The Bumpy Road To Selection Patents In India 19/11/2018 by Intellectual Property Watch 1 Comment Share this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) The views expressed in this article are solely those of the authors and are not associated with Intellectual Property Watch. IP-Watch expressly disclaims and refuses any responsibility or liability for the content, style or form of any posts made to this forum, which remain solely the responsibility of their authors. Namrata Chadha, of K&S Partners, a Tier 1 Indian law firm, discusses various crucial aspects relating to patenting of selection inventions in India, especially in pharmaceuticals and chemicals. Summary: The patenting of selection inventions is not plain sailing in India. The patentability of such inventions must be determined in accordance with the general provisions of the Indian Patents Act, as there is no separate provision for the same in the Act. Of the said general provisions, the assessment of inventive step and testing under section 3(d) of the Indian Patents Act can be perceived as the most critical to patentability of selected novel species. Additionally, the concepts of ‘implicit disclosure’ and the contrasting views on ‘coverage vs disclosure’ frequently makes it challenging for applicants to defend their novel selection under the Indian scenario. Given the lack of enough precedents in India on this aspect, to date the fate of selection patents depends mostly on the judgement of the patent controllers. Not all hope is lost, however, since not only the Indian Patent Office, but also the IPAB and higher Courts have time-and-again acknowledged the existence of selection patents in India. The Concept – Choosing the Most Suitable The category of ‘Selection patents’ pertains to inventions which are individually novel but selected from a group of a previously known class, and show some surprising or unexpected benefits over the prior art. Although selection patents are mostly seen for chemical species/ compound, selection may also be made from a numerical range such as temperature/pressure conditions in production methods. Different countries adopt different guidelines for patentability of selection inventions, although the basic criteria of patentability i.e., novelty, inventive step and industrial applicability remain the same worldwide. Further, the countries that allow patentability of selection inventions uniformly require the applicants to demonstrate that the selection is not arbitrary and the claimed selection results in an unexpected advantageous effect. Unlike countries such as in Europe, India does not have clear guidelines or directives for patenting selection inventions. This article assesses the historical, statutory and current position of selection patents in India and some of the decided cases on this aspect. Is Selection Patent a Statutory Miss? Maybe Not! The Indian Patents Act does not have any specific provision for selection inventions. While some may argue that there is no clear-cut and unambiguous direction on patentability of selection inventions in India, the fact remains that the basic criteria of patentability are irrespective of the type of invention. Selection inventions, like any other invention, are required to pass the test of novelty, inventive step and industrial applicability as provided by section 2(1)(j) of the Indian Patents Act. Additionally, they must not fall within the preclusion of sections 3 and 4 of the Act. The distinguished author P. Narayanan in his book on Patent Law (4th edition), notes the following: “The term ‘selection patents’ is not used in the Act but well recognized judicially as indicating a category of patents capable of being granted by application of the general principles of patent law.” Given the lack of a specific provision on selection inventions, guidance can only be sought from a handful of orders/judgments from Intellectual Property Appellate Board (IPAB) and Courts as well as some decisions issued by the Indian Patent Office in the past. Early Jurisprudence The earliest of the jurisprudence on the aspect of selection inventions dates to 1969 in a Unichem Laboratories’ case, where the Bombay High Court held the following: “Even where an invention consists of the production of further members of a known series whose useful attributes have already been described or predicted, it may possess sufficient subject matter to support a valid patent provided the somewhat stringent conditions prescribed by Maugham. J., as he then was, in I.G. Farbenindustrie A.G.’s Patents (1930) 47 RPC 289 as essential to the validity of a selection patent are satisfied, i.e. the patent must be based on some substantial advance to be gained from the use of the selected members of the known series or family of substances, the whole (or substantially the whole) of the selected members must possess this advantage, and this advantage must be peculiar (or substantially peculiar) to the selected group.” Thus, the Bombay High Court did identify the concept of ‘selection patent’ but required that the selected members must possess an advantage peculiar to the selection. The next major ruling in the respect of selection inventions came from the IPAB in 2009 in the famous Novartis Imatinib Case. The IPAB in its ruling observed that although there is no specific provision of ‘selection patent’ in India, if the basic criteria of novelty, inventive step, industrial applicability, and patentability under sections 3 and 4 are met, the inventive step can be demonstrated by way of an inventive selection. The IPAB further remarked that “In the context of a selection patent the inventive step will generally lie in making the discovery that what has been selected provides a genuine advantage over the generality from which it was selected. The advantage being one that could not be predicted.” The IPAB also laid guidelines for patentability of selection inventions in this case, which are the only guidelines on this concept to date. The minimum requirements as specified by these guidelines are as follows: Whether there is any statement in the specification where the nature of the invention concerns with some kind of selection. Whether the selection is from a class of substances which is already generally known. Whether the selected substance is new. Whether the selection is a result of any research by human intervention and ingenuity opposed to mere verifications. Whether the selection is unexpected or unpredictable. Whether the selected substance possesses any unexpected and