BiosimilarsIP

Authored by @rothwellfiggIP, covers news and provides updates and analyses related to #biologics and #biosimilars under the #BPCIA.

[BiosimilarsIP @BiosimilarsIP]

Artificial intelligence (AI) is making significant progress in the biosimilar industry, and last month, the FDA made 2 big contributions to the conversation surrounding the integration of AI in the biotech field. #AI #aiinbiotech #biotech #biosimilars https://t.co/W2zgkd0or0

[BiosimilarsIP @BiosimilarsIP]

In light of the USPTO's updated guidance on the duty of candor and duty to disclose in relation to submissions made to other government agencies, particularly the FDA, #patentapplicants and #patentowners should expect to see some changes. #FDA https://t.co/iQDskbFPQh

[BiosimilarsIP @BiosimilarsIP]

The #SupremeCourt decision on Friday to review the standard for enablement of genus claims after the Federal Circuit’s decision in #Amgen v. #Sanofi raises the possibility that patent owners will see the pendulum shift back in favor of genus claims. https://t.co/idYBEfn6ga

[BiosimilarsIP @BiosimilarsIP]

A recent decision in the District of Delaware provides guidance to ANDA applicants seeking to maintain a case or controversy for declaratory judgment counterclaims under the Hatch Waxman Act. #ANDA #declaratoryjudgment #HatchWaxman https://t.co/hRAsEIhVww

[BiosimilarsIP @BiosimilarsIP]

Yesterday, @Coherus_Bio announced that the FDA approved CIMERLI™ as a #biosimilar product #interchangeable with Lucentis® for all 5 indications, meeting the FDA’s rigorous standards to the reference product, including safety, efficacy, and quality. https://t.co/4jzAWGW8cF

[BiosimilarsIP @BiosimilarsIP]

Patent thickets appear to have caught the ire of many U.S. senators. Recent letters provide insights into the tools they believe are available to address overlapping patents covering a single pharmaceutical product. #patentthickets #pharmapatents https://t.co/87oPwuH9vD

[BiosimilarsIP @BiosimilarsIP]

The Supreme Court’s invitation to the Solicitor General to file a brief expressing the views of the US in Amgen v Sanofi, which involves important questions of enablement for genus claims, signals the Court’s interest in the case. #AmgenSanofi #biosimilars https://t.co/BByxLoElyO

[BiosimilarsIP @BiosimilarsIP]

The Federal Circuit's recent denial of Biogen's petition for rehearing appears to set a higher standard for written description requirement, at least for claims directed to therapeutic methods. #Biogen #therapeuticmethods https://t.co/oYCmiE8cjf

[BiosimilarsIP @BiosimilarsIP]

Compare the biosimilar approvals and products in the pipeline in the U.S. and European markets - updated mid-March #biosimilars #FDA #EMA
https://t.co/oPPR83TVDt

[BiosimilarsIP @BiosimilarsIP]

Rothwell Figg attorneys achieved a favorable outcome following the filing of a Petition for Post-Grant Review on behalf of their client, Celltrion #PTAB #PGR #iplaw
https://t.co/oeaEwBEuQU

[BiosimilarsIP @BiosimilarsIP]

The Federal Circuit recently held in a 2-1 decision in Novartis Pharmaceuticals v. Accord Healthcare that the claims of Novartis’ U.S. Pat. No. 9,187,405 met the written description requirement under 35 U.S.C. § 112(a) #MPEP #patents #litigation https://t.co/CnhmFjUNSO

[BiosimilarsIP @BiosimilarsIP]

In late January, a federal court in Delaware unsealed an opinion supporting its grant of summary judgment that the '509 patent is invalid for lack of #enablement. #antibodyclaims #patents #infringement

https://t.co/rn324cqm51

[BiosimilarsIP @BiosimilarsIP]

A victory for generic manufacturers - Delaware court found that Hikma's "skinny label" for a generic version of icosapent ethyl did not infringe on the branded product's patents, reassuring generic companies that the "skinny label" regime lives on. #IPlaw
https://t.co/FC8tLx14ri

[BiosimilarsIP @BiosimilarsIP]

Details you need to know about the three #amicuscuriae briefs filed following the petition for a #writofcertiorari in Amgen Inc. v. Sanafori, Inc., filed at the end of December, 2021. #SupremeCourt #Patentlaw
https://t.co/YJ9QV0W1rl

[BiosimilarsIP @BiosimilarsIP]

Congratulations to RF associate Kristen Logan who was sworn into the D.C. Bar. A graduate of Georgetown University Law Center, with a degree in the computer sciences, she serves clients in wireless, eCommerce, electronics and software. #IPLaw https://t.co/knmKPtK5l3

[BiosimilarsIP @BiosimilarsIP]

#SupremeCourt asked to overturn the Federal Circuit's ruling on Amgen v. Sanofi with two questions about enablement. Will they hear this challenge?#IPLitigation https://t.co/XxsXFrMGQc

[BiosimilarsIP @BiosimilarsIP]

The USPTO's recent move in two IPRs is the latest development in a series of battles over #Eylea®, which has been marketed in the US since 2011, has enjoyed $8.36B in revenues in 2020, and is the third highest grossing #biologic product in the world. https://t.co/Z45XbMVCuh

[BiosimilarsIP @BiosimilarsIP]

While the EU’s significant head start in #biosimilar product authorizations led to an imbalance in the number of #biosimilardrugs available in the EU versus the US, the EU’s higher rate of approvals in recent years has widened its lead over the US. https://t.co/BxY8LsBnmH

[BiosimilarsIP @BiosimilarsIP]

Takeaways from the FDA's approval of Boehringer Ingelheim's Cyltezo®, the first interchangeable biosimilar for Humira, and the first interchangeable monoclonal antibody to be approved. #Humira #interchangeablebiosimilar #biosimilar #Cyltezo https://t.co/wEb1e89V4y

[BiosimilarsIP @BiosimilarsIP]

Congressional leaders sent a letter to the USPTO requesting that it reevaluate the PTAB's view on discretionary denials of petitions for IPRs, emphasizing that they are contributing to the high price of drugs. #drugpricing #discretionarydenials #fintiv https://t.co/mmnCql5gkp