patient. Genentech’s comparator choice during prosecution of the
’441 patent applies equally to the same claim term that appears in the ’549
patent, which shares a specification and is in the same patent family. Given
this relationship between the patents, the Board construed the relevant terms
consistently in all six inter partes reviews. We see no error in the Board’s
constructions.
GALDERMA LABS., L.P. v. AMNEAL
PHARMS. LLC (March 29, 2020)
Claim: An oral pharmaceutical
composition of doxycycline, which at a once-daily dosage will give steady state
blood levels of doxycycline of a minimum of 0.1 μg/ml and a maximum of 1.0
μg/ml, the composition consisting of (i) an immediate release (IR) portion
comprising 30 mg doxycycline; (ii) a delayed release (DR) portion comprising 10
mg doxycycline; and optionally, (iii) one or more pharmaceutically acceptable
excipients.
“Immediate release” or IR is
defined by the ’patent as “a dosage form that is intended to release
substantially all of the active ingredient on administration with no enhanced,
delayed or extended release effect.”
“Delayed release” or DR is not
expressly defined.
We have held that “statements made by a patent owner during an IPR
proceeding can be considered during claim construction and relied upon to
support a finding of prosecution disclaimer” so long as the statements are
“both clear and unmistakable.”
There is no doubt that the Board
rejected the Patent Owner’s attempt to limit the meaning of delayed release.
See J.A. 17023 (“[W]e agree with Amneal that the broadest reasonable
construction of ‘delayed release,’ in light of the specification of the ’740
patent, is not limited to formulations requiring that there be no substantial
release in the stomach.”). Because the Board rejected the Patent Owner’s
arguments regarding the meaning of delayed release, the record before the
Patent Office clearly put the public on notice that the meaning of delayed
release with respect to the Chang Patents is not limited to formulations
requiring that there be no substantial release in the stomach. While clear and
limiting statements made by the patent owner can give rise to disclaimer, they
do not in this case where those statements were clearly and expressly rejected
by the Patent Office. Because the record makes clear to a skilled artisan that
Patent Owner’s arguments were rejected, those arguments do not impact claim
scope. Accordingly, we see no error in the district court’s conclusion that
Galderma was not precluded by these statements from asserting the doctrine of
equivalents.
KAKEN PHARMACEUTICAL CO., LTD.
v. IANCU (March 13, 2020)
Kaken responded by submitting an
amendment that cancelled claim 1, clarified the wording of claim 18, and
asserted the important difference between mycosis and onychomycosis. Noting
that the “[t]reatment of onychomycosis significantly differs from the general
treatment of mycoses claimed in ’994,” Kaken explained that “[o]nychomycosis is
a condition that specifically affects the nail plate.” Kaken further argued
that the “present invention shows the unexpected ability of an azolylamine
derivate to penetrate nail and be retained by the nail.”
In allowing the claims, the
examiner stated, under the heading “Examiner’s Reasons for Allowance,” that
“unexpectedly and in contrast to previously evaluated compositions/methods, the
instantly claimed method cures the onychomycosis because the medicament upon
direct administration to the nail, penetrates through the nail plate and eradicates
the infection at the site.”
This exchange would leave a skilled
artisan with no reasonable uncertainty about the scope of the claim language in
the respect at issue here. Kaken is bound by its arguments made to convince the
examiner that claims 1 and 2 are patentable. Thus, Kaken’s unambiguous
statement that onychomycosis affects the nail plate, and the examiner’s
concomitant action based on this statement, make clear that “treating
onychomycosis” requires penetrating the nail plate to treat an infection inside
the nail plate or in the nail bed under it.
