PreGrant Opposition: Erlotinib Polymorph B Rejected

In December 2008, the Delhi Patent Office rejected OSI Pharmaceuticals patent application no. IN/PCT/2002/507/DEL for polymorph B form of erlotinib hydrochloride in a pre-grant opposition proceeding filed by Cipla. Cipla challenged the application on the grounds of (1) prior publication, (2) publicly known and used in India, (3) obvious and lack in inventiveness, (4) not an invention/not patentable, and (5) failure to disclose information under section 8. In its [decision], the Patent Office found application lacking comparative data with respect to known substance to prove improvement in therapeutic and subsequently rejected claims for polymorph B of erlotinib hydrochloride under section 3(d) of the Patents Act, 1970. The decision was decided on December 15, 2008. Rejected application has corresponding patent in the United States listed with Orange Book. It is considered that Roche marketed Tarceva tablets contains polymorph B form of erlotinib hydrochloride.

PreGrant Opposition: Erlotinib Polymorph B Rejected

In December 2008, the Delhi Patent Office rejected OSI Pharmaceuticals patent application number IN/PCT/2002/507/DEL for polymorph B form of erlotinib hydrochloride in a pre-grant opposition proceeding filed by Cipla. Cipla challenged the application on the grounds of (1) prior publication, (2) publicly known and used in India, (3) obvious and lack in inventiveness, (4) not an invention/not patentable, and (5) failure to disclose information under section 8. In its [decision], the Patent Office found application lacking comparative data with respect to known substance to prove improvement in therapeutic and subsequently rejected claims for polymorph B of erlotinib hydrochloride under section 3(d) of the Patents Act, 1970. The decision was decided on December 15, 2008. Rejected application has corresponding patent in the United States listed with Orange Book. It is considered that Roche marketed Tarceva tablets contains polymorph B form of erlotinib hydrochloride.

PreGrant Opposition: Crystalline Adefovir Dipivoxil Rejected

The Delhi Patent Office lately rejected Gilead’s patent application no. 712/DEL/2002 for crystalline adefovir dipivoxil in a pre-grant opposition proceeding filed by Ranbaxy. Ranbaxy challenged the application on the grounds of: (1) the subject matter of the application is not novel, (2) the subject matter of the application lacks inventive step, (3) the invention has no utility, (4) the application could not have been filed under section 5(2) of the previous Act, (5) claims are indefinite, (6) no patent can be granted for a new form of a known substance, and (7) no patent can be granted for a composition. In its [decision], the Patent Office found application lacking inventive step and lacking comparative data with respect to known substance to prove improvement in the therapeutic efficacy. The decision was made on March 18, 2009. Adefovir dipivoxil is a diester prodrug of adefovir marketed by Gilead under the brand name Hepsera having therapeutic activity against human hepatitis B virus (HBV).

Roche et al vs. Cipla Ltd.

[Download] the Delhi High Court decision rejecting Roche appeal against the Delhi HC judgment dated March 19, 2008 declining their appeal for grant of an interim injunction to restrain the Cipla from manufacturing, offering for sale, selling and exporting the drug Erlotinib. We will be bringing exclusive analysis on this decision soon.

Note: Our humble request to those having issue with our watermark, please refrain yourself from downloading the decision from our blog. This and other decisions available on our blog are public property and we do not hold any ownership on them, please feel free to download them from other free sources.

Glaxo's Application for Rosiglitazone Salt Rejected

After giving GlaxoSmithKline Beecham an opportunity for hearing under section 14 and 15, the Delhi Patent Office has rejected the patent application no. 295/DELNP/2003 (corresponding application of US20040044043A1) for ethane sulphonate salt of anti-diabetic drug rosiglitazone [download]. The application found rejected after Glaxo failed to establish that ethanesulphonate salt of rosiglitazone is better in terms of the efficacy with respect of the rosiglitazone. Though Glaxo provided four supporting Annexures in their written submissions but the Delhi Patent Office do not found them supporting the application efficacy with respect to the known rosiglitazone.

