Posts Tagged: FDA
Other Barks & Bites for Friday, March 8
This week in Other Barks & Bites: The United Nations highlights the importance of women in innovation on International Women's Day; Comments due today on USPTO Section 101 Guidance; …
Federal Circuit Rules Momenta Has No Standing after Ceasing Development of a Biosimilar
Earlier this month, the Federal Circuit dismissed an appeal from the Patent Trial and Appeal Board (Board) where the Board upheld the patentability of a biologics patent. …
Blockbuster Restasis Patent Goes Down at Federal Circuit a Victim of Rule 36
Without any explanation, analysis or justification, Chief Judge Prost, and Judges Reyna and Hughes affirmed the decision of colleague Judge Bryson. A patent to a blockbuster drug …
IPR Outcomes of Orange Book Patents and its Effect on Hatch-Waxman Litigation
Out of the 230 Orange Book patents challenged in IPR proceedings, 90.4% (208) of these patents were also challenged in Hatch-Waxman litigation perhaps due to the lucrative 180-day exclusivity incentive …
The Updated PTAB Trial Practice Guide – Not Quite There Yet
While the changes to the Trial Practice Guide begin to move the rules in the right direction, more is needed before post-grant proceedings will be accepted as …
Federal Circuit Treatment of ‘Commercial Success’ in Hatch-Waxman Cases
In order to establish that the commercial success factor supports a non-obviousness finding, the patentee must establish that a connection (or nexus) exists between the novel aspects …
Federal Circuit Affirms District Court’s Finding of Validity of Claims Directed to Aveed®
When relying on scientific guidelines to support an obviousness rationale, practitioners should offer evidence for why contradictory guidelines should be discounted. A claimed constituent is not “necessarily …
Prescription Tracking Patents Confirmed as Unpatentable After IPR Appeal
The Federal Circuit reviewed whether certain prior art was “publicly accessible,” because Jazz alleged the material was not a “printed publication” under Section 102(b). Jazz argued that …
Nasal Spray Patents Covering Migraine Drug Zomig Not Invalid As Obvious
The sole question on appeal was whether it would have been obvious to make zolmitriptan into a nasal spray. The Federal Circuit agreed with the district court …
Denying Inducement to Infringe in Face of a Drug Label: A Fool’s Errand?
Proving inducement to infringe requires showing that the accused infringer possessed “specific intent” to infringe. In pharmaceutical cases, particularly those arising in the Hatch-Waxman framework, specific intent …
China extends drug patent exclusivity to 25 years
Among members of the news media, patents have been a popular whipping boy when contemplating why Americans pay higher drug prices relative to the rest of the …
Petitioner Has Standing to Appeal PTAB Decision Where Litigation is Inevitable
Altaire filed two complaints against Paragon: (1) alleging a breach of the non-disclosure clause of the Agreement, and (2) seeking declaratory judgment that the ‘623 patent was invalid. Paragon, in …
Hatch-Waxman Litigation: 60 Percent Increase in ANDA Lawsuits from 2016 to 2017
In 2017, U.S. district courts saw a total of 417 patent infringement suits related to ANDA filings made by drugmakers with the U.S. Food and Drug Administration (…
Mary Engle Pennington: The Mother of Modern Food Preservation
The preservation of food and beverage products for safe consumption despite extended shelf lives at grocery stores is a major global industry. Both consumers and companies have …
Controversy Over Restasis Patents is Misplaced
Competitors like Mylan and Teva, rather than inventing better treatments or cures for dry eyes chose the shortcut. They attacked Allergan’s patent in the PTAB. Allergan …
