Director Iancu is knowingly and intentionally seeking to provide hope in the words he speaks because he believes a strong patent system is necessary for the U.S. economy to flourish. In part one of our interview we also discussed the need for transpare…Continue Reading ...
In Energy Heating v. Heat On-The-Fly, the court did not abuse its discretion in finding clear and convincing evidence that the inventor knew that the prior uses were material and specifically intended to deceive the PTO by not disclosing them. The court had sufficient evidence – including evidence of 61 commercial sales dating back to 2006 and no contemporaneous evidence of experimentation – to disbelieve Mr. Hefley’s testimony to the contrary.
The post Inequitable Conduct Renders ’993 Patent…
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In Texas Advanced Optoelectronic Solutions v. Renesas Electrics, a jury found Renesas liable for both patent infringement and trade secret misappropriation. The jury awarded a reasonable royalty for infringement and a disgorgement of profits for misapp…Continue Reading ...
On appeal, WesternGeco argued 1) the Board erred as to its unpatentability determinations; and 2) the IPR proceedings were time-barred under 35 U.S.C. § 315(b) because ION acted in privity with PGS, and over a year passed between its infringement complaint against ION and the PGS IPR petition. Based on the Federal Circuit’s en banc decision known as Wi-Fi One, the time-bar issue was appealable, but WesternGeco’s argument was unpersuasive because the relationship between ION and PGS was not…
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The Biotechnology Innovation Organization (BIO) will be holding its annual BIO International Convention June 4-7, 2018 in Boston, MA. Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of biotechnology c…Continue Reading ...
The Federal Circuit Bar Association (FCBA) will be offering a webcast entitled “Last Party Standing: Who Has Standing to Appeal Administrative Decisions to the Federal Circuit?” on May 22, 2018 from 3:00 pm to 4:30 pm (EST). Russell E. Cass of Clark Hi…Continue Reading ...
Strafford will be offering a webinar entitled “Oil States and SAS: Implications of the Supreme Court’s Decisions for Patent Practice” on May 31, 2018 from 1:00 to 2:30 pm (EDT). Thomas L. Irving, Amanda K. Murphy, and Barbara R. Rudolph of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel on two recent Supreme Court patent decisions. The panel will provide an analysis of the Court’s Oil States and SAS decisions and discuss the impact of these decisions on daily patent practice. The webinar will review the following issues: • Has there been an increase in IPR…Continue Reading ...
The Intellectual Property Law Association of Chicago (IPLAC) Litigation Committee will be presenting a panel discussion entitled “Nuances in Amending Patent Claims before the PTAB and Avoiding Tribal Immunity at the PTAB” on May 22, 2018 from 5:00 to 7…Continue Reading ...
Strafford will be offering a webinar entitled “Divided Infringement after Travel Sentry v. Tropp: Direct Infringement Liability for Third-Party Conduct” on May 24, 2018 from 1:00 to 2:30 pm (EDT). Thomas L. Irving, Paul W. Browning, and Barbara R. Rudo…Continue Reading ...
From the Pensacola News Journal article titled Escambia High rewrites yearbook page on school’s racial history, claims student plagiarized :
Escambia High School administrators removed and rewrote a page from this year’s student yearbook that contained information about the school’s origin and race-related issues, claiming the student who wrote the page plagiarized information from the internet.
But the student, 18-year-old yearbook co-editor Sasha Slack, believes the school rewrote the page because they are “trying to change the history of Escambia High School because they’re too ashamed to admit that our school was founded as an all-white school.”
In the 60th anniversary edition of the yearbook, Slack wrote about the school’s pre-segregated era and the on-campus race riots of 1976. The senior said she researched multiple websites and wrote a long paragraph titled “Escambia’s Past” in her own words, which the school claims to be false. [emphasis added]
Murphy said that ultimately, he did not want Slack’s original writing to reflect poorly on the school.
