Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s...more
In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation...more
For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic competition. As discussed during the first installment of our Hatch-Waxman series,...more
Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 2024-1398 (Fed. Cir. (D. Minn.) Sept. 16, 2024). Opinion by Mazzant (sitting by designation), joined by Moore and Prost....more
This issue of The PTAB Review begins by providing an analysis of how institution decisions consider declaration testimony submitted by a patent owner. Next, it summarizes proposed rulemaking from the United States Patent and...more
Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more
Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more
Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more
In the most recent of a series of litigations by AbbVie against manufacturers seeking to market biosimilar versions of Humira®, the world’s most profitable drug, AbbVie initiated an action against Alvotech in the district...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
THE COURT GRANTED PLAINTIFFS’ MOTION TO DISMISS DEFENDANT’S ANTITRUST AND PATENT MISUSE COUNTERCLAIMS AND RELATED AFFIRMATIVE DEFENSES. Case Name: Duke Univ. v. Akorn, Inc., Civ. No. 3:18-cv-14035-BRM-TJB, 2019 U.S. Dist....more
In a precedential decision delivered this week, the Federal Circuit shot down arguments from Appellants BTG International Limited; Janssen Biotech, Inc.; Janssen Oncology, Inc.; and Janssen Research & Development, LLC (BTG),...more
St. Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., Appeal No. 2018-1638, -1639, -1640, -1641, -1642, -1643 (Fed. Cir. July 20, 2018} - In a groundbreaking decision issued on Friday, the Federal Circuit held that tribal...more
Case Name: Allergan, Inc. v. Sandoz, Inc., Nos. 2016-1085, -1160, 2017 U.S. App. LEXIS 4733 (Fed. Cir. Mar. 17, 2017) (Circuit Judges Reyna, Wallach, and Chen presiding; Opinion by Wallach, J.) (Appeal from M.D.N.C., Eagles,...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Takeda Pharmaceutical Co. Ltd. v. Lee - 1:16-cv-00852; filed July 1, 2016 in the Eastern District of Virginia ...more
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more
The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more
When inter partes review (IPR) proceedings became effective in September 2012, few people would have predicted the transformative effect it would have on patents and the litigation landscape. Three years in, IPR has become...more
On September 2, 2015, the USPTO Patent Trial and Appeal Board (PTAB) denied institution of another Inter Partes Review brought by Kyle Bass, the Coalition for Affordable Drugs, and other related entities. In denying the...more
The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision...more
On August 19th, the USPTO released a new set of proposed rules related to post-grant proceedings before the Patent Trial and Appeal Board (PTAB). Among the many offered rules was the addition of a “Rule 11-type certification”...more
Last month, in a letter to Congressional leadership, 79 Members of Congress expressed their support for the Innovation Act (H.R. 9) but sought inclusion of language in the bill "to preserve the integrity of the Drug Price...more
Addressing the “safe harbor” provision under 35 U.S.C. § 121, the U.S. Court of Appeals for the Federal Circuit upheld a district court ruling that a reissue patent was invalid for obviousness-type double patenting. G.D....more