14 EXPERT COMMENT LSIPR Newsletter 10:14

Challenges to the patenting of “essentially biological processes” in India

A recent decision from the IPAB on the patent eligibility of biological processes could change the biotech playing field in India, say Swarup Kumar and Shivaarti Bajaj.

ommenting on the US Supreme made by researchers at Harvard University does provide leverage for member countries Court’s historic decision to develop cancer in order to aid the testing to define expressions such as “essentially Diamond v Chakrabarty, 447 US of drugs for cancer treatment. Patents were biological processes” or set specific criteria for 303 (1980), which permitted the granted on different facets of the invention their patentability. Cpatenting of life forms, Justice Warren Burger in Europe, Canada and the US among other said: “No one will be able to deter the scientific jurisdictions, as each jurisdiction had its own The Indian scenario mind from probing into the unknown any law and practice. In India, the Patents (Amendment) Act 2002 more than Canute could command the tides”. For instance, the European Patent Office dealt introduced Section 3(j) which prohibits Probing into the unknown and the possibility with the issue of morality through a utilitarian patenting of “plants and animals in whole or of patenting one’s invention is what has balancing test that reviewed potential benefits any part thereof other than microorganisms catalysed scientific advancement in all fields of of the invention—the treatment of cancer and but including seeds, varieties and species and technology. medical research—against its negative aspects. essentially biological processes for production Nonetheless, the grant of patents in one of the On the other hand, in Canada, the patent and propagation of plants and animals.” The most demanding fields—for life forms, biological office initially rejected the patent claims for expression “essentially biological process” materials and biological processes—continues Oncomouse as such but eventually allowed has not been specifically defined either in the to cause apprehension in view of the associated claims directed to the process for obtaining the statute or through judicial decisions or the ethical, moral and political sensitivities. Oncomouse: the “biological process”. manual of the patent office. On the other hand, it would appear that the US and the EU have If one looks at international treaties to find Oncomouse case taken steps towards defining in the statute uniform benchmarks in this area, there is or through judicial pronouncements the The primary ground for opposing the much room for divergence. Illustratively, the broad criteria for what constitute “essentially patenting of life forms and essentially Trade-Related Aspects of Intellectual Property biological processes”. biological processes has been the position Rights (TRIPS) Agreement allows member that ownership of or right over life forms countries to exclude certain subject matter In 2002, the path-breaking Dimminaco case and naturally occurring biological processes from patentability under Article 27.3. Such (Dimminaco v Controller of Patents and would be detrimental to society and may excluded subject matter covers “essentially Designs & Others) came before the Calcutta influence public morality and/or order. The biological processes”. However, in order to High Court and opened the doors to the Oncomouse case related to a transgenic mouse define the threshold of patentability, TRIPS grant of patents to inventions where the final

