The world of nanotechnology opened its eyes to the world in 1959, when Caltech physicist Richard Feynman painted a vision of the future of science. In a talk titled “There’s Plenty of Room at the Bottom,” Feynman hypothesized that atoms and molecules could be manipulated like building blocks.[i] The first “proof-of-principle” that atoms could be precisely positioned by a manmade tool took place in 1989 when scientists at IBM manipulated 35 xenon atoms to form the letters ‘IBM’. While the old philosophy of creating things was to start with something big and makes it smaller, nanotechnology starts with something atomic and builds things with it. Since then, the exploration within nanotechnology has ramped up substantially a world full of surprises and potential, dissolving the barriers between chemistry, biology at molecular level, materials sciences, and condensed matter physics.[ii]
Nanomaterials are the building blocks of nanotechnology that can be positioned and manipulated for appropriate applications to create complex materials, devices and systems.[iii] Atoms, which are the basic units of matter, can be combined together to form more complex structures like molecules and compounds. When the arrangements of the matter are within a length of 1- 100 nanometers, it can yield unique characteristics. The making of these building blocks involve two methods: top down and bottom up. The top-down method involves carving nanomaterials out of bulk materials[iv] including slicing or successive cutting of a bulk material to arrive at a nano sized particle. The bottom up approach refers to the buildup of a material from the bottom: atom by atom, molecule by molecule or cluster by cluster.
Nanotechnology is increasingly regarded as future technology. From ‘ever higher, ever wider’ the motto is changing to ‘ever smaller, ever faster’. Nanotechnology provides access to the world of the smallest things which brings with it the biggest concerns including its patenting and regulation. Nanotechnology demands more from all perspectives including the traditional laws regulating its areas of operation.
The uniqueness of nanotechnology demands laws and procedures regarding its patenting to be more comprehensive and flawless. In a developing country like India, which is a powerhouse in science and technology and the fourth largest military power in the globe, patenting the multi-disciplinary and versatile technology attracts more attention. The extensive scope of the technology and advancement of law and procedures of the state have significant impacts on the growth of nanotechnology inventions raising concerns over both the rights of the proprietor and the society at large.
In India, nanotechnology research and development for commercial application are broadly categorized into five heads[v], namely (a) physical[vi] (b) chemical[vii] (c) biological[viii] (d) hybrid[ix] and (e) other exotic methods.[x]Along with rapid growth in nanotechnology Research and Development in Indian research institutions, commercial initiatives of the same are demonstrating a cumulative progression in Indian markets. Nanotech products are now available in the Indian markets from a vast variety of manufacturers.
India follows the absolute novelty for patent regime. Any sort of publications, anywhere in the globe, will fall under the basket called prior art. The interdisciplinary characteristics of nanotechnology makes the prior art broad enough, which challenges the crux of nanotechnology inventions and poses a fundamental issue. The novelty criterion stages some conflicts with nanotechnology inventions as the technology mainly concentrates on reduction of size in existing inventions in a compatible and enhanced manner.
A strict interpretation of the novelty provision will retard the scope of nanotechnology inventions. Philip Morris Co. gained an Indian patent[xi]on the process of conversion of carbon monoxide, emitted while smoking cigarette, to carbon dioxide by a catalyst[xii] comprising nanoscale metal particles. According to the claims made by the Philip Morris Co. mixed nanoscale metal oxide catalysts are able to reduce the concentration of carbon monoxide in the mainstream smoke of a cigarette while smoking. These nanoparticles are integrated into components of cigarette such as tobacco cut filler, cigarette paper and/or cigarette filter material.[xiii]The nanoscale multiphase mixed metal oxide catalyst used in this invention contains bonded nanoparticles of least two metal oxides chosen from the group consisting of iron oxide, copper oxide, titanium oxide and cerium oxide. Cigarettes produce both mainstream and sidestream smoke while smoking and during static burning.[xiv] Carbon monoxide is the main component in both the mainstream and sidestream smoke.[xv] As carbon monoxide is main reason for environmental pollution and hazardous diseases, it is desirable to annihilate the amount of Carbon monoxide emission while smoking cigarettes. A nanoscale mixed metal oxide catalyst can be integrated into smoking article components in various ways.
