Posts Tagged: biologics


New Dance Moves? Purple Book Amendments Require Public Disclosure of ‘Patent Dance’ Patent Lists

Innovator (or “reference”) biologic drug makers and small-molecule drug makers face differing legal obligations with respect to public patent disclosures. Under the Hatch-Waxman Act, reference small-molecule drug …
By Christopher Loh
2 months ago 0

Bills to Lower Prescription Drug Costs and Boost Biosimilars Sent to Biden’s Desk

The U.S. House of Representatives yesterday approved two bills meant to lower prescription drug prices and sent them on to President Joe Biden for approval. The …
By Eileen McDermott
5 months ago 1

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
1 year ago 1

USMCA Takes Another Step Forward in 25-3 Senate Committee Vote

The United States Senate Finance Committee today considered the U.S.-Mexico-Canada Agreement (USMCA) in an Open Executive Session and voted 25 to 3 to move the bill forward. …
By Eileen McDermott
2 years ago 0

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
2 years ago 0

Final USMCA Text is a Missed Opportunity for Innovation

Earlier this week, Speaker of the House of Representatives Nancy Pelosi (D-CA) reached an agreement with President Donald Trump on passage of the United States-Mexico-Canada Agreement (USMCA), …
By Gene Quinn
2 years ago 3

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 years 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
2 years 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 …

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
3 years 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
3 years 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
4 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
4 years ago 1