Pfizer Loses Caduet PreGrant Opposition

The Delhi Patent Office has lately ruled against Pfizer in pre-grant opposition [download] filed by Torrent Pharma Ltd. against the patent application no. 2571/DEL/1998 for therapeutic combination of amlodipine and atorvastatin. The combination is marketed as Caduet by Pfizer and has US Patent No. 6,455,574 listed with Orange Book. The Delhi Patent Office rejected the application on grounds of (1) lack of inventive step under section 25 (1) (e), (2) not patentable under section 25(1)(f) and (3) insufficiency of description under section 25(1)(g). The application is also found not patentable under section 3(d) (lack of enhanced efficacy) and 3(e) (lack of synergy).

Roche Wins Post Grant Opposition for Pegasys

Swiss-drug major F. Hoffman-La-Roche has successfully defended its patent for hepatitis drug Pegasys in post-grant opposition [download] filed by Mumbai-based biotech company Wockhardt and Mumbai-based NGO Sankalp Rehabilitation Trust. Interestingly, the recommendation of Opposition Board was to revoke the granted patent for Pegasys, i.e. IN198952 but the Assistant Controller T.V. Madhusudan meritoriously ruled against the recommendation of Opposition Board and upheld the validity of patent. This decision is possibly the first post-grant opposition decided by the Indian Patent Office and we strongly recommend reading it.

Novartis Loses PreGrant Opposition for Imatinib Alpha Form

The Chennai Patent Office lately ruled against Novartis in pre-grant opposition [(download] filed by Sun Pharmaceutical Industries Ltd., Time Cap Pharma Labs Pvt. Ltd. and Okasa Pvt. Ltd. (collectively Opponents) against the patent application no. 799/CHE/2004 for alpha crystalline form of imatinib mesylate. The Chennai Patent Office refuses the grant of patent after Opponents successfully succeeded in (1) establishing the ground of Obviousness under 25(1)(e), (2) proving the ground of ‘not an invention’ under section 25(1)(f), (3) non-patentable under section 3(d), and (4) proving the ground of ‘insufficiency’ under section 25(1)(g). The application is divisional application of the patent application no. 1602/MAS/1998 claiming beta-crystalline form of imatinib mesylate which was also rejected by the Chennai Patent Office but subsequently appealed by Novartis. Currently, Intellectual Property Appellate Board is hearing the beta-crystalline patent application.

Indian Patent Office ruled against Gilead in Tamiflu PreGrant Opposition

California-based Biotech Company Gilead Science Inc. has lately lost crucial pre-grant opposition [download] for its anti-influenza drug Oseltamivir Phosphate marketed as Tamiflu. The Delhi Patent Office decided the pre-grant opposition in favor of Cipla Ltd. after it found that the applicant (Gilead) failed to provide any supportive evidence in the specification by means of comparative data or by way of examples which would have supported the inventive merit of Oseltamivir. The Delhi Patent Office particularly relied on the decision of European Board of Appeal (T-0133/01) stating that alleged but unsupported advantages cannot be taken into consideration in respect of the determination of the problem underline the claimed invention. The Delhi Patent Office also found anti-influenza agent Oseltamivir to fall within the provisions of section 3(d) and not patentable. Tamiflu is marketed by Roche in India and in 2005 entered into sub-license agreement with Hyderabad-based Hetero Drugs for the production of oseltamivir.

From the Desk of Patent Circle: Is Patent-Drug Regulatory Linkage a Necessity? Part II

Case Study – 01

Let us take example of Bristol-Myer Squibb (BMS) patented drug Dasatinib for which Hetero Drugs filed an application with the DCGI for marketing approval of generic dossier of Dasatinib. Suppose the Delhi High Court judgment goes in favor of Hetero and the DCGI gives Hetero the marketing approval but BMS cannot sue Hetero till the generic version is not launched in the market. Now following Hetero’s approval for generic Dasatinib another generic company Cipla too files an application with the DCGI for marketing approval of generic Dasatinib and subsequently obtains the marketing approval. Following Hetero and Cipla, dozens of other generic companies files applications with the DCGI for marketing approval of their generic versions of Dasatinib and subsequently obtains marketing approval. Interestingly BMS cannot stop or sue any of generic company till they launch their generic product in the market.