Mixed metal oxide catalysts in the form of a dry powder can be dusted on cut filler tobacco and/or added to the raw materials used to make cigarette paper. The catalyst can also be combined with cigarette filter material during and/or after manufacture of the cigarette filter material. The nanoscale mixed metal oxide catalysts can be mixed with water or other suitable liquid to form a paste or dispersion. A paste can be combined with the smoking article components prior to or during the cigarette manufacturing process. A dispersion can be coated such as by spray-coating onto the smoking article component. The smoking article component can then be incorporated into the cigarette making process.[xvi]
The merit of the invention can be struck down, when a strict reading of the novelty provision has been done, because the invention is derived from a pre- existing technology[xvii]which deals with conversion of carbon monoxide into carbon dioxide in motor vehicles through a catalyst reaction. The technology is being used in almost all automobiles in order to control the carbon monoxide emission; thus the technology is anticipated by the prior art.
Generally the technical advancement and economic significance criteria do not create complexities and seems to be adequate enough to deal with patentability issues. For example, the Krishidhan Research Foundation Pvt. Ltd. and Jawaharlal Nehru University, New Delhi have developed a better-quality and cheaper anticancer chemotherapeutic agent, using nanotechnology, for effective treatment of lung cancer and a system for direct local delivery or by injection of drugs through systematic circulation.[xviii] The invention has evident technological advancement as well as economic significance. It will not be difficult to identify the inventive step criterion. Likewise, in case Mahindra and Mahindra decide to patent their invention with respect to viper less windscreens using the lotus effect the inventive step would not be a hurdle for obtaining patent, as the technical advancement is unambiguous here.
The size of the product doesn’t matter; but the scenario is entirely different with nanotechnology inventions, where most of the inventions are with respect to optimization and advancement of features of the product and curtailing the size. In such special circumstances the statutory definitions and other criteria appear to be inadequate. The terms ‘technical advancement’ and ‘non-obviousness’ lead to complexities.
For example, in In re Dillon[xix] an application for patent for the invention of tetra-orthoesters as fuel additives in order to lessen soot formation upon combustion was rejected by the U.S patent office on the basis of two prior-art references. The first one was regarding use of tri-orthoesters as additives to hydrocarbon fuels to dewater the fuels and second one was the use of tri-orthoesters and tetra -orthoesters as water scavengers for hydraulic fluids. But the Federal Circuit Court held that, “a comparison of test data showing that the claimed compositions possess unexpectedly improved properties or properties that the prior art did not have..”[xx] Coming back to the Philip Morris Co.’s patent[xxi] on conversion of carbon monoxide to carbon dioxide while smoking cigarette, the merit of invention can be struck down as the invention is obvious for a person skilled in the art. The conversion of carbon monoxide to carbon dioxide through catalyst reaction of metal oxide is already there in the prior art, so even if there is technical advancement the non obviousness factor may invalidate the invention. For the proprietor the result of inventive step will not be as good as Graham factors if the patent office applies the TSM test[xxii] as the collective teaching of prior art results, undoubtedly, is obvious for a person skilled in the art.
This shows a big lacuna in the statutory provisions of ‘technological advancement’ and ‘non obviousness’. The application of TSM test causes additional rigidity to the inventive step criterion of nanotech inventions. The criteria is ambiguous and complex and it will inversely affect the patentability of nanotechnology inventions unless the patent office explicitly defines the level and mode of ‘technological advancements’ and ‘non obviousness’ related to nanotech inventions.
A product or process without an industrial application is not eligible for obtaining patent in India.[xxiii] The rationale behind this clause is to omit an abstract idea or purely intellectual creation that cannot be put into use from being patented. The provision seems to be necessary for attaining the real objective of the patent system. But for nanotechnology inventions, the clause appears a bit problematic.
A plain reading of legislation[xxiv] and precedents[xxv] show that India follows the ‘substantial utility’ method. Substantial utility means ‘real world use’.[xxvi] Strict adherence towards ‘capable of being used in an industry’ causes some crisis in nanotechnology patents. Nanotechnology is an ‘unpredictable’ art, where huge disparities are likely to occur between laboratory results and real world results.[xxvii] In a laboratory, the test will be done under a controlled environment and it is easy to determine the external factors. The situation is not the same in the real world where external factors may have an influence on the test results, eventually failing to fulfill the patentability criteria.
Taking a hypothetical situation of lithium batteries as an example, the chemical composition and specific conductivity of nanometerials make the battery more longstanding, less energy consuming, less expensive and safer. But the results that the inventors observed in the laboratory may be different from the results in the real world. External factors like heat, humidity and other factors influencing the chemical configuration and conductivity of nanometerials may affect the battery performance and eventually compel the patent office to reject the application for lacking inventive step and utility.
