Reporter: Aviva Lev-Ari, PhD, RN
The court upheld its original opinion that Actavis had not infringed on the patent, but it held this time that Actavis had not carried out the experimentation to the extent laid out by the patent.
Cephalon, Inc. v. Watson Pharm., Inc.
Before REYNA, BRYSON,∗ and WALLACH, Circuit Judges.
WALLACH, Circuit Judge.
This action arises out of the filing of an Abbreviated New Drug Application (“ANDA”) by Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. (collectively, “Watson”) for a generic version of FENTORA®. In response to Watson’s ANDA filing,
Cephalon, Inc. and CIMA Labs, Inc. (collectively, “Cephalon”) instituted this patent infringement suit at the United States District Court for the District of Delaware asserting U.S. Patent Nos. 6,200,604 (“the ’604 patent”) and 6,974,590 (“the ’590 patent”). After a bench trial, the district court found that Watson’s ANDA products did not infringe and held the asserted patents invalid for lack of enablement. Cephalon, Inc. v. Watson Pharms., Inc., 769 F. Supp. 2d 729, 761 (D. Del. 2011). We reverse on the issue of enablement because Watson failed as a matter of law to show with clear and convincing evidence that Cephalon’s patents require undue experimentation to practice the invention. As to the noninfringement finding, the district court did not clearly err. Thus, we reverse– in–part and affirm–in–part.
Courts: Teva’s Cephalon fells Actavis in oral painkiller delivery appeal
February 20, 2013 | By Michael Gibney
A federal appeals court reversed its decision in favor of Cephalon in a dispute with Actavis ($ACT) over an oral mucosal painkiller delivery patent.
Cephalon, a subsidiary of Teva Pharmaceuticals ($TEVA), patented the delivery platform Fentora, an approach to the oral absorption of the painkiller fentanyl for cancer patients that uses penetration enhancers and pH-controlling materials to ease the passage of the drugs through the mouth.
The decision is a reversal of a lower court’s decision to side with Actavis–at that time Watson Pharmaceuticals ($WPI)–in 2011 when the company’s generic version of Cephalon’s Fentora came under question as a possible infringement against the patented technique.
Back in 2011, when the courts first overturned Cephalon’s patents, the decision threatened the financial viability of Fentora, which brought the company $181.6 million globally in 2010–about 6% of its revenue. But the reversal of that decision comparatively represents a clear blow to generic drugmakers, particularly to the feasibility of their latching onto the market.
SOURCE:
Teva jacks up prices on Cephalon legacy brands
December 7, 2011 | By Tracy Staton
Citing a wholesale pricing report from Medi-Span, Deutsche Bank analysts say Teva hiked the prices on Cephalon painkiller Fentora and wakefulness drug Provigil 15%–and raised the price on Provigil follow-up Nuvigil 25%. The latter increase came on top of an 8% price rise just 6 months before.
The analysts approved of the increases, Globes news service reports. “Taken together, these recent increases could likely bolster the outlook for Teva’s North American pharmaceutical sales in the fourth quarter, and, more importantly, in 2012,” they wrote (as quoted by Globes). Together with Teva’s profit-sharing deal with Ranbaxy on copycat Lipitor, its recent launch of a Zyprexa copy, and the planned debut of generic Lexapro, Deutsche Bank figures Teva’s new target price at $46, compared with yesterday’s $40 close.
Teva jacks up prices on Cephalon legacy brands – FiercePharma http://www.fiercepharma.com/story/teva-jacks-prices-cephalon-legacy-brands/2011-12-07#ixzz2LSwmSlMG
Cephalon sues to block generic Fentora sales, citing dangers
March 16, 2011 | By Liz Jones Hollis
Fentora maker Cephalon is fighting back against potential generic competition. It has asked a federal judge to block the sale of Watson Pharmaceuticals’ generic version of the drug, alleging it is potentially dangerous because it contains “a novel salt form” never approved by the FDA.
In its suit brought against the government in the U.S. District Court for the District of Columbia, Cephalon maintains that “[b]arring an injunction,” the FDA’s approval of Watson’s product “will usher into the marketplace a generic drug of untested safety and efficacy.”
Cephalon filed its suit four days after a federal judge in Delaware ruled the generic made by Watson didn’t infringe two patents exclusively licensed to Cephalon. The company said at the time it is reviewing the decision and is weighing its options. Patents on Fentora are due to expire in 2019, according to the FDA’s Orange Book.
Cephalon sues to block generic Fentora sales, citing dangers – FiercePharma http://www.fiercepharma.com/story/cephalon-sues-block-generic-fentora-sales-citing-dangers/2011-03-16#ixzz2LSxRdxQx
Court overturns two patents for Cephalon painkiller
March 14, 2011 | By Ryan McBride
The U.S. District Court for the District of Delaware ruled on two of three patents in the case involving Frazer, PA-based Cephalon and Watson Pharmaceuticals, according to the companies. Cephalon said Friday it is reviewing the decision and is weighing its options, including an appeal. Patents on Fentora are due to expire in 2019, according to the FDA’s Orange Book.
The decision might open the door to Watson and other generic drug makers to start marketing copycat versions of Fentora. Watson obtained FDA approval of a generic version of the painkiller in January. Cephalon previously made an agreement with Teva Pharmaceutical Industries through which the generics giant would hold off from marketing its version of the treatment until 2018. But that deal gives Teva the green light to start sales if another competitor begins selling a generic version.
Louise Chen, an analyst for Collins Stewart, tells the AP that Cephalon might decide to increase the price of Fentora and then start sales of its own generic version of the drug. Cephalon would be protecting a product that brought $181.6 million in worldwide sales in 2010, or about 6 percent of the company’s total annual revenue.
http://www.fiercepharma.com/story/court-overturns-two-patents-cephalon-painkiller/2011-03-14
Court overturns two patents for Cephalon painkiller – FiercePharma http://www.fiercepharma.com/story/court-overturns-two-patents-cephalon-painkiller/2011-03-14#ixzz2LSzBfsSb
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This is very insightful. There is no doubt that there is the bias you refer to. 42 years ago, when I was postdocing in biochemistry/enzymology before completing my residency in pathology, I knew that there were very influential mambers of the faculty, who also had large programs, and attracted exceptional students. My mentor, it was said (although he was a great writer), could draft a project on toilet paper and call the NIH. It can’t be true, but it was a time in our history preceding a great explosion. It is bizarre for me to read now about eNOS and iNOS, and about CaMKII-á, â, ã, ä – isoenzymes. They were overlooked during the search for the genome, so intermediary metabolism took a back seat. But the work on protein conformation, and on the mechanism of action of enzymes and ligand and coenzyme was just out there, and became more important with the research on signaling pathways. The work on the mechanism of pyridine nucleotide isoenzymes preceded the work by Burton Sobel on the MB isoenzyme in heart. The Vietnam War cut into the funding, and it has actually declined linearly since.
A few years later, I was an Associate Professor at a new Medical School and I submitted a proposal that was reviewed by the Chairman of Pharmacology, who was a former Director of NSF. He thought it was good enough. I was a pathologist and it went to a Biochemistry Review Committee. It was approved, but not funded. The verdict was that I would not be able to carry out the studies needed, and they would have approached it differently. A thousand young investigators are out there now with similar letters. I was told that the Department Chairmen have to build up their faculty. It’s harder now than then. So I filed for and received 3 patents based on my work at the suggestion of my brother-in-law. When I took it to Boehringer-Mannheim, they were actually clueless.