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product of the claimed process contained salt tolerance, or drought tolerance” based on intervention was held not to change the position living microorganisms. The matter related to a the following key grounds: on patentability as the invention was otherwise process for the preparation of a live attenuated 1. That the subject matter of claims was found by the IPAB to be unpatentable in view of vaccine for protecting poultry against bursitis considered to lack inventive step in view of obviousness and new use of known substance. infection. According to the Controller of prior art documents cited in the office action; Nevertheless, the fact that the human Patents, the claimed process was only a natural intervention factor—in the manner disclosed process devoid of any manufacturing activity 2. That the claims in the application were in the specification—was not only considered and the end product contained live attenuated not considered to qualify as an invention. but also formed the basis of the IPAB’s decision material. Thus, the claims were considered The reason offered for rejection was that marks a new chapter in the field of biotech unpatentable. the structure and function of a cold shock protein was disclosed in the cited prior art, process patents in India. The significance of Hearing the appeal, the Calcutta High Court and was, therefore, obvious to a person this decision becomes more apparent when it broke new ground with its observation that “if skilled in the art to make a transgenic plant; is contrasted with the “broccoli and tomato” the end product is a commercial and vendible (G 2/07 and G 1/08) cases in which the 3. The claimed invention was considered entity, and for that, presence of living virus / European Board of Appeal held that a process unpatentable as it was regarded as a mere microorganism in the end product is necessary, for production of plants comprising the steps application of an already known cold shock it cannot be a bar to its patentability.” of crossing and selection is excluded from protein in producing cold stress tolerant patentability even if it contains an additional The Indian Patent Office issued biotechnology plants as well as plants tolerant to heat, salt step of a technical nature. Interestingly, the guidelines in March 2013, but with no and drought conditions; and reference as to what constitutes “essentially inclusion of an act of human intervention on biological processes”. In fact, the guidelines 4. Last but not least, it was held that the claims a plant cell and production in that plant cell list several illustrative examples in relation to in the Monsanto patent application fell of some changes (technical) was considered Section 3 (j) of the Patents Act. One of them under the proscription of Section 3(j) of enough to render process claims patentable in states that a claimed method involving the step the Patent Act. The primary reason offered the Monsanto case. for rejection under this ground was that of cross-breeding for producing pure hybrid In view of such a positive interpretation the claims related to “essentially biological seeds, plants and crops would be an essentially of Section 3(j) by the IPAB, jurists, processes” of regeneration and selection, biological process and thus not allowable biotechnologists and practitioners will have which in turn included growing of plants in under Section 3(j). But what this example a crucial role to play in developing criteria specific stress conditions. fails to clarify is that if there are intermittent as to what constitutes “essentially biological steps in the claimed method, which involve Dissatisfied by the controller’s decision, processes” and what does not. The good news substantial human intervention, whether or Monsanto filed an appeal before the IPAB. is that subject matter that was once considered not they would render the claimed method Considering the matter after hearing both to fall beyond the realm of patentability is now patentable. parties, the board upheld the decision of the beginning to be seen with a more nuanced eye Indian Patent Office on the first three grounds In contrast, if one looks to the European Patent and the stage looks set for interesting times listed above but, significantly, overruled the Convention, essentially biological processes as ahead in biotech jurisprudence. n patent office’s findings on Section 3(j). The IPAB provided by Article 53(b) have been defined by affirmed that the claimed method of the case Swarup Kumar is partner-designate at Rule 23(b) (5) which states that “a process for the being considered included an act of human Remfry & Sagar. He can be contacted at: production of plants and animals is essentially intervention on a plant cell and produced in that [email protected] biological, if it consists entirely of natural plant cell some changes, which took it outside Shivaarti Bajaj is a senior associate at phenomena such as crossing or selection.” The the proscription of Section 3(j). expression “entirely” would appear to leave scope Remfry & Sagar. She can be contacted at: [email protected] for interpretation open. Conclusion Monsanto case Although Monsanto’s patent was rejected on almost all key grounds, the IPAB’s decision is The case of Monsanto Technology v Controller “The fact that the a landmark one. The interpretation of Section General of Patents (2013) brought this 3(j) outlines a significantly forward-looking human intervention particular aspect into focus before the approach towards defining the elusive expression Indian Intellectual Property Appellate Board factor was not only “essentially biological processes”. In this decision, (IPAB) last July. Although the appeal filed by a series of individual steps involving human considered but also Monsanto against the patent office’s decision intervention was considered sufficient to overrule was eventually rejected by the IPAB, the patent formed the basis of the the patent office’s finding that Monsanto’s office’s decision is extremely significant in claimed process was proscribed by Section 3(j) IPAB’s decision marks that it interprets the expression “essentially of the Patents Act. In the IPAB’s view, the method biological processes”. a new chapter in the claimed did not involve a simple leap from prior The Indian Patent Office had refused the grant art to the invention but entailed a journey with field of biotech process of a patent to Monsanto for an invention many generic method steps that were essentially patents in India.” described as “a method of producing a biological which, taken in sequence, were not transgenic plant with increased heat tolerance, inventive. Therefore, the mere act of human

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