Similarly, the Board rejected
Kaken’s objective indicia of non-obviousness because it concluded, relying on
the claim construction we have concluded is erroneous, that there is no nexus
between the objective indicia and the challenged claims. In its Patent Owner’s
response, Kaken identified KP-103 as the “active pharmaceutical ingredient in
Jublia®, the first FDA-approved monotherapy for the topical treatment of
onychomycosis.” Kaken made several objective-indicia arguments based on
Jublia®: that Jublia® produced unexpected results; that Jublia® has had
significant commercial success; that Jublia® received industry praise; and that
Jublia® fulfilled a long-felt, but unmet need. But before considering any
of those arguments, the Board pointed to evidence that the FDA approved Jublia®
as a “topical treatment of onychomycosis of the toenails,” and Jublia®’s label
directs the user to “apply Jublia® to affected toenails once daily.” Because
“Jublia® is directed to treatment of specific fungal infections in toenails,
and not to a ‘nail’ or to treat ‘onychomycosis,’” the Board explained, the
“method for Jublia®’s use is not reasonably commensurate with the [scope] of
the challenged claims.” Thus, the Board concluded, the objective indicia
presented by Kaken “do not weigh in favor of a finding that the subject matter
of the claims would not have been obvious.” I
The foregoing determinations are
infected by the erroneous claim construction. In this court, the Director has
sought to support the Board’s factual findings with little or no reliance on
the claim construction we have held to be erroneous. But that effort is more a
reconstruction of the Board’s analysis than a description of the Board’s actual
reasoning. We conclude that the appropriate course in this case, as in so many
others involving a reversal of a Board claim construction, is to vacate the
Board’s decision and remand the matter.
ILLUMINA, INC. v. ARIOSA
DIAGNOSTICS, INC. (March 17, 2020)
Claim 1. A method for preparing a
deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for
analyzing a genetic locus involved in a fetal chromosomal aberration,
comprising: (a) extracting DNA from a substantially cell-free sample of blood
plasma or blood serum of a pregnant human female to obtain extracellular
circulatory fetal and maternal DNA fragments; (b) producing a fraction of the
DNA extracted in (a) by: (i) size discrimination of extracellular circulatory
DNA fragments, and (ii) selectively removing the DNA fragments greater
than approximately 500 base pairs, wherein the DNA fraction after (b) comprises
a plurality of genetic loci of the extracellular circulatory fetal and maternal
DNA; and (c) analyzing a genetic locus in the fraction of DNA produced in (b).
’751 patent col. 7 l. 54–col. 8 l. 57. 1. A method, comprising: (a) extracting
DNA comprising maternal and fetal DNA fragments from a substantially cell-free
sample of blood plasma or blood serum of a pregnant human female; (b) producing
a fraction of the DNA extracted in (a) by: (i) size discrimination of
extracellular circulatory fetal and maternal DNA fragments, and (ii)
selectively removing the DNA fragments greater than approximately 300 base
pairs, wherein the DNA fraction after (b) comprises extracellular circulatory
fetal and maternal DNA fragments of approximately 300 base pairs and less and a
plurality of genetic loci of the extracellular circulatory fetal and maternal
DNA fragments; and (c) analyzing DNA fragments in the fraction of DNA produced
in (b).
In Ariosa, we recognized that the
inventors had made a discovery with implications that would allow what had
previously been discarded as medical waste to be used as a tool for determining
fetal characteristics. We acknowledged the profound impact that the discovery
had on the field of prenatal medicine, including that it “created an
alternative for prenatal diagnosis of fetal DNA that avoids the risks of
widely-used techniques that took samples from the fetus or placenta.”
Nevertheless, under guidance from the Supreme Court, we determined that the
discovery of that natural phenomenon, no matter how significant it was to the
medical field, was not itself patentable, and neither was a method for
detecting it. The invention in this case is the product of further research on
cell-free fetal DNA. This time, the inventors discovered that, not only does
the fetal DNA exist in the bloodstream of a pregnant mother, but it has
characteristics that make it distinguishable, and therefore separable, from the
maternal DNA. Again, regardless how groundbreaking this additional discovery
may have been, the inventors were not entitled to patent the natural phenomenon
that cell-free fetal DNA tends to be shorter than cell-free maternal DNA.
