Back to Blogging

After a hectic work schedule and a gap of more than two months we are back to our regular blogging. We sincerely apologize to our readers that we abruptly stopped postings without intimidating about our temporary break. However, it is always great to be back in action. We lastly left our discussion on section 3(d) incomplete which we will surely be completing in our coming posts. We will also try to cover and analyze some of recent happenings in Indian patent scenario in particularly Tenofovir patent application rejection, update on Tarceva patent dispute and Bayer Sorafenib patent decision. So let enjoy blogging again and look forward to great discussions ahead.

Is Section 3(d) Separating Wheat from the Chaff?

Prior to the third amendment, the Indian patent law categorically barred patent protection not only to chemical and drug compounds and intermediates but also to pharmaceutical compositions, drug combinations, drug deliveries and any physical/chemical modification to chemical/drug compounds (such as polymorph, co-crystals, complexes, enantiomers and so on). However, ten-year transitional period provided by TRIPS agreement mandated India to allow patent protection to all fields of technology that included drug and chemical products. This mandate was met with strong resistance and protest from local pharmaceutical companies and public health NGOs, and one of the most heated issues was ever-greening. Acknowledging industry concerns about ever-greening and weighing flexibilities provided under TRIPS agreement, the Government of India diligently amended section 3(d) to separate wheat from the chaff. In other words, section 3(d) was amended to separate genuine inventions from frivolous inventions. In patent law, a frivolous invention is an invention which fails any of three criteria of patentability, that is, novelty, inventive step and utility. But if an invention satisfies all three criteria of patentability then it is not frivolous and is patentable until and unless categorically excluded under the law (such as section 4). Notably, the criteria of patentability are same in almost every country having patent law but the benchmark to judge those criteria may differ country to country (such as judicially evolved doctrine).

What differentiate patent law from other disciplines of law is that this is the only subject of law that specifically and particularly deals with advance science and latest technology. Obviously with the advancement of scientific research and technology, certain practices that may have well thought-out inventive almost a decade back has now become more or less a customary practice to a person skilled in the art. For example, almost 10-15 years back resolution of racemic mixture into isomers/enantiomers was novel and inventive practice considering the state of technology and scientific practice prevailing at that particular point of time but now it has become known and customary to an ordinary person skilled in the art. Similarly, concepts such as bilayer tablet or controlled release formulation using HPMC that may obviously thought inventive almost a decade (or two) back is now a common formulation practice. However, despite such practices becoming customary and obvious in state-of-the-art, patents are regularly been issued for inventions using /based on such practices. Unfortunately, the patent law is not able to keep in race with the changing technology and scientific practices and in many cases still scrutinizing inventions keeping in account decade old scientific practice. Such patents are now a major point of concern in healthcare industry, which not only hamper healthy competition but also create litigious market, and is often used as a part of business strategy positively referred as Product LifeCycle Management and negatively referred as Ever-greening.

History is witness that many countries in past, from time to time, amended their patent law to support their social and economic development and India is no exception to that. In 1970, following observations and recommendations made by Ayyenger Committee, the Government of India abolished patent protection to chemical, drug and food products which was a well-thought recommendation to support social and economic situation of India. The impact of that recommendation resulted into strong indigenous generic drug industry which not only supported widely-concern public health issue but also brought new business and employment opportunities for India. In 2005, India again carefully brought changes to its patent law not only in conformity to TRIPS agreement but also to support its socio-economic development. Inclusion of amended section 3 (d) is an example of such diligent approach to balance social and economic development and at the same time keeping patent law in pace with changing technology and scientific practices.

In our continuing post, we will particularly discuss section 3(d) in detail and will also try to rationalize the spirit and scope of section 3(d). However, we will be happy to welcome comments from our readers on this post and their opinion on section 3(d). Hope we can bring some value and clarity to section 3(d).

IPO Procedures Streamlined - Recommendations of FICCI-DIPP Working Group Accepted

This is further to my blog post on “Patent Prosecution Made Easy” which reflects the initiatives taken by DIPP in making the patent prosecution easier for the applicants upon recommendations given by FICCI’s IPR Division. We would like to inform our readers that a lot more has been achieved as a result of FICCI-DIPP Consultative Working Group on Patents, Designs and Trade Marks System in India (read here).

The IPO has issued a detailed Patent Office Procedures (POP) in an attempt to streamline the procedures of the Patent Office and the POP became effective on July 1^st, 2009. Under the POP, all the functions of the Patent Office, except the administrative functions, are divided under different sections, fixing responsibilities on each individual functionary. There will be separate sections for initial receipt and screening of the patent applications, record management and information dissemination, general patent matters, examination and grant, and patent office journal.

The POP provides for quick digitization of the patent applications, including the amendments filed, in Optical Character Recognition (OCR) format and making it available online for public access. This is a welcome step as this will ease the prior art search of the filed documents which was otherwise not possible with the scanned digitized documents. Also, there are directions in the POP that ensures data verification at various levels before the application is made available to the public, so that the public is able to access the correct information. Now, by the implementation of the POP, the applicants and the patent agents will be able to easily identify the status of their applications and can easily track the movement of the applications. The applicant will easily come to know before which examiner the file is pending, for how long it is pending, etc.

