Lilly and Sanofi Reach Settlement Agreement

Eli Lilly and Company has entered into a settlement agreement to resolve patent litigation with Sanofi regarding its insulin glargine product, Basaglar®. As a part of the agreement, Lilly and its alliance partner, Boehringer Ingelheim, will have the ability to launch Basaglar in the U.S. on December 15, 2016. 

 Under the terms of the agreement, Sanofi has granted Lilly a royalty-bearing license so Lilly can manufacture and sell Basaglar in the Kwikpen® device globally. Further details regarding the settlement are confidential. The U.S. Food and Drug Administration tentatively approved Basaglar in August 2014. With this resolution, Lilly plans to request final approval of Basaglar from the FDA.

India rejects patent on Pfizer's arthritis drug

India has again denied Pfizer Inc a patent on its rheumatoid arthritis drug tofacitinib, the latest setback for a multinational drugmaker seeking to enforce its intellectual property rights in the country. Pfizer sought a patent that covers an important chemical formulation of the active compound in the medicine, but the Indian Patent Office said the company would have to establish that the compound for which it is seeking a patent is therapeutically more effective than the active compound.

"The invention disclosed and claimed in the instant application ... is not considered as an invention under the provisions of the Act," Bharat N S, an assistant controller at the patent office, wrote in an order dated Sept. 3. Pfizer is reviewing its options for further action, a Mumbai-based company spokesman said in an emailed statement. 

Drug patents have become a thorny issue for global drugmakers seeking to expand in India's fast-growing healthcare market. Companies including Pfizer, Bayer and Roche have in recent years struggled to retain exclusivity on drugs in India, and have blamed patent laws they say are designed to favor the local industry.

India, however, has said its drug patents policy is designed to ensure medicines remain affordable for the country where less than 15 percent of the population has health insurance.

India's patent office had rejected Pfizer's application to patent tofacitinib in 2011, but was ordered to reconsider the decision by the Intellectual Property Appellate Board, after Pfizer appealed.

Allergan Confirms Generic Noxafil® Patent Challenge

Allergan plc confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Posaconazole Delayed-Release Tablets, 100mg. Allergan's ANDA product is a generic version of Merck's Noxafil^® which is an antifungal agent indicated for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high-risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplantation recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

Merck Sharp & Dohme Corp. filed suit against Allergan on August 6, 2015 in theU.S. District Court for the District of New Jersey seeking to prevent Allerganfrom commercializing its ANDA product prior to the expiration of U.S. Patent No. 5,661,151. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Allergan's ANDA for up to 30 months from the date the plaintiffs received notice of Allergan's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Based on available information, Allergan believes it may be a "first applicant" to file an ANDA for the generic version of Noxafil^® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. For the 12 months ending June 30, 2015, Noxafil® had global sales of approximately $143.6 million, according to IMS Health data.