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.

Cipla Files Post-Grant Opposition for Lapatinib Patent

After Erlotinib and Sorafenib, Cipla is targeting yet another anticancer drug Lapatinib marketed by Glaxo under the brand name Tykerb. Moneycontrol reports that Cipla has filed a post grant opposition against Lapatinib patent on grounds of obviousness and lack of inventiveness. Cipla CEO Amar Lulla said: “If we win the opposition, we will begin production of the product, Lapatinib, immediately and launch it within a couple of months. It will also be priced substantially lower than what GSK charges in India.” Last year we hinted that Cipla may possibly target patented drugs, mostly tyrosine kinase inhibitors.

Minor Modification & Structural Similarity Not Sufficient to Establish Obviousness - II

Continuing from our earlier preliminary post on Erlotinib pre-grant opposition, we now discuss the pre-grant opposition judgment in detail. Following Natco’s pre-grant opposition, the Assistant Controller prominently discussed the obviousness arguments in detail. Natco argued that the compound of the present invention is an obvious derivative derived from 4- Anilinoquinazoline nucleus and such compounds have been covered by earlier patents EP 0566226A1, EP0602851A1, EP0635507A1, EP0635498A1, EP0520722A1 published before the priority date of the present invention. Natco further argued that combination of simple functional groups like alkoxy, alkyl, alkynyl, halo to already known basic nucleus or compound is obvious to a person of ordinary skill in the art. Interestingly, while arguing obviousness Natco provided a chemical structure and argued that Erlotinib is easily derived from the structure when a person skilled in the art made obvious substitution of R1 with CH3CH2CH2O (2-methoxy), R2 with CH3OCH2CH2O (2-methoxyethoxy), R3 with H (hydrogen) and R4 with 3-ethynyl (not one, not two there are four conditional substitutions of functional group to render Erlotinib obvious). However, Natco nowhere argued that what may have motivated the person skilled in the art to arrive at obvious substitution of R1, R2, R3 and R4. Natco further broadly argued that prior art compounds are structurally similar to Erlotinib and hence rendering Erlotinib obvious. In counter statement, the Applicant (Pfizer) argued that Natco created their own chemical structure to establish that the claimed compound is an obvious derivation of said structure which is actually not found in any of the prior art citation. Applicant further emphasized inventiveness of substituting an “ethynl group” at methane position of phenyl group. After hearing both Natco and Pfizer (Applicant), the Controller decided that Natco probably failed to properly evaluate the strength of the invention. He further concluded that sometimes the modification in the prior art technologies which appear to be minor may bring great revolutions in the world which could never be predicted by the society of intellectuals. Also adding that a structural similarity as deduced by Natco for a compound (Erlotinib) having great medicine value may not be accepted to establish Erlotinib as obvious. During hearing Natco also brought section 3(d) argument but the Assistant Controller rightly argued that once the invention has been found inventive (non-obvious) it cannot be held non-patentable under section 3(d).

Natco also challenged the issuance of patent on the ground of insufficient disclosure arguing that the Application failed to disclose polymorphic form of Erlotinib. Natco further added that it is very pertinent and relevant to have the details of the current form for the product claimed in the current application. In reply, Applicant strongly objected Natco arguments stating that the object of the invention was to provide a potent EGFR inhibitor Erlotinib and not to provide polymorphic form of the compound of the present invention. The Assistant Controller without any further thought rejected Natco’s insufficient disclosure argument. We, in fact, wonder what can be more frivolous argument than Natco’s objection for insufficient disclosure asking XRD data in the patent application covering the active drug substance (not polymorphic form).

We finally end our post with some intriguing questions for our readers to think about. Why Cipla’s counsel argued the Court to disregard the IPO finding in favor of Roche? Why Cipla argued that the Controller merely addressed arguments on “novelty” and did not even considered obviousness arguments during the pre-grant opposition? Are such arguments misleading to the Court? Was it intentionally done to deceive the Court proceedings? Or was it done to tarnish pre-grant opposition judgment of the Controller?