Another major highlight of the POP is that now the information regarding the ‘Working of Patent’, i.e., the extent to which the patented invention has been worked in India, will be made available to the public through the official journal every year. This will prove to be valuable information both for people who are interested in filing the application for grant of compulsory license and for the Government in case the patented invention has not been worked in India. FICCI-DIPP Consultative Working Group advocated for streamlining the Patent Office procedures in various meetings. Any of our readers having any suggestions, recommendations or concerns related to patents, TMs, copyrights and designs, please send it to Sheetal Chopra, Head IPR Division of FICCI at sheetal.chopra@ficci.com so that she make take those issues during various Working Group meetings.

Incremental Patents: IPAB Creates Confusion III

As far as section 3(d) issue was concerned, it was ruled against Novartis. The Appellate Board concluded that the bioavailability is not as same as therapeutic efficacy and hence cannot be considered to prove significant efficacy under section 3(d). What is worth noting is that during discussion over section 3(d), Novartis Counsel argued to the Appellate Board that since it was already acknowledged during the hearing that patent application for beta-crystalline variant of imatinib mesylate is novel and constitute inventive step, so section 3(d) should not be applicable. In reply, the Appellate Board reasoned that since the application for beta-crystalline imatinib mesylate falls under drugs/pharmaceuticals/pharmacology, hence section is applicable.

To sum up the whole IPAB proceedings: the patent application for beta-crystalline variant of imatinib mesylate is found novel and non-obvious (inventive step) but still not allowable under section 3(d). Does this judgment really make sense? In other words, a patentable invention which is novel, non-obvious and industrially applicable will not be allowable under section 3(d). Is this the purpose behind section 3(d) to stop patentable inventions? Or was it included to stop frivolous inventions? The Appellate Board has not only made very irrational reasoning for applying section 3(d) for patentable inventions but also diluted the spirit of patent law. However, the Appellate Board reasoning does not end here they moved a step further to reject application for beta-crystalline imatinib mesylate under section 3(b) on the grounds of public morality (considering pricing issue). The Appellate Board specifically reasoned that Glivec price is too unaffordable to the poor cancer patients in India and hence not allowable under section 3(b). However, we will running a quick post analyzing section 3(d) exclusively and will try to bring clarity and spirit behind the inclusion of section 3(d).

Incremental Patents: IPAB Creates Confusion II

Continuing from our last post where we briefly discussed about the background of rejection of patent application for beta-crystalline variant of imatinib mesylate, Novartis writ petition to challenge the Chennai Patent Office decision and finally the Appellate Board denying the patent application for beta-crystalline variant. Now we will discuss and analyze the findings of the Appellate Board. The main issues raised and discussed were – (1) priority date, (2) novelty/anticipation, (3) inventive step/non-obviousness, (4) selection patent, and (5) section 3(d).

Issue regarding the priority date was decided in the favor of Novartis citing judgment made by Calcutta High Court in Agouron Pharmaceuticals Inc. v. Controller of Patents (AID No. 2 of 2001). The Appellate Board specifically reasoned that issue of priority date for mail-box application need to be considered as per situation on the date of examination not from the date of filing of application.

Novelty/anticipation issue was also decided in favor of Novartis. The Appellate Board specifically reasoned that none of prior art references produced by the Opposing parties disclose or anticipated beta crystalline variant of imatinib mesylate. Discussing anticipation, the Appellate Board also acknowledged the doctrine of enablement and concluded that a person skilled in the art just cannot predict the polymorphism and prepare beta-crystalline imatinib mesylate from EP 0564409 (disclosing imatinib free base and salts thereof) disclosure.

Inventive-step/non-obviousness issue too was decided in favor of Novartis. The Appellate Board specifically reasoned that the Opposing parties has not submitted any evidence that any person has prepared imatinib mesylate and found it to be present only in beta-crystal form prior to the application for beta-crystalline imatinib mesylate. Apart from this, the Appellate Board combined the selection patent argument made by Novartis counsel to strengthen inventive-step of the beta-crystalline form.

Selection patent issue as we already mentioned in our last post, helped Novartis to constitute inventive step for its beta-crystalline imatinib mesylate. The Appellate Board reasoned following minimum guidelines for a patent to be a selection patent.

(1) Whether there is any statement in the specification where the nature of the invention concerns with some kind of selection.

(2) Whether the selection is from a class of substances which is already generally known.

(3) Whether the selected substance in new.

(4) Whether the selection is a result of any research by human intervention and ingenuity opposed to mere verifications.

(5) Whether the selection is unexpected or unpredictable.

(6) Whether the selected substance possesses any unexpected and advantageous property.

The Appellate Board found that patent application for beta-crystalline variant of imatinib mesylate satisfied all the minimum requirements of above guidelines (though we leave it for our readers to decide the merit of the Appellate Board reasoning to reach such satisfaction).

Incremental Patents: IPAB Creates Confusion - Part I

The Intellectual Property Appellate Board (IPAB), so called specialized and apex body for patent and trademark disputes, has finally put the last nail in the three year old, high-profile dispute concerning the patentability of Novartis’s anticancer drug Glivec, specifically beta-crystalline variant of Imatinib Mesylate which earlier got rejected by the Indian Patent Office. Well we personally believe this was one of the important cases that possibly will be deciding factor for incremental patents in India. Though the Appellate Board took a lengthy period of three years to decide the matter but the decision made by the Appellate Board is nothing more than confusion and despair for the Indian Patent Law.