advantageous property. Thus, as per IPAB, an inventive selection of a new, unexpected, and advantageous single member from a known series of a genus can be accepted but the ‘seed’ of selection invention should be in the original specification itself. Selection Inventions, Section 3(d) and Evergreening Section 3(d) of the Indian Patents Act and the concept of evergreening is one of the major barriers in the patenting of selection inventions in India. Evergreening is a predominant aspect of pharmaceutical patenting, whereby patent owners frequently try to extend the term of patent by filing artful patents on an already protected invention. Section 3(d) prevents evergreening by barring the patentability of new forms of known substances unless they show enhanced efficacy in comparison to the known substance. The ‘new forms’ could be salts, esters, ethers, polymorphs etc. as detailed in the ‘Explanation’ to section 3(d). The argument of evergreening becomes more predominant when the selection patent application is filed by the same applicant as the prior broader patent. Nevertheless, it is arguable that selection patents are valid even in the face of the argument of ‘evergreening of patents’. The Supreme Court of Canada’s observation in the case of Apotex Inc Vs Sanofi Synthelabo Canada Inc. 2008 is of high relevance in this context. The Court observed that “The inventor selects only a bit of the subject matter of the original genus patent because that bit does something better than and different from what was claimed in the genus patent…”. In this landmark decision, the Supreme Court gave considerable strength to selection patents by holding selection patents like any other type of patent in nature. That said, the jurisprudence in India is a bit ambivalent in this regard. The Supreme Court of India, the highest court of law in India, gave a landmark judgment on the interpretation of section 3(d) in the Novartis’ Imatinib case in 2013. In relation to the issue of selection inventions, one of the arguments taken by Appellant was that there is a difference between that ‘which is covered’ and that ‘which is disclosed’. However, the Supreme Court held that ‘coverage’ should be considered as equivalent to ‘disclosure’. The Supreme Court in its judgment stated: “We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.” Thus, the Supreme Court of India was not much inclined to accept the differences between ‘coverage’ and ‘disclosure’. The court observed that what is ‘covered’ by any specification should be considered as ‘disclosed’ therein. This frequently becomes complicated and troublesome for applicants when dealing with selected species in India as the applicants frequently wish to patent the non-enabled advantageous selection. Furthermore, section 3(d) sets a higher standard of inventive step in India whereby apart from establishing novelty and inventive step, it is also necessary to show that the claimed modifications show enhanced efficacy when compared to the known substance. In case of drugs, efficacy should be shown by way of ‘therapeutic efficacy’. Thus, the invention needs to meet the requirements of section 2(1)(j) as well as section 3(d). The Delhi High Court further reconfirmed this aspect in 2015 in the case of F Hoffman-La Roche v. Cipla Ltd., where the Court held that section 3 is not an exception to section 2(1)(j). Thus, while dealing with the selection patents in India, along with the inventive step there are two more hurdles that must be overcome, especially with respect to therapeutic moieties – The novelty of the selected species must be reasoned on the ‘disclosure vs coverage’ Once the selected species is held to be novel (in absence of any ‘enabling disclosure’), patentability under section 3(d) must be established, as the selected species can still be considered as a new form of the structurally closest enabled species of the prior art. While the inventive step of a selected species may be established by demonstrating physico-chemical improvements, for section 3(d) it is essential to show enhanced efficacy (therapeutic efficacy for chemicals/drugs/medicines) of this selection over the prior art. The Standpoint of Indian Patent Office Having seen the stand of higher courts and IPAB for selection inventions, it is also important to look at the perspective of Indian Patent Office in this regard. It is imperative to note here that despite the absence of any specific provision in the Act, the patent office has never denied the existence and patentability of selection inventions in entirety. The Manual of Patent Office Practice and Procedure, (Version 01.11, as modified on March 22, 2011), issued by Indian Patent Office, while discussing novelty mentions that “a generic disclosure in the prior art may not necessarily take away the novelty of a specific disclosure. For instance, a metal spring may not take away the novelty of a copper spring.” However, it also mentions that “A specific disclosure in the prior art takes away the novelty of a generic disclosure. For instance, a copper spring takes away the novelty of a metal spring.” Further, the guidelines on patentability of pharmaceutical inventions in India were issued by the Indian Patent Office in 2014. While these guidelines do not discuss the concept of selection inventions exhaustively, but they do recognize that the pharmaceutical inventions contain claims related to selection inventions (relating to product and process). Further, while detailing the ways of assessing novelty, these guidelines reconfirm that a generic disclosure does not take away novelty of a specific disclosure. In addition, the guidelines provide an example whereby the claimed markush compound of the invention falls within the claimed markush of the prior art. For this specific example, the guidelines by the Patent Office state: “It is to be checked from the prior art, whether compounds disclosed specifically in the prior art are of such structure so that they can unambiguously take away the novelty of the compound(s) in question. If the compounds of prior art disclosed specifically do not take away the novelty of the compounds in question, then the generic disclosure in the prior art may still be cited for the purpose of inventive step.” At the same time, the guidelines also provide a second example whereby a fumaric acid salt of a compound is an implicit disclosure when the prior art enables only methane sulfonic acid salt but discloses fumaric acid amongst a laundry list of salt forming acids. In relation to implicit disclosure, the