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4 Key Takeaways | Updates in Standard Essential Patent Licensing and Litigation
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Wolf Greenfield Attorneys Preview What’s Ahead in 2024
Noteworthy Points in the Rules for the Implementation of China's Patent Law 2023
5 Key Takeaways | Best Practices in Patent Drafting: Addressing 112 and Enablement after Amgen
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Regeneron filed an eighth BPCIA litigation (Case No. 2:24-cv-08760 (D.N.J.)) related to an EYLEA® (aflibercept) biosimilar, against Sandoz’s Enzeevu™ (aflibercept-abzv). The Complaint alleges infringement of 46 of...more
Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more
Welcome to Venable’s BiologicsHQ Monthly Injection – June 2024...more
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation....more
In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more
On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more
As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. The...more
As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions,...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
As one BPCIA case came to a close in May, 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...more
Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation...more
The court has issued a scheduling order in Regeneron’s aflibercept BPCIA case against Mylan. The court scheduled a 2-week trial in June 2023, less than a year from Regeneron’s filing of its complaint in August 2022....more
On September 9, 2022, Biogen Inc. and Biogen MA Inc. (“Plaintiffs”) filed suit against Sandoz Inc., Sandoz International GMBH, Sandoz GMBH, and Polpharma Biologics S.A. (collectively, “Defendants”) in the District of Delaware...more
This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
After reflecting upon the events of the past twelve months, Patent Docs presents its 15th annual list of top patent stories. For 2021, we identified nine stories that were covered on Patent Docs last year that we believe had...more
The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act...more
On September 20, 2021, the District Court for the Northern District of Illinois entered a scheduling order in AbbVie v. Alvotech, No. 21-2258, 21-2899 (N.D. Ill.). As we previously reported, AbbVie Inc. (“AbbVie”) brought an...more
Reference product sponsors often obtain patents claiming methods of using a known drug to treat a condition or disease. Because generic and biosimilar developers typically do not treat patients, and thus do not directly...more
In December 2020, the U.S. District Court for the District of Columbia issued a decision in Teva v. FDA, reviewing FDA’s definition of “protein” in connection with the agency’s determination that Teva’s Copaxone®, a...more
Introduction - The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since...more