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Posts Tagged ‘Abbreviated New Drug Application’

Teva’s Cephalon’s FENTORA vs Watson Pharm’s Generics ACTAVIS

Posted in BioSimilars, FDA Regulatory Affairs, Health Law & Patient Safety, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, tagged , , , , , , , on February 20, 2013| Leave a Comment »

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.

Justia.com Opinion Summary: The patents relate to a method of drug delivery via the mucous membrane lining or mucosa in the oral cavity. The oral mucosal route provides direct access to the bloodstream without having to travel through the gastrointestinal tract, which allows the drug to avoid the “first pass effect,” the percentage of drug lost to metabolization in the liver. Drug delivery across the oral mucosa potentially provides patients with rapid onset of action at a lower dosage. The patents disclose use of effervescent agents used as penetration enhancers, which influence drug absorption across the buccal, sublingual and gingival mucosae and use of an additional pH adjusting substance in combination with an effervescent agent for promoting the absorption. Watson filed an Abbreviated New Drug Application for a generic version of FENTORA®. In response, Cephalon instituted a patent infringement suit. The district court found that Watson’s ANDA products did not infringe and held the asserted patents invalid for lack of enablement. The Federal Circuit reversed on the issue of enablement, holding that 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. The court upheld the noninfringement finding.
SOURCE:

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 

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.

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.

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 

Here’s one way to increase your drug sales overnight: First, buy a company. Then, raise its product prices up to 25%. That, apparently, is Teva Pharmaceutical Industries’ ($TEVA) strategy for Cephalon ($CEPH), the U.S.-based drugmaker it acquired just a couple of months ago. Almost as soon as the deal closed, Teva “implemented a series of unusually robust price increases” for several of Cephalon’s branded meds, Deutsche Bank says.

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.

 http://www.fiercepharma.com/story/teva-jacks-prices-cephalon-legacy-brands/2011-12-07

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 

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.

http://www.fiercepharma.com/story/cephalon-sues-block-generic-fentora-sales-citing-dangers/2011-03-16

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 

Cephalon ($CEPH) is weighing its options after a federal court overturned two patents related to the painkiller Fentora.

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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