The application for beta-crystalline Imatinib Mesylate (1062/MAS/1998) was filed by Novartis on July 17, 1998 claiming priority from corresponding Swiss application. Importantly, when Novartis filed the application in India, Switzerland was not recognized as a conventional country to India. Technically, a priority can only be claimed to a foreign patent application filing date if the country in which the patent application is first filed is conventional country to the later filed country (concept originated from Paris Convention). In fact, claiming priority from Switzerland was one of the grounds made during the pre-grant opposition. The beta-crystalline Imatinib Meyslate application was filed in 1998 but it was not taken for examination till 2005 (mail-box application). Post 2005, the application was separately opposed by Cancer Patients Aid Association, Natco Pharma Ltd., Cipla Ltd., Ranbaxy Ltd. and Hetero Drugs Ltd. and subsequently got rejected by the Chennai Patent Office on January 25, 2006. Following refusal from the Chennai Patent Office, Novartis filed writ petitions before the Madras High Court against the Assistant Controller decision to reject patent application for beta-crystalline imatinib mesylate. However, during the pendency of the writ petitions, the Central Government by notification made the IPAB operational and following that the Madras High Court transferred the writ petitions to the Appellate Board to decide the patentability of the beta-crystalline variant of Imatinib Mesylate.

On June 26, 2009, the Appellate Board finally denied to allow beta-crystalline imatinib mesylate application for grant of a patent. In its 192-pages decision (a copy of judgment can be found on the website of SpicyIP and we sincerely appreciate Shamnad for the same), the Appellate Board detailed the lengthy arguments and counter arguments made by the parties during the hearing focusing on issues of priority date, anticipation, inventive step, selection invention and section 3(d). Odd 133 pages discussed the arguments made by the parties, however, one of the arguments that we would like to make special mention is argument made by Novartis Counsel in support of patentability of beta-crystalline imatinib mesylate. Novartis counsel interestingly brought concept of selection invention in context of polymorph which was quite unlikely. This argument was strongly opposed by the defendants. The concept of selection invention is often discussed when a particularly compound/group of compounds is claimed from earlier known markush structure, even selection of specific salt of drug compound is considered to be selection invention. During the hearing, Novartis Counsel puzzled the Appellate Board by combining two different phenomenons to make case of selection patent, first selection of mesylate salt from large number of known salts of imatinib and second selection of beta-crystal. Interestingly, Novartis Counsel was successful in making the Appellate Board accept the argument for selection invention in context of polymorph application and also to consider that such selection constitute inventive step.

Patent Prosecution Made Easy

One of our great friend and well wisher, Sheetal Chopra has updated us that the Indian Patent Office has decided to issue electronic notifications to patent applicants. This step is a landmark achievement in the history of the Patent Office and was a long felt need to the patent stakeholders. FICCI, during the fifth Consultative Working Group Meeting on Patents, Designs and Trademarks in India held in April 2009, made strong recommendations to the Patent Office about the need for initiating electronic correspondences regarding any matter related to patent prosecution. The notification has become effective on the 1st of July, 2009. This has come as a great respite for applicants or patent agents as they would now be receiving all communications from the Patent Office, including notices and examination reports, electronically. Further, the notification also directs the applicants and patent agents to provide their email ids at the time of filing the patent application.

The new mechanism of sending electronic communication will alleviate the burden of both the Patent Office and the applicants. The significance of electronic communications in the digital era has been reiterated time and again as the easiest mode of communication, with provisions for easy access and storage. Further, the applicants need not be physically present at the mailing address. Another major problem with paper communication was the delay in receiving the communication, which can even result in abandonment of the patent application. This issue also is resolved by resorting to the electronic mode of communication. Introduction of electronic correspondence is a boon for stakeholders as it will ease the task of patent prosecution in India, especially for applicants residing in foreign countries. Mr. P H Kurian, Controller General of the Patent Office, deserves to be appreciated for this major accomplishment and for his zealous efforts to reform the patent regime in India. This is a major step taken by the Patent Office to reaffirm its commitment to raise its standards and competence at par with international standards and also to expedite the patent granting process.

Patent Circle would also like to thanks and appreciate the contribution and painstaking efforts made by Sheetal and FICCI in recommending and bringing constructive changes in the working of the Indian Patent Office. We hope their efforts and hardwork will continue to bring positive changes and transparency in the Indian patent system.

Back from vacation

Sorry we have been out of blogging for quite a sometime now as we took off from our hectic work schedule and went out for vacation at Dharamshala and McLeodGanj both located in Himachal Pradesh in beautiful hills of Dhauladar Range. It was a great trip away from ever running and hectic life of Mumbai. Anyhow it’s time to get back to work and resume blogging. Also, we sincerely thank all our readers who voted for Patent Circle in IPWatchdog voting for top patent blogs. We are pleased to inform that your votes made Patent Circle stood second in the list of favorite blog after Patently-O and fourth in the list of regularly read blog. However, in overall ranking which combines Technorati and Alexa ranking, we slipped to 24th position.

Vote for the Top Patent Law Blogs

IPWatchdog is conducting voting for the top patent law blogs and has listed around 50 blogs to select from. Incidentally Patent Circle is also included in the list. If any of our reader like to vote for Patent Circle (if you think we are deserving enough for your vote) or for his/her favorite patent law blog then visit this link and vote for your favorite blog. 

