Jury orders Gilead's Kite Pharma to pay $752M for CAR-T
patent infringement
In a high-stakes patent lawsuit between CAR-T companies
Bristol-Myers Squibb and Gilead Sciences, BMS has come up with a victory. After
a two-week trial, jurors in California ordered Gilead’s Kite Pharma to pay $752
million to BMS’ Juno Therapeutics and its partners, which sued in 2017 for
patent infringement. A BMS spokesperson said the company is "pleased"
with the decision, while a Gilead representative said the company is
"steadfast in our opinion" that the patent isn't infringed and is
invalid. Gilead said it'll address its concerns in post-trial motions and
through a potential appeal. In its lawsuit, Juno alleged Kite scientific
collaborators copied research by scientists at Sloan Kettering to advance
Kite’s CAR-T work and eventually win approval for Yescarta. In 2013, Juno
exclusively licensed a patent from Sloan Kettering and the Memorial Sloan Kettering
Cancer Center covering the technology. .
Judge Connolly Denies Orexo’s Motion for a New Trial in
Hatch-Waxman Patent Action
By Memorandum Opinion entered by The Honorable Colm F.
Connolly in Orexo AB et al. v. Actavis Elizabeth LLC et al., Civil Action No.
17-205-CFC (D.Del. December 11, 2019), the Court denied Plaintiffs’ Orexo AB
and Orexo US, Inc. (collectively, “Orexo”) motion for a new trial, pursuant to
Federal Rule of Civil Procedure 59(a), on the issues of infringement,
willfulness and damages. Orexo had alleged that Defendants generic versions of
the anti-opioid addiction drugs Suboxone® and Subutex® directly and indirectly
infringe claim 2 of U.S. Patent No. 8,454,996 (“the ‘996 patent”). Following a
five-day trial, the joint verdict form did not ask the jury whether Orexo had
proven direct infringement and the jury found that Defendants did not induce or
contribute to infringement. Accordingly, the Court entered judgment for
Defendants…
HIV Prevention Group Files Petition with U.S. Patents
Office Alleging Gilead Delayed Improved HIV Drug Development to Gain Profits from
Older Medicines
Gilead delayed safer HIV drug to extend monopoly profits,
advocates allege
“…An HIV-prevention group called PrEP4All Collaboration
filed a petition Wednesday with the U.S. Patent and Trademark Office contending
Gilead knew its new, improved drug — approved in 2015 and now part of Gilead’s
combination therapies Genvoya and Descovy — was safer. But it alleged Gilead
postponed development so it could continue to gain monopoly profits from its
older combination HIV drugs, including Viread and Truvada, for a longer period,
before those drugs went off patent and faced generic competition. Gilead used
the delaying tactic even though the older drugs posed more risks to bone and
kidney health, PrEP4All alleged…”
Supreme Court: PTO Cannot
Recoup its Attorney Fees in Defending §145 Civil Actions
In a short,
unanimous decision, the Supreme Court has upheld the “American Rule” of fee
shifting — holding that the “all expenses of the proceedings” provision of §
145 does not authorize reimbursement of PTO attorney/paralegal costs associated
with working on the case. The question presented in this case is whether such
“expenses” include the salaries of attorney and paralegal employees of the
United States Patent and Trademark Office (PTO). We hold that they do not.
The court’s interpretation of “all the expenses of the
proceedings” is as follows:
The complete phrase “expenses of the proceeding” is similar
to the Latin expensæ litis, or “expenses of the litigation.” This term has long
referred to a class of expenses commonly recovered in litigation to which
attorney’s fees did not traditionally belong. See Black’s Law Dictionary 461
(1891) (defining “expensæ litis” to mean “generally allowed” costs) … These definitions
suggest that the use of “expenses” in §145 would not have been commonly
understood to include attorney’s fees at its enactment. .
Guidelines published for filing
a PPH request
Guidelines for filing PPH (Patent Prosecution Highway) request under the
PPH pilot program between IPO (Indian Patent Office) and JPO (Japan Patent
Office) have been published. Union Cabinet chaired by the Prime Minister Shri
Narendra Modi had approved in Novemebr 2019 the proposal for adoption of Patent
Prosecution Highway (PPH) programme by the Indian Patent Office (IPO) with
patent offices of various other interest countries or regions. The PPH
programme would initially commence between Japan Patent Office (JPO) and Indian
Patent Office (IPO) for a period of three years and the guidelines fo filing a
PPH rquest under this programme have now been published.
