Eli Lilly Wins Evista Patent Ruling in Teva Case

Eli Lilly & Co. won a ruling that its patents for its Evista osteoporosis treatment are valid, blocking an attempt by Teva Pharmaceutical Industries Ltd. to sell a generic version of the bone-loss drug.

U.S. District Judge Sarah Evans Barker in Indianapolis, in a ruling yesterday, barred Teva from selling the drug in the U.S. before Eli Lilly’s patents have expired. The judge in April temporarily barred Teva from launching its product until she reached a final decision.

The ruling provides protection for Evista through March of 2014, Indianapolis-based Eli Lilly said in a statement. Evista, in which the key ingredient is raloxifene, generated $1.08 billion in global sales last year, the company reported Jan. 29. That includes $700.5 million, or an average of almost $2 million a day, in the U.S.

“We are pleased with the court’s rulings on Evista’s method-of-use patents,” Robert A. Armitage, Eli Lilly’s general counsel, said in the statement yesterday. “We have always been very confident that these patents are valid and enforceable and today’s court ruling sends a clear message on the strength of those patents.”

FDA Approval

Teva, based in Petah Tikva, Israel, received U.S. Food and Drug Administration approval for its generic version of the drug just before the nonjury trial began in March.

Teva, which alleged Lilly’s patents are obvious variations of already known science, had been prepared to begin marketing the drug immediately prior to the Barker’s April ruling blocking the release.

Lilly countered that prior know-how wouldn’t have led drug companies to come up with raloxifene and its property should be protected. Barker agreed, finding Teva infringed its patents and barring Teva from manufacturing and selling the raloxifene product.

“Teva has failed to meet its burden to demonstrate by clear and convincing evidence invalidity of the bone loss patents on the basis of obviousness,” Barker wrote in her 120- page decision.

Teva plans to appeal the ruling, the company said in a statement.

Lilly fell 4 cents to $32.41 at 10:03 a.m. in New York Stock Exchange composite trading.

Teva American depositary receipts, each representing one ordinary share, rose 15 cents to $50.76 in Nasdaq Stock Market trading.

The case is Eli Lilly v. Teva, 06-cv-01017, U.S. District Court, Southern District of Indiana

Teva Animal Health closes shop

Teva Animal Health has stopped manufacturing generics and its DVM Pharmaceuticals line of products following a crackdown by the U.S. Food and Drug Administration (FDA) on the company’s quality control practices.

“We have no additional information to provide at this time, but will keep our customers apprised of the situation as we have news to share,” says Denise Bradley, senior director of Teva’s North America Corporate Communications.

Members of the Veterinary Information Network (VIN) report that some Teva Animal Health products are on backorder. The company is commonly known for its medicated shampoos and skincare products, as well as supplements.

In an e-mail to the VIN News Service, Bradley adds the following prepared statement:

“Teva Animal Health regrets the deficiencies in our manufacturing practices, and we have already initiated corrective actions to ensure that we will swiftly meet all regulatory requirements. These actions include conducting a complete analysis of each individual product; retraining all of our production employees, and revalidating our equipment, processes and methods.”

Teva’s efforts are in response to a lawsuit filed by FDA on July 31 in U.S. District Court, suing Teva Animal Health, as well as the regulatory agency’s move last Friday to shut down the company’s Missouri plant. An injunction prohibits the company from manufacturing and distributing adulterated veterinary drugs.

FDA alleges that three regulatory inspectors documented “numerous” Good Manufacturing Practice violations.

Other FDA complaints include a reported failure by the company to establish a quality control unit, provide adequate employee training, conduct adequate equipment maintenance and reject drug products that failed to meet quality specifications.

Teva Animal Health is an arm of Israeli-based Teva Pharmaceutical Industries Ltd. It was born in January 2006, when Teva Pharmaceuticals acquired IVAX Corp., its subsidiary, IVX Animal Health. IVX Animal Health is comprised of Phoenix Science Inc., the largest manufacturer of generic pharmaceuticals for the U.S. animal-health market, and DVM Pharmaceuticals, a specialty veterinary pharmaceutical company focusing on topical dermatologicals and nutraceuticals for pets, which had merged in 2005 under the IVX Animal Health name.

“The FDA will not tolerate the manufacture and distribution of adulterated animal drugs,” says Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, in a news release. “Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate to assure their safety and quality.”

Earlier this month, Teva Pharmaceuticals voluntarily recalled two lots of the anesthetic propofol following a federal government investigation of recent cases of nonrespiratory febrile reactions among human patients undergoing endoscopy in the United States.

Teva’s Bradley insists that the incident is not connected to FDA’s actions against Teva Animal Health.

According to the lawsuit’s consent decree, future violations will cost the company $20,000 for each day that Teva fails to comply with any provision of the decree and an additional $25,000 for each shipment of veterinary drugs in violation of the decree, up to $7.5 million per year.