Atossa Therapeutics, Inc.’s Post

Well, that was a really interesting conference and I enjoyed providing an update on EPO Boards of Appeal decisions relating to data needed to support antibody claims. Hazel Ford, Mark van Gardingen and I also discussed an interesting hot off the press USPTO decision that may provide a new option for claiming antibodies in the US. There were lots of really informative talks on topics including UPC action updates, plausibility, priority, patent linkage and the negotiations going on to establish a unitary SPC. #biotechpatents #ipstrategy

A recent bipartisan bill unanimously passed by the U.S. Senate—the Affordable Prescriptions for Patients Act of 2023—proposes changes to the Patent Act which could affect future patent infringement suits under the Biologics Price Competition and Innovation Act (BPCIA). If enacted, the bill would amend the Patent Act to limit the number of certain types of patents that biologic innovators can assert against biosimilar applicants in BPCIA litigation. Read here for our insights, https://bit.ly/4fJOTGm.

🔎View the structures of the small molecule drugs approved by the FDA in 2023 that are in the Cambridge Structural Database (CSD). Discover more about what conditions they treat, and access the structural data of the active ingredients and their solvates. 🔗https://lnkd.in/gh7C7Rkj #SmallMolecule #FDA #Crystallography

The Leahy-Smith America Invents Act (AIA) has led to a significant impact on the decisions of the Patent Trial and Appeal Board and district courts, resulting in differences that often disadvantage patent holders. This disparity is attributed, in part, to variations in the burdens of proof between the two forums, with the Board requiring a preponderance of evidence and the courts demanding clear and convincing evidence. As a consequence, concerns have been raised about the potential for inconsistent outcomes and the implications for patent holders. The article also highlights specific cases, including Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, Inc. and Malvern Panalytical Inc. v. TA Instruments-Waters LLC, to underscore the practical implications of these differences. These developments underscore the ongoing impact of the AIA on patent law and the need for continued examination of its effects on patent holders and the legal system.

Key Patent Timelines for Weight Loss Drugs GLPs (Sema/Tirz) going off patent by 2032 - what would be the balance between peptide generics & fast-followers IP protected peptides and small molecules

VOSSIUS’ Patent Attorneys Dr. Peter Hoecherl and Dr. Michaela Wesse have successfully defended Nippon Shinyaku’s patent EP 2 447 254 relating to a specific polymorph of Selexipag before the Boards of Appeal at the EPO (file no.: T 0672/21). This decision underlines the importance of obtaining patent protection for new polymorphs in order to strengthen the position against competitors on the European market.   For more information, please read the news on our website: https://lnkd.in/dmpFcKfU   #intellectualproperty #IPprotection #patentlitigation #pharmaceuticals #patents

Thoughts on this? >> Intellia to respond to lawsuit over in vivo therapy patents >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #pharma #pharmaceutical #healthcare #biotech

The US Supreme Court passed up United Therapeutics Corporation’s request to review its failed bid to revive a patent for its blockbuster lung-disease drug Tyvaso, dealing a blow to its efforts to keep Liquidia Corporation’s competing treatment off US shelves. The high court on Monday declined to review what UTC had called the “inconsistent and irreconcilable stances” of the United States Court of Appeals for the Federal Circuit regarding the USPTO’s reliance on arguments that weren’t presented in requests for patent validity reviews. Liquidia shares jumped as much as 18% in New York trading Monday, while United Therapeutics shares were down around 1.3% as of 10:30 a.m. Justice Ketanji Brown Jackson didn’t participate in the court’s consideration of UTC’s petition, according to the court’s announcement. UTC sued Liquidia in Delaware federal court in June 2020 alleging the competitor infringed US Patent No. 10,716,793 with its pulmonary arterial hypertension drug Yutrepia. Liquidia challenged the patent at the Patent Trial and Appeal Board, which invalidated it in July 2022. The tribunal’s decision was based on journal publications provided at professional conferences and not evidence entered into record. The Federal Circuit affirmed that decision in December. “We are grateful that this specific chapter has come to a close and that the ’793 patent will now be forever unenforceable,” Roger Jeffs, Liquidia’s chief executive officer, said in a statement. “We will continue to fight for the earliest possible launch of Yutrepia so that patients and physicians have access to the unique benefits that Yutrepia can provide.” UTC declined to comment. UTC argued in its petition to the justices that the appeals court allowed its patent to be canceled based on theories not addressed during the PTAB’s inter partes review. Some Federal Circuit panels review PTAB decisions de novo while others defer to the PTO’s discretion, UTC’s petition said, calling the PTO’s interpretation of the statute that created the IPR process unlawful. “There is no such split,” Liquidia said in its Aug. 27 opposition brief. “UTC’s effort to create one misrepresents the cases it cites and conflates two entirely distinct issues.” The parties are also continuing to fight in other venues. Click for full coverage.

A statistical spotlight on EPO Opposition Divisions vs Boards of Appeal in the pharmaceutical sector... Opponents at the European Patent Office frequently feel like they’re facing a steep challenge when dealing with the opposition divisions (OD). However, they often find this challenge less daunting when they reach the Technical Boards of Appeal (BoA).     Notably in the pharmaceutical sector, the difference between the revocation rate (in red on the attached pie charts) of OD and BoA is:  ·       16% when the decision is based on the set of claims that also formed the basis of the preceding decision (22 versus 38%), and  ·       22% when the decision is based on a set of claims that differs from the claims that formed the basis of the preceding decision (41% versus 63%).    You can see more insights comparing EPO opposition Divisions and Board of Appeals in a recent article written with Dr. Malte Köllner, patent attorney, now available on #epi information: https://lnkd.in/eUxcGDRu

We see patent litigation between Roche and Zydus for the Pertuzumab formulation patent. https://lnkd.in/d29JqiSB Patents in question: IN464646 from app no. 6979/CHENP/2015, family to US9815904 IN268632 from 1730/delnp/2007 Reminds me of Roche v. Biocon litigation for Trastuzumab (on some points).