By James DeGiulio --
Takeda Completes Settlements with 11 Generics, Finally Ending Actos Patent Dispute
Takeda has completed settlements with all defendants in the patent litigation brought against several generic companies in response to their ANDAs for the diabetes drug Actos. Takeda has filed a number of infringement suits in the Southern District of New York since 2003, accusing several generics drug makers of infringing its Actos patents, U.S. Patent Nos. 5,965,584; 6,329,404; 6,166,043; 6,172,090; 6,211,205; 6,271,243; and 6,305,640.
Takeda has granted Mylan, Watson, and Ranbaxy licenses to enter the U.S. market with generic Actos on August 17, 2012, subject to regulatory approval, or earlier under certain circumstances. These companies are first-filers of ANDAs with Paragraph IV certifications for Actos, and it is anticipated that the FDA will grant these companies 180-day marketing exclusivity. The remainder of the generics have licenses to enter the U.S. market with generic Actos at various times after the entry of the first-filers, most after the 180-day period of exclusivity.
Lupin Settles Lunesta Patent Litigation with Sunovion
Lupin has become the latest generic company to reach a settlement with Sunovion (previously Sepracor) in the multi-defendant infringement suit brought over the sleep drug Lunesta. In March 2009, Sunovion brought suit in the U.S. District Court for the District of New Jersey against several generic companies who intended to make generic versions of Lunesta. Sunovion alleged that the generic maker's ANDAs infringed four patents covering the drug: U.S. Patent Nos. 6,319,926; 6,444,673; 6,864,257; and 7,381,724 (see "Court Report," March 29, 2009).
Under the agreement, Sunovion will grant Lupin a license to market generic eszopiclone either on Nov. 30, 2013, which is two and a half months prior to the expiry of the '673 patent, or on May 30, 2014, depending on whether Sunovion obtains pediatric exclusivity for Lunesta. Additional terms of the settlement were not disclosed.
AstraZeneca Denied Asserting Method Patents in Crestor Litigation
The generic companies seeking to market a generic version of the drug Crestor enjoyed a positive ruling after AstraZeneca was prevented from asserting two method patents to block generic versions of its blockbuster drug. In April, AstraZeneca brought suit against ten generics in the U.S. District Court for the District of Delaware, accusing them of infringing U.S. Patent Nos. 6,858,618 and 7,030,152 by submission of their ANDAs (see "Court Report," May 2, 2010). These patents cover various methods of using Crestor to treat certain types of hypercholesterolemia and patients with elevated levels of C-reactive protein. Earlier this year, Judge Farnan ruled that AstraZeneca's U.S. Patent No. RE37,314, covering Crestor's chemical compound, was valid, and that the generic companies' ANDA filings constituted infringement (see "Biotech/Pharma Docket," July 1, 2010).
On December 15, Judge Robert B. Kugler issued the ruling that AstraZeneca cannot rely on the two method patents because the generic-drug companies sought to market their versions of the drug for uses not covered by those patents. However, the generics are still precluded from producing generic Crestor due to infringement of the '314 patent. If Judge Farnan's ruling of validity and infringement stands, the generics would not be able to manufacture generic Crestor until that patent expires in 2016. They have appealed the decision to the U.S. Court of Appeals for the Federal Circuit.
Comments