Minor Modification & Structural Similarity Not Sufficient to Establish Obviousness - I

Erlotinib PreGrant Opposition

Roche lawsuit against Cipla for willful infringement of Indian Patent No. 196774 covering anticancer drug compound Erlotinib still seems to be not reached any conclusion and is likely to be not near from over with next hearing scheduled on February 24, 2009. In counter attack, Cipla raised invalidity and non-infringement defenses against the ‘774 patent. Having earlier lost to obtain temporary injunction order, Roche later appealed against the Delhi High Court order rejecting temporary injunction on the ground of public interest. An Appellate Bench comprising Chief Justice AP Shah and Justice S. Muralidhar finished hearing the arguments and reserved its judgment. Readers interested knowing more detail on this may visit Shamnad’s blog who excellently and extensively covered Erlotinib litigation proceedings.

Recently we just got hold-on Erlotinib pre-grant opposition judgment and thought of posting an analysis over it. This pre-grant opposition is of great significance to Erlotinib litigation proceedings as Cipla’s counsel repeatedly and notably referred to it (read post by SpicyIP) and even argued the Court to disregard the Indian Patent Office (IPO) finding in favor of Roche particularly on the ground that the Controller (of Patents) merely addressed argument on “novelty” and did not even considered obviousness arguments during the pre-grant opposition. However, on reviewing Erlotinib pre-grant opposition judgment we found Cipla’s argument contradicting and fallacious. Not only the Controller considered the obviousness ground but specifically and prominently discussed the same during the pre-grant opposition hearing.

The pre-grant opposition was filed by Natco Pharma Ltd. and decided by the Assistant Controller on 4^th July 2007 after hearing made on 27^th June 2007. In its pre-grant opposition, Natco challenged the issuance of patent against the claims of Erlotinib Application 537/DEL/1996 on the grounds of obviousness and insufficient disclosure. Natco particularly cited EP 0566226A1, EP 06335507A1, EP 0635498A1, and EP 0520722A1 to support its obviousness arguments. However, on the date of hearing Natco filed an interlocutory petition to place additional non-patent literatures on record and to question amendments made in claims during the examination under sections 57 and 59 of the Patents Act, 1970. The Assistant Controller considered the petition to allow additional non-patent literatures to be taken on record to examine the strength of opposition but rejected Natco’s argument against claim amendment. While rejecting argument against claim amendment, the Assistant Controller argued that the amended claims are well within the preview of the original claims and are more restrictive in scope as compared to originally filed claims, and such amendment are not prohibited under section 57 and 59.

Special Thanks!

Patent Circle would personally like to extend a special thanks to Mr. Sandeep Rathod (author of Generic Pharmaceuticals and IP blog) who time to time provided us with valuable information to help us in bringing important piece of news for our readers. He notably provided us with Valganciclovir pre-grant opposition judgment and Sorafenib High Court order. We sincerely acknowledge his contribution to Patent Circle.

Valganciclovir PreGrant Opposition: A Case of Frivolous Objection II

Continuing from our earlier post where we discussed how the NGOs frivolously objected Valganciclovir patent application under section 25 (1) (f) based on their irrational presumption that any compound not published but invented before 1995 is a pre-1995 public disclosure, we now focus on another ground of objection raised by the NGOs under section 25(1)(h). Section 25(1) (h) allows an opponent to challenge the issuance of patent if the applicant –

(1) failed to disclose to the Controller of Patents the information required under section 8, or

(2) furnished the information which in any material was false to his knowledge.

Here again, the NGOs rather than providing evidences to show that Roche failed to disclose the information under section 8 or furnished any false information, argued that Roche delayed in providing information under section 8 (which is, in fact, not a valid ground under section 25(1)(h)). Roche while replying to pre-grant opposition argued that section 25(1)(h) does not give right to the opponent to challenge whether the information required by section 8 has been disclosed within the prescribed time period, especially in the light of the fact that the Patent Applicant has already sought, and obtained, leave of the Controller for the condonation of delay under rule 137 on 23^rd May 2006, which was well before the filing of the Opponent’s Written Statement. Roche also argued that from the filing of the instant application in 1995 and up to the last date of deciding the application, the procedure for filing information and taking extension for filing the said information with a petition to the Controller were changed number of times during the period 1995 to 2007 (around 12 years).

The Chennai Patent Office agreed with Roche’s argument that the ground of opposition under section 25(1)(h) is only limited to (1) the applicant failed to disclose to the Controller the information required by section 8, and (2) has furnished the information which in any material particular was false to his knowledge. The Chennai Patent Office further added that the delay in filing the information to the Patent Office is purely procedural aspect during prosecution of the application and not at all ground for opposition under section 25(1)(h). Also adding that the Controller has the power to extent the time and condone the irregularity in the procedure, if the applicant prays for such an action with a relevant petition and fees. Hence, the opposition under section 25(1)(h) is not maintainable.

