Wednesday, July 16, 2008

Abbott Files Para IV Litigation Against Dr. Reddy's Labs

Abbot Laboratories has filed an infringement lawsuit against Hyderabad-based Dr. Reddy’s Laboratories for the infringement of US Patent Nos. 6,511,678, 6,528,090, 6,713,086 and 6,720,004 following DRL paragraph IV certification as part of an abbreviated new drug application (ANDA) to manufacture a generic version of Depakote ER (divalproex sodium extended release tablet). Depakote ER is anti-seizure drug with US sales of $1.48 billion in 2007. The lawsuit is filed in the United States District Court for the District of New Jersey. In 2005 and 2007, Abbott filed similar infringement lawsuits against Mylan, Impax Laboratories, Teva and Wockhardt Ltd. but earlier this year entered into agreement with Mylan to allow launching a generic version no later than January 1, 2009. Mylan believes to have 180-day exclusivity period for 500 mg strength and under terms of agreement also obtained a license for the 250mg strength tablets to be launched no later than January 1, 2009.

Monday, July 14, 2008

Will it be Raining Patent Litigations in India?

Last edition of IDMA Bulletin (Vol. XXXIX No. 25) has interesting piece of advertisement from Cipla announcing brand names of 20 generic drugs likely to be introduce shortly. Just for the information of overseas readers, in India (unlike the US) generic companies sell generic versions under their own brand names. Here also, the list advertised by Cipla is of brand names not generic names so there is always a possibility of error in identifying the exact drug substance from brand name but still few brand names seems to closely resemble the generic names. The list includes brand names like Soranib (resembling Bayer’s anti-cancer drug Sorafenib), Sunitib (resembling Pfizer’s anti-cancer drug Sunitinib), Sprydas (resembling Bristol-Myer’s anti-cancer drug Dasatinib marketed as Sprycel), Lapanib (resembling Glaxo’s anti-cancer drug Lapatinib) and Nilotib (resembling Novartis’s anti-cancer drug Nilotinib). All these anti-cancer drugs belong to the same class of Tyrosine Kinase Inhibitors and for which either patent applications are pending or patents are granted in India (see here). Bristol-Myer has already received the Indian Patent No. 203937 for Dasatinib and last year Delhi Patent Office granted Pfizer the Indian Patent No. 209251 for Sunitinib. If Patent Circle guess about brand names is proper then possibly it will be raining patent litigations in India? It seems to be like Erlotinib (Tarceva), Cipla will again go ahead disrespecting patents for other anti-cancer drugs. Watch out … Roche may have company to join.

Saturday, July 12, 2008

Teva Tasting Own Medicine

The world’s largest generic manufacturer Teva Pharmaceutical Industries instead of challenging Innovators’ drug patents will now be defending its own patented drug Copaxone against the Para IV certification made by Momenta and its partner Sandoz. Generically referred as Glatiramer Acetate, Copaxone is an anti-sclerosis drug that had US sales of $ 1.1 billion last year. Glatiramer is a biotech drug and Teva firmly believes that it would be difficult product to replicate and will require full clinical trials to get approval for the generic Copaxone. Teva said it intended to sue Momenta and Sandoz for alleged patent infringement of Orange Book listed patents. There are seven OB listed patents (US 5,981,589, US 6,054,430, US 6,342,476, US 6,362,161, US 6,620,847, US 6,939,539 and US 7,199,098) covering active ingredient Glatiramer Acetate, pharmaceutical compositions containing it, and methods of using it.

Friday, July 11, 2008

Federal Circuit Ruled Against Apotex Reverse Doctrine of Equivalents

The Federal Circuit has disagreed with Apotex that a district court erred in failing to find non-infringement under the reverse doctrine of equivalents and upheld the district court decision granting summary judgment that Roche’s US Patent No. 5,110,493 is valid and infringed by Apotex’s ANDA for generic version of anti-inflammatory eye drug Acular LS. Acular LS is an ophthalmic solution containing ketorolac tromethamine marketed by Allergan for the treatment of inflammation associated with glaucoma, conjunctivitis and eye surgery.

The ‘493 patent claims an ophthalmic formulation comprising a non-steroidal inflammatory drug, a quaternary ammonium preservative, and the non-ionic surfactant, octoxynol 40 (O40). In its Appeal, Apotex did not dispute that its ANDA falls within the literal scope of claim 1 of the ‘493 patent but instead argued that the district court erred in failing to find non-infringement under the reverse doctrine of equivalents. The Federal Circuit explained that the reverse doctrine of equivalents (“RDOE”) “is an equitable doctrine designed to prevent unwarranted extension of the claims beyond a fair scope of the patentee’s invention.” The court referred to Supreme Court’s RDOE test, set forth in the Graver Tank case:

Where a device is so far changed in principle from a patented article that it performs the same or a similar function in a substantially different way, but nevertheless falls within the literal words of the claims, the reverse doctrine of equivalents may be used to restrict the claim and defeat the patentee’s action for infringement.

Apotex argued that the ‘principle’ of the ‘493 patent is “the use of O40 in an amount sufficient to cause the formation of micelles and thereby provide robust stability to the formulation by preventing interactions between ketorolac tromethamine and benzalkonium chloride.” The Federal Circuit disagreed and found no support for this principle in the specification, prosecution history or prior art. According to the Federal Circuit, Apotex relied exclusively on the declaration of its expert and agreed that Apotex failed to make out a prima facie case of non-infringement under the reverse doctrine of equivalents, and therefore summary judgment of infringement was proper. The Federal Circuit also agreed with the district court that Apotex’s invalidity arguments were barred by claim preclusion (e.g., res judicata).

