Novartis Trouble Over Diclofenac Patent

Earlier this month, on May 03 US-based Biogan Biopharmaceutical and Swiss-based Jagotec filed a patent infringement lawsuit against Novartis Consumer Health Inc. (NCH) in the US District Court for District of New Jersey alleging infringement of the US Patent Nos. 5,852,002 (the ‘002 patent), 5,929,048 (the ‘048 patent) and 5,985,850 (the ‘850 patent) covering topical gel formulation of Diclofenac sodium, marketed as Solaraze®. The subject patents are assigned to Jagotec and exclusively licensed to Bioglan, and are directed to claims for dosage form and method of treatment. The complaint is filed in response to NCH submission of New Drug Application (NDA) No. 22-122 to the US FDA under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act along with Para IV certification (21 USC § 355(b)(2)(A)(iv)) seeking approval to sell diclofenac sodium topical gel before the expiration of Solaraze Orange Book listed ‘002, ‘048 and ‘850 patents. In its complaint, Bioglan alleged that NCH had actual and constructive notice of the ‘002, ‘048 and ‘850 patents prior to the filing of the NCH NDA and filed the NDA with a Para IV certification without adequate justification for claiming the patents will not be infringed.

PDL Biopharma Sued Sun Pharmaceutical Over Cardene® I.V. Patent

On April 16 and 17, 2007 US-based biopharmaceutical company PDL Biopharma has filed patent infringement complaints in the US District Court for the Eastern District of Michigan Southern Division and District Court for the District of New Jersey against India-based generic drug manufacture - Sun Pharmaceutical Industries alleging infringement of the US Patent No. 5,164,405 (the ‘405 patent) covering marketed Cardene® I.V. formulation. Cardene® I.V. is a parenteral composition of nicardipine hydrochloride in 2.5 mg/ml dosage strength. The complaint filed in response to Sun’s submission of the abbreviated new drug application (ANDA) No. 78-405 to the US FDA seeking approval to sell generic approval of injectable nicardipine hydrochloride product before the expiration of the Orange Book listed ‘405 patent. In its complaint, PDL Biopharma alleged that Sun’s ANDA product would infringe, either literally and/or under the doctrine of equivalents, at least one claim of the ‘405 patent pursuant to USC 35 § 271(e)(2).

Apotex Moves Para IV for Allergan’s Alphagan

Canadian generic drug maker – Apotex has made a Para IV certification with its Abbreviated New Drug Application (ANDA) Nos. 78-479 and 78-480 to manufacture and market generic version of Allergan’s Alphagan P, generically known as brimonidine tartrate 0.15% and 0.10% ophthalmic solutions before the expiration of Alphagan five Orange Book listed patents – US 5,424,078; US 6,562,873; US 6,627,210; US 6,673,337; and US 6,641,834 (collectively “Allergan Patents”). Subsequently Apotex notified Allergan, and in response of which Allergan filed a complaint for patent infringement in the US District Court for the District of Delaware alleging that submission of Apotex’s ANDAs for approval to sell brimonidine tartrate 0.15% and 0.10% ophthalmic solutions before the expiration of Allergan patents will constitutes an act of infringement under USC 35 § 271(e)(2). Allergan patents cover various aspects of the Alphagan P 0.15% and 0.10%.

Smithkline Blocks Generic Avandaryl

On May 11, 2007 Smithkline Beecham filed a patent infringement lawsuit against Teva Pharmaceutical Industries alleging that the Teva’s submission of ANDA for approval of sell generic version of Smithkline’s Avandaryl would constitute an act of infringement pursuant to 35 USC § 271(e)(2). In its complaint, Smithkline alleged that the Teva proposed generic formulation would infringe Avandaryl Orange Book listed patents – US 5,002,953 (the ‘953 patent) and US 5,741,803 (the ‘803 patent). Earlier Teva submitted ANDA with Para IV certification to the FDA for marketing approval of generic version of Avandaryl (combination of rosiglitazone maleate and glimepiride) before the expiration of the ‘953 and ‘803 patents. The ‘953 patent is directed to substituted thiazolidinedione derivatives exemplified by markush structural formula which covers rosiglitazone as 5-(4-[2-(N-methyl-N-(2-pyridyl) amino) ethoxy] benzyl) 2, 4-thiazolidinedione. The ‘803 patent is species patent covering maleic acid salt of rosiglitazone.