Now after reviewing the Valganciclovir pre-grant opposition, we do not find any reasonable ground on which the Assistant Controller would have earlier considered giving a hearing opportunity to the NGOs on such frivolous grounds. Obviously Assistant Controller has sufficient knowledge skills to evaluate such frivolous grounds and to decide whether there is a further need for hearing opportunity or not. If such was the arguments made in the pre-grant opposition then the Assistant Controller was reasonably correct in denying opportunity for hearing to the NGOs and creating unnecessary delay in the issuance of patent. It seems to be this pre-grant opposition was just an attempt to delay the Chennai Patent Office proceedings and/or to mislead the Patent Office with irrational arguments. However, what is quite annoying that when the NGOs failed to convince the Chennai Patent Office they approached the Chennai High Court to assure that the Chennai Patent Office waste its precious time discussing their frivolous arguments. We feel extremely sorry for the Assistant Controller who despite made correct observations got bitter pill from the Chennai High Court.

Valganciclovir PreGrant Opposition: A Case of Frivolous Objection I

It seems to be that the Chennai Patent Office was quite correct in its approach not to consider giving opportunity of hearing for Valganciclovir pre-grant opposition filed by the Tamil Nadu Networking People with HIV/AIDS and the Indian Network for People living with HIV/AIDS (collectively hereinafter referred as ‘the NGOs’) which not only lacked substance to challenge the issuance of patent but also irrationally burdening the Indian Patent Office with legally absurd and unsupported objections. No doubt it takes no special efforts to make public statement quoting Valganciclovir a pre-1995 molecule not qualifying for patent protection but when it comes to patent law one do require pre-dated publications to corroborate the statement. This is what Valganciclovir pre-grant opposition seems to reflect that the NGOs just went on stating pre-1995 objection without any proper understanding and records to prove it. In their application for pre-grant opposition, the NGOs made objections on the following grounds namely:

(1) That the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act under section 25(1)(f); and

(2) That the applicant has failed to disclose to the Controller of Patents the information required by section 8 or has furnished the information which in any material was false to his knowledge under section 25(1)(h).

The objections was raised relying on four supporting evidences submitted by the NGOs which include a copy of press release from Hoffman-La-Roche dated 2^nd April 2001, a copy of European Patent No. EP 0694547A2, a copy of online European Patent Register, and a copy of US Patent No. 6083953. What is notably important to note that none of the supporting evidences was published before the priority date (and even the filing date) of Valganciclovir Application 959/MAS/1995 which is sufficiently enough for someone of Assistant Controller rank in the Indian Patent Office to acknowledge the fact that none of the evidences even adequate to uphold the pre-1995 objection. Now before going further into objections raised by the NGOs let us discuss what exactly pre-1995 argument mean? After India amended its patent law to allow patent applications for drug compounds under mail-box provision, it was well considered that drug compounds known prior to 1995 are not eligible for patent protection. In other words, it is consider that any drug compound known or published prior to 1995 (in short pre-1995 public disclosure) is not to be granted patent in India (the argument reasonably acceptable in patent law that any invention publicly known or published in literature cannot be patented). Based on such theory, the NGOs objected Valganciclovir patent application, however, while submitting the pre-grant opposition the NGOs went a step ahead on pre-1995 argument to conclude that any compound even though not published or reported prior to 1995 but was invented before 1995 is a pre-1995 public disclosure and not eligible for patent protection in India. Quoting section 25(1)(f), the NGOs argued that the Valganciclovir patent application ought to be rejected as it claims priority from a pre-1995 convention country application (precisely referring to Valganciclovir priority document i.e. US Serial No. 08/281,893 dated July 28, 1994). Again it is a well-known fact that a patent application is not considered to be in public domain till it is published which is usually made on completion of 18 months from the date of filing of application. Now considering that Valganciclovir priority document was filed on July 28, 1994 then the possible earliest date for its publication would have been January 27, 1996 (reasonably beyond 1995). Further to prove their pre-1995 argument, the NGOs submitted documents which are published on much later date of filing of Valganciclovir Indian Application. Obviously after reviewing the NGOs pre-1995 argument (i.e. an invention not published but invented before 1995 is a pre-1995 public disclosure) and inappropriate documents submitted to corroborate the objection, the Assistant Controller would have been in no better position to dismiss the pre-grant opposition. But what is even more interesting that the NGOs were so damn confident about their arguments that they in fact approached the Chennai High Court to order the Chennai Patent Office to consider their frivolous objections.