“I just feel that we cannot allowed plagiarized work to be presented in a journalism class,” Murphy said. “That is the issue here. That’s the only issue here, is the plagiarism.” [emphasis added]
There are several issues here
was there plagiarism? [copying without attribution]
if no plagiarism, was the motivation of the school an unfavorable portrayal in the yearbook? Was the portrayal false?
was the plagiarism claim a pretextual makeweight argument or a reasonable response to a concern about bad journalism?Continue Reading ...
The co-plaintiff is the exclusive licensee Dynamic Advances, a Delaware corporation whose principal
place of business is located at 1345 Avenue of the Americas, 46th Floor, New York, NY.
Paragraph 41 of the complaint refers to patent citation:
The ’798 Patent has been repeatedly cited in subsequent patent
applications filed by leading technology companies. The ’798 Patent, its published
application, or other patents within the same family, have been cited in patent
applications filed by Hewlett-Packard, Microsoft, IBM, Sony, Google, and Apple.
Complaint available at:Continue Reading ...
(SCALE)Continue Reading ...
$$ A single chip can thus be provided that comprises an integrated detection device with on-chip processing of the picoamp scale currents o…
The case is nominally an appeal of a PTAB decision:
Appellant Altaire Pharmaceuticals, Inc. (“Altaire”)
sought post-grant review of claims 1–13 (“the Asserted
Claims”) of Appellee Paragon Bioteck, Inc.’s (“Paragon”)
U.S. Patent No. 8,859,623 (“the ’623 patent”). The U.S.
Patent and Trademark Office’s Patent Trial and Appeal
Board (“PTAB”) issued a final written decision determining
that Altaire failed to prove that the Asserted Claims
were unpatentable for obviousness over two production
lots of Altaire’s phenylephrine hydrochloride ophthalmic
solution products, Lots #11578 and #11581,
There is much more going on here; from the dissent:
The undisputed facts are these: In 2011, Altaire and
Paragon entered into an agreement to pursue U.S. Food
and Drug Administration (“FDA”) approval for Altaire’s
phenylephrine hydrochloride products (the “Agreement”).
By its terms, the Agreement terminates on May 30, 2021.
See Joint Appendix (“J.A.”) 1909. Subsequently, a dispute
arose between the parties, which apparently led Altaire to
file two lawsuits in federal court in the Eastern District of
New York. In the first suit, Altaire Pharmaceuticals, Inc.
v. Paragon BioTeck, Inc., Case No. 2:15-cv-02416
(E.D.N.Y.) (“the breach of contract suit”), Altaire alleges
that Paragon breached the Agreement by, among other
things, disclosing Altaire’s confidential and proprietary
product information in its patent application and in its
resulting U.S. Patent No. 8,859,623 (“the ’623 patent”).
See Complaint and Jury Demand at 7 (No. 2:15-cv-02416)
(E.D.N.Y. April 28, 2015). P
BUT the issues decided are evidentiary in nature.
There was an initial standing issue, which was a basis for the dissent
opinion; the majority noted:
We recently “established the legal standard for
demonstrating standing in an appeal from a final agency
action,” including “the burden of production[,] the evidence
an appellant must produce to meet that burden[,]
and when an appellant must produce that evidence.”
Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1172
(Fed. Cir. 2017) (footnote omitted). We explained that
“[a]n appellant’s obligation to establish injury in fact
remains firm even though it need not meet all the normal
standards for redressability and immediacy when, as
here, a statute provides that appellant with a right to
appeal.” Id. at 1172 n.2 (internal quotation marks and
citation omitted); see 35 U.S.C. § 141(c).
While we recognize that “[a] claim is not ripe for adjudication
if it rests upon contingent future events that may
not occur as anticipated, or indeed may not occur at all,”
Texas v. United States, 523 U.S. 296, 300 (1998) (internal
quotation marks and citation omitted), we conclude that,
under these circumstances, Altaire’s injury is inevitable.
Therefore, Altaire has satisfied its burden of production
by producing sufficient evidence that the threat of infringement
litigation is an injury that is “real” and “imminent.”
Prasco, 537 F.3d at 1339.