“Groundbreaking, innovative, or even brilliant discovery does not by itself
satisfy the § 101 inquiry.” Thus, they could not claim a method directed
to the natural phenomenon, e.g., a method for determining whether a fragment of
cell-free DNA is fetal or maternal based on its length. And they did not attempt
to patent such a method. The inventors here patented methods of preparing a DNA
fraction. The claimed methods utilize the natural phenomenon that the inventors
discovered by employing physical process steps to selectively remove larger
fragments of cell-free DNA and thus enrich a mixture in cellfree fetal DNA.
Though we make no comment on whether the claims at issue will pass muster under
challenges based on any other portion of the patent statute, under § 101 the
claimed methods are patent-eligible subject matter.
GENENTECH, INC. v. HOSPIRA, INC.
(Jan. 10, 2020)
Claim 1: A method of purifying a
protein which comprises CH2/CH3 region, comprising subjecting a composition
comprising said protein to protein A affinity chromatography at a temperature
in the range from about 10°C to about 18°C.
A prior art reference that
discloses an overlapping but different range than the claimed range can be
anticipatory, even where the prior art range only partially or slightly
overlaps with the claimed range. See Ineos USA LLC v. Berry Plastics Corp., 783
F.3d 865, 870–71 (Fed. Cir. 2015) (affirming summary judgment of anticipation
of patent claims for composition with “0.05 to 0.5% by weight of at least one
saturated fatty acid amide” lubricant in view of a prior art reference
disclosing the same class of lubricant in an overlapping range of “0.1 to 5
parts by weight,” and the parties agreed that a measurement in “% by weight”
was equivalent to one in “parts by weight”). Once the patent challenger has
established, through overlapping ranges, its prima facie case of anticipation,
“the court must evaluate whether the patentee has established that the claimed
range is critical to the operability of the claimed invention.” Id. at 871; see
also E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1008 (Fed.
Cir. 2018) (“‘where there is a range disclosed in the prior art, and the
claimed invention falls within that range, the burden of production falls upon
the patentee to come forward with evidence’ of . . . criticality”) (quoting
Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013)).
Here, the Board found that Genentech failed to establish that the claimed
temperature range of “about 10°C to about 18°C” is critical to performing
protein A chromatography. ’837 Decision, 2018 WL 1187484, at *10–11. Genentech
does not challenge the Board’s finding as to criticality, and accordingly,
whether or not the claimed temperature range achieves different performance
results than WO ’389’s disclosed temperature range is not at issue on appeal.
Hospira responds that WO ’389 uses
the term, “room temperature (18–25°C),” to describe the temperature for
conducting protein A affinity chromatography, and all the components involved
in that process, including the composition to be purified. According to
Hospira’s expert, Dr. Przybycien, in the field of antibody purification, absent
contrary language, a skilled artisan would understand that experiments are
being conducted at ambient temperature with all materials equilibrated in order
to obtain robust scientific data. Based on WO ’389’s disclosure that the
composition was cold or frozen after the viral inactivation step, Hospira
contends that WO ’389 specifically called out the temperature of the
composition when requiring it to be at a temperature other than room
temperature. Here, substantial evidence supports the Board’s finding that the
HCCF subject to protein A affinity chromatography in WO ’389 is within the
claimed temperature range of claim 1. The Board reasoned that it would have
been redundant to specifically call out the temperature of the HCCF during
protein A affinity chromatography in light of WO ’389’s blanket statement to
carry out all steps at “ The Board considered, but disagreed with, Dr. Cramer’s
interpretation of WO ’389 as disclosing a process with HCCF that was warmer
than “18–25°C” because his opinion was predicated on the view that the ’799
patent is directed to large-scale, industrial processes, which it is not. Id.
