by April Breyer Menon | Jul 31, 2023
As of July 24, 2023, the United States Patent and Trademark Office (USPTO) revised the interim Director Review process and replaced the Precedential Opinion Panel (POP) with the Appeals Review Panel process, which will review decisions in ex parte, re-examination, and...
by April Breyer Menon | Jun 30, 2023
On June 22, 2023, Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) announced the reintroduction of legislation to reform the patent eligibility requirements under 35 U.S.C. § 101. The “Patent Eligibility and Restoration Act of 2023,” similar to the...
by April Breyer Menon | May 18, 2023
Earlier today, the Supreme Court issued a unanimous decision in Amgen v. Sanofi, construing the statutory enablement requirement. The case concerns antibodies that help reduce levels of LDL cholesterol. In 2014, Amgen obtained patents which purported to claim “the...
by April Breyer Menon | Mar 17, 2023
Introduction It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market. While there have been challenges over this time, the U.S. biosimilar market has come a long way and...
by April Breyer Menon | Feb 3, 2023
On January 31, 2023, Amjevita™ (adalimumab-atto) entered the U.S. market as the first biosimilar of Humira® (adalimumab), after receiving approval in September 2016. Amjevita will be available in a low-concentration, citrate-free formulation (40 mg/0.8mL and...
by April Breyer Menon | Nov 30, 2022
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve a biosimilar as interchangeable. Unlike...