Posts Tagged: biologics


As Lighthizer Negotiates on USMCA, Former HHS Secretary Warns Against Buying Into ‘Myths’

On September 13, U.S. Trade Representative Robert Lighthizer reportedly expressed a willingness to negotiate on several points of contention regarding the U.S.-Mexico-Canada Agreement (USMCA), including …
By IPWatchdog
2 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
4 months ago 0

Patent Trends Study Part Eight: Therapeutic and Diagnostic Molecules Industry

In our last article exploring patent trends across 12 industries, we addressed the industrial design industry. Today’s article pertains to the therapeutic and diagnostic molecules industry. Few …
By Kate Gaudry & Thomas Franklin
6 months ago 2

A Vote for the USMCA Will Secure the Innovation of Tomorrow

Promoting public health has always been a bipartisan priority in Washington, D.C. Under the previous administration, lawmakers passed the 21st Century Cures Act and launched the …
By Patrick Kilbride
9 months ago 0

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 …

District of Delaware Makes it Harder to Corner the Market on Antibody Patents in MorphoSys v. Janssen

Patents covering an antibody are often claimed by the antibody’s function (the residues where it binds to the antigen) rather than its structure (amino-acid sequence). This …
By Zachary Silbersher
10 months ago 2

The Evolution of Antibody Patents

As the pharmaceutical industry continues to shift toward biologic-based drugs, including monoclonal antibodies, protecting the underlying technology has been and continues to be a priority for companies. …

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
2 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
2 years ago 1

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 …

Report shows drug patents fare better in IPR proceedings at PTAB

While the Patent Trial and Appeal Board (PTAB) has not been friendly to patent owners, to put it mildly, the PTAB has not been inhospitable to pharma …
By Steve Brachmann
2 years ago 36

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
2 years ago 2

Understanding the BPCIA Litigation Pathway to Avoid Expensive, Incurable Mistakes

Modeled after the Hatch-Waxman Act, the BPCIA seeks not only to encourage competition in the field of biologics but also to promote innovation by, among other things, …
By Chittam Thakore Ph.D.
3 years ago 1

Courts Answer Key Questions Over the Reach of the BPCIA

Two recent Federal Circuit opinions provide some answers to the issues presented by complaints alleging non-compliance with the BPCIA. In Amgen Inc. v. Sandoz Inc., the Federal …