Indian Patent Office Categorized Examiners and Controllers into Technology Groups

Following earlier circular dated April 29, 2009, the Controller General of Patents P.H. Kurian in its latest circular dated May 13, 2009 has categorized Examiners and Controllers in all four patent offices into Technology Groups. The move is to uniform allotment of patent applications for examination at the Patent Offices as per field of expertise to the controllers/examiners and to further improve quality of patent examination. Each group is having a Group Leader. On the first Monday of every month, the Group Leader is likely to receive required number of files from the Record Section based on the serial order of the Request of Examination pending under the Group Subject. Files will be allotted to the group members after group discussion. Group 1 is for Chemistry and Allied Subjects covering chemistry, biochemistry, pharmaceuticals, agrochemicals and food. Group 2 is for Biotechnology, Microbiology and Allied Subjects. Group 3 is for Electrical, Electronics and Related Subjects covering electrical, electronics, computer, communication and biomedical engineering and physics. Group 4 is for Mechanical Engineering and Other Subjects covering mechanical, civil, textile engineering and other subjects not specified in other groups. As a patent pracititioner, this move is highly appreciable as this will not only able to improve quality of examination but also help patent agents to effectively prosecute patent applications and put across their technical opinions.

More Problems for Tarceva

Revolutionary anticancer drug Tarceva seems to be moving more into problems now. Last month, the Delhi High Court in highly unexpected findings that may create setback for drug research companies in India concluded that if an active ingredient (Erlotinib hydrochloride) of the drug (Tarceva) is sold in a polymorphic Form then that active ingredient in not covered/protected by the compound (drug substance) patent. To cut short, Pfizer received Indian Patent No. 196774 (the ‘774 patent) for Erlotinib hydrochloride (corresponding of US 5,747,498) and had a pending application for polymorphic Form B of Erlotinib hydrochloride (corresponding of US 6,900,221) which eventually got rejected in pre-grant opposition filed by Cipla. Both corresponding US patents are listed with Orange Book as Tarceva marketed tablet formulation contain polymorphic Form B. Roche brought infringement suit against Cipla with respect to granted patent in India (the ‘774 patent) but in counter-claim Cipla argued (rather framed argument) that Tarceva sold in India is polymorphic Form B of Erlotinib hydrochloride and not Erlotinib hydrochloride per se covered by granted the ‘774 patent. The Court unhesitantly agreed with Cipla’s arguments that Tarceva sold in India is not covered by granted ‘774 patent claiming Erlotinib hydrochloride but is a polymorphic Form B for which Roche do not hold a patent. Knowing that the Indian Courts are unfamiliar with even basic understanding of pharmaceutical patents and technical know-how of pharmaceutical science, Cipla opportunistically deceived the divisional bench by arguing that the ‘774 patent covering Erlotinib hydrochloride per se is a mere admixture of polymorph A and B of Erlotinib hydrochloride. Cipla further argued that since the ‘774 patent is admixture of polymorph A and B of Erlotinib hydrochloride and marketed Tarceva tablet is polymorphic Form B, Roche cannot sue them for the ‘774 patent. Further capitalizing on admixture of polymorph A and B story, Cipla also challenged the validity of the ‘774 patent arguing that polymorph are not patentable under section 3(d). Unfortunately, the divisional bench was so inclined by Cipla’s arguments that the Court penalized Roche to pay Cipla Rs. 5 Lakhs (approx. USD 10000) for making false case against Cipla for the drug Tarceva for which Roche did not yet hold a patent. Surprisingly, the divisional bench never even bothered to look into independent claim of the ‘774 patent which reads as –

“A novel [6,7-bis(2-methoxyethoxy)quinazolin-4-yl]-(3-ethynylphenyl) amine hydrochloride compound of the formula A.”

Clearly the independent claim is no where restricted to any polymorph form or admixture polymorph A and B of Erlotinib hydrochloride (as argued by Cipla). The independent claim is covering compound Erlotinib hydrochloride per se and technically such claim cannot be circumvented and designed around by any polymorphic Form of Erlotinib hydrochloride (even a fresher working in pharmaceutical patents reasonably knows that). Why the divisional bench do not refer to the claims of the ‘774 patent? Though after reading the case we feel even the divisional bench would have referred the claims of the ‘774 patent they would not have understood anything (we are least confident about the divisional bench familiarity with basic pharmaceutical science and claim construction). But what is really interesting is the tactic used by Cipla’s lawyers (though completely and technically fallacious) that worked in favor of Cipla. What Roche lawyers can do in a case where unexpected arguments were raised by Cipla’s lawyers (which they possibly never thought in wildest dream) and the divisional bench was not familiar with nuances of basic pharmaceutical science and patent? Just imagining what Roche counsels back in Swiss Headquarters thinking about the judgment?

At least this case gives a cautionary picture that patentees should not be surprised to hear any unexpected reasoning from the judiciary and may think twice before spending money in procuring patents in India that may worth nothing after issuance. At least such decisions will be enough to shatter confidence of small companies and inventors who spent a decent amount of money to file and procure patents in India. How such small companies and inventors will be able to enforce their patents (most of them even do not have enough money to fight litigations). Companies like Cipla will always take advantage of system shortcomings, sometimes playing trump card of public health for their business interests whereas research/innovation will continue to die the way it is dying in India for so many years, decades.

Coming back to Tarceva, lately the United States Food and Drug Administration (FDA) announced a black box warning for Tarceva (read here). In a letter dated April 2009, Genentech and OSI said that there had been reports of patients suffering gastrointestinal perforations while undergoing Tarceva therapy. This risk is greatest for patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease. According to the letter, some instances of perforation had been fatal. The letter also said that some Tarceva patients had developed bullous, blistering and exfoliative skin conditions, which in some cases were suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis. Finally, the letter warned that patients treated with Tarceva had experienced corneal perforation or ulceration. Other eye disorders including abnormal eyelash growth, keratoconjunctivitis sicca and keratitis, have also been observed with Tarceva treatment. Last year in October, we reported Tarceva post-approval study reported a death. Such studies and report are often done by Innovator to avoid any post-launch tragedy.