guidelines further state that the lack of novelty must normally be taken from the explicit teaching of the prior art. However, if the disclosure in the prior art is so implicit that it leaves no doubt in the mind of the examiner, an objection regarding novelty should be raised. It further states the following: “The lack of novelty must normally be clearly apparent from the explicit teaching of the prior art. However, since the prior art is read through the eyes of the person skilled in the art, the implicit features of a document may also be taken into account for determining novelty. Thus, if the person skilled in the art would read a disclosure as including a particular feature without it being specifically mentioned, it would be considered an implicit feature of that disclosure and lack of novelty may be implicit in the sense that, in carrying out the teaching of the prior document, the skilled person would inevitably arrive at a result falling within the terms of the claim.” Thus, although the Guidelines have acknowledged that a generic disclosure may not specifically take the novelty of the specific disclosure, at the same time, it also states that the lack of novelty should not be implicit in the prior art. The table below shows some approaches adopted by Indian controllers in deciding on patent applications involving selection from a prior art genus. S.No. Indian Application Number Status Summary of IPO decision 1. 194/DELNP/2009 Granted Though the concept of selection invention was not discussed in strict sense, the specific compounds falling within the generic disclosure of prior art were allowed once the unexpected effect was demonstrated. 2. 2784/CHENP/2007 Refused Although the existence of selection invention was acknowledged by the controller, application was rejected on the basis that no unexpected property of the compound was demonstrated. 3. 1879/KOLNP/2009 Granted Application was allowed after improved/ unexpected activity of claimed specific compounds over the generic prior art compounds demonstrated. 4. 2196/DELNP/2003 Granted The allowability of selection patents in India was acknowledged by the controller. The controller specifically noted “The arguments regarding the selection patent is acceptable and the present invention very well comes under category of the selection patent and fulfills all the norms as per the well established practice in India for grant of a selection patent.” 5. 841/DEL/1996 Refused Although novelty was acknowledged, the application was rejected on lack of inventive step and section 3(d). The controller specifically cited the absence of conclusive evidence regarding the technical advancement and implicit and motivating disclosure of the claimed compounds within the prior art as the reasons for his conclusion. Clearly, a selected species was considered as eligible for protection if shown to have surprising/unexpected property. At the same time, however, importance was also given to implicit disclosure, such that even if the specific compounds disclosed do not take away the novelty of the compounds in question, generic disclosure in the prior art was still cited as ‘motivating disclosure’ for the assessment of inventive step. Given the contradictory views of the Indian Patent Office, these principles can only be judged on case to case basis. The Quest for the Silver Lining It follows from the above that in general, for protecting a selection invention in India, the selection should not only be novel but also result in an unexpected and advantageous effect. The selection should be a result of inventive ingenuity and not mere verification or optimization. Further, the selected species must pass the combined test of inventive step and section 3(d). That said, there are polarized views about the differences between ‘disclosure vs coverage’. One view being that there is a difference between ‘disclosure’ and ‘claimed subject matter’. A subject matter which is merely embraced by patent claims, but not specifically disclosed in the prior art can still be validly claimed as a selection invention. The other view contends that the doctrine of ‘enabling disclosure’ cannot be read into the Indian Patents Act. Although the Supreme Court of India has not ruled in favor of the contention that only the ‘enabled’ subject matter should be considered as covered, it does not follow that the selection inventions are denied in its entirety. The judgment by the Supreme Court of India in the Novartis case was more focused on the interpretation of section 3(d) and not on ‘selection inventions’ per se. Further, the Judge clearly stated that section 3(d) does not bar protection for all incremental inventions in chemical and pharmaceutical substance. The Court specifically observed the following: “We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of section 3(d) of the Act but that is not to say that section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment.” The Guidelines on pharmaceutical inventions issued by the Indian Patent Office after the Supreme Court of India’s judgement in Novartis’ Imatinib case also do provide some indication that selection inventions are not viewed strictly as black or white in India. Apart from the above-stated limited guidance, applicants can also rely on numerous judgments and literature available for selection inventions under the European laws, which have clear guidance on criteria for assessing such inventions. Although the foreign judgements are not binding on Indian judiciary, they are definitely persuasive and help in shaping up a stronger case. Having said the above, the concept of selection inventions is yet to be tested and interpreted by higher courts and till then, the patentability of selection inventions in India remains debatable. Thus, amid the cloudy scenario, there is hope that although there are no statutory provisions in the Indian Patents Act dealing specifically with selection patent, India does not put a strict bar to the protection of such inventions. A partner with K&S Partners, an IP boutique firm in India, Namrata Chadha represents clients primarily in chemistry and pharmaceutical patent matters in both contentious and non-contentious proceedings. Link to full bio is here. Author’s disclaimer: This disclaimer informs readers that the views, thoughts, and opinions expressed in the text belong solely to the author, and not necessarily reflect the position or policy of the author’s employer, organization, committee or other group or individual. 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