The United States and China incorporated certain provisions in order to overcome this lacuna. According to the USPTO, ‘utility’[xxviii] of a product or process can be credible, specific and substantial. Unlike in India, it is not mandatory that there should be a real world utility for the product; it can either be credible utility or specific utility. Credible utility means that the assertion of utility should be credible, i.e. the “assertion of utility is believable to a person of ordinary skill in the art based on the totality of evidence and reasoning provided.” Specific utility explicitly targets the subject matter. i.e., the utility must not be general in nature but specific to the particular subject matter.[xxix] Chinese patent office requires mere laboratory results in order to overcome the utility criterion.
Thus, restricting the scope of ‘industrial application’ only toward the real world application, which is being followed in India, negatively affects the scope of nanotechnology inventions and their patentability.
Patentable subject matter
In India, any invention seeking patent rights should not fall under the sixteen non patentable subject matters enlisted in chapter III of the Patent Act, 1970. It is the first hurdle an invention has to triumph over, before finally getting patented; the other criteria like novelty, inventive step and industrial application come only afterwards. A few out of the long list relate to nanotechnology inventions. The provisions which have significance in the area of nanotechnology are sections 3(d),[xxx] 3(i), 3(p)[xxxi]and section 4.[xxxii] The subject matters of section 4 and section 3(p) of the Patent Act also have significance with relation to nanotechnology. However, the paper does not intend to focus on the provision because it is beyond the scope of this paper.
Methods of treatment: section 3(i)
The huge majority of countries around the globe regard method of treatment as a non-patentable subject matter, with the exception of the U.S.A and Australia.[xxxiii] The rationale behind excluding such inventions from commercialization and the patent regime is the influence of some political, professional, ethical and humanitarian reasons.
The political reason for non-patentability of the subject matter is that the competition with respect to research and development wouldn’t appear appropriate in the medical services. Further, almost all the inventions are made in universities and large hospitals obviating the need for incentives. When prior approval becomes mandatory the end result of such research would rather become inaccessible to society. Advocates argue against patenting the methods of medical treatment pointing out the scope for broad and extensive ethical violations. Research should be conducted only on human beings and it is not possible without patients’ cooperation, this may tend to result in a violation of medical ethics.[xxxiv]
By virtue of the TRIPS agreement, an invention should be patentable in its member countries if the invention meets the basic requirements for patentability (novelty, inventive step and industrial application).[xxxv]But the member countries ‘may’ exclude the “diagnostic, therapeutic and surgical methods for the treatment of humans or animals”[xxxvi]from the scope of patentability. India framed the patent law adhering to these provisions and the rationale discussed above.
The emergence of the revolutionary nanotechnology in the field of medicine changed the entire picture with the introduction of new products, processes and methods of treatment questioning the very relevance and scope of section 3(i) of Indian Patents Act. Firstly, the product patents in the field of medicine and treatment are mostly granted after considering the huge expenses for research and development[xxxvii] which necessitates the need for incentives. Likewise, the huge investment in research and development of nanotech methods of treatment demands their patentability. Thus, for a developing country like India, granting patents for methods of treatment will have some positive impact. Incentives help the inventor to recover the investment and to boost research and development which would definitely encourage extensive access to more advanced and effective medical treatments.
Secondly, a patented method of treatment has to undergo all sorts of practical and theoretical experiments and tests. Only an invention which has efficacy and safety gets the patent from the Patent Office. This could help eradicate unhealthy and risky medical treatments and guarantee advanced and safe methods of treatment for the subjects. For example, the development and use of regenerative medicines[xxxviii] increase with the emergence of sophisticated nanotechnology. The transplantation process has uses other than that of surgical applications. The use of the technology in the cosmetics industry is immense. Allowing such techniques under the umbrella of patents implies a careful and scientific review in order to meet the assured safety.
Thirdly, it is ironic that equipments, apparatus and other products for medicinal, surgical, curative, prophylactic diagnostic, therapeutic and other treatments are patentable while the method of treatment itself is not patentable. The role of nanotechnology revolutionized the medical field with the introduction of complex and sophisticated products, processes and methods. One nanotechnology based product may be designed only for a certain method of treatment and without that product the treatment may not be performed. For example, laser treatment is the best way for treating eye diseases and disorders. The laser device is patentable while the method of treatment is not. Another example of this lacuna in patent law is the blood-brain barrier device.[xxxix]The device is a sophisticated nanotechnology product for treatment of a vast variety of diseases/disorders varying from immunity, inflammation, metabolism and hormone related diseases/disorders.[xl] If it is submitted for a patent in India, the product may avail patentability while the process per se is not patentable.