Further, Dr. Cramer testified that even for large-scale industrial processes,
he was not aware of any process where HCCF was applied directly into the
chromatography column after being removed from the bioreactor and filtered. Id.
at *10 (citing J.A. 1075 at 85:6–15). The Board instead credited Dr.
Przybycien’s testimony that no skilled artisan would contact 37°C HCCF to the
chromatography column, and report having performed the step at “room
temperature (18–25°C)” because using HCCF that was warmer than the
chromatography column would raise the temperature of the entire system, making
it impossible to conduct “[a]ll steps . . . at room temperature.” To the extent
that the experts disagreed with each other, the Board reasonably chose to
credit the testimony of Dr. Przybycien over the testimony of Dr. Cramer.
ELI LILLY AND COMPANY v.
HOSPIRA, INC. (August 9, 2019)
Claim 12. An improved method for
administering pemetrexed disodium to a patient in need of chemotherapeutic
treatment, wherein the improvement comprises: a) administration of between
about 350 µg and about 1000 µg of folic acid prior to the first administration
of pemetrexed disodium; b) administration of about 500 µg to about 1500 µg of
vitamin B12, prior to the first administration of pemetrexed disodium; and c)
administration of pemetrexed disodium.
We agree with Hospira. It was
clearly erroneous for the district court to hold that the “administration of
pemetrexed disodium” step was met because Hospira’s pemetrexed ditromethamine
product will be dissolved in saline before administration. A solution of
pemetrexed and chloride anions and tromethamine and sodium cations cannot be
deemed pemetrexed disodium simply because some assortment of the ions in the
solution consists of pemetrexed and two sodium cations. As Lilly acknowledges throughout
its brief, pemetrexed disodium is a salt. (pemetrexed toxicity is caused “by
pemetrexed itself once dissociated in solution,” not pemetrexed disodium); see
also Hospira J.A. 1596 (October 2017 Alimta® Label referring to the drug
substance as the “disodium salt” of pemetrexed). Once diluted, the salt’s
crystalline structure dissolves, and the individual ions dissociate. See
Hospira J.A. 2820 (declaration of Lilly’s expert). In other words, pemetrexed
disodium no longer exists once dissolved in solution, and, as a corollary, a
different salt of pemetrexed dissolved in saline is not pemetrexed disodium.
We conclude that to literally
practice the “administration of pemetrexed disodium” step under the district
court’s claim construction, the pemetrexed disodium salt must be itself
administered. (“‘[A]dministration of pemetrexed disodium’ . . . refer[s]
to a liquid administration of pemetrexed disodium. . . ., accomplished by
dissolving the solid compound pemetrexed disodium into solution . . . .”); see
also Tex. Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558, 1563
(Fed. Cir. 1996) (“To literally infringe, the accused . . . process must
contain every limitation of the asserted claim.” (citing Laitram Corp. v.
Rexnord, Inc., 939 F.2d 1533, 1535 (Fed. Cir. 1991))). There is no dispute that
Hospira has only sought approval to market pemetrexed ditromethamine, and
that neither its proposed product nor methods of administering it will
constitute administering the pemetrexed disodium salt. Accordingly, Hospira
will not practice the step of “administration of pemetrexed disodium,” and the
district court’s finding of literal infringement must be reversed.
Doctrine of equivalents
Prosecution History Estoppel
But here, we conclude that this
consideration is not dispositive because the rest of the prosecution history,
and the ’209 patent itself, show that it is implausible that the reason for
Lilly’s amendment was to surrender other pemetrexed salts. Indeed, such a
relinquishment would effectively dedicate the entirety of Lilly’s invention to
the public and thereby render the ’209 patent worthless, and it would have been
irrelevant for distinguishing the prior art. Again, the prosecution history
strongly indicates a less sweeping and more sensible reason for Lilly’s
amendment: to surrender antifolates other than pemetrexed. Thus, we conclude on
this prosecution record that Lilly’s amendment was merely tangential to
pemetrexed ditromethamine.
