Analysis of patent litigation, PTAB practice, prosecution and pharma IP, written on the data behind LexDana.
Tagged pharmaceutical · clear
In late August, we published our third annual ANDA Litigation Intelligence Report, covering important statistics and evaluating all stakeholders in Hatch-Waxman litigation, including attorneys, local counsel, law firms, generic and brand pharmaceutical…
The FDA evaluates the generic versions of a drug and approves them only if studies show that it is bioequivalent with the brand, meaning that both drugs have the exact same amount of the active ingredient. As for size, color, shape, and other visual…
In early 1983, Bolar Pharmaceutical Inc. wanted to bring a generic version of the Dalmane drug, a sleeping pill, to the market. At that time, Roche Products Inc. held patent rights for flurazepam hydrochloride, the active ingredient in the drug.…
The pandemic we just went through was one of the examples of how important is the patent system in strengthening the public health. Already many vaccines and medicines have been created thanks to this system and people nowadays live significantly longer…
Global health care spending is predicted to reach $10 trillion USD during 2022 with almost 30% of it belonging to the USA. It might sound like a good industry to be in, but keep in mind that the costs of developing a new drug range from $300 million up to…
Earlier in August, we released our second ANDA Litigation Intelligence Report. We analyzed all parties involved in Hatch-Waxman cases and ranked the top law firms and attorneys based on their activity and performance. Today we will shed some light on the…
Federal Circuit Summary Before Moore, Linn, and Chen . Appeal from the United States District Court for the District of Delaware. Summary: A prior art reference does not inherently disclose the elements of a claim limitation if the prior art describes the…
Federal Circuit Summary Before Newman, Lourie , and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: References were sufficiently accessible to the public to constitute printed publication prior art even if they were not searchable or indexed…
Written by Peter E. Heuser , Schwabe, Williamson & Wyatt, P.C. The Circuit issued only one precedential patent case this week, reversing a determination of obviousness as to a Millennium Pharmaceutical patent covering its blockbuster cancer drug…
Written by Daniel K. Yarbrough, Ph.D. and Nathanael R. Luman, Ph.D. The PTAB denied institution of an IPR based on patent owner’s challenge to the prior art status of a PCT publication that was asserted by the petitioner as pre-AIA 35 U.S.C. §…
Written by Robert J. Hilton, Ph.D. and Jing Liu, Ph.D. On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. f. 3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 f. 3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit.…