Section 3(d) and nanotechnology
Nanotechnology inventions are multi-disciplinary and multi-industrial in nature. i.e., a single invention in its nature would have a broad range of applications that often comes with broader claims of patentability. Section 3(d) of the Patent Act, 1970, as amended by the Patents (Amendment) Act 2005, classifies new forms of a known substance as non-patentable unless the new form of the substance exhibits improved efficacy of that substance already known. The enhancement in efficacy is further explained in the Explanation to the sub-section. The enhanced efficacy must necessarily display substantial changes in properties with respect to efficacy. Thus “the dividing line between being an eligible subject matter to be considered for grant of a patent and not being patent eligible is the efficacy”.[xli]To be precise, under section 3(d)[xlii], “the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant” is not regarded as an invention.
“The objective of repealing and including a new criterion in Section 3(d) of the 2005 Act was to increase the ambit of patenting”.[xliii]The intention behind the enactment of the new provision was to include in the list of inventions, ‘the discovery of a known substance’ that has a higher efficacy than the already known substance.[xliv] Section 3(d) was enacted to reduce, and in long term, prevent ever-greening.[xlv]
Section 3(d) clarifies that a new form of known substance is patentable only when such new form of the known substance differs substantially in its properties with respect to ‘efficacy’. Hence, the requirement as to patentability is not just a trivial increase in efficacy but substantial improvement of the same. The relevant question here is not whether it could be regarded as an invention or merely be classified as a discovery of something already possessed by the subject matter of the patent, but if there has been an increased level of efficacy of the newly invented substance.
With respect to pharmaceutical substances, as it is all about increasing the efficiency of medicine and not inventing a totally different medicine every time, the question would always be regarding increased efficacy rather than invention of a totally new substance.[xlvi] It is interesting however, to note that a “standard of efficacy” is not provided under Section 3(d) or any other law in force in India.
In India, the criteria mentioned in Section 3(d) are likely to create problems in obtaining nanotechnology patents. According to Muller, Section 3(d) has previously caused many difficulties in patenting biotechnology inventions. For e.g., as the section creates presumptions against ‘novelty’ of combination medicines many such problems were encountered by Indian biotech companies inventing combination vaccines in patenting them.[xlvii]As nanotechnology is still in its infancy in India, there have only been a few cases arising out of nanotechnology patents in India. Hence, it can only be presumed that section 3(d) possibly will pose serious threats to patenting nanotech inventions. The main reason behind this apprehension is that nanomaterials in most cases are “combinations of many particles or technologies or a nanoparticle of an existing material” and patents for the newly found substance will not be possible without substantial difference in character, efficacy and industrial application.[xlviii]
The explanation to Section 3(d) clearly provides that particle size cannot be the only criterion for patentability; the invention must also possess substantial differences in properties of the components increasing its efficacy. Hence, an invention only with a difference in size becomes non-patentable, if the same doesn’t cause any change in efficacy.
Further, it is interesting to note that the term efficacy has not been defined in the Patents Amendment Act 2005, though a criterion of efficacy was introduced under Section 3(d).Hence, efficacy becomes too difficult to define in an area such as nanotechnology which is in its infant stages and it could seriously hinder developments in the field. Once the ‘gateway’ is closed it would obstruct the possibility of flow of information for future research. So far, Courts in India have strictly interpreted Section 3(d) taking a tough stand on efficacy like the Madras High Court in Novartis AG v. Union of India and Others[xlix], where the issue was discussed in detail. Section 3(d) while effectively preventing ‘ever-greening’, could delay innovations in nanotechnology.
Nanotechnology is in its initial stages of growth. “The confluence of the sciences under nanotechnology is considered a sphere that will make it an immensely powerful field, while its convergence with other technologies like biotechnology, information technology and cognitive science is expected to increase significantly the transformative potential of new technologies as a whole”.[l]Nanotechnology is widely believed to reach levels presently unimaginable in the near future.[li]Contributing its outcomes to virtually every sector, nanotechnology is expected to make contributions in health, medicine, computing, electronics, energy, transportation and many other commercial sectors.[lii]
However, rapid development in the field of nanotechnology raises questions as to health and safety, environmental concerns, legal and regulatory issues etc.[liii]Excessive patenting of basic inventions in nanotechnology raises apprehensions as to “tragedy of the commons” in the future[liv] as well as a “tragedy of the anticommons”.[lv] The “tragedy of the commons” is where the “ownership of basic information conflicts with the common good”,[lvi] while the “tragedy of the anticommons” would be “when several patentees have rights of exclusion leading to overlapping and conflict”.[lvii]As it narrows down the gap between different sciences, it complicates the whole assumption behind the principles of patenting.[lviii]Patenting nanotechnology thus raises challenges not only to the currently prevailing patent classification systems but also in addressing the disproportionate delays in granting patents in India.