Disclosure-Dedication Rule
We are unpersuaded by DRL’s
arguments. As the district court noted, Akimoto’s formula, includes seven
functional group variables and encompasses thousands of compounds, and while
Akimoto discloses about fifty exemplary compounds, none of them is pemetrexed.
Moreover, Akimoto does not even disclose tromethamine expressly but only
generically among dozens of other salts. At most, Akimoto discloses ammonium
salts generally, which is far from a description of tromethamine. In similar
circumstances, we have held that “sufficient description of a genus” requires
that a skilled artisan be able to “‘visualize or recognize’ the members of the
genus.” See Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350
(Fed. Cir. 2010) (quoting Regents of the Univ. of Cal. v. Eli Lilly & Co.,
119 F.3d 1559, 1568–69 (Fed. Cir. 1997)). Akimoto does not so describe
pemetrexed ditromethamine, and we see no reason why a skilled artisan would set
out on DRL’s winding path to cobble together pemetrexed ditromethamine. While
the ’209 patent teaches that pemetrexed disodium is the “most preferred”
antifolate, that knowledge would not change the skilled artisan’s understanding
of what Akimoto discloses. Because Akimoto contains only a “generic reference”
to pemetrexed ditromethamine, PSC Comput., 355 F.3d at 1360, we conclude that
it was not dedicated to the public.
SANOFI-AVENTIS U.S., LLC v.
FRESENIUS KABI USA, LLC (August 9, 2019)
Even assuming there was some
general motivation to make docetaxel more lipophilic to combat drug resistance,
the district court also did not clearly err in finding that Fresenius failed to
establish a motivation to do so by specifically making simultaneous methoxy
substitutions at C7 and C10. The court found that taxane researchers
investigated substitutions at many positions, and the voluminous references in
this case support that finding. For example, Commerçon disclosed that C3′, C7,
C9, and C10, and to a more limited extent C2′, were modifiable. And as
summarized above, the other references investigated a diverse set of
substitutions. Fresenius reads this panoply of teachings as rendering obvious
simultaneous C7 and C10 methoxy substitutions. But despite the apparent
interest in taxane analogs, not a single reference relied on by Fresenius made
simultaneous substitutions of any kind at C7 and C10. And of the references
that made individual methoxy substitutions at C7 or C10, none tested those
taxane analogs against drug resistant cell lines or taught that the analogs
would overcome drug resistance. On this record, the court did not clearly err
in finding no motivation to make C7 and C10 methoxy substitutions on docetaxel
to improve its activity against drug-resistant cancers.
Considering Fresenius’s
reference-specific arguments, we agree with the district court that they are
emblematic of hindsight reasoning. Fresenius contends that Commerçon would have
pointed a skilled artisan towards C7, C10, and (less desirably) C9
substitutions because those positions were “flexible,” and away from C2′ and
C3′ substitutions because those positions were “crucial.” CrossAppellants’ Br.
57–58. However, this argument plainly mischaracterizes the reference. Commerçon
expressly identified the sidechain position C3′ as “flexible,” and indicated
that C2′ could be modified with certain substitutions if the configuration was
maintained.
PHIGENIX, INC. v. GENENTECH,
INC. (Sept. 5, 2019)
Claim 1 recites “[a] method for
treating a breast condition” by administering a composition that inhibits PAX2
expression or activity, and/or expresses DEFB1.
In its complaint, Phigenix alleged
that Genentech induced infringement of the ’534 patent by encouraging health
care professionals to prescribe and administer Kadcyla to breast cancer
patients who had previously received the chemotherapy drugs “trastuzumab and a
taxane, separately or in combination.”
In February 2017, the district
court issued a summary judgment order holding that the asserted claims of the
’534 patent are not entitled to the priority date of the 2005 provisional
application. Phigenix did not move to amend its infringement contentions in
response. Several months later—after fact discovery had closed and expert
reports had been exchanged—Phigenix narrowed the relevant population to Kadcyla
patients who were pretreated exclusively with trastuzumab and a taxane—i.e.,
trastuzumab, a taxane, and “and nothing else.” J.A. 317–19. Phigenix did not do
so by affirmatively moving for leave to amend its infringement contentions.
