We previously reported on the ongoing dispute between Amgen and Sanofi regarding enablement of genus claims. But, the case is nearing a final decision. On January 31, the Supreme Court set arguments to address Question 2...more
Article 76 of the Fourth Amendment1 to the Chinese Patent Law links regulatory approval of a generic drug and patent protection of the brand-name drug. It establishes a legal framework for resolving drug patent disputes...more
To satisfy the written description requirement under 35 U.S.C. 112, a patent specification must describe the claimed invention in such sufficient detail that a person of skilled in the art (POSA) can reasonably conclude that...more
Drug pricing and innovation are hot topics in Washington right now with several bills making their way through the legislative process, many in a bipartisan fashion. On April 23, 2021, two of these bills were signed into law...more
As previously reported on March 31, 2021, AbbVie Inc. has petitioned the U.S. Supreme Court for a writ of certiorari to review the Third Circuit’s ruling determining the biopharma company’s patent infringement suit was a sham...more
Approval Processes -
The regulatory approval pathway for a new “biological product” submitted as a Biologics License Application (BLA) under the Biologics Price Competition and Innovation Act (BPCIA), is now separate from...more
The U.S. House of Representatives generated buzz in November 2020 when it passed a bill aimed at removing a loophole in the Orphan Drug Act. Although the bill did not make it far in the Senate, the bipartisan legislative push...more
Statutory Basis For Label Carve-Outs -
Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use...more
For several years, China has been evaluating changes to its drug approval system to promote drug innovation and patient access to medicines. The year 2020 saw China begin taking steps towards adopting some of those changes....more