Patent Office Rejects Valganciclovir PreGrant Opposition

The Chennai Patent Office has dismissed the pre-grant opposition [download] made by the Tamil Nadu Networking People with HIV/AIDS and the Indian Network for People living with HIV/AIDS (collectively hereinafter referred as the ‘the NGOs’) against the Application No. 959/MAS/1995 claiming antiviral drug compound Valganciclovir. The Chennai Patent Office was hearing the Valganciclovir pre-grant opposition after been directed by the Chennai High Court [download] to consider and hear the pre-grant opposition made by the NGOs who earlier filed a petition against the Chennai Patent Office decision for denying opportunity for hearing under the Section 25 (1) of the Patents Act, 1970 before the issuance of Patent No. 207232 for Valganciclovir. However, Roche later challenged the Chennai High Court order in the Supreme Court of India. The Supreme Court modified the order to add that “while deciding the above application (959/MAS/1995), the Assistant Controller shall take into account the pre-grant opposition filed in this case (which is on record) by respondent nos. 1 and 2 (NGOs) herein.” Also adding “The third respondent (Assistant Controller of Patent & Designs) need not consider any other pre-grant objection pursuant to this judgment.”

New Book Release: Patent Agent Examination

One of my close friend and indeed a dedicated and knowledgeable patent professional, Sheetal Chopra has recently wrote an interesting reference book on patents particularly for readers preparing and appearing for patent agent qualifying examination. This is a commendable effort by her to provide students as well as professionals who are aspiring to become patent agent with relevant study material useful for preparing and qualifying patent agent examination. Sheetal is a qualified organic chemist and registered patent agent with rich experience in handling complex patent issues while working with India’s largest global generic company Ranbaxy before joining FICCI. At FICCI, she has been very instrumental in raising industry’s concerns regarding intellectual property laws and policies, and also bridging much-needed gap between industry and policy-makers. Notably, she is been actively involved in conducting and promoting various IP awareness seminars and workshops across the country.

Her book surely will be of great resource for readers which not only explain the substantive and procedural patent laws in detail but also provide model answers to previous years’ question papers and useful tips on the viva voce. I am grateful to Sheetal for considering and giving me an opportunity to review her book before going into publication. And it is must recommended for those who are keen to understand Indian patent laws and looking to appear for patent agent qualifying examination. The book is published by LexisNexis the details of which can be found here.

US Patent Litigation Updates

Widely read biotech and pharma patent law blog, PatentDocs reported some of the latest patent infringement disputes involving Indian drug manufactures.

Oscient Pharmaceuticals Corp. et al. v. Lupin Ltd. et al

Oscient Pharmaceuticals Corporation, holder of the NDA license for anti-cholesterol drug Antara (generically Fenofibrate) jointly with Guardian II Acquisition Corporation and Ethypharm has filed a civil action for patent infringement against Pune-based Lupin Ltd. for infringement of Orange-Book listed US Patent No. 7,101,574 (“Pharmaceutical composition containing fenofibrate and the preparation method”). The ‘574 patent is issued to Ethypharm and exclusively licensed to Guardian II.

Wyeth v. Torrent Pharmaceuticals Ltd. et al

Ahmedabad-based Torrent Pharmaceuticals Ltd. is accused of patent infringement by Wyeth for infringement of Orange Book listed US Patent Nos. 6,274,171 (“Extended release formulation of venlafaxine hydrochloride”), 6,403,120 (“Extended release formulation of venlafaxine hydrochloride”), and 6,419,958 (“Extended release formulation of venlafaxine hydrochloride”) for anti-depressant drug Effexor XR (generically Venlafaxine extended release).