Instead, Phigenix first revealed its narrowed definition during the deposition
of its expert on May 23, 2017, and only in response to questioning by
Genentech. Phigenix does not dispute that the narrowed population of relevant
patients comprises only about 4% of the total population of Kadcyla patients.
Yet at no point did Phigenix move to amend its infringement contentions to
reflect this narrower population.
After learning about the narrowed
patient population, Genentech moved to strike the infringement opinion of
Phigenix’s expert. Agreeing that Phigenix had failed to provide adequate notice
of its narrowed infringement theory, the district court struck Phigenix’s
expert infringement opinion and granted summary judgment of noninfringement
based on the resulting lack of direct infringement evidence. The district court
specifically noted that if its determination regarding the 2005 priority date
was the impetus for Phigenix’s narrowed infringement theory, then “Phigenix
could have moved soon thereafter to amend its infringement contentions and to notify
Genentech of this change in position.” J.A. 16. Phigenix’s failure to do so
“deprived Genentech [of] a timely disclosure of this new theory, as well as any
potential accommodation in the case schedule the Court would entertain.”
Phigenix first argues that its
revised infringement theory is not newly propounded because it falls wholly
within the scope of its original infringement contentions. While technically
accurate, this argument fails to acknowledge the notice function served by
infringement contentions. Patent local rules bolster discovery under the
Federal Rules because they “allow the defendant to pin down the plaintiff’s
theories of liability . . . thus confining discovery and trial preparation to
information that is pertinent to the theories of the case.” The Northern
District’s patent local rules, furthermore, expressly require that the
identification of the accused methods in infringement contentions “shall be as
specific as possible.” N.D. Cal. Patent L.R. 3-1(b). We agree with the district
court that the broader theory disclosed in Phigenix’s infringement contentions
is not sufficiently specific to disclose its narrowed theory. If, as Phigenix
suggests, plaintiffs could include broadly scoped infringement theories in
their contentions only to unilaterally narrow them after the close of fact
discovery, infringement contentions would provide little relief to defendants.
Finally, Phigenix argues that
striking Phigenix’s entire expert infringement opinion is an abuse of
discretion because it is (at least in Phigenix’s view) heavy-handed. In
support, Phigenix avers that Genentech has not adequately explained how it was
prejudiced. Phigenix further argues that Genentech fails to explain why a less
severe sanction would not address any concern the district court had. Phigenix
even boldly asserts that Genentech was obligated to seek clarification if it
was confused by the scope of Phigenix’s infringement contentions.
As a threshold matter, we need not
consider the prejudice to Genentech in evaluating whether the court abused its
discretion. See O2 Micro, 467 F.3d at 1368 (“Having concluded that the district
court could properly conclude that [the plaintiff] did not act diligently in
moving to amend its infringement contentions, we see no need to consider the
question of prejudice to [the defendant].”). In any event, Genentech adequately
explained how it was prejudiced by Phigenix’s untimely narrowing of its
infringement theory.
The consequences imposed on
Phigenix, furthermore, are not beyond the discretion of the district court.
Both the Ninth Circuit and this court have concluded that the exclusion of
evidence is often an appropriate sanction for a party’s failure to comply with
the patent local rules. O2 Micro, 467 F.3d at 1369 (first citing SanDisk, 415
F.3d at 1292; then citing Wong v. Regents of Univ. of Cal., 410 F.3d 1052, 1060
(9th Cir. 2005)). Thus, even if other courts might have chosen a less potent
remedy in these circumstances, we assess only whether the district court abused
its discretion in prescribing a harsher one. On these facts, we conclude that
it did not.