Wednesday, July 09, 2008

Playing Double Standards?

Often accusing foreign MNCs for ever-greening of patent protection, Cipla has filed fair number of patent applications for new forms of known drug substances such as Alfuzosin, Tolterodine, Perindopril, Citalopram, Fexofenadine, Levosulbutamol, Sibutramine, Topotecan, Clopidogrel, Duloxetine, Montelukast, Olanzapine. Over the years, Cipla has successfully pioneered reverse-engineering of innovator drugs with an ability to launch generic versions within shortest possible time. This business strategy not only made Cipla a preferred choice for cheap generic drugs but also transformed into Billion Dollar Company. Though Cipla lacked any expertise in drug discovery or research but went ahead challenging the validity of Tarceva patent under section 3(d) arguing that Erlotinib is a mere derivative of known drug (Gefitinib). I wonder do reverse-engineering expertise gives sufficient insight to complex drug discovery and make such statement (which essentially requires strong research experience and scientific evidence). It is almost like a chemistry department of third-tier University questioning research ability of premier National Chemical Laboratory (NCL) or Indian Institute of Technology (IIT). Interestingly, Cipla recently got patent for inclusion complex of esomeprazole with cyclodextrin, which technically is a case of frivolous patenting but instead they booked Roche for frivolous patenting of Erlotinib. In India, there seems to be case evolving for ‘differential non-obviousness’ and why not Cipla is not innovator and at their level of expertise any patent application filed by them (though how obvious that is) is non-obvious but when it comes to copying of innovator drugs everything under the sun is obvious.

Friday, July 04, 2008

AstraZeneca Wins Summary Judgment

AstraZeneca has been granted summary judgment for no inequitable conduct in Seroquel patent litigation and strategically avoided running into expensive and time-consuming expert discovery trial that was scheduled to begin on August 11 against the generic manufacturers Teva Pharmaceutical Industries and Sandoz. Teva and Sandoz had already conceded infringement and the validity of the ‘288 patent, leaving only inequitable conduct contentions. Teva said it plans to appeal the judgment by the US District Court for the District of New Jersey. AstraZeneca sued Teva in September 2005 for willful infringement of Orange book listed US 4,879,288 protecting Seroquel drug substance Quetiapine Fumarate. The lawsuit was in response to an Abbreviated New Drug Application filed by Teva with the United States Food & Drug Administration seeking marketing approval of generic Seroquel before the expiration of the ‘288 patent. Later in April 2007, AstraZeneca sued Sandoz following submission of an Abbreviated New Drug Application by Sandoz intended for marketing approval prior to the expiration of the ‘288 patent. In February 2008, AstraZeneca filed a motion for summary judgment that the ‘288 patent is not obvious and that there has been no inequitable conduct.

Tuesday, July 01, 2008

More Patents for New Forms Issued to Generics

There are some more patents issued by the Indian Patent Office to generic companies for new form of known drug substances.

  1. Teva Pharmaceutical Industries received Indian Patent No. 210420 for novel hydrate forms of alendronate sodium having water content of 1.35% to 11.7%. Patent was issued last year in October by the Mumbai Patent Office against the application no. 497/MUMNP/2005 which is national phase application of WO 2000/012517. The WO disclosure do not made any data suggesting improved efficacy over the known substance.
  2. Indian Patent No. 219014 issued to Torrent Pharmaceuticals Ltd. for Form T1 of nebivolol and its pharmaceutically acceptable salts against the mail-box application no. 811/MUM/2004. The patent issued earlier this year in April. Equivalent WO 2006025070 does not disclose any data suggesting improved efficacy over the known form.
  3. Indian Patent No. 212951 for polymorph Form I and 2 of desloratadine hemifumarate issued to Sandoz against the application no. 139/CHENP/2005 which is national phase application of WO 2004012738. The WO disclosure gives no data suggesting improved efficacy over the known form.
  4. Indian Patent No. 219489 for amorphous and crystalline forms of losartan potassium issued to Teva Pharmaceutical Industries against the mail-box application no. 1286/DELNP/2004 which is national phase application of WO 2003048135. The WO disclosure does not suggest any data relating to improved efficacy over the known form.

Note: Above information is based on title and abstract available on official website of Indian Patent Office not on issued claims.

Daiichi Filed Infringement Suit Against Indian Drug Company

Daiichi Sankyo which recently shocked Indian generic industry by announcing to buy out controlling stake in India’s largest drug company Ranbaxy has lately filed an infringement suit in the United States District Court for the District of New Jersey against Matrix Laboratories for alleged infringement of the US Patent No. 5,616,599 (the ‘599 patent) claiming active ingredient olmesartan medoxomil. The infringement suit is in response to Matrix’s submission of an abbreviated new drug application (ANDA) to the United States FDA, seeking approval to market generic version of anti-hypertension Azor tablets containing the active ingredients amlodipine besylate and olmesartan medoxomil before the expiration of the ‘599 patent. The suit was filed on June 03, 2008. Matrix is believed to be First-to-File Para IV applicant, which if succeed would give Matrix 180-day market exclusivity.