TAG supports opposition of
Sanofi TB drug patents in India
Treatment Action Group (TAG), a US-based organisation focused on research
of diseases such as HIV/AIDS and tuberculosis (TB), has applauded an opposition
that aims to block Sanofi from patenting a new TB drug in India. On December 5,
TAG issued a statement of support for a TB survivor, Ganesh Acharya and Delhi
Network of Positive People (DNPP), saying that the drugs being claimed by
Sanofi are “public goods”. The oppositions, submitted on November 5 at the
Indian Patent Office in Kolkata, are against two patents applied-for by Sanofi.
The first patent, titled “Anti-tuberculosis stable pharmaceutical composition
in the form of a coated tablet comprising of granules of isoniazid and granules
of rifapentine and its process of preparation” covers a new TB treatment. The
second patent covers a water-dispersible formulation for young children…
Solicitor General Recommends against
Cert in Vanda, Perhaps Bolstering Athena’s Bid for Review
The United States Office of the Solicitor General (SG) has filed its
brief in response to the Supreme Court’s March request for views in Hikma
Pharmaceuticals v. Vanda Pharmaceuticals. The December 6 brief says that the
Federal Circuit correctly held the relevant claims of Vanda’s patent-in-suit
eligible, and that the case is therefore “not an optimal vehicle for bringing
greater clarity” on the topic of Section 101 law. Instead, said the SG, the
High Court should grant certiorari in a case like Athena Diagnostics v. Mayo
Collaborative Services, in which the order denying en banc rehearing “was
accompanied by multiple separate opinions articulating different understandings
of Mayo and seeking clarification from this Court.”…
Abraxis Bioscience dismisses
patent infringement complaint filed against SPARC
Sun Pharma Advanced Research Company announced that Abraxis Bioscience
LLC. has dismissed the patent infringement complaint filed against SPARC
regarding SPARC's New Drug Application for PICS (Paclitaxel Injection
Concentrate for Suspension). SPARC will also inform the USFDA of the dismissal
of the complaint to vacate the 30-month stay…
Full Fed. Circ. Won't Review
Celgene's Retroactive IPRs
The full Federal Circuit said Monday it won't review whether the
government violated the Fifth Amendment by invalidating in inter partes review
two Celgene Corp. cancer drug patents that were issued a decade before the
American Invents Act passed, creating the IPR procedure...
Fed. Circ. Affirms Actavis
Infringed Anti-Nausea Drug Patent
The Federal Circuit on Wednesday upheld a Texas federal judge's decision
that Actavis' proposed generic version of Sancuso, a drug administered through
a skin patch used to prevent nausea and vomiting after chemotherapy, infringes
a ProStrakan Inc. patent..
New USMCA agreement scraps
ten-year marketing exclusivity provision
The US, Canada and Mexico have signed a new, finalised trade
agreement to replace the old North American Free Trade Agreement. In a press
conference on Tuesday, December 10, Nancy Pelosi, the speaker of the US House
of Representatives, said the agreement will not include an earlier proposition
which would have given pharmaceutical companies ten-years of market exclusivity
for biologics in both Canada and Mexico. Pelosi said the new agreement is
“infinitely better than what was initially proposed by the Trump
administration”. Also speaking at the conference, congresswoman Jan Schakowsky,
who serves on the US-Mexico-Canada (USMCA) Working Group, described the
administration’s initial proposal as “deeply flawed” …
AAI Defends California’s
Pay-for-Delay Legislation in Federal Court (AAM v. Becerra)
AAI has submitted an amicus brief
in the Eastern District of California opposing a motion by a generic
pharmaceutical association seeking to thwart pro-consumer pay-for-delay
legislation. California Assembly Bill 824 (AB 824), signed into law by Governor
Gavin Newsom in October 2019 and scheduled to take effect in January 2020,
creates a framework for California courts to treat pay-for-delay agreements as
presumptively unlawful under the Cartwright Act. AAI has long advocated for a similar approach
under both state and federal law in numerous amicus filings in courts
throughout the United States. In November, the Association for Accessible
Medicines (AAM), a trade association that represents the interests of generic
pharmaceutical manufacturers, filed a motion for a preliminary injunction
against California Attorney General Xavier Becerra, seeking to bar the state
from implementing or enforcing AB 824.
Among other things, AAM argues that AB 824 will prevent procompetitive
patent litigation settlements, leading to fewer generic challenges to branded pharmaceuticals,
higher drug prices, and diminished public health..
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