Dr. Reddy’s Laboratories Ltd. et al. v. Eli Lilly & Co

Dr. Reddy’s Laboratories Ltd. has filed a motion for declaratory judgment of non-infringment, invalidity, and unenforceability of US Patent Nos. 5,910,319 (“Fluoxetine enteric pellets and methods for their preparation and use”), 5,985,322 (“Method for the treatment of CNS disorders”), and RE39,030 (“Fluoxetine enteric pellets and methods for their preparation and use”) with respect to Dr. Reddy’s ANDA for generic Prozac Weekly (generically Fluoxetine delayed release pellets).

From the Desk of Patent Circle: Is Dasatinib Order Contravenes Bolar-Provision?

Continuing from our earlier post, we will now focus on another issue whether the Delhi HC Dasatinib order contravenes bolar-provision? However, before going further into details of this let us briefly discuss what is bolar-provision?

Bolar-provision, also referred as Regulatory-use exemption is a statutorily created exemption from the patent infringement under Sec. 107A (1) of the Patents Act, 1970 which states –

(a) any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product;

In simple words, the exclusive right conferred under Sec. 48 does not extend to prevent third party from any act specifically and reasonably necessary in the development and submission of information required under regulatory laws in India or any other country. The bolar-provision is of high importance to generic manufacturers to conduct certain trials on patented drug needed to generate data to demonstrate bioequivalence prior to the expiry of the patent. The purpose of bolar-provision is to ensure that the generic drugs are on the market immediately after the patent expiry – we again emphasize immediately after the patent expiry, not during the lifetime of the patent. In other words, the bolar-provision allows generic manufacturer to use and make patented drug for conducting necessary trials to generate data to demonstrate bioequivalence and to prove the drug is similar to the reference product (as needed by the Drug Regulatory agencies) without the consent of the patentee. However, exemption under Sec. 107A (1) does not extend to use of patented drug to obtain the license to manufacture and distribute the generic drug before the patent expiry.

We would like to add a word of caution that the bolar-provision exempts use of patented product (drug) to generate necessary regulatory data, not use of patented product to obtain license to manufacture and distribute the drug before the patent expiry and not even to induce willful patent infringement. Usually applicability of the bolar-provision comes in use just couple of years before the patent expiry not at least 10-12 years before the expiration.

Now coming back to our main issue – whether the Delhi HC Dasatinib order contravenes Bolar-provision? Considering (1) the scope of Sec. 107A (1) allows “the use” of patented product to generate bioequivalence data and (2) Hetero while seeking generic drug approval would have generated and submitted the same to the DCGI, it seems there is no contravention of “bolar-provision” by the Delhi HC Dasatinib order. In fact, if the DCGI gives Hetero the approval for marketing and Hetero possibly launches the drug before patent expiry then in such case none of Hetero’s action will be exempted under Sec. 107A (1) and will definitely lead to a case of blatant willful infringement. It is quite unfortunate that exemption under Sec. 107A (1) is distortedly portrayed as statutory go-ahead for willful infringement.

On the lighter note, if Hetero has already conducted bioequivalence studies without having a bona fide intention to launch the generic drug after the patent expiry then Hetero cannot seek immunity under Sec. 107A (1) and has already made a case of patent infringement, possibly willful …

From the Desk of Patent Circle: Delhi HC Dasatinib Order

A patent has no value if it cannot be monitored and enforced under the law and Indian patent is no exception to it. Though the Indian Patent Office (IPO) has started granting patents for drug compounds but industry runs serious concerns about their enforceability. Enforcement is not possible without proper and regulated monitoring which is already a major problem in fragmented Indian drug industry and the gravity of which can be gauged by the fact that about 20 percent drugs marketed in India are spurious drugs despite having both Central and State drug regulatory agencies. Both domestic and foreign companies are constantly struggling to tackle and raid counterfeit and spurious drugs in India. Even the government has shown serious concern over spurious drugs and has brought the Drugs and Cosmetic (Amendment) Bill, 2008 which is already been passed by both the Houses of Parliament and lately got approval of the President. However, the issue of spurious drug is not our main concern of discussion here it is just to give an idea about what extreme damage lack of proper monitoring policies can bring to Indian drug industry and consumer. Our focus of discussion is a recent order of the Delhi High Court (HC) restraining generic Dasatinib. Albeit we are bit late in reporting on this but still personally believe that the Delhi HC order got invariably distorted in the news media. So we thought running a post on the Delhi HC Dasatinib Order.

