Target to $58 from $83
Tuesday, January 3, 2023
Amgen files brief to Supreme Court ahead of oral arguments — with industry amicus support
Amgen is coming out swinging against Sanofi and Regeneron in a Supreme Court case with substantial implications.
In its brief filed Dec. 27, the Big Pharma laid out its case, saying among other things that the Federal Circuit’s standard harms innovation and alters the “basic patent bargain” — denying an inventor a patent based sheerly on the number of possible embodiments, even if the patent’s disclosures teach the world how to “make and use” the claimed invention. The crux of the case is around enablement, which is essentially if someone “reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation,” per the US Patent and Trademark Office.
The Court will consider Amgen’s request to revive patents on its blockbuster biologic Repatha and block the sale of Praluent, Sanofi and Regeneron’s independently developed but similar PCSK9 inhibitor antibody drug. Both drugs, which are antibodies that differ in amino acid sequence and bind to PCSK9, reduce low-density lipoprotein cholesterol.
Amgen scored a win in 2019 in an initial trial, but a Delaware federal judge overturned that ruling and ruled in favor of Sanofi and Regeneron. That decision was then upheld in the Court of Appeals for the Federal Circuit, denying a rehearing in 2021 and leading Amgen to file an initial petition to SCOTUS in November that year. Amgen claimed that the Federal Circuit decision incorrectly requires patent owners to identify and make all or nearly all possible variations of the invention — without “substantial time and effort.”
Sanofi had previously said that Amgen’s patents surrounding Repatha were overly broad, which the federal judge had concurred with.
GSK filed an amicus brief to the Supreme Court Tuesday in support of Amgen, saying that genus claims — a type of patent that covers not just one specific entity, but a group of related entities — are necessary to protect “groundbreaking discoveries in the life sciences,” and encourage downstream innovation. Instil Bio also filed a brief supporting Amgen, noting that using a requirement called the “full-scope requirement” to determine enablement is inconsistent with the statute, and asking for the court to revert the standard to an “undue experimentation” requirement.
Amgen’s writ of certiorari — which was accepted two months ago — faced setbacks starting out, one of which occurred when Solicitor General Elizabeth Prelogar wrote in a 27-page brief in September that Amgen’s arguments “lack merit and further review is not warranted.”
“Petitioners contend that the court of appeals erred by treating enablement as a question of law and by examining the full scope of the claims in assessing whether they are fully enabled,” she wrote at the time.
Sanofi has until Feb. 3 to file its brief to the case, after which oral arguments will be made before the bench.
Gilead and EVOQ Therapeutics Announce Collaboration to Advance Immunotherapies
Gilead Sciences, Inc. (Nasdaq: GILD) and EVOQ Therapeutics, Inc. (EVOQ) today announced a collaboration and licensing agreement to advance EVOQ’s proprietary technology for the treatment of rheumatoid arthritis (RA) and lupus. EVOQ’s NanoDisc technology is designed to enable lymph-targeted delivery of disease-specific antigens and has the potential to change the paradigm for the treatment of autoimmune diseases. Under the agreement, Gilead and EVOQ will collaborate on preclinical development. Gilead has the option to exclusively license rights to EVOQ’s NanoDisc technology to pursue product candidates for RA and lupus indications and will be responsible for clinical development and commercialization.
https://finance.yahoo.com/news/gilead-evoq-therapeutics-announce-collaboration-133000401.html
RedHill: Positive Phase 2 Study Results for Once-Daily Oral RHB-107 in Non-Hospitalized COVID
Positive data from a U.S. Phase 2 study of once-daily oral RHB-107 (upamostat) in symptomatic COVID-19 published in the peer-reviewed International Journal of Infectious Diseases
RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including faster recovery from severe COVID-19 symptoms (median of 3 days to recovery vs. 8 days with placebo) and 100% reduction in hospitalization due to COVID-19
RHB-107, a novel, broad-acting, host-directed, once-daily oral antiviral, is expected to act independently of viral spike protein mutations including Omicron BA.5 sub-variant[1]
Inclusion of once-daily oral RHB-107 in a multinational platform trial for COVID-19 outpatients pending. Discussions for external non-dilutive funding for additional Phase 3 COVID-19 development advancing
Several collaborative projects, with government and non-government bodies, on a range of preclinical studies against other viral targets for pandemic preparedness ongoing and under discussion
https://finance.yahoo.com/news/redhill-announces-publication-positive-phase-120000969.html
Jasper: Positive Data in Phase I/II Trial of Treatment in Sickle Cell, Beta Thalassemia
All three sickle cell disease participants treated with briquilimab successfully engrafted with neutrophil engraftment within 12-16 days
First two participants with peripheral blood chimerism at 60 days after allogeneic stem cell transplant achieved 100% donor myeloid chimerism
First participant treated has a total hemoglobin level of 13.3 g/dL at five months follow up, increased from 8-9 g/dL at baseline
Aurinia: Patent Challenge Settlement Reached With Sun
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) announces it has entered into a settlement agreement with Sun Pharmaceutical Industries, Inc., Sun Pharmaceuticals Industries, Ltd., and Sun Pharma Global FZE (collectively, Sun Pharmaceuticals) that involves both Aurinia and Sun Pharmaceuticals filing a joint motion to terminate the ongoing Inter Partes Review (IPR) directed at Aurinia’s U.S. Patent No. 10,286,036, as well as settlement of the ongoing patent infringement litigation in the United States (U.S.) related to Sun’s CEQUA® product. Under the settlement agreement, which is contingent upon the U.S. Patent Trial and Appeal Board approving the joint motion to terminate the IPR, both parties agreed to dismiss their claims and counterclaims against each other and cease bringing any future further action against the other.
https://finance.yahoo.com/news/aurinia-announces-lupkynis-voclosporin-patent-141200042.html
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