Timing the filing of an inter partes review for companies in the early stage of developing a biosimilar product should be carefully considered based on the recent Federal Circuit case, Momenta Pharmaceuticals, Inc. v Bristol-Myers Squibb Co., Appeal No. 2017-1694 (February 7, 2019). Momenta filed an IPR before the PTAB to challenge the validity
Choose Your Weapon: Senate Amendment Pits ANDA/BPCIA Pathway Against Post-Grant Proceedings
Per Senator Orrin Hatch, the America Invents Act has disrupted the “careful balance” he struck with Senator Waxman in the development of the decades-old Hatch-Waxman Act governing the adjudication of generic drug litigation. On June 13, 2018, Senator Hatch filed an amendment in the Senate Judiciary Committee to remedy the perceived conflict between the “carefully
“Rigged” Pricing, Contracting and Rebate “Schemes,” and Drug Pricing “Shell Games:” FDA Commissioner Scott Gottlieb Lets Loose on the U.S. Biosimilar Market While Offering Peek at New Policies
In a few short days, the United States will mark the eight-year anniversary of the Biologics Price Competition and Innovation Act (“BPCIA”). Signed into law on March 23, 2010, the BPCIA creates a regulatory pathway for the approval of biosimilar drugs in the United States and a mechanism, albeit voluntary, for resolving patent right disputes relating to the innovator biologic products.
Continue Reading “Rigged” Pricing, Contracting and Rebate “Schemes,” and Drug Pricing “Shell Games:” FDA Commissioner Scott Gottlieb Lets Loose on the U.S. Biosimilar Market While Offering Peek at New Policies
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
Webinar: Bridging the Gap Between EU and U.S. Biotech Inventions Protection
This webinar is hosted by The Knowledge Group.
On April 17th at 10 a.m. ET, Dr. Dean Fanelli and Dr. Thomas Haag, along with Jens Viktor Nørgaard of HØIBERG, Niklas Mattsson of Awapatent, Mr. Glyn Truscott of Elkington + Fife LLP and Jennifer O’Farrell of Boult Wade Tennant, will present a live webcast on
Webinar: Biosimilar Litigation and Your BPCIA Compliance: Key Strategies In Light of AbbVie v. Boehringer
This webinar is hosted by The Knowledge Group.
On March 22nd at 12 p.m. ET, Dean Fanelli and Jamaica Szeliga, along with Timothy Shea of Sterne, Kessler, Goldstein & Fox P.L.L.C., will present a live webcast on Biosimilar Litigation and Your BPCIA Compliance: Key Strategies In Light of AbbVie v. Boehringer.
The previous
Now Available! Seyfarth Shaw’s Hatch-Waxman and Biosimilars Litigation: 2017 Year-in-Review
Seyfarth Shaw Offers Hatch-Waxman And Biosimilars Litigation: 2017 Year-in-Review
Today’s rapid scientific and technological advances demand not only a thorough understanding of the complex technology, but also a meticulous application of intellectual property law to protect the technology.
Seyfarth’s Intellectual Property and Hatch-Waxman Litigation practitioners are pleased to announce the release of Hatch-Waxman And Biosimilars
“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