Now Cipla launches generic Dasatinib in June 2009 and consequently sued by BMS for patent infringement in the Delhi High Court. Now what should be the minimum time period we can expect judgment from the High Court? Let us be too positive to consider such period be around two years. If Cipla wins case then obviously there will be no issue and all other generic companies will be free to enter market without risk. But let us consider judgment is delivered after two years (June 2011) and goes in favor of BMS. Now Hetero launches its generic Dasatinib in August 2011 soon after BMS-Cipla case and sued by BMS for patent infringement. Again let us consider the judgment is made in favor of BMS after two years of court proceedings (around September 2013) and Hetero is prevented for selling generic Dasatinib. Even after BMS wins case each against Cipla and Hetero it doesn’t mean that other companies may not launch their generic launch. Suppose after few months of BMS-Hetero case another generic company launches its generic Dasatinib then again BMS will file and litigate the patent infringement suit. The question is how many times BMS need to go to the Court to enforce its patent for Dasatinib against the generic manufacturers having marketing approval for generic Dasatinib? Does it make any sense that BMS keep fighting multiple infringement lawsuits to enforce the same patent and keep losing crucial patent term and money in just fighting back to back litigations? Is such situation not creating liability on patentees? We know reading this case study seems to be little absurd but one cannot really ruled out such possibility of events. What can be the possible solution to avoid such unjust and unfair liability on patentee? Is such situation not likely to create burden for the Courts and judiciary?

From the Desk of Patent Circle: Is Patent-Drug Regulatory Linkage a Necessity? Part I

Some time back we ran couple of thought provoking posts touching issues pertinent to the Delhi HC Dasatinib order. In our first post we particularly analyzed that both Bristol-Myer Squibb (BMS) and the Delhi High Court acted within the periphery of the law and the Delhi HC order nowhere created any sort of “patent-drug regulatory” linkage, an argument unnecessarily sensationalized and propagandized by newspaper media. In second post we tried to clear distorted arguments that the Delhi HC Dasatinib order contravenes Bolar-provision aka section 107A (1) but at the same time emphasized that exemption under sec. 107A (1) is not a statutory go-ahead for willful infringement. Now continuing from our earlier two posts, we will analyze two important aspects – (1) Enforcement of drug patents, and (2) Patent-drug regulatory linkage.

Enforcement is the heart of drug patents and in absence of proper enforcement policies a patent is not even worth a penny. Proper enforcement is not possible without regulated monitoring mechanism particularly in a country such as India which has vastly fragmented drug industry. Often it is not easy for a company located in some part of India to track and monitor what drugs are been sold in market in other parts of country, for example, any company located in Gujarat or Maharashtra will not be in position to track and monitor what drugs are been marketed in extreme north-eastern states or deep southern cities of India. And, if a company needs to keep account of drugs marketed in all parts of India then obviously need to spend enough time and resources in preparing expert teams or hiring investigation agencies to track such information which will undoubtedly bring undue burden on companies. Even we have witnessed cases where drugs are widely sold to patients loosely (without any packaging/packaging details) by doctors and dispensaries. Such practices make patent enforcement almost improbable as it is not possible to track and monitor such loosed drugs even in metropolitan city like Mumbai then what to say about whole India.

Many countries both developed and developing made enforcement and monitoring of drug patents possible at drug regulatory level. Drug regulatory agencies in countries like Singapore, Thailand, Malaysia, Russia and CIS countries, and European contracting states opt to reject generic dossier outrightly if there is an Innovator patent for the drug compound/product and generic manufacturer is seeking marketing approval before the expiration of patent. The only option for generic manufacturers to submit generic dossier for market approval is to first challenge the validity of patent and get it invalid/non-infringing. Quite understandable any law abiding country will never create a chaotic situation where a legal right granted by the government/sovereign is diluted by its own government body. India too need to frame proper policy for monitoring patent enforcement and that can only be possible at drug regulatory level. The policy should permit the DCGI to reject application for generic dossier of a patented drug before the expiration/validity of patent.

However, there is a strong section of people arguing that a mere marketing approval to a generic manufacturer (for the generic version of a patented drug) by the DCGI is not a violation of patent right under sec. 48 of the Patents Act, 1970 – the infringement is only possible when the generic manufacturer launches its product in market. Though we do have difference of opinion on this but still let us assume that in India the DCGI is not allowed to reject application for generic dossier of patented drug before the expiration of patent and generic manufacturers can obtain marketing approval for generic versions of patented drugs. In other words, obtaining marketing approval for generic version of patented drug is not an infringement of patent right which mean that a patentee has no legal stand for filing patent infringement suit based on presumption that the marketing approval will lead to product launch until and unless the generic manufacturer(s) launches its generic product in market. Now let’s put this situation into hypothetical case studies.