The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs designated as Competitive Generic Therapies. The FDARA, according to FDA commissioner, Scott Gottlieb, “is part of our broader effort to foster generic competition and help address the high cost of drugs […] key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.”
Continue Reading Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”
FDA Approves First Marijuana-Based Drug to Treat Epilepsy
On June 25, 2018, the Food and Drug Administration (“FDA”) approved Epidiolex (cannabidiol), the first marijuana derived drug for use in the United States, to treat two rare forms of epilepsy. This decision for the FDA could have sweeping effects for the marijuana industry. While the FDA has previously approved drugs comprising synthetic (manufactured) cannabinoids,
An Illustrated Guide to the USPTO’s New Memo on Method of Treatment Claims
The U.S. Patent and Trademark Office (“USPTO”) has renewed the hopes of applicants looking to patent method of treatment claims. A recent memo from the USPTO (the “Memo”) provides guidance on method of treatment claims, suggesting that when correctly drafted, such claims should generally be considered patent eligible subject matter.
The Memo comes
Innovation in Hatch-Waxman and ANDA Litigation
The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and development; and (2) to help generic drugs reach the market more quickly. Through amendments to both the patent and the food and drug laws, the Act established several practices intended to provide brand-name firms
“Tax Cut and Jobs Act” H.R. 1 Passes House Of Representatives: Provisions To Watch
Sandoz v. Amgen: The Latest in Biosimilar “Dances”
Finding against the Federal Circuit once again on a patent case, the Supreme Court issued a unanimous decision in Sandoz v. Amgen relating to the interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) in its first decision on the Act. The Supreme Court’s decision firmly establishes the availability of a third
Legislative Overview: First Quarter 2017
One goal of BioLoquitur is to provide commentary and analysis on important developments in U.S. law affecting the pharmaceutical and biologics industry. It can be easy to forget that legal developments are not limited to the latest court decisions or agency actions, however. The most profound changes in U.S. law arise from legislation. This post