Takeda Sues Torrent Pharma for Diabaetic drug, pioglitazone

Source reports that Takeda Pharmaceutical Co., a Japan based company  sued India’s Torrent Pharmaceuticals Ltd. to prevent it from selling a copy of the Actos diabetes pill in the U.S. until 2016.

Torrent, based in Ahmedabad, India, is seeking U.S. Food and Drug Administration approval to sell a copy of the medicine. Takeda, Asia’s biggest drugmaker, contends the versions would infringe six patents on the medicine and wants a court to block approval until they expire in 2016.

Actos is the world’s best-selling diabetes drug, responsible for 387 billion yen ($4 billion), or 25 percent, of Takeda’s sales for the year ended March 31. Last month, Takeda failed to gain FDA approval for another drug, called alogliptin, that the company is counting on to replace Actos revenue when generic competition begins as early as January 2011, when a patent on the drug expires.

The six patents in the complaint relate to ways to use the compound pioglitazone, the active ingredient in Actos, in combination with other medicines. Torrent’s proposed label wouldn’t restrict use of the generic drug, so “Torrent will be marketing pioglitazon with specific intent” to infringe the patents, Osaka-based Takeda said in the complaint, filed July 2 in federal court in New York.

In its FDA application, Torrent maintained that it would not infringe any valid and enforceable patent by selling a generic version of Actos. Under federal law, Takeda’s suit triggers an automatic 30-month period in which the FDA can’t approve Torrent’s application unless a judge rules in the generic-drug maker’s favor before then.

Finally, Novartis loses battle for cancer drug patent

Business Standard reports that the Novartis’s famed cancer drug, Glivec, will not get patent protection in India. The apex body on patent and trademark disputes, the Intellectual Property Appellate Board (IPAB), has ruled that the drug “lacks innovation” and the high price tag of Rs 1,20,000 per month per patient would be too high for the common man. “Any patent granted to support such a high monopoly price would be against ‘public order’,” the ruling said. This brings the curtains down on a high profile three-year legal battle over patent rights between the Swiss multinational drug major and the Indian government.

The IPAB panel, comprising Chairman ZS Negi and Technical Member PC Chakraborti, ruled that the beta crystalline version of the drug was not patentable under section 3(d) of the Indian Patent Act and lacked “significant enhanced efficacy” over and above the prior known molecule. The panel, in its decision on June 26, also ruled that the patents granted for the drug in about 40 countries may not be applicable to India.