Para IV Move: ZETIA™ (Schering-Plough/Glenmark)

Schering-Plough has filed a patent infringement lawsuit in the US District Court for the Distirct of New Jersey against Glenmark in response to Glenmark’s ANDA submission with the US FDA seeking approval to market generic Zetia tablet, generically known as ezetimibe before expiry of the Orange Book listed patents. Zetia which is worth US $ 1.9 billion in 2006 is developed by Schering-Plough and co-marketed by Merck & Co. In its complaint, Schering-Plough alleges that Glenmark “had no adequate good faith basis” for claiming to the FDA that its version of Zetia would not infringe any valid and enforceable patents. Glenmark, which filed ANDA in October, last year, believes to have first-to-file status for Zetia and likely to entitled for 180-day market exclusivity period.

Sepracor Inc. faces patent infringement dispute

Merck KGaA’s Dey unit has filed a patent infringement lawsuit against Sepracor Inc. in the U.S. District Court for the District of New York to prevent commercial launch of Brovana used for the treatment of chronic bronchitis and emphysema. Dey alleged that the Sepracor’s Brovana infringes its patent for a spray to open bronchial passage. Arformoterol tartrate, the active ingredient of Brovana is exemplified in the US 3,994,974 (the ‘974 patent). Brovana which got US FDA approval last year in October has currently four Orange Book listed patents covering formulations and method-of-use of arformoterol tartrate.

Generics Eye Gemzar

Sicor Pharmaceuticals Inc., Mayne Pharma Inc. and Sun Pharmaceutical Industries Inc. had separately filed Para IV challenges against Eli Lilly’s blockbuster anticancer Gemzar eyeing US $ 1.4 billion market. In response, Lilly has filed three separate patent infringement lawsuits against the generic challengers, which subsequently triggered 30-months stay of final generic approval against the ANDAs. Gemcitabine hydrochloride, the active ingredient of Gemzar is protected by the US 4,808,614 (the 614 patent) which is valid till November 15, 2010 including pediatric exclusivity whereas it’s FDA approved indication is covered by the US 5,464,826 (the ‘826 patent) including pediatric exclusivity. Gemcitabine hydrochloride is analog of pyrimidine nucleosides exemplified in the US 4,211,773 (the ‘773 patent).

Generics Cracked Norvasc US Market!!!

US Court of Appeals for the Federal Circuit has issued a decision reversing a lower court ruling that upholds the Pfizer’s U.S. Patent No. 4,879,303 (the ‘303 patent) covering amlodipine besylate, the active ingredient of Norvasc worth US $ 4.86 billion in Sales in 2006. The ruling came on an appeal made by Apotex, which lost a patent challenge in January 2006 when the US District Court for the Northern District of Illinois had ruled the ‘303 patent valid and enforceable. Following CAFC decision, Mylan, which earlier lost patent challenge over Norvasc last month, has launched its generic Norvasc in the US. Mylan claims to have first-to-file status for Norvasc and likely to enjoy 180-days of marketing exclusivity. It is expected that Mylan earlier introduction of generic Norvasc may cost Pfizer US $ 1 billion in sales. CAFC found claims 1-3 of the ‘303 patent invalid for obviousness contradicting Pfizer’s assertion that (1) amlodipine besylate exhibits unexpectedly superior results would be enough to overcome the objection of obviousness over the prior art, and (2) finding of amlodipine besylate corresponds to ‘discovery’ as it was obtained through the use of trial and error procedures. Read CAFC decision Pfizer, Inc. v. Apotex, Inc.

Ostuka’s Abilify Patent under Generic Threat

Barr Pharmaceuticals has made a Para IV challenged against Japanese drugmaker Otsuka Pharmaceutical over atypical antipsychotic drug Abilify, generically known as Aripiprazole worth US $ 1.9 billion annual sales (based on IMS sales data ending January 2007). In response to Barr Para IV challenge, Otsuka has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey. Abilify is used in the treatment of schizophrenia and the manic and mixed episodes associated with bipolar disorder and currently been licensed to Bristol-Myers Squibb Co. which got US approval in 2002. Para IV certification would likely give Barr 180 days of exclusive marketing rights.

Pfizer received Indian patent for Ziprasidone suspension

Pfizer Products Inc has received an Indian Patent No. 201 982 (the ‘982 patent) titled Ziprasidone suspension against its application number 472/MUM/2000 filed May 23, 2000. The ‘982 patent claims its priority from US Provisional Application No. 60/136,268 filed May 27, 1999 against which the U.S. 7,175,855 (the ‘855 patent) is issued on February 13, 2007. The ‘855 patent is currently listed with Orange Book for Ziprasidone Suspension oral solution marketed under the brand name Geodon. The ‘855 patent is directed to a composition comprising ziprasidone hydrochloride, water, polysorbate 80, xanthan gum, and colloidal silicon dioxide.