Wyeth-Lupin Settles Effexor ER Patent Dispute

Business Standard reports on patent infringement settlement between Wyeth and Lupin over USD 3 billion antidepressant drug Effexor ER, generically known as Venlafaxine extended release capsule. As per the term of settlement, Lupin will be licensed to launch a generic version of the drug in the US after June 01, 2011, or earlier under certain circumstances (not disclosed) but not before January 01, 2011. Lupin earlier filed a paragraph IV certification challenging the validity or non-infringement to to Orange Book listed US Patent Nos. 6,274,171, 6,403,120 and 6,419,958. This settlement will give Lupin a definite launch date as OB listed patents for Effexor ER will run expiration till late September 2017, however, what would be really interesting is the profit margin that Lupin will possibly be making from this settlement considering that Wyeth had already made multiple settlements for the same drug with other generic drug manufacturers. Lupin settlement agreement is quite similar to Wyeth’s earlier settlement agreements with Impax Labs and Anchen Pharmaceuticals for the same drug. In July 2008 and November 2008, Wyeth under the terms of settlement licensed Impax and Anchen to launch their generic versions of the drug on or after June 01, 2011, or earlier under certain circumstances, but not before January 01, 2011 in return of certain percentage of profits from the generic sale. In October 2005, Wyeth settled patent lawsuit for the same drug with Teva and as per agreement licensed Teva to launch a generic version in July 01, 2010 in return of certain percentage of profits from the generic sale. In October 2007, in a significant development Wyeth issued a “Covenant Not to Sue” Sun Pharmaceuticals for generic tablet formulation of Effexor ER. Sun too filed a paragraph IV certification for the same drug. Wyeth seems to be moving good business strategy by avoiding any further legal cost in patent disputes and at the same time receiving certain percentage of profits from the generic competition.

Chantix Patent in Post Grant Proceeding

Pfizer is involved in a post-grant opposition proceeding for its patent covering hugely popular antismoking drug Chantix. The post-grant opposition is filed by Dr. Reddy’s Laboratories against the Indian Patent No. 204091 (the ‘091 patent) covering tartrate salt of Varenicline, the active ingredient of Chantix. The ‘091 patent is issued against the Application No. 863/MUMNP/2003 and corresponding of Orange Book listed US Patent Nos. 6,890,927 and 7,265,119. Last year in February, Pfizer launched the Varenicline prescription drug in India under the brand name Champix. However, in past there had been an alarming and strong adverse reports related with the use of Varenicline causing a wide spectrum of injuries, including serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression and suicide (read here). In November 2007, the United States FDA issued a safety alert for Varenicline reporting cases of suicidal thoughts and aggressive and erratic behavior in patients taking Chantix. Report also described Chantix affecting patients’ ability to drive or operate machinery. Later in May 2008, the United States FDA issued another alert highlighting important revisions made to the prescribing information for Chantix. Earlier this year in February, CBC News reported that Health Canada received 818 complaints for Canadian patients, many of them reporting mood swings, depression or suicidal thoughts.

We really wonder and concern whether the Indian Drug Regulatory had taken the Varenicline adverse reports seriously enough (read Mint story) and into consideration before giving marketing approval in India. Particularly considering that in India, it is not unusual to buy prescription drugs without doctor’s prescription – Varenicline may seriously pose high risk to Indian patients. And what if Varenicline generic versions also steps in?

Cipla Took the Delhi High Court for a Ride

Finally after quite a hectic work schedule, we got some time to bring analysis on recent judgment by the Delhi HC in a high-profile patent litigation case between Roche and Cipla. On 24^th April, the divisional bench at the Delhi HC dismissed an appeal made by Roche against a last year single judge decision (dated 19^th March 2008) that rejected their appeal for grant of temporary injunction to restrain Cipla from manufacturing, offering for sale, selling and exporting the drug Erlotinib. Almost every leading Indian newspaper covered judgment story, some even provided sort of expert analysis on the judgment. In fact, daily English newspaper Mint quoted “judgment certainly go down as a landmark ruling.” We made this judgment publicly available and downloadable on our blog for our readers on April 27. Hope many of our readers have already gone through the judgment and may also reviewed the decision for its merit both on legal and technical grounds. However, before we proceed with our (as usual) critical analysis on this judgment we would like to know from our readers – how many of our readers think the decision is a landmark judgment? And how many consider the judgment not only lacked to take into account basic technical knowledge but also lacked basic ABC of pharmaceutical patent, reflecting sheer inability of judiciary to handle even not so complex patent issues? Will this judgment possibly go down as a low of Indian patent law? We would surely love to know our readers’ comments on this. This judgment is not a mere judgment but an eye opener to many believing in intellectual property to rethink before investing in research and innovation in India. We do not know what sort of precedent will be set by this judgment but feel that it will considerably question and distort image of Indian patent law. Let us move to our analysis on the judgment. Please note statements included in bracket in bold are our remarks.

