Friday, January 21, 2011

Writ petition questioning competence of IPAB

Economic Times lately reported that a group of patent lawyers under the aegis of a newly formed public interest group, Promoting Public Interest Lawyering (P-PIL) have filed a writ petition challenging the legality of the Intellectual Property Appellate Broad (IPAB) saying the members are incompetent to hear IP cases. The patent lawyers have requested the Madras High Court to prevent IPAB from adjudicating any cases pending the disposal of the petition. Shamnad Basheer prompted P-PIL for the purpose of using the law and legal instruments for public interest causes. It is indeed a welcome move and must congratulate Shamnad for making such much-needed initiative.

In fact, it is not only IPAB whose competence is questionable but also many patent examiners (mostly promoted to Assistant Controller level) lack technical expertise and common sense to examine the applications. Particularly examiners handling pharma applications not only lacking technical nuances of pharmaceutical science but at the same time applying inventive-step in such a manner that they themselves worked in R&D for at least 20-30 years. In the patent law, non-obviousness is judged by considering working knowledge of a person ordinarily skilled in the art. Such ordinary skilled person is usually considered to have average technical level in the field of the invention but in India, the level of a person ordinarily skilled in the art has exceed average and is not less than a scientific genius/veteran with considerably strong experience in drug discovery and pharmaceutical development. In most of the orders (u/s 15) and opposition decisions related to pharmaceutical, new drug compounds and formulations are made look so easy and obvious that it seems to be that drug discovery is nothing complex and obvious to even first year pharmacy student or day-to-day practiced by scientists/pharmacists working in India. But in reality the situation is so miserable that it is impossible for our so-called person ordinary skilled in the art to develop anything until and unless the source of copying is not provided. Corruption and incompetence has become pretty common in the government agencies.

Wednesday, January 19, 2011

Patent Office continue refusing pharmaceutical formulations under S.3 (d) and (e)

The Delhi Patent Office lately refused the Application Number 4015/DELNP/2006 filed by Warner Lambert claiming topical formulation of Pfizer’s potential potassium channel opener UK-157147 for the treatment of alopecia, which got discontinued in phase II trials. The Application got refused on the grounds of lack of inventive step and not patentable under S.3 (d) and (e). During the prosecution, Warner tried to substantiate the inventive step in terms of selection of UK-157147 from thousands of potassium channel openers disclosed in the closest prior art document. Warner also argued that the closest prior art document generically suggested that potassium channel openers can be delivered orally, by inhalation, rectally, or topically, and also list twenty different diseases that may be treated which included male pattern baldness. The Controller found Warner’s argument unconvincing and held that the prior art document disclose all elements of the claims at issue and hence lack inventive step under S.2 (1) (j). It is bit harsh that a broad, presumptive generic disclosure will make the claims obvious. 

Over S.3 (d) and (e) objections, Warner argued that the claims relate to pharmaceutical formulation and is neither a mere new form of a known substance under S.3 (d) nor a mere admixture under S.3 (e). The independent claim at issue, as amended during the prosecution, recites topical formulation containing UK-157147 with inactive ingredients propylene glycol and ethanol. In his order, the Controller held that formulation is merely a new form of the known substance which is not patentable under S.3 (d). He further equated using inactive excipients with active agent with mere combination that needs efficacy data under S.3 (d). It is unfair to equate use of excipients in formulations and compositions with mere combination. 

The Controller further held that the claims fail to prove the enhanced efficacy against the combined efficacy of the individual component of the formulation and hence claimed formulation is a mere admixture of UK-157147 and excipients which fall under S.3 (e). Firstly, this is absolute ridiculous that enhanced efficacy is quoted under S.3 (e) when there is no such requirement mandated by S.3 (e). Secondly, the pharmaceutical formulation is not a mere admixture where components used have additive effect, it is always the synergistic effect of components (active and inactive ingredients) which results in proper delivery and therapeutic effect of active agent. There is no doubt that in absence of proper guidelines, S.3 (d) and (e) are often and erroneously applied against pharmaceutical formulations, drug delivery systems and compositions.

Monday, January 17, 2011

Application for dabigatran polymorphic form II refused under S.15

The Delhi Patent Office lately refused the Application Number 924/DELNP/2006 filed by Boehringer Ingelheim claiming polymorphic form II of anticoagulant drug dabigatran etexilate mesylate, marketed under the brand name Pradaxa. The Application was refused on the grounds of lack of inventive step and not patentable under S.3 (d). During the prosecution, Boehringer tried to substantiate the inventive step in terms of better solubility resulting into higher bioavailability and argued that none of the cited prior art documents provide any hint that mesylate salt have better solubility and exists in different polymorphic modifications. The Patent Office was of opinion that Boehringer’s argument of higher bioavailability lack experimental and comparative data. In its post hearing reply, Boehringer argued to substantiate and validate that bioavailability translates in enhanced efficacy a clinical trial in human beings would be required and for which regulatory approval is needed. Boehringer argued that such a regulatory permission just for the sake of complying efficacy requirement under S.3 (d) would hardly be granted.

Monday, January 10, 2011

Patent for anti-hypertension combination drug Valturna revoked

The Indian Patent Office lately revoked the Patent Number IN212199 issued to Novartis claiming single-pill combination of aliskiren and valsartan marketed as Valturna. The patent was revoked after Novartis failed to overcome the post-grant opposition filed by Sun Pharmaceuticals Ltd. The decision is yet another case where combination claim was found lacking inventive step on the ground of ‘obvious-to-try’. Interestingly, one of the grounds of revocation was lack of enablement and best method requirements as none of the examples exemplified the combination of aliskiren and valsartan. More interestingly, another ground of revocation was lack of sufficiency of disclosure as one of the dependent claims used the generic name ‘aliskiren’ but the whole specification disclosure nowhere used the generic name. Complete review of the decision can be read here.

Sunday, January 09, 2011

Application for telavancin hydrochloride refused under S.15

The Delhi Patent Office lately refused the Application Number 1770/DELNP/2006 filed by Theravnce, Inc. claiming hydrochloride salt of antibacterial drug Telavancin. The Application was refused on the grounds of lack of novelty and inventive step and not patentable under S.3 (d). Complete review of the order can be read here.

Application for contraceptive drug Yasmin refused in pre-grant opposition

The Chennai Patent Office lately refused the Application No. IN/PCT/2002/410/CHE filed by Bayer Schering Pharma, AG claiming contraceptive formulation of drospirenone and ethinylestradiol (EE) marketed as Yasmin and Yaz/Yasminelle in Europe and the US. The Application was refused after Bayer failed to overcome the pre-grant oppositions filed against the Application by generic manufacturers Cipla Ltd. and Natco Pharma Ltd. The decision was more or less influenced by the District Court and the CAFC decisions in Bayer Schering Pharma AG v. Barr Laboratories, Inc. which held US6787531 obvious and invalid. The Application is equivalent of the ’531 patent. The decision seems to be silent affirmation to KSR “obvious-to-try” test that may have far reaching impact on Indian patent practice. Complete review of the decision can be read here.