Having determined that Altaire faces imminent injury,
we next must determine whether that injury is concrete
and particularized. See Spokeo, 136 S. Ct. at 1548
(“Particularization is necessary to establish injury in
fact . . . .”); id. (“Concreteness . . . is quite different from
Graver Tank is cited:
First, § 42.65(b) does not require that the affidavit
corroborating the technical test or data be submitted by
an expert. Cf. Graver Tank & Mfg. Co. v. Linde Air
Prods. Co., 339 U.S. 605, 609 (1950) (stating that, in the
context of the doctrine of equivalents, “[p]roof can be
made in any form,” including “through testimony of
experts or others versed in the technology” (emphasis
Of evidentiary issues:
Although the PTAB “has broad discretion to regulate
the presentation of evidence,” Belden, 805 F.3d at 1081,
that discretion is not without limits, see Ultratec, Inc. v.
CaptionCall, LLC, 872 F.3d 1267, 1274 (Fed. Cir. 2017)
(stating that “[t]he agency does not have unfettered
discretion in [evidentiary] matters”). The PTAB’s decision
to assign no weight to Mr. Al Sawaya’s testimony was an
abuse of discretion. See id. at 1275 (holding that the
PTAB “abused its discretion when it refused to admit and
consider . . . trial testimony”); cf. Aqua Prods., Inc. v.
Matal, 872 F.3d 1290, 1325 (Fed. Cir. 2017) (en banc)
(plurality opinion) (“[A]n agency’s refusal to consider
evidence bearing on the issue before it is, by definition,
arbitrary and capricious within the meaning of 5 U.S.C.
§ 706, which governs review of agency adjudications.
That means that the agency must take account of all the
evidence of record, including that which detracts from the
conclusion the agency ultimately reaches.” (citations
On remand, the PTAB must consider Mr. Al Sawaya’s testimony when
evaluating the reliability of the TMQC-247 and optical
rotation test data.
As to evidence in a reply:
After Paragon unexpectedly challenged Altaire’s
TMQC-247 test data for failure to comply with § 42.65(b)
in its Patent Owner Response, see J.A. 1112–15, Altaire
submitted its Reply, appending additional information on
the TMQC-247 test, see J.A. 1418–25, 1505–606. This
included Exhibits 1027 and 1028. See J.A. 1505–32.
Similar to the Second Al Sawaya Declaration, Altaire
properly “respond[ed] to [those] arguments raised in
[Paragon’s Patent Owner R]esponse” by submitting additional
evidence demonstrating the reliability of the
TMQC-247 testing method. 37 C.F.R. § 42.23(b); see 5
U.S.C. § 556(d); see also Belden, 805 F.3d at 1078. To the
extent Paragon wished to contest this additional evidence,
the PTAB could have permitted Paragon to file a surreply.
See Belden, 805 at 1081.
In light of Paragon’s past reliance on the TMQC-247
test data, we conclude that the PTAB abused its discretion
by “refus[ing] to consider evidence” regarding the
reliability of the TMQC-247 testing method. Aqua, 872
F.3d at 1325 (citation omitted); see Ultratec, 872 F.3d at
1275. On remand, the PTAB shall consider all relevant
TMQC-247 information in determining whether Altaire
satisfied the requirements of § 42.65(b) and, if it did,
whether the TMQC-247 test data render obvious the
Some odd arguments:
Finally, regarding the optical rotation test, the PTAB
determined that Paragon “presented sufficient evidence to
challenge the accuracy of estimating enantiomer purity
based on the specific rotation,” such that it “[was] not
persuaded that [Altaire]’s optical-rotation data amount to
a preponderance of the evidence to show that Altaire’s
[p]roduct[s] meet the chiral-purity limitations of the
[Asserted C]laims.” J.A. 19, 20. As with the TMQC-247
test data, Paragon relied upon this optical rotation test
data before the FDA. See J.A. 783–91. Indeed, the ’623
patent itself recognizes that the optical rotation test can
be used to determine chiral purity. See ’623 patent col. 4
Nevertheless, the PTAB rejected the data, stating
that, “for the optical rotation data, as for the [TMQC-247]
data, [Altaire] has not provided any affidavit in compliance
with . . . § 42.65(b).” J.A. 19. However, as explained
above, see supra Section II.B–C, the PTAB abused its
discretion by refusing to consider Mr. Al Sawaya’s testimony
and the additional information on the TMQC-247
test data. To the extent the PTAB’s decision to reject as
unpersuasive the optical rotation test data rested upon
these erroneous determinations, the PTAB must reconsider
the reliability of the optical rotation test data pursuant
to § 42.65(b) on remand.