After the single judge rejected Roche’s appeal for temporary injunction against Cipla, Roche appealed the single judge decision. However, before deciding the case, the divisional bench reviewed the proceedings and conclusion of the single judge. The divisional bench particularly noted two points in Roche’s plaint made before single judge – (1) Patent No. 196774 (the ‘774 patent) is granted for Erlotinib hydrochloride marketed as Tarceva, and (2) no details of the specification of the ‘774 patent or the x-ray diffraction of Tarceva or Cipla’s generic product (Erlocip) was indicated [wonder why XRD data is asked by the single judge/divisional bench, particularly when Roche filed for infringement of Erlotinib drug compound patent not a particular polymorph patent?]. The divisional bench also noted arguments made by Cipla before single judge against the injunction application which include the following notable points.

(1) questioned the date of grant of patent, and also argued patent could not be presumed to be valid unless it was more than six years old,

(2) argued invalidity of patent under section 3(d) and obvious to a person skilled in the art, particularly argued the alleged patented product (Erlotinib) is nothing but a derivative from Gefitinib,

(3) argued patent is not worked fully and commercially in India, further adding no sales figures for the product for India provided in the plaint.

(4) argued public interest issue that the drug should be made available at cheap and affordable prices.

(5) placed US Pat. No. 6,900,221 (the ‘221 patent) on records filed by OSI for polymorphic Form B of Erlotinib hydrochloride. [this was interestingly deceptive move by Cipla]

The divisional bench also noted counter-claim arguments made by Cipla before single judge, most importantly the argument stating that the ‘221 patent clearly stated that the compound Erlotinib hydrochloride was a mixture of two polymorphs A&B and that one needed to separate and purify that polymorphic Form B so as to get to the claimed compound (Erlotinib) for acceptable efficacy. Further adding that the ‘221 patent clearly defeated the inventive step of alleged invention (the ‘774 patent). [Does this mean that later dated patent is a prior art for earlier dated patent? Quite a new concept framed by Cipla and that too for “compound per se patent”] Cipla further argued [now this is the trick that made real impact on deceiving and confusing both single judge as well as the divisional bench] the ‘774 patent had been obtained by the plaintiffs by suppression of material information stating that the patentee knowingly suppressed the fact that the claimed product is in the form of polymorph.

Cipla further filed an application to dismiss injunction suit before the single judge [this move put the final nail in the coffin]. Cipla argued that plaintiffs filed two separate applications for grant of patent in respect of the same chemical compound for polymorphic Form B. Further arguing the ‘774 patent is mixture of polymorphs A and B which was known to plaintiffs but never stated in the application made before the Patent Controller. Cipla also provided x-ray diffraction data of Tarceva before the single judge to show Tarceva tablets are polymorphic Form B, not mixture of A and B polymorph and based on x-ray data argued that Tarceva sold by Roche in India is covered by pending patent applications and not by granted ‘774 patent. [what a statement made against compound per se patent? Does this mean if an active ingredient of a drug is sold in a polymorphic form then active ingredient is not covered by compound per se patent?] Cipla further argued that case made by plaintiff is completely false and incorrect and also suppressed the fact that it has made two further patent applications for the same compound in polymorphic Form B.

During proceedings, the divisional bench particularly referred to polymorphic Form B story raised by Cipla and was of opinion that the ‘774 patent is for erlotinib hydrochloride polymorph A&B mixture and Tarceva is polymorphic Form B for which the plaintiffs did not yet hold a patent and therefore no prima facie case was made out by the plaintiffs as they were seeking an injunction against Cipla in respect of a drug for which they did not yet hold a patent. [Now this sounds something out of the world analysis that compound per se patent is circumvented by polymorph patent] The divisional bench also was of opinion that the story framed by Cipla had been suppressed by the plaintiffs both before the Controller of Patents as well as in the suit and on this sole ground injunction ought to have been refused. [Now what to expect further when the divisional bench already got preconceived by Cipla’s arguments, better Roche to forget thinking about fair judgment]

The divisional bench further was of opinion that the plaintiff were trying to mislead both the Court as well as Controller of Patents to the effect that polymorph B was subsumed in Polymorphs A and B after the divisional bench found patentee (plaintiff) argument made before the Controller of Patents that the closest prior art i.e. US ‘498 did not teach a compound of polymorph B free of polymorph A contradictory to later statement dated 18^th August 2008 by plaintiff that the earlier compound (disclosed in the ‘498 patent) included all known and unknown polymorphs. [A statement technically and patently correct and widely known to any patent practitioner in pharmaceutical area] But the divisional court opined that if Tarceva correspond to polymorphs A and B then there was no need for the plaintiffs to have applied for a separate patent in respect of polymorph B. [Obviously the divisional bench seems not able to understand basic ABC of pharma patenting]. The divisional bench also pointed that polymorphic Form B of Erlotinib hydrochloride was not known to the plaintiffs at the time they applied for a patent for Erlotinib hydrochloride as a combination of polymorphs A and B and therefore polymorphic Form B could not be said to be subsumed in the compound of combination of polymorphs A and B.

The divisional bench further discusses more issues pertaining to polymorphic Form B, polymorphs A and B mixture which was unfortunately crude, irrational and technically absurd and bizarre to read and understand. We do not even know how to pen down into words, observations made by the divisional bench is not only laughable but also annoying to read. Interestingly the divisional bench was of opinion that an applicant for a patent of a pharmaceutical product be bound to disclose the details of all other applications made by the applicant for grant of patent of derivatives or forms of such product. Also, there are some statements made by the division bench which we have no clue such as this one – “the Controller of Patents has confused the tests of inventiveness with obviousness (page 42).” Interestingly, the divisional bench also was of opinion that the Controller finding about obviousness of Erlotinib hydrochloride during pre-grant opposition is not obviousness but was about anticipation. [Does the divisional bench really understand what anticipation means in patent law?] We would request our readers to please go through the text of judgment, line by line to feel depth of absurdity.