Abbott Moved Patent Infringement Complaint Against Wockhardt

Abbott Laboratories - the RLD status holder of Depakote ER has filed a patent infringement complaint in the US District Court for the District of New Jersey against India-based generic drug manufacture - Wockhardt Ltd. alleging that Wockhardt’s ANDA # 78-705 submitted to the US FDA for generic approval of divalproex sodium extended release tablets infringes Abbott’s US Patent No. 6,713,086 (the ‘086 patent) expiring on December 18, 2018. The complaint is intended to prevent the FDA from approving Wockhardt’s generic version of Depakote ER before expiry of the ‘086 patent. In its complaint, Abbott alleged submission of ANDA # 78-705 for approval to sell divalproex sodium extended-release tablets in 500mg dosage strength before the expiration of the ‘086 patent will constitutes an act of infringement pursuant to 35 USC § 271(e)(2). The ‘086 patent is directed to controlled release formulation of divalproex sodium.

Dr. Reddy’s Burns Down to Aciphex Patent Dispute

ut Eisai Inc has successfully defended its U.S. Patent 5,045,552 (the ‘552 patent) for the heart burn drug Aciphex, knocking down India-based Dr. Reddy’s Laboratories and Israel-based Teva Pharmaceuticals Industries Ltd. move to launch their respective generic versions of Aciphex before the ‘552 patent expiry in May 2013. Aciphex, generically known as Rabezpraxole Sodium, is co-marketed by PriCara (Unit of Ortho-McNeil) and Eisai in the United States raking up US sales of US $1 billion in 2006. In its ruling, the US District Court Southern District of New York ruled that the ‘552 patent is enforceable, which in earlier ruling, confirmed the validity of the ‘552 patent. During trial Dr. Reddy’s and Teva alleged, among other things, that the ‘552 patent is unenforceable because of Eisai’s inequitable conduct before the United States Patent & Trademark Office during prosecution of the patent, which judge Gerard Lynch ruled against Dr. Reddy’s and Teva after defendants (Dr. Reddy’s and Teva) failed to establish the defense of inequitable conduct by clear and convincing evidence.

Teva Para IV Punch to MSD’s SINGULAIR

Merck Sharp & Dohme Pharmaceuticals (MSD) has filed a patent infringement complaint in the US District Court for the District of New Jersey against Teva Pharmaceutical Industries alleging infringement of the US 5,565,473 (the ‘473 patent) protecting Montelukast sodium, the active ingredient of MSD’s SINGULAIR. The complaint is to prevent the US FDA from approving Teva’s abbreviated new drug application (ANDA) No. 78-605 for generic montelukast sodium tablets before expiry of the ‘473 patent. In its complaint, MSD argued that Teva has no adequate good faith basis for filing its ANDA containing certification of the invalidity, unenforceability, and/or non-infringement of the claims of the ‘473 patent.

Para IV Move: SEROQUEL™ (AstraZeneca/Sandoz)

AstraZeneca has filed a patent infringement complaint in the US District Court for the District of New Jersey against Novartis generic unit – Sandoz alleging infringement of the US 4,879,288 (the ‘288 patent) protecting Quetiapine fumarate, the active ingredient of SEROQUEL, and methods of using that compound. The complaint is result of Sandoz’s Para IV certification for generic SEROQUEL tablets in 25mg strength prior to expiration of the ‘288 patent. On March 22, 2007 Sandoz notified AstraZeneca that it had submitted abbreviated new drug application (ANDA) No. 78-679 to the US FDA seeking approval for commercial manufacturing, using and selling of quetiapine fumarate tablets. The ‘288 patent earlier received a patent term extension under 35 U.S.C. § 156 extending its term for a period of 1,651 days from March 20, 2007 to September 26, 2011.

Barr Eye Generic Ambien CR

Barr Laboratories has submitted abbreviated new drug application for insomnia drug Ambien CR, generically Zolpidem Tartrate Extended-Release tablets with Para IV certification challenging Sanofi’s Orange Book listed patents. Subsequent to Barr Para IV move, Sanofi, on April 05 2007 filed a patent infringement lawsuit in the U.S. District Court of New Jersey to prevent Barr from proceeding with the commercialization of its generic Ambien. According to IMS sales data, Ambien CR had sales of approx. $ 659 million for the twelve months ended February 2007.

Bayer Sues Teva over Generic Avelox

Bayer HealthCare AG has filed a patent infringement lawsuit against Teva Pharmaceuticals USA Inc. for infringing its Orange Book listed US Patent Nos. 4,990,517 (the ‘517 patent) and 5,607,942 (‘942 patent) for antibiotic drug Avelox, generically known as moxifloxacin hydrochloride. The infringement action is in response to Teva’s ANDA No. 77-437 with Para IV certification, seeking approval from the US FDA to manufacture and sell a generic Avelox before expiry of ‘517 and ‘942 patents. The lawsuit is filed in the US District Court for the District of Delaware.