Dasatinib is an anti-cancer drug belonging to the class of tyrosine kinase inhibitors first approved in the United States on June 28, 2006 and marketed by Bristol-Myer Squibb (BMS) under the brand name Sprycel. BMS has a granted Indian patent (IN203937) for drug compound dasatinib conferring BMS the exclusive right under Sec. 48 of the Patents Act, 1970 to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing dasatinib in India. Regardless of patent protection, Hyderabad-based generic manufacturer Hetero Drugs submitted an application with the Drug Controller General of India (DCGI) for a grant of license to manufacture and distribute generic dasatinib tablets in India. Although BMS said to inform Hetero about the dasatinib patent but Hetero kept unanswered to BMS and continued to pursue its application before the DCGI. Clearly, the DCGI approval of license for generic dasatinib would have been a blatant violation of BMS right under Sec. 48 of the Patents Act, 1970. What is important to note that patent is a statutory right created by the legislature and it is duty of the executive (government) to enforce the right of the patentee. Also, it would be a complete mockery of jurisprudential aspect of ‘right’ if one government body (Indian Patent Office) confers BMS the exclusive right to prevent third parties from the act of making, using or selling dasatinib in India and the other government body (DCGI) dilutes, in fact, ignores the same right by issuing license to third party for making and selling dasatinib in India.

In law, there is a well-established legal maxim that says “ubi jus ibi remedium”: where there is a right, there is a remedy. Now in absence of any legal provision which would have prevented Hetero from pursuing application before the DCGI or would have authorized the DCGI to stop regulatory approval for generic version of patented drug, BMS had valid grounds and reason for approaching the judiciary for remedy against its right under Sec. 48 of the Patents Act, 1970. To make an appropriate case, BMS sought a legal recourse under Sec. 151 of the Code of Civil Procedure (CPC) from the Court to pass an ex parte ad interim order to restrain Hetero from manufacturing, selling, distributing, advertising, exporting or offering for sale generic dasatinib, and also an ex parte relief to restrain Hetero from pursuing their application before the DCGI. Sec. 151 of CPC triggers inherent powers of Court particularly in cases where there is no specific provision provided under the law. The Court is open to pass an appropriate consequential order under Sec. 151 of CPC as may as necessary for ends of justice.

After hearing BMS counsel and considering a prima facie case for grant of ex parte ad interim order, the Court restrained Hetero from manufacturing, selling, distributing, advertising, exporting or offering for sale generic Dasatinib. While referring BMS ex parte relief of restraining Hetero from pursuing their application before the DCGI, the Court added that it is expected that the DCGI while performing statutory functions will not allow any party to infringe any laws and if the drug for which approval has been sought by defendants (Hetero) is in breach of the patents of plaintiffs (BMS), the approval ought not to be granted to the defendants (Hetero). The Court further instructed BMS to make a representation to the DCGI within one week making out a case that Hetero generic drug for which approval has been sought being in breach of the patent granted to BMS.

Important to note that the learned Judge knowing that there is no legal provision to restrain the DCGI from approving the application for generic Dasatinib, has diligently and aptly used the word ‘ought’ while referring BMS ex parte relief of restraining Hetero from pursuing application before the DCGI. In fact, the Delhi HC order finds reasonable support in Sec. 2 of the Drugs & Cosmetic Act, 1940 (DCA) which states that the provisions under DCA shall be in addition to and not in derogation of any other law for the time being in force. Further it is important to note that this is just a temporary order which is passed to stop Hetero generic dasatinib during the pendency of the trial and also the order is restrictively limited to Hetero case. Till here, both the Delhi HC and BMS acted within the periphery of the law. The order nowhere creates any ‘patent-drug regulatory’ linkage or authorizes the DCGI to monitor drug patents and framing such an opinion at this moment when the Delhi HC has not even started hearing on the issue (just made a temporary order) and judgment still awaited is completely irrational. The issue is been unnecessarily sensationalized by the newspaper media, further creating more confusion and chaos among the domestic pharma companies and patent practitioners, however, the whole dasatinib episode has surely left us with few questions that now need utmost attention.

(1) Whether approval of generic version of a patented drug violates the exclusive right of the patentee under Sec. 48 of the Patents Act, 1970?

(2) Is there a need to formulate substantive and procedural laws under Drugs & Cosmetic Act, 1940 regarding approval of generic version of a patented drug?

(3) How enforcement of drug patents feasible in India?