Delay in nanotech patents in India
Indian Patent Office granted around 370 nanotechnology patents till March 2012.[lix]A huge delay has been observed in the IPO examination process. The paper examined all granted nanotechnology patents in India and shortlisted 358 patents which have full particulars, without duplication. The paper converted the analysed patents in a graph showing the average time in granting patents.
The graph shows a steady progress in the examination procedures and found that the average time taken for the patent applications filed in the year 1995 is 14 years. In contrast to this, the average time taken for, thirty one, patent applications filed in 2007 is 3.5 years; but the pending patents filed in the same year may change the value. It is apparent that the average time taken by the IPO to grant nanotech patents has significantly reduced over the years. The research has found that the average time taken for granting nanotech patents by IPO during 1995-2012 is 7.2 years.
3.1.1 The tale behind the delay
As the exclusive monopoly over an invention is limited for twenty years,[lx] the delay in granting patent applications have significant impact on the proprietor’s rights. The delay in granting patent rights depends on different variables. The delay in granting patent applications in India can be calculated by the following simple formula:
D (delay) = N-n
Here ‘N’ is the actual time taken by the Indian Patent Office. In other words it is the difference between the date of grant and the date of filing of the patent application. ‘n’ here is the minimum time permitted by the Indian Patents Law for granting a Patent. From the research conducted for the paper, the average time taken by the Indian Patent Office for granting nanotechnology patent between 1995 and 2012 is 7.2 years.
The process of calculating the minimum time sanctioned is kind of complicated. It involves Rules 24,[lxi] 24B (3)[lxii] and 24B (4)[lxiii]of the Indian Patents (Amendment) Act 1970. Reading together these provisions in the Indian patent legislation, an examination process should take 18+6+12=36 months; that is three years. Thus ‘n’ is three years. While substituting the value of ‘n’ and ‘N’ in the equation,
The delay D = (7.2-3) = 4.2 years
There is bundle of reasons for the delay in the process of granting patent, which is basically caused by the basic characteristics of the nanotechnology inventions and extends to many patent office issues like availability of the examiners for the nanotech patent examination, heavy work load and nonexistence of an inclusive prior art database. In order to find a comprehensive solution for the delay in granting nanotech patents, the research examines a range of challenges in nanotechnology patent examination.
The basic characteristic of nanotechnology is the nanometer size.[lxiv]In the patenting scenario, the problems of broad patent claims and multi industrial applications of the nanotech inventions get prominence. These specific features distinguish nanotechnology patenting from patenting other inventions. In India, major patent office issues regarding nanotechnology patenting are with respect to Patent Examiners and the Prior Art searches.
Patent examiners are authorized persons to investigate patent applications and check prior art and patentability of inventions.[lxv] The patent backlog is supposed to be caused by the deficiency of qualified examiners and expert examination group for revolutionary sciences like nanotechnology. The dearth of qualified and expert patent examiners affects not only India, but also many pioneers in the field like the U.S.A.[lxvi] The average time taken for granting a U.S nanotech patent is 32 months (3.6 years)[lxvii], incongruously half the time taken by Indian Patent Office.[lxviii]
The main hurdle in the Indian patenting regime is undoubtedly the deficiency of examiners. In 2004-05, Indian Patent Office granted 1,911 patents with 150 patent examiners.[lxix] In the very next year, the number of granted patents climbed to a massive 7,539 patents with the strength of 133 Patent Examiners.[lxx] Amazingly, the Patent Office granted 16,061 patents with mere 75 patent examiners& 70 Asst. Controllers.[lxxi]However in the year 2010, the number of granted patents by the IPO drastically reduced to 6168 with apparently the same number of patent examiners.[lxxii] 1,20,000 patent applications were published during 2006-2009 and ironically no patent examiners were appointed during 2004-2009.[lxxiii]In addition to this vacuity, 55 patent examiners left the IPO and 47 examiners were promoted as Assistant Controllers.[lxxiv]The annual report of the Patent Office in the year 2009-2010 shows that this shortage of patent examiners reduced the number of patents granted during the period.[lxxv]
In Contrast to the Indian scenario, a whopping 1,35,110 patents were granted in the year 2010 by the neighboring economic giant China; out of which 79767 were obtained by domestic institutions and the rest 55343 patents by foreign players.[lxxvi]The SIPO examined 3,91,000 patent applications, which is 24% higher to the patent applications filed in 2009.[lxxvii] The SIPO recruited 3839 persons only for the examination procedures during the year 2010.[lxxviii]It has been reported that at present China has around 4,500 patent examiners and the Patent Office is supposed to enlarge the number to 9,000 by 2015[lxxix]while Indian Patent Office works with around 250 patent examiners.
