Biologics
About
Biologics is part of our work in ライフサイエンス.
急速に成長する産業の複雑な科学を保護
約10年前に導入された生物製剤価格競争・革新法（BPCIA）は、バイオ後続品企業が米国食品医薬品局（FDA）の承認を得て、先発バイオ医薬品の後続品（バイオシミラー）又は代替可能医薬品（インターチェンジャブル）を製造・販売できる道を開きました。先発バイオ医薬品企業（参照品スポンサー）に対しては、12年間の排他的期間が定義されています。BPCIAは、参照品スポンサーとバイオシミラー申請者の間で特許訴訟を行うための法的根拠を定義しています。医薬品に係る特許によっては、参照品にさらなる排他的期間が認められる可能性があるためです。ハッチ・ワックスマン法とは異なり、BPCIAでは、参照品スポンサーがオレンジブックに相当する特許を記載することは義務付けられていません。その代わりに、独自の紛争前手続（パテント・ダンス）を定義しており、関連する特許と、侵害及び有効性に関する各当事者の根拠の提示等が求められています。
実績
Finnegan is lead and preferred IP transactions counsel for one of the largest pharmaceutical companies in the world, handling more than 50 diligence projects each year, including all IP and related transactional aspects of the matters. The transactions span the full gamut of technologies from small molecule through biologics such as antibodies, oligonucleotides, and gene therapies. Finnegan also provides extensive assistance with post-deal integration procedures and subsequent global prosecution and portfolio strategy, ensuring a seamless transition of IP assets to the company and maximum value from acquired IP.
Finnegan is lead and preferred IP strategy counsel for one of the largest pharmaceutical companies in the world, handling all aspects of prosecution and portfolio management for multiple top-tier products for the client. The work spans the gamut from drafting and prosecution through larger strategic planning, patent term extension, and pre-litigation preparation on blockbuster small molecule and biologic products in the oncology, rheumatology, immunology, neuromuscular, and cell and gene therapy spaces.
Represented Rocket Pharmaceuticals, Inc. in district court litigation involving claims of trade secret misappropriation and breach of contract against corporate and individual defendants relating to complex treatments for genetic disorders. Obtained successful outcome including permanent injunction and other remedies against all defendants.
3:24-cv-02170, D. Or., Judge Simon
Representing Sarepta in defensive patent litigation involving Elevidys®, a one-time gene therapy for the treatment of a neuromuscular disease known as Duchenne muscular dystrophy (DMD) and in parallel offensive inter partes reviews (IPRs).
1:24-cv-00882, D. Del., Judge Andrews
Successfully represented Incyte in patent litigation, including preliminary injunction proceedings related to Sun Pharmaceuticals’ deuterated Janus kinase (JAK) inhibitor, LEQSELVI™. Case settled favorably for our client.
2:24-cv-06944, D.N.J., Judge Padin
Represented Rocket Pharmaceuticals, Inc. in district court litigation involving claims of trade secret misappropriation and breach of contract against individual and corporate defendants and relating to complex treatments for genetic disorders. Successfully opposed motion to dismiss key claims and obtained settlement with all defendants following completion of fact discovery.
1:23-cv-09000, S.D.N.Y., Judges Castel, Aaron