Since the America Invents Act (“AIA”) established a new venue for hearing patent disputes, the Patent Trial and Appeal Board (“PTAB”), much ink has been spilled regarding the impacts of this forum on patent litigation and the overall intellectual property strategies employed by both patentees and challengers. The Promoting and Respecting Economically Vital American Innovation
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. The Federal Circuit affirmed the district court’s decision that Teva’s patents were improperly listed and must be
On December 3, 2024, Bristol Myers Squibb announced a collaboration agreement with three-year-old startup AI Proteins.[1] According to its founder, Chris Bahl, PhD, AI Proteins uses “AI, synthetic biology, and laboratory automation to rapidly design and optimize novel miniproteins with ideal drug-like properties.”[2] The end goal of this collaboration is likely biologic products
The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for patent infringement in response to Amneal’s ANDA filing seeking to make and sell a generic version of ProAir HFA (albuterol sulfate)
As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. Thus, we reviewed the UPC’s first decision and provide a summary of the first revocation of a European patent by the new Unified Patent Court (UPC).
Please note that
On November 17, 2023, Genentech, Hoffman-La Roche, and Biogen (collectively “plaintiffs”) filed a complaint in the federal district court for the District of New Jersey against Dr. Reddy’s Laboratories and Fresenius Kabi (collectively “defendants”) (DNJ No. 23-cv-22485). The plaintiffs allege that the defendants infringe or intend to infringe fifteen patents related to the biologic rituximab
As one BPCIA case came to a close in May[1], another got underway. On May 1, 2023, Amgen filed a complaint in the District of New Jersey, accusing Sandoz of infringing patents that relate to denosumab, the active ingredient in Amgen’s PROLIA and XGEVA. PROLIA is prescribed for a high risk of bone
On Tuesday, May 23, 2023, Janssen and Amgen settled their case regarding Amgen’s proposed biosimilar to Stelara in Delaware district court.[1]
Stelara, also known as ustekinumab, is an anti-IL-12/IL-23 antibody drug used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Amgen has created a biosimilar of Stelara called ABP 654, which
After the Supreme Court invited the Solicitor General to file a brief expressing the views of the United States regarding Teva Pharms USA, Inc. v. GlaxoSmithKline LLC, et al., the Solicitor General filed its brief amicus curiae on March 29, 2023. The Solicitor General urged the Supreme Court to grant Teva’s petition for a
The United States Patent and Trademark Office (USPTO) issued updated guidance on the duty of candor and duty to disclose in relation to submissions made to other government agencies, particularly the Food and Drug Administration (FDA). The Notice did not constitute new rule making and instead aims to clarify the obligations of patent applicants and