Lupin Makes Patent Assignment worth $ 27 million

In one of the significant transaction made on intellectual property assignment, Indian drug manufacture Lupin has received 20 million euros (US $ 26.7 million) from a patent assignment made with French drug company Servier. According to Lupin’s Managing Director Kamal Sharma, “the company has received 20 million euros from Laboratories Servier of France for the sale of certain patent applications and other related intellectual property from perindopril for multiple countries.” He further added, “the income from this sale significantly boosts our performance for the previous quarter. It obviously goes a long way to demonstrate our Research and IP capabilities.”

Product Patent Update

Novartis has obtained an Indian Patent Number 202283 titled Benzothiadiazoles and derivatives against Indian Application Number IN/PCT/2000/233/CHE filed February 01, 1999 claiming earliest priority from British patent application dated February 03, 1998 published as GB 9802251. The ‘283 patent has equivalent US Patent Number 6,756,367 (the ‘367 patent). The compounds exemplified in the ‘367 patent disclosures exhibits antagonistic activity at CRF1 receptors. Chennai Patent Office has issued an Indian Patent Number 203560 titled New heterocyclic compounds, process for their preparation and pharmaceutical compositions containing them. The ‘560 patent is assigned to Dr. Reddy’s Laboratories against its Indian Application Number 1147/MAS/1998. F. Hoffman La Roche has received an Indian Patent Number 203568 titled Dihydro-benzo [b][1, 4] diazepin-2-one derivatives as MGLUR2 antagonists II against Indian Application Number 1610/CHENP/2003 filed April 02, 2002. The ‘568 patent claims earliest priority from European patent application dated April 12, 2001 against which EP 1379511 (the ‘511 patent) is published. The compounds exemplified in the ‘511 patent disclosure are metabotropic glutamate receptor antagonists and used for the treatment or prevention of acute and/or chronic neurological disorders.

Patent Appellate Board Goes Functional

On April 02, 2007 the Central Government issued a notification which triggered Section 117G of the Patents Act, 1970 providing that all pending appeals in high court shall be transferred to the Appellate Board set up under Section 116 of the Act, effective from the date of the issue of notification. Till this notification the Appellate Board existed in theory, and not operational with Technical Members to deal with patent matters. Section 117G read as follow – All cases of appeals against any order or decision of the Controller and all cases pertaining to revocation of patent other than on a counter-claim in a suit for infringement and rectification of register pending before any High Court shall be transferred to the Appellate Board from such date as may be notified by the Central Government in the Official Gazette and the Appellate Board may proceed with the matter either de novo or from the stage it was so transferred. Following the notification, Justice R. Balasubramanian and Justice Prabha Sridevan of the Madras High Court yesterday ordered to transfer the case to Appellate Board regarding rejection of Novartis’s patent application for beta-crystalline form of imatinib mesylate – a polymorphic form likely used is marketed formulation of Novartis’s blockbuster anticancer drug Gleevec. The Appellate Board will likely to decide the merit of the patentability of beta-crystalline form of imatinib mesylate under the Patents Act, 1970. But it is still need to be seen that whether Appellate Board will proceed with the matter either de novo or from the stage where the Madras High Court had left. However, the Madras High Court will continue to proceed and deal with the constitutional validity of Section 3 (d) of the Patents Act, 1970. Moreover, in yesterday hearing the Madras High Court did not fix a date when it would hand down its ruling on the Novartis challenge and reserved its order on the constitutional validity of Section 3(d).

Generic Lipitor: Hard Target

The US Supreme Court has rejected an appeal by Ranbaxy over a judge’s ruling that information withheld by Pfizer during a Lipitor patent case was immaterial. The Supreme Court, without comment, turned down arguments from Ranbaxy to block a patent term extension for the U.S. 4,681,893 (the ‘893 patent) that protects Lipitor through March 2010. Ranbaxy argued that Pfizer forfeited its right to an extension as Pfizer withheld information when the U.S. Patent & Trademark Office extended one of the patents for more than three years. However, Pfizer urged the Supreme Court not to hear the appeal. Moreover, Pfizer has also approached federal patent examiners to re-issue the U.S. 5,273,995 (the ‘995 patent) that would prevent generic penetration until June 2011.

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.