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).