Another issue that the Indian Patent Office and the pioneers of nanopatenting in the globe face is the availability of qualified patent examiners for the nanotech patent applications. In the U.S, it has been reported that one out of every two patent examiners recruited by the USPTO left the office during the period 2002-2006. Adding to this deficiency of patent examiners, more than 70% of the patent examiners left the Patent Office with less than 5 years of experience. This resulted in a huge backlog of patent applications in the USPTO. The IPO faces the same issue in an exigent manner as many IPO patent examiners left the office after a short period of experience as the career prospects are limited in the patent office.
In case of nanotech patents, prior art search turns out to be another hurdle as the subject matter may be located under diverse areas. The Indian Patent Office, incidentally, moves to outsource its normal patent searches to CSIR due to its workload.[lxxx] India follows the International Patent Classification,[lxxxi] which recently incorporated the special nanotechnology patent classification B82Y, inspired from the EPO’s Y01N classification.[lxxxii]
|B82Y5||Nanobiotechnology or nano-medicine|
|B82Y10||Nanotechnology for information processing, storage and transmission|
|B82Y15||Nanotechnology for interacting, sensing and actuating|
|B82Y20||Nanotechnology for optics|
|B82Y30||Nanotechnology for materials and surface science|
|B82Y35||Methods or apparatus for measurement or analysis of nanostructures|
|B82Y40||Manufacture or treatment of nanostructures|
This Patent classification, somehow, helped the patent offices to overcome the searching challenges: but the process is limited. IPO lacks proficient automation tools for nanotech prior art searches. In the absence of an ample database which classifies nanotechnology patents and accurately places the information in the knowledge basket; the Indian Patent Office will fall behind in the global technology race.
The words and terms used in patent claims determine the scope of the claim and ultimately the fate of application.[lxxxiii]Dictionaries, encyclopedia, treatises and other publicly available materials regulate the meanings of each nanotech term.[lxxxiv]But these definitions may be broad or sometimes limited, hence it is difficult to form a uniform definition leading to more ambiguities in defining terms[lxxxv] and complexities inside the patent office. In case the matter comes before a Court, the definition varies depending on choice of the judge and facts of the case.
Defining a new term creates ambiguities as the Court has to combine different dictionary meanings or various expertise opinions, which may ultimately distort the patentee’s intended meaning and his claims. If the task is to make a definition of a new term which has no dictionary meaning or related terms defined yet, the patent offices will be compelled to dedicate more time for examinations and there is a resulting delay in granting patent rights. In addition to this the Courts in India cause further delay in the process of patent examination and critically affect duration of proprietor’s ownership rights.
The USPTO incorporated an inclusive list of nanotechnology terms in the 977 classification, which is the most appropriate solution for issues relating to conflicting definitions. In India, patent examiners and patent offices have no such comprehensive guidelines which define broad nanotech terminology inclusively. This issue causes many complexities in IPO examination and is a reason for delay in nanotech patens.
It has to be noted that, patent office alone cannot be accused for the delay in granting patents. The role of applicants too is significant in this issue. The clerical errors in applications and delay in responses from applicant’s part also adds to the delay.
Impact of the delay in granting patent on the growing technology
The ownership right in patent is a negative right which enables a patent owner to prevent others from making, using or selling his inventions.[lxxxvi]Considering the time taken by the IPO for granting patent rights it seems the purpose of patent system as such is at stake. In most cases, the delay of 4.2 years is an administrative delay on the part of the IPO and not a delay caused by the applicant. As per the Indian Patents Law, the owner of the patent can enjoy his ownership rights for 20 years from the date of filing the patent application.[lxxxvii]
Considering the mandatory time period for examination and other procedures, an inventor will enjoy his complete patent rights for at least 17 years[lxxxviii]. However, at present, in India, the patentee will be able to enjoy only 17-4.2(4.2years of administrative delay) = 12.8 years. But the inventor will not get any compensation/adjustment for that. The research has observed a delay of 14 years on the part of IPO; in such cases the patentee enjoys the monopoly over the product or process for a mere six years. This is a critical threat to the Indian nanopatent regime.
