Weekly Patent Litigation Round-Up

Weekly Patent Litigation Round-Up

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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