Mashelkar Resigned!!!

Eminent Scientist Dr. R.A. Mashelkar has resigned as the chairman of the Technical Expert Group on Patent Laws in light of a “personalized attack” against him that questioned his integrity, competence and motives. He submitted his resignation on March 15, 2007 a day after the Left parties alleged that vital portions of the report were an “act of plagiarism and cheating” and were aimed at protecting the interest of multinationals. CPI (M) leaders had wanted the Mashelkar report to be rejected and felt that the Technical Expert Group had “gone beyond its terms of reference”. He said the four colleagues in the Technical Expert Group, whose eminence and integrity were beyond any question, could undertake the remaining task of reviewing and rectifying the technical inaccuracies in Mashelkar report. In his resignation letter, Dr. Mashelkar wrote “I want to guard my reputation and, hence, step aside. I am relinquishing the position of committee chairman.”

Shires sues generics companies over Adderall patents

Shire PLC has filed a patent infringement lawsuit against Colony Pharmaceuticals Inc and Actavis Inc. in the US District Court for the District of Maryland alleging infringement of its drug Adderall XR worth US $ 863.6 million in sales 2006. The lawsuit is result of abbreviated new drug applications filed by defendants seeking approval to make generic versions of 5mg, 10mg, 15mg, 20mg, 25mg and 30mg Adderall XL before the expiry of Orange Book listed patents. Defendants’ has made Para IV certification with respect to the U.S. Patent Nos. 6,322,819 (the ‘819 patent), 6,605,300 (the ‘300 patent) and 6,913,768 (the ‘768 patent).

Para IV Move: EFFEXOR XR™ (Wyeth/Lupin)

Wyeth has filed a patent infringement complaint against Lupin Pharmaceuticals in the US District Court for the District of Maryland after receiving a letter dated January 26, 2007 from Lupin that it had filed an abbreviated new drug application (ANDA) No. 78-543 to obtain US FDA approval for the commercial manufacture, use, and sale of Venlafaxine hydrochloride extended-release capsules in 37.5mg, 75mg, and 150mg dosage strengths, generic versions of Wyeth’s Effexor XR capsules before expiry of the US Patent Nos. 6,274,171 (the ‘171 patent), 6,403,120 (the ‘120 patent) and 6,419,958 (the ‘958 patent). Lupin has made Para IV certification with respect to ‘171 and ‘120 patents alleging that the claims of ‘171, ‘120 and ‘958 patents are not infringed and/or invalid. In its complaint, Wyeth has moved action for intentionally and willfully infringement.

Sanofi filed patent infringement complaint against Synthon

World third-largest pharmaceutical company Sanofi-Aventis has filed a patent infringement complaint against Snython in the US District Court for the Middle District of North California in response to Synthon’s submission of abbreviated new drug application (ANDA) No. 78-483 with US FDA to obtain marketing approval of Zolpidem tartrate extended release tablets in 6.25mg and 12.5mg dosage strengths, generic version of Sanofi’s Ambien CR before expiry of the US Patent No. 6,514,531 (the ‘531 patent). Synthon has made Para IV certification with respect to the ‘531 patent.

Pfizer sued Ranbaxy over Caduet Patent

Ranbaxy has yet again made Pfizer to defend their patents for blockbuster drug products now adding anti-cholesterol drug Caduet in their ongoing list of patent litigations. Pfizer filed a patent infringement suit against Ranbaxy in response to Ranbaxy’s ANDA submission with the US FDA for marketing approval of generic Caduet before expiry of Orange Book listed patents. Caduet is combination of amlodipine besylate and atorvastatin calcium. In its complaint, Pfizer alleged that Ranbaxy’s ANDA products would infringe Pfizer’s patents for Caduet. However, Ranbaxy is believed to have first-to-file status for Caduet.

Caraco filed lawsuit for declaratory judgment against Forest

Caraco Pharmaceutical Laboratories has brought a lawsuit against Forest Laboratories and H. Lundbeck A/S for declaratory judgment of patent non-infringement regarding the U.S. 6,916,941 (the ‘941 patent) which claims crystalline particles of escitalopram oxalate. The lawsuit is result of Caraco’s submission of an abbreviated new drug application (ANDA) to the US FDA seeking marketing approval for generic Lexapro, generically known as escitalopram oxalate before expiry of Orange book listed patents. Earlier on July 10, 2006 Forest and Lundbeck collectively filed a patent infringement lawsuit against Caraco, following Caraco’s ANDA submission along with Para IV certification with respect to the U.S. RE 34, 712 (the ‘712 patent) and ‘941 patent, alleging that Caraco’s ANDA products will infringe the ‘712 patent. However, Forest do not sued Caraco for infringement of the ‘941 patent.