However, in the USA, there is a guarantee that an inventor will enjoy his patent right for at least 17 years (i.e. there is maximum 3 years pendency time for a patent application) under 35 U.S.C. §154 of the US Patents Law.[lxxxix]Japan too has incorporated such a provision for extending the term of patents up to five years from the original expiration date of the patent, in case of delay in granting the patent.[xc]
The demands and challenges raised by nanotechnology are more than what a traditional patent regime can answer. Whereas on the qualitative side the patent offices have not ‘enough qualified persons’, on the quantitative side there is a lack of ‘enough persons’. The pendency time of patent applications, seemingly unavoidable even in developed countries, needs to be effectively addressed. Extreme delays caused by patent applications in India can cause significant adverse impact on patenting nanotechnology. With a growth in nanotechnology research, it is high time India has to address the issue of delay in granting nanotechnology patents which, otherwise, can raise apprehensions in the minds of inventors and industrialists.
The progress in examining patent applications and granting patents in recent years cannot be ignored. The study conducted by the paper itself shows an advancement in part of the IPO. Recruitment of new patent examiners and expertise administration capabilities in recent years resulted in this radical change.
Nanotechnology is redefining intellectual property rights and raising challenges as against patentability, which poses serious threats to the growth of the new technology. It seems certain that different models and different layers of open and closed intellectual property will be forced to co-exist but as nanotechnology is the need of the hour, and future of science and hitherto technological advancement, laws must provide for greater innovation, parallel research and development, removal of patent bottlenecks and faster product development. The requirement of the moment is neither stringent laws nor softer provisions but a mechanism that realizes the needs of the future and the potentials of research and development in an immensely promising technology that would help devise the future of mankind.
Indian patent law is not comprehensive enough to handle the challenges, with respect to nanotech patents, inside and outside the patent office. Absence of a comprehensive legislation or guidelines by patent office which deals with the level of application or interpretation of patentability criteria, definitions of nanotech terms, guarantee of patent term, controlling upstream patenting and licensing and inclusive prior art or nanotech classification create voluminous hurdles in the Indian Patent regime.
Secondly, the inadequacies in Indian patent law and procedures create many substantial legal and practical issues in nanotech inventions. The above mentioned substantive inadequacies and Patent Office’s procedural shortfall lead to many issues like strict patenting criteria and consequently rejection of vast number of inventions; lack of sufficient number of patent examiners, proper prior art databases and inclusive nanopatent classifications which lead to delay in granting patents; patenting upstream researches and broad patent claims retards the downstream nanotechnology innovations and causes delay in marketing the product.
Lastly, Indian patent regime has to be made competitive enough by incorporating special provisions for nanotechnology patents. Incorporation of advanced legal and procedural strategies, which are being followed by the pioneers in nanotech inventions and patenting, will indisputably boost nanotech inventions as well as nanotech patenting.
Nanotechnology inventions and patenting in India, even now, is in its embryonic stage.[xci]But the science is expected to be the dominating one in next 10 years.[xcii]The growth of nanotechnology invention is vital for the technological advancement and improvement in the basic social needs of India.
[i] Richard P. Feynman, There’s Plenty of Room at the Bottom, available at https://www.zyvex.com/nanotech/feynman.html.(last visited on 13/07/2014) (“Consider the possibility that we, too, can make a thing very small which does what we want—that we can manufacture an object that maneuvers at that level!”)
[ii] John C Miller et al., THE HANDBOOK OF NANOTECHNOLOGY BUSINESS, POLICY AND INTELLECTUAL PROPERTY LAW, (New Jersey: John Wiley & Sons 2005) at 15
[iv] In the original Feynman interpretation, the top-down approach means to build generations of successively smaller machines, until the nanometer scale became accessible.
[v]Prasenjit Sen, Nanotechnology: The Indian Scenario, 5 Nanotech. L. & Bus. 225 (2008) at 226.
[vi]The physical approaches can be further subdivided into mechanical methods and vapour deposition methods. Amongst the mechanical methods the ones in considerable use are high energy ball milling and melt mixing, while vapour deposition techniques comprises of physical vapour deposition, laser ablation, sputter deposition, electric arc deposition and ion implantation.