ALLERGAN SALES, LLC v. SANDOZ,
INC. (August 29, 2019)
Claim: A method of treating a
patient with glaucoma or ocular hypertension comprising topically administering
twice daily to an affected eye a single composition comprising 0.2% w/v
brimonidine tartrate and 0.68% w/v timolol maleate, wherein the method is as
effective as the administration of 0.2% w/v brimonidine tartrate monotherapy
three times per day and wherein the method reduces the
incidence of one o[r] more adverse events selected from the group consisting of
conjunctival hyperemia, oral dryness, eye pruritus, allergic conjunctivitis,
foreign body sensation, conjunctival folliculosis, and somnolence when compared
to the administration of 0.2% w/v brimonidine tartrate monotherapy three times
daily.
We are not persuaded by Sandoz’s
primary counterarguments, including Sandoz’s reliance on Bristol–Myers, 246
F.3d 1368, In re Copaxone Consolid. Cases, 906 F.3d 1013 (Fed. Cir. 2018), and
Georgetown Rail Equip. Co. v. Holland, L.P., 867 F.3d 1229 (Fed. Cir. 2017). In
Bristol–Myers we expressly noted that the disputed claim terms “w[ere]
voluntarily made after the examiner had already indicated . . . the claims were
allowable” and such “unsolicited assertions of patentability made during
prosecution do not create a material claim limitation.” 246 F.3d at 1375.
Likewise, in Copaxone we held that the disputed claim terms were not “necessary
or relevant to the examiner’s approval.” 906 F.3d at 1024. Finally, in
Georgetown Rail we explained that the disputed claim terms were not relied upon
during prosecution to “distinguish the patented invention from the prior art.”
867 F.3d at 1238. Here, however, both Allergan and the Examiner explicitly
relied on the “wherein” clauses to distinguish the claimed methods over the
prior art during prosecution. The “wherein” clauses were neither unnecessary
nor irrelevant, but were instead material to the Examiner’s patentability
determination.
AMGEN INC. v. COHERUS
BIOSCIENCES INC. (July 29, 2019)
Claim 1: A process for purifying a
protein on a hydrophobic interaction chromatography column such that the
dynamic capacity of the column is increased for the protein comprising mixing a
preparation containing the protein with a combination of a first salt and a
second salt, loading the mixture onto a hydrophobic interaction chromatography
column, and eluting the protein, wherein the first and second salts are
selected from the group consisting of citrate and sulfate, citrate and acetate,
and sulfate and acetate, respectively, and wherein the concentration of each of
the first salt and the second salt the mixture is between about 0.1 M and about
1.0.
We hold that argument-based
prosecution history estoppel applies here because Amgen clearly and
unmistakably surrendered unclaimed salt combinations during prosecution. In its
January 6, 2011 response, Amgen distinguished Holtz on the basis that Holtz did
not teach or suggest the “particular combinations of salts” recited in Amgen’s
claims. Indeed, Amgen emphasized “particular” and referred to its particular
salts three times in the span of two pages. The Declaration attached to Amgen’s
response also highlights and discusses the same particular combinations recited
in Amgen’s claims. For example, the Declaration refers to sulfate/citrate and
sulfate/acetate as “particular dual salt combination[s]” that resulted in
increased dynamic capacity as compared to a single salt. It also explains
that using a sulfate/citrate, sulfate/acetate, or acetate/citrate 10
combination (the only claimed combinations) resulted in reduced commercial manufacturing
costs as compared to using only a single salt. Notably, Amgen’s response to the
examiner’s office action quotes the Declaration’s conclusion that “[u]se of
this particular combination of salts greatly improves the cost-effectiveness of
commercial manufacturing by reducing the number of cycles required for each
harvest and reducing the processing time for each harvest.” . Amgen’s response
and Declaration do not mention any salt combinations other than those claimed.
Based on Amgen’s statements during prosecution, we agree with the district
court’s conclusion that “a competitor would reasonably believe” that Amgen
surrendered unclaimed salt combinations.