The dissent as to standing:
I start from the premise that the standing issue in
this case turns entirely on the pending litigation in the
Eastern District of New York. I say that because, although
both Altaire and the majority point to the Agreement’s
2021 termination date, Appellant’s Br. 47–48,
Majority Op. at 12, I am unable to see how the fact that
the Agreement is scheduled to terminate in 2021 supports
standing at this point. Put most simply, what we have is
a situation in which the parties to a contract that is due to
terminate in approximately three years are in a dispute.
At the same time, in view of the terms of the Agreement,
Altaire cannot infringe the ’623 patent while the Agreement
is in effect. These circumstances, it seems to me,
come nowhere near providing Altaire with grounds for
claiming that it is subject to imminent harm. Timing is
important for a showing of imminence, or immediacy.
The longer the time between when suit is initiated and
when potential infringement may occur, “the more likely
the case lacks the requisite immediacy.” Sierra Applied
Scis., Inc. v. Advanced Energy Indus., Inc., 363 F.3d 1361,
1379 (Fed. Cir. 2004).
***In passing, this is a case about enantiomers.Continue Reading ...
An attempt by AIDS HEALTHCARE FOUNDATION at a DJ against Gilead failed:
Healthcare argued that in view of the lengthy time
consumed by litigating patent validity, such litigation
needed to start well in advance of expiration of the fiveyear
exclusivity period. See, e.g., AHF Br. 5; Dist. Ct. Op.
at *4–5. Healthcare filed this declaratory action in January
2016, two months after the FDA approved Genvoya®—the
first TAF-containing product to receive FDA
This appeal is from the dismissal of a declaratory
judgment action filed by AIDS Healthcare Foundation,
Inc. (“Healthcare” or “AHF”) against Gilead Sciences, Inc.
et al. (“Defendants”) in the United States District Court
for the Northern District of California.1 On appellate
review, we conclude that this action does not meet the
requirements of the Declaratory Judgment Act.
The CAFC began its discussion:
Exercise of the Constitution’s judicial power is limited
to actual cases and immediate controversies. Muskrat v.
United States, 219 U.S. 346, 356 (1911). When this constitutional
requirement is not met, a court has no authority
to decide the issues presented, whatever the
“convenience and efficiency” of such judicial action.
Hollingsworth v. Perry, 133 S. Ct. 2652, 2661 (2013)
(quoting Raines v. Byrd, 521 U.S. 811, 820 (1997)); see
Muskrat, 219 U.S. at 356 (“[U]nless [the exercise of the
judicial power] is asserted in a case or controversy within
the meaning of the Constitution, the power to exercise it
is nowhere conferred.”).
Some of the issues in this case
The existence of a patent, without more, does not create
a case of actual controversy. See Prasco, LLC v.
Medicis Pharm. Corp., 537 F.3d 1329, 1339 (Fed. Cir.
2008) (“[J]urisdiction generally will not arise merely on
the basis that a party learns of the existence of a patent
owned by another or even perceives such a patent to pose
a risk of infringement, without some affirmative act by
the patentee.” (quoting SanDisk Corp. v. STMicroelectronics,
Inc., 480 F.3d 1372, 1380–81 (Fed. Cir. 2007))).