While considering arguments framed by Cipla and observations made by the divisional bench, the Court concluded that Cipla has been able to demonstrate prima facie case that Roche do not hold a patent yet for the drug Tarceva, which is the polymorphic Form B of the substance for which they hold a patent. [Landmark ruling that active ingredient sold in polymorphic form is not covered by drug compound patent!!!] The court also concluded that Roche failure to bring the fact about filing of patent application for polymorphic Form B to the notice of the Controller of Patents was not consistent with the requirement of a full disclosure. Finally the divisional bench fined Roche to pay Rs. 5 lakhs to Cipla. [God knows why?] Is Roche penalized because the story framed by Cipla was suppressed by them?

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.

Patent Circle To Resume Blogging

Dear Readers,

Thank you for all your support and encouragement to our blog. We sincerely and heartily appreciate your comments and requests to reconsider our decision to stop blogging. After weighing requests made by our readers and well-wishers we have decided to put back this issue and temporarily resume back to blogging. We feel absolutely sorry for the unfortunate incident which could definitely be avoided. Though we have decided to put end to this but still would like to make our position clear in whole episode.

In last few months, particularly after internal circular issued by newly appointed Controller General of Patents, Mr. P.H. Kurian instructing officials to clear pending opposition decisions by the end of March 2009, the Indian Patent Office decided and published number of opposition decisions, both pre- and post-grant. Keeping our usual practice of tracking and bringing notice of patent office decisions and granted patents (though we later stopped reporting granted patents), we kept track of most of the opposition decisions. We particularly took note of notable pharma pre-grant opposition decisions that include (1) rejection of crystalline adefovir dipivoxil application (712/DEL/2002), (2) rejection of tenofovir intermediate application (963/DEL/2002), (3) rejection of erlotinib polymorph application (IN/PCT/2002/507/DEL), rejection of oseltamivir application (396/DEL/1996), (4) rejection of alpha crystalline imatinib application, (5) rejection of amlodipine and atorvastatin combination application (2571/DEL/1998), (and also noted couple of Controller decisions under section 15) (6) rejection of budesonide and formoterol aerosol HFA combination (2145/DELNP/2004) and (7) rejection of rosiglitazone ethane sulphonate salt (295/DELNP/2003). However, we only reported four decisions, namely, (1) alpha crystalline imatinib rejection, oseltamivir rejection, amlodipine-atorvastatin combination rejection, and (4) rosiglitazone salt rejection. We believed that information regarding rejections of these applications (and in sequence) was first made public by our blog.

After a couple of days of our posts on these rejected applications, SpicyIP in its two posts mentioned about these rejected applications (interestingly in same sequence). This gave us an impression that possibly SpicyIP has referred this sequential rejections information from our blog. So in good faith, we wrote a friendly comment to SpicyIP as reproduced below.

“Shamnad,

I would surely be happy if you could acknowledge

Patent Circle

for Caduet and Oseltamivir pregrant oppositions as wellas Glaxo’s rosiglitazone salt decision. Apart from our blog these info is not available anywhere.”

In our comment, we just made friendly request. Obviously it was put to SpicyIP to consider or not. Same day we saw an Anonymous comment being made to our comment --- raising issue of Patent Circle watermark and making personal remarks against us. It was shocking to us. We were not shocked about Anonymous comment but on SpicyIP decision not to moderate the comment and made it public. Immediately we made another comment replying to Anonymous issue of watermark and also requesting SpicyIP to remove the comment made by Anonymous. Following our second comment, Shamnad replied to let us know that his knowledge/information does not come from our blog and also give supporting evidences of DWS website (they also borrowed news from our blog only) and Shamnad personal contacts in law firms who keep him updated about Glaxo’s patents.

We believed Shamnad words (may be it was a big coincidence that same decisions mentioned in similar sequence) but we felt bad that still SpicyIP not removed Anonymous comment. We made yet another comment (third one) yet again requesting SpicyIP to remove Anonymous comment but again no action by SpicyIP. In response we decided to stop blogging and took off all our past posts from

Patent Circle

. Following that we received a partially friendly and partially unfriendly personal email from Shamnad which he later made public on SpicyIP. In his email, he admitted to have extremely sour opinion about us after parallel imports post and also accused us of sending flunkeys or masqueraded myself to post some very disparaging comments about his blog. To put this loud and clear --- someone cannot accuse us of an act which he himself is involved on his blog. We have all the guts and knowledge to comment in our own name. Also, we are hardcore patent practitioners not having time for such stupid gimmickry. One can make facts sound spicy but cannot change the reality. This is not the first time that SpicyIP has unprofessionally targeted us, earlier also SpicyIP targeted us in their post on parallel importation.

All said and done, finally that Anonymous comment is now removed by SpicyIP (that also considering Anonymous comment) after further commenting that the word “selfish” used by Anonymous is very mild. If SpicyIP had issue with acknowledgement then they should have restricted to that only. Why to make personal remarks? And if accidentally such comment got published then why SpicyIP not bothered to remove it after our couple of friendly requests? As far as reporting of patent office decisions are concerned let us consider that it is coincidence that SpicyIP also reported same decisions in same sequence. We hope we have made our stand clear to our readers in whole episode. Yes we do accept that decision to stop blogging was more emotional, irrational and not professional.

