Patenting Of Nanobiotechnology Inventions: Exploring The Challenges Under The Indian Patent Law – Intellectual Property – India – Mondaq

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Nanotechnology is a vast field which includes a range oftechnologies at the nano scale, being applied to pharmaceuticals,biotechnology, genomics, neuroscience, robotics and informationtechnologies and more. In India it holds importance particularly inthe nanobiotech & nanomedicine segments. The commencement ofnanobiotechnology in India has unfurled a series of questions andchallenges in terms of intellectual property protection. Therefore,it is of immense importance to explore whether the Indian PatentSystem presents suitable atmosphere for appropriate patentprotection in India.

Like any new technology, nanobiotechnology also createsopportunities as well as challenges in adapting the patent regimeto its particular context. This article strives to highlightproblems and challenges faces by Nanobiotechnology invention owingto their multi-disciplinary character, crosssectoral applications,broad claims, as well as difficulties in fulfilling thepatentability criteria of novelty, non-obviousness, and industrialapplication.

Challenges for Nanobiotechnology Invention under Indian PatentsAct 1970

Nanotechnology is a novel and revolutionary branch oftechnology, where reduction in size has demonstrated magnificentresults. Intersection with the field of biotechnology has givenrise to nanobiotechnology. Involvement of living forms and thepotential to meet human necessities have raised issues that areunique to nanobiotechnology. It has emerged as an interdisciplinaryfield of research and development that integrates engineering,physical sciences, and biology through the development of verysmall physical and biological devices using biomimetically inspirednanofabrication techniques1 .

Following challenges are faced under Indian Patent regime inPatenting of Nanobiotechnology Inventions:

According to section 3(d) of the Act, if there is vagueness inthe "particle size", it attracts the possibility of beingincluded in non-patentable subject matter. In case ofnanobiotechnology, the newness of technology is significantlyderived from the reduction in size. The primary ambiguity is lackof a universal definition of nanobiotechnology. The word"nano" encompasses inventions of 100nm in size orsmaller. Pharma industry is likely to be the most beneficiarysegment from nano biotechnology aided research. Nano particleefficacy or accuracy of methods using nano particles for drugdelivery is significantly ruled by particle size which may vary asdifferent drugs are effective with different particle size. Forthis reason, fixing a size limit of 100 nm may rule out thepatenting of such particles under the "nano"regime.5 There is lack of a standard for determinationof the efficacy and quantification of enhancement of efficacy inthe Indian patent regime.

Under this regime, nanotech invention would remain nonpatentableunless the particle size differed in its properties have showedenhanced efficacy. Patentability of drugs would revolve around thereduction in particle size to certify better efficacy, suchcontraventions with provision 3(d) is likely to occur. For example,Abbott Pvt. Ltd. sold an HIV drug Kaletra under brand name"Alluvia". To overcome the storage problems of the drug,Abbott claimed a heat-stable form of the same drug. Apre-opposition was filed by the organization, 'Initiative forMedicines, Access and Knowledge,' under section(d) of thePatents Act 1970.6

Utility requirement is crucial for nanobiotechnologybasedinventions. Nano biotechnology falls under the class of"unpredictable" arts like biotechnology. There is thepossibility of huge variation in the laboratory results andauthentic results when technology such as nanobiotechnology is putto use. In the laboratory stage, it is not possible to determinethe possible impact of external factors on products born out of atechnology. Inoperability of such products may render themnon-patentable as they would fail to comply with the utilityrequirements.7

In addition, the problem-solving approach applied in both Europeand India would render them as not being inventions (thus renderingthe problem insolvable). The case of EMI Group North America Inc vCypress Semiconductor Corp8 provides a better insightinto the requirement. The applicant claimed a patent for aninvention that lacked utility.

The Nanobiotechnology patent can be sought over the process ofpreparing the nanoparticles; the process of transfer of nanoparticles into the patient's body; the medical devices usedetc.9 Here significant question is the distinctclassification of methods as medicinal, surgical, curative,prophylactic, diagnostic and therapeutic and the subject matterthat each of them cover. It is argued that exempting medicalmethods from the purview of patentability is on the one hand, infavour of public policy, whereas allowing patents in this fieldwould draw unwarranted ethical, moral and practical problems andmay also fail to fulfil the industrial applicability criteria.

The problem in the present perspective is whether methods usingnanoparticles constitute diagnostic, surgical or therapeuticmethods. Amendments to the Indian Patents Act 1970, sec 3(i) can beimported from the European jurisdiction which has proposedsignificant amendments to their provisions similar to the IndianPatents law, regarding medical methods. Many of the technologiesbeing currently developed blur the line between non-patentablemethods for treatment and diagnostics practiced on the human bodyon one side and patentable products (substances or compositions)and apparatus used in such activities on the other. Some of theseimportant developments in diagnostics and treatment operate totallyin vitro, others entirely in vivo, some have a combination ofphases in vitro and in vivo, posing patentability questionsconcerning the patentability exception for Methods for treatmentand diagnostic (Hosseini et al., 2011; Daneshyar et al.,2006)10.

Followings are some examples of Nanobiotechology inventionsemployed as drug delivery system in medical methods for treatmentand diagnostic purposes:

Nanoparticles due to their small size have proved to be moreefficient, target specific, water soluble and stable tools in drugdelivery compared with the conventional routes of drugadministration. For decades pharmaceutical sciences have been usingnanoparticles to reduce toxicity and side effects of drugs. Thistechnology raises issues which are in disagreement withintellectual property rights protection and non-commercial laws(such as the environmental laws). In the absence of consonantpatent law provisions, nanotechnology is facing challenges withrespect to the criteria of novelty, inventive step, being capableof industrial application and eligibility of subject matter undersection 3 of the Indian Patents Act 1970.

Nanobiotechnology inventions have generated technologicalrevolution and emerged as a key technology for economic developmentin the twentyfirst century. The use of eco marks on nanobiotechnology products are proposed to ensure environmental safetyand consonance. This would further assist in dealing with thechallenges discussed in the nanobiotechnology products Since patentlaw is technology-specific, providing guidelines to examiners forassessment of patent applications is a good practice and should beencouraged as it would aid in the issuing of better qualitynanobiotechnology patents.

1 Daneshyar SA, Kohli K and Khar RK (2006) Biotechnologyand intellectual property. Sci. Res. Essay. 1, 020-025

2 http://www.indjst.org/March%2012-%20web/38%20paper-6.pdf

3 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp.

4 http://www.indjst.org/March%2012-%20web/38%20paper-6.pdf

5 Hosseini et al., 2011; Daneshyar et al.,2006

6 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp

7 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp

8 "Intellectual Property Rights of Nanobiotechnologyin Trade Related Aspects of Intellectual Property Rights Agreement(TRIPS)" Vol. 6, 5664, 2012, Journal ofBionanoscience

9 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp

10 Hosseini SJ, Esmaeeli S and Ansari B (2011) Challengesin commercialization of nano and biotechnologies in agriculturalsector of Iran. Afr. J. Biotechnol. 10, 6516-6521.; Daneshyar SA,Kohli K and Khar RK (2006) Biotechnology and intellectual property.Sci. Res. Essay. 1, 020-025.

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Patenting Of Nanobiotechnology Inventions: Exploring The Challenges Under The Indian Patent Law - Intellectual Property - India - Mondaq