Healthcare presents several additional arguments for
declaratory jurisdiction, including that (1) Healthcare is
an indirect infringer of the TAF patents based on its
requests to potential producers to provide the patented
products; (2) Gilead’s non-response to Healthcare’s request
for a covenant not to sue created a present controversy;
and (3) public policy favors invalidation of invalid
patents and thus the testing of “weak” patents. The
district court, receiving all of Healthcare’s arguments,
correctly held that the declaratory judgment criteria were
No immediacy here:
Healthcare argues that it meets this requirement because
of the lengthy time required for patent litigation,
such that an immediate start is needed. However, the
time consumed by litigation of a speculative future controversy
does not provide the “immediacy and reality”
required for declaratory judgment actions; nor is a declaratory
tribunal precluded from providing expedited relief
when such is warranted. In this case, where there is no
present infringement, no threat of or possibility of infringement
litigation, and no meaningful preparation to
infringe, the “immediacy and reality” criteria are not met.
See, e.g., Prasco, 537 F.3d at 1338–39
The district court observed the absence of evidence of
preparation to produce a product covered by any of the
TAF patents, and found “significant uncertainty about the
nature of any hypothetical product.” Dist. Ct. Op. at *5.
The uncertainty of whether future infringement might
occur at all weighs against the immediacy and reality
requirement of declaratory action. Matthews, 695 F.3d at
1328–29. In addition, precedent illustrates that the mere
possibility of future infringement does not meet the
immediacy and reality criteria, for “[a] party may not
obtain a declaratory judgment merely because it would
like an advisory opinion,” id. at 1329 (quoting Cat Tech,
528 F.3d at 881). For example, in Benitec Australia, Ltd.
v. Nucleonics, Inc., 495 F.3d 1340, 1349 (Fed. Cir. 2007),
this court held that a representation that the declaratory
plaintiff “expects to begin work shortly” on “potentially
infringing” activities was of insufficient immediacy to
support a declaratory action.
Liability for induced infringement requires that some
other entity is directly infringing the patent. Power
Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
843 F.3d 1315, 1331 (Fed. Cir. 2016).
Fina was distinguished
In Fina Research, the declaratory plaintiff was a foreign
entity that was manufacturing and selling an ingredient
of drilling mud abroad; the holder of United States
patents on compositions containing the drilling mud had
sent letters to the foreign producer, stating that the
patentee would sue for infringement if the ingredient
were introduced in the United States. The court held that
such a direct threat of suit against an existing product
and its producer established declaratory jurisdiction.
Fina Research, 141 F.3d at 1482–84; see also SanDisk,
480 F.3d at 1382 (describing how the presentation of “a
thorough infringement analysis” and “element-byelement”
product analyses created a case or controversy
supporting declaratory judgment jurisdiction). In contrast,
here the record does not refer to threats of litigation
on importation of existing product, or even an identification
of any product whose importation may violate Gilead’s
patent rights. No such TAF-containing products are
reported to exist.
As to policy arguments:
Healthcare argues that public policy is served by invalidation
of invalid patents, and thus supports immediate
challenge to the “weak” TAF patents. Yet the HatchWaxman
Act is already a balance of several policy interests,
seeking to preserve the patent incentive to invent
new drugs, while enabling validity challenge by ANDA
filers before actual infringement occurs. Andrx Pharm.,
Inc. v. Biovail Corp., 276 F.3d 1368, 1371 (Fed. Cir. 2002).
The present policy reflects a balance of several factors
and public interests; any policy change would require reexploration
of all aspects. Healthcare’s proposal of a
change in policy to facilitate challenge to drug patents
would warrant legislative consideration, not departure
from precedent. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348,
1358 (2018) (“Policy arguments are properly addressed to
Congress, not this Court.”)
UPDATE. Post to Patent Docs:
As to the drug — tenofovir alafenamide fumarate (“TAF”)–, note that Truvada with –tenofovir disoproxil fumarate (“TDF”) — made the recent FDA list of Reference Listed Drug (RLD) Access Inquiries (with no REMS issue). The FDA approved generic Truvada in 2017, with Teva and Gilead making a deal. Some of the lawsuits involving Gilead and TAF are over issues other than patents. If, hypothetically, there were an obviousness issue it might be that TAF is obvious over TDF.Continue Reading ...
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