However, in whole incident one thing that really concerns us is comment made by SpicyIP that “friends of mine that deal with this case keep me appraised of all the developments re: this patent and other related patents of GSK.” The GSK rosiglitazone salt application was decided on January 06, 2009 and got published soon thereafter. We reported rosiglitazone salt rejection decision on April 16 and SpicyIP reported on April 18 (two days after our post). If SpicyIP had access of rosiglitazone decision through his friends then why SpicyIP posted rosiglitazone information after three months, and that also after our post? Secondly, this is quite concerning and unfortunate to know law firm/agent representing Glaxo’s patent applications in India are indulge in leaking and disclosing confidential information (even undecided matters) to outsiders.

Thank you,---

Patent Circle

Patent Circle Will Stop Blogging

Coincidently three years back Dennis Crouch, a US patent attorney and author of leading patent law blog Patently-O suggested me to start a patent law blog to keep posting my views and articles rather than sending them to other bloggers to publish and from there came the idea of

Recently, SpicyIP in their recent post referred about recent pre-grant oppositions decided by the Indian Patent Office which is incidentally reported by our blog only. We wrote a friendly comment to Shamnad’s post about the fact that these decisions are exclusively reported by our blog and we would surely appreciate if his post can acknowledge our blog. In fact, we too have made same mistake in past when we accidentally and unknowingly used a phrase coined by SpicyIP without acknowledging them, for which we later apologized to Shamnad. In reply to our comment to Shamnad’s post, an Anonymous reader made (what we feel) a derogatory remark against me which we are reproducing below.

“VC,

For your information, these decisions are first available on the Indian patent office..... From where u take and put your water mark to claim its yours....

Don't become so selfish and mean. It's already there in the public domain and how can you claim that its only available in your blog???”

We made a counter reply to above comment which we are reproducing below.

“Anonymous,

No idea who you are but sole purpose of putting watermark is to distinguish the source if someone download the decision from our blog and obviously not to claim ownership. If you have any problem with that then who is asking you to refer and download from our blog (feel free to surf around patent office website). Indeed decisions are available on official website of patent office but why it was still not reported anywhere in media or news even after 15 days of decision made available on official website. Simple nobody knows about the decision even the companies involved in opposition proceedings. In fact, it was our blog that keep monitoring and retrieving such decisions to bring them in notice of our readers. There are more than 15 decisions listed in February and March 2009 but we decided only to cite five of them and incidentally SpicyIP referred those decisions only (except Pegasys) and sufficient to understand that author has referred those decisions from our blog only. Is it wrong to ask author to acknowledge our blog for such info? Yes if you do not feel respecting and acknowledging someone time and effort for bringing such valuable information in public then we have no point of discussion here.”

We do not know how to react to such comments but this is for first time we are showing our displeasure to such activities. In fact, we are very disturb knowing that such comment is not moderated by Shamnad and made public despite having personal remarks against us. In our counter reply we also wrote to Shamnad which we are reproducing below.

“@Shamnad,

We always have great respect for you, both personally and professionally, and your contribution to IP awareness. As you referred in past that you moderate comments made to your blog. We sincerely expect such professionalism at least from you that any comment making personal remarks specific to someone using words like “selfish” and “mean” should be avoided from being posted in public.”

This episode has finally brought us to an understanding that our time, expertise and resources are not appreciated by readers and anyone can anytime disrespect our contribution and hard work. We sincerely feel it is our duty now that we should take reasonable measures to hold our respect and dignity by stopping blogging anymore in future. Readers do have right to criticize our posts/views but they have no right to make personal remarks against us. We appreciate your support and contribution in bringing success to

Patent Circle

and hope you too enjoyed the journey as do we. Thank you.

Patent Circle

. Thanks Dennis!!! And from there on it was a great journey, never thought my views and articles would be widely read by hundreds of readers working in corporate R&D, law firms, news media and universities across the globe. Not only

Patent Circle

became regularly read patent law blog from India but also brought us a decent recognization in patent domain. We started writing posts to create patent awareness and understanding, and to keep our readers updated with latest developments across the globe, particularly India. Obviously we enjoyed doing that and sharing our knowledge without any selfish interest. Over past few months we focused more on Indian patent landscape such as parallel importation, pre-grant and post-grant oppositions, compulsory licensing, patent-drug regulatory linkage, and so on, however, some our posts brought us some criticism which is well understandable. We always encourage constructive debate and positive criticism from our readers but unfortunately some readers rather criticizing our post made personal remarks against us. Some Anonymous readers commented us for showing bias attitude in our writing which is still acceptable as everyone has his/her own way of judging our posts. But there are few readers who made personal remarks against our integrity and questioned our motive behind writing posts. If fact one of the reader (Ajay Chauhan) went ahead to write full-fledged post on his blog against me (which he later deleted) --- accusing me to be manipulative in our posts. He even earlier bluntly pointed fingers on my integrity making comment that our posts are tailored to lure foreign law firms. In other instance, one of his co-author Jeena raised finger on our credibility in writing posts by questioning our motive. Obviously such comments are not tolerable and completely unprofessional. However, we still maintain patience despite such absurd comments because comments made by any Tom, Dick and Harry cannot question the hard work and integrity of our blog.

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.