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.

 

 

Medicis Sued Ranbaxy for Solodyn

Medicis Pharmaceutical Corp. filed a suit against Ranbaxy Laboratories Ltd. India for allegedly trying to market a generic version of Medicis’ Solodyn, a extended release tablet of minocycline HCl.

Medicis alleges Ranbaxy infringed on one or more claims under Medicis’ U.S. Patent 5,908,838 when it submitted an abbreviated new drug application for a generic version of Solodyn to the U.S. Food and Drug Administration.

In its suit, Medicis is requesting a permanent injunction preventing Ranbaxy from infringing its patent by selling the generic version.

Last year, Ranbaxy entered in to agreement with Pfizer to settle the worldwide patent dispute involving cholesterol lowering drug Atorvastatin. LIPITOR, which generated $12.7 billion in sales in 2007. The agreement allowed Ranbaxy to introduce a generic version of the drug in November 2011, with 180 days of exclusivity in the U.S.

Ranbaxy Laboratories Ltd., India’s largest pharmaceutical company, settled a patent infringement lawsuit with AstraZeneca in April 2008. AstraZeneca had filed a patent infringement lawsuit against Ranbaxy for trying to market a generic version of AstraZeneca’s Esomeprazole magnesium capsules, Omeprazole tablets and Felodipine capsules in the United States. Ranbaxy will be allowed to exclusively sell its generic version of Nexium (generic name Esomeprazole magessium) under a license from AstraZeneca on May 27, 2014. During the 180-day period following that date, Ranbaxy will distribute the only generic Esomeprazole magnesium product in the U.S.

 

RANBAXY FILED A POST GRANT OPPOSITION FOR OLANZAPINE PAMOATE SALT

An opposition under section 25 (2) has been filed by M/s Ranbaxy Limited, India on May 21, 2009 for the Patent No. 220287 (IN/PCT/2001/338/KOL) entitled “AN OLANZAPINE PAMOATE SALT LAND PHARMACEUTICALLY ACCEPTABLE FOLVATE THEREOF” in the name of M/s Eli Lilly and company.

Infringement Suit between Shire and Natoco for Fosrenol

PHILADELPHIA, April 2/ Shire plc announces that it has filed a lawsuit in the U.S. District Court for the Southern District of New York against Natco Pharma Limited ("Natco") for infringement of two of Shire's patents: U.S. Patent No. 5,968,976 ("'976 Patent"); and U.S. Patent No. 7,381,428 ("'428 Patent");

The lawsuit was filed in response to an ANDA (Abbreviated New Drug Application) filed by Natco seeking FDA approval to market and sell generic versions of Shire's 500 mg, 750 mg, and 1 g FOSRENOL(R) (Lanthanum Carbonate) products.  Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving Natco's Paragraph IV notification letter, the FDA must refrain from approving Natco's ANDA for 30 months, or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier. The stay on generic approval will expire on April 26, 2012 unless terminated earlier.
 

Shire has asserted the '976 and '428 patents based upon information provided to it by Natco. Shire will continue to evaluate the situation throughout the litigation and will take all necessary actions to protect its rights to the fullest extent possible. Shire has a robust patent estate and is confident that it will protect the FOSRENOL franchise.

Abbott Laboratories sues Mylan for AIDS drug 'Kaletra' patent dispute

Abbott Laboratories accused rival Mylan Inc. of infringing two U.S. patents for the AIDS drug Kaletra. Kaletra is a combination of two anti-HIV drugs Lopinavir and Ritonavir used for the treatment of HIV infectionm. Abbott contends that Mylan plans to sell low-cost generic copies of Kaletra tablets before the patents expire in 2021, according to complaints filed in federal courts in Delaware and Chicago.

"Abbott will be irreparably harmed" if generic versions of the drug aren't blocked by a judge, Abbott claimed in the Chicago suit.

The lawsuits were filed after Mylan announced that its India-based Matrix Laboratories Ltd. had received tentative U.S. Food and Drug Administration approval for the tablets under the president's Emergency Plan for AIDS Relief.

 

Natco Pharma Successfully opposes Indian patent application for Glatiramer Acetate

NATCO Pharma Ltd has successfully opposed a patent application in India that covers the composition of Glatiramer Acetate, the generic version of Teva Pharmaceutical Industries' Copaxone. The patent application was submitted to the Indian Patent Office (New Delhi) by Yeda Research & Development Company, which licensed the Glatiramer Acetate product to Teva.

Glatiramer Acetate, marketed in pre-filled syringes, is used to treat multiple sclerosis (MS). NATCO has successfully commercialized its Glatiramer Acetate product in India and the Ukraine. NATCO challenged the Yeda patent application in the Indian Patent Office on several grounds including that it was obvious over the prior art. The Patent Office agreed with NATCO's arguments and refused to grant the application because of  "obviousness and lack of inventiveness” over the prior art.

 

Oscient Sued Lupin for Antara, a Cholesterol Fighting Drug

Oscient Pharmaceuticals Corp. have filed a patent-infringement suit in Maryland district court against Lupin Pharmaceuticals Limited, based in India, for the  cholesterol-fighting drug Antara (Generically known as Fenofibrate).

Oscient  based in Waltham, Mass., said it received a certification notice from Lupin on Dec. 3 advising the company that Lupin would seek FDA approval to market a generic version of Antara prior to the drug’s patent expiration (US7101574) in 2020. US7101574 claims a pharmaceutical composition in the form of granules, wherein each granule comprises a neutral micro-granule on which is a composition comprising: micronized fenofibrate, a surfactant, and a binding cellulose derivative as a solubilization adjuvant, and wherein said fenofibrate is present in an amount greater than or equal to 60% by weight, relative to the weight of said pharmaceutical composition, and further wherein said binding cellulose derivative represents between 2 to 15% by weight, relative to the weight of said pharmaceutical composition.

 A generic company needs to have either non-infringing composition of the claim or invalidate the claim to market the product in US.