Posts Tagged: biosimilars


Federal Circuit Upholds Patent for Biologic Drug Enbrel; Judge Reyna Dissents

On July 1, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a holding of the U.S. District Court for the District of New …
By Rebecca Tapscott
5 months ago 1

Federal Circuit Upholds $70 Million Judgment for Amgen in Epogen Biosimilar Case

Yesterday, in an opinion authored by Judge Moore, the Court of Appeals for the Federal Circuit (CAFC) affirmed the District of Delaware’s decision that: 1) U.S. …
By Nancy Braman
12 months ago 0

Amidst Push for a Summer Vote on USMCA, Report Argues RDP Requirement Would Not Raise Drug Prices

In the face of pressure to pull provisions in the United States-Mexico-Canada Agreement (USMCA) that would grant 10 years of regulatory data protection (RDP) for biologics inventions, a …
By Eileen McDermott
1 year ago 0

Accelerating Generic Entry: A Proven Solution to the Problem of Prescription Drug Pricing

High prescription drug prices and their impact on costs borne by the government in Medicaid, Medicare Part D and other federal programs, is a front burner topic …
By Bert Rein
2 years ago 15

Freedom to Operate and the Interplay of Patent and Regulatory Exclusivity for Life Sciences

While part one of this two-part series on intellectual property (IP) due diligence focused on a life science company’s own IP portfolio, part two will address …

The Myth of ‘Trivial’ Drug Patents

Critics of drug patents often claim that when initial drug patents expire, drug companies stuff their patent portfolios with “trivial” patents that unjustifiably extend their patent monopoly …
By David Forman
3 years ago 6

CAFC sides with Sandoz, Amgen’s state claims preempted by BPCIA

Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar …
By Aubrey Haddach
3 years ago 1

Did the Federal Circuit doom Amgen’s Enbrel® monopoly?

In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned …
By Zachary Silbersher
3 years ago 1

IP Strategy is a Tricky Balancing Act for Pharmaceuticals

The 20 years of protection afforded by a patent is intended to promote innovation by allowing inventors a chance to recoup development costs and derive a profit from …
By Shai Jalfin
3 years ago 2

CAFC denies Amgen discovery in biosimilar patent dispute

In a patent infringement case governed by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Federal Circuit found that it lacked jurisdiction to compel discovery …

SCOTUS says OK to give notice of commercial marketing before FDA license under Biologics Price Competition and Innovation Act

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(…

Industry Reaction to SCOTUS decision in Sandoz v. Amgen

The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry …
By Gene Quinn
3 years ago 2