(4) Is ‘patent-drug regulatory’ linkage a necessity?

(5) Importantly is India really serious about drug patents or possibly we are moving toward creating more chaos?

The Delhi HC order has surely opened a wide platform for policy discussions, particularly related to ‘patent-drug regulatory’ linkage and enforcement of patent right.

Indian Patent Examiners Inching at Par with Global Counterparts

Beginning 2009 I completed four years in patent practice after completing post-graduation specialization in patent laws from National Law University Jodhpur. It was an exciting journey so far, full of challenges, great learning and some personal achievements. I still clearly remember my first experience visiting Mumbai Patent Office, feeling both nervous and excited. Being a patent practitioner and knowing the gravity and depth of this complex profession I always had a great respect and regard for Patent Examiners. Believe me role of a Patent Examiner is no joke and require unparallel level of commitment and scientific temperament. Unfortunately, my initial visits to the Patent Office were not very impressive as I can easily sense poor resources and dearth of continuous training provided to Patent Examiners. Though my initial discussions with Patent Examiners disclosed their unfamiliarity with some of technical jargons used and needed to understand the invention but what was encouragingly positive that with every visit Examiners showed considerable improvement in their understanding of technical know-how and great zeal to learn. Today when I compared my initial days with recent times, I feel that Indian Patent Examiners are inching at par with US and European counterparts. It is commendable how Indian Patent Examiners have improved in past couple of years and that also with limited resources and support from the Central Government.

In past there had been constant allegations about the functioning of Indian Patent Office but in my personal opinion that is prominently due to bureaucratic policies not primarily because of Patent Examiners. Government has not only failed to keep Patent Office out its bureaucratic incompetence but also failed to provide clear guidelines about some of the complex provisions of patent law, particularly section 3(d). In fact, some of the Patent Examiners are of the opinion that the Government should clarify what qualify as “enhanced efficacy” under section 3(d) so that it can help them in uniform and consistent examination process of patent applications falling under section 3(d). Interestingly, even many of the global pharmaceutical companies are of same opinion of defining “enhanced efficacy” for clear picture of patentability but unfortunately there seems to be a strong lobby of domestic generic companies preferring to keep section 3 (d) surrounded by chaos for their own business interest. In absence of such guidelines, patent applicants and opponents all have their own way of looking into “enhanced efficacy” which eventually put Patent Examiners in dilemma that what exactly constitute “enhanced efficacy”. I personally feel very sorry about the Indian Patent Examiners who are accused of overlooking section 3 (d) which is in fact government lack of willingness to clear ‘avoidable’ confusion.

Sumatriptan Generic Space | Ranbaxy's Delay is Dr. Reddy's Gain

In an interesting piece of news reported by Khomba Singh of Economic Times, India’s largest drug manufacturer Ranbaxy has strangely missed their expected December 2008 deadline to launch generic version of Glaxo’s blockbuster anti-migraine drug Imitrex, generically known as Sumatriptan Succinate in the United States. He further reported that delay is likely due to Ranbaxy not yet received the final regulatory approval from the US Food and Drug Administration. Analysts keeping close eyes on the development projected Ranbaxy to suffer a potential loss of up to Rs. 300 crore due to regulatory delay. This seems to be a rare case where a generic manufacturer with 180 days market exclusivity delayed in launching first-time generic due to regulatory process. Last year in January, Ranbaxy settled Imitrex patent litigation with GlaxoSmithKline and announced expected launch of generic Imitrex (25mg, 50mg and 100mg strengths) in December 2008 with 180 days market exclusivity.

Ranbaxy strong business rival Dr. Reddy’s Laboratories was also in race for generic Imitrex space and was sued by GlaxoSmithKline following paragraph IV certification for Imitrex and like Ranbaxy settled patent litigation with Glaxo but in more strategic agreement and importantly before Glaxo-Ranbaxy settlement. Under the terms of agreement, Glaxo allowed Dr. Reddy’s to launch an authorized generic in the last quarter of 2008 before the expiration of the pediatric exclusivity on US5037845. In November 2008, Dr. Reddy’s as per agreement launched the authorized generic of Imitrex tablets 25mg, 50mg and 100mg in the US. Now considering Ranbaxy’s delay in launching generic Imitrex there is no doubt that it is a welcome new year for Dr. Reddy’s (and Glaxo too).