New Developments in Obviousness-Type Double Patenting and Original Patent Requirements — Patents: Post-Grant Podcast
Inter Partes Review: Validity Before the PTAB
The answer to this inquiry is “yes” — but maybe “no.” Will confidentiality agreements shield any prior art concerns? Once again, maybe “yes” — but maybe “no.” Indeed, do clinical trials constitute an experimental use that...more
Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more
The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations...more
PERSION PHARMACEUTICALS LLC v. ALVOGEN MALTA OPERATIONS LTD. Before O’Malley, Reyna, and Chen. Appeal from the U.S. District Court for the District of Delaware. Summary: The FDA’s acceptance of safety data for a...more
OSI PHARMACEUTICALS, LLC v. APOTEX INC - Before Stoll, Newman, and Taranto. Appeal from the Patent Trial and Appeal Board. Summary: A pharmaceutical company’s statement touting the completion of Phase I safety trials...more
On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more
WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more
Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more
Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more
After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more