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.