[vii] The chemical methods employed to produce nanomaterials in several laboratories are colloid based synthesis, sol-gel methods, Langmuir-Blodgett films, reverse micelles and micro-reactors.
[viii]Biological routes to nanomaterial synthesis involve use of bio membranes, enzymes and micro organisms.
[ix]The hybrid routes to synthesis consist of electrochemical, chemical vapour deposition, particle inclusions in glass, ceramics, zeolites and polymers and micro-emulsions.
[x]Other exotic methods to produce, metal, metal oxide and novel materials utilize electro-explosion of wires employing the pulsed wire discharge configuration as well as the needle-plate explosion geometry.
[xi]IPO, Patent No. 249962
[xii] The catalyst can be prepared by combining a metal precursor solution with high surface area support particles to form a mixture, or by combining a metal precursor solution with a colloidal solution to form a mixture, and then heat treating the mixture
[xiii] Alton Parrish , Philip Morris USA Scientists Reveal Nanoscale Mixed Metal Catalyst Additives to Reduce Carbon Monoxide in Cigarette Smoke, January 11, 2010, available at https://nanopatentsandinnovations.blogspot.in/2010/01/philip-morris-usa-scientists-reveal.html (last visited on 13/07/2014)
[xv] IPO, Patent No. 249962
[xvi] Supra note 63; see also, IPO, Patent No. 249962
[xvii] Samuel George, The catalyst convertor, 2002, available at https://www.krioma.net/articles/Catalytic%20Converter/Catalytic%20Converter.htm (last visited on 13/07/2014)
[xviii]See,https://www.google.co.in/url?sa=t&rct=j&q=bharat%20biotech%2C%20hyderabad%20nanotechnology&source=web&cd=1&ved=0CCMQFjAA&url=https%3A%2F%2Fdbtindia.nic.in%2Fsbiri%2FSuccessfulSBIRIApplicantsJan.doc&ei=Tgc2T5fKC4SdiAfv7tmBAg&usg=AFQjCNGvQIoTH5eOd8ghdzUJq40zgXa1iQ&sig2=C6Dq4DhnQRzynPc1T5aL5A(last visited on 13/07/2014)
[xix]In re Dillon, 919 F.2d 688
[xx]Id. at 692-93, cited at Sanjay Pandey ,Patenting Nanotechnology in India, available at https://www.intelproplaw.com/Articles/cgi/download.cgi?v=1125360993(last visited on 13/07/2014)
[xxi] IPO, Patent No. 249962
[xxii] According to the TSM test, a patent application will be invalidated if the collective teaching of two or more prior art search results disclose the claims, if and only if the prior art provides some teaching, suggestion or motivation that would have led a person of ordinary skill in the art to combine or modify the references in the manner claimed.
[xxiii] Patent Act, 1970 has explicitly stated that capability of industrial application is a criterion for patentability in section 2(1)(j).
[xxiv] According to section 2(1)(ac) of Patent Act 1970, “Capable of industrial application, in relation to an invention, means that the invention is capable of being made or used in an industry.”
[xxv] In Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries, AIR 1982 SC 144 at 118; it was held that “Section 26(1)(f) of the 1911 Act recognized the lack of utility as one of the grounds on which a patent could be revoked”, cited at 1 South Centre, A guide to pharmaceutical patents, (Carlos M Correa ed., 2008) at 81
[xxvii] K Sharma &A Chugh, Legal Aspects of Nanobiotechnology Inventions: An Indian Perspective, (2009) 6:2 SCRIPTed 433, at 440; available at https://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp (last visited on 13/07/2014)
[xxviii] Alternative for ‘industrial application’
[xxix] “For example, a claim to a polynucleotide whose use is disclosed simply as a “gene probe” or a “chromosome marker” would not be considered to be specific in the absence of disclosure of a specific DNA target.”
[xxx] “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant;” is not an invention.
[xxxi]“an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components: is not an invention.”
[xxxii] “No patent shall be granted in respect of an invention relating to atomic energy falling within sub-section (1) of section 20 of the Atomic Energy Act, 1962 (33 of 1962)”
[xxxiii] Japan Patent Office, Application of Methods related to Medical Activity to the Patent Law, available at https://www.jpo.go.jp/shiryou_e/toushin_e/shingikai_e/pdf/iryou-wg_re.pdf (last visited on 13/07/2014)
[xxxv] Paragraph 1, Article 2
[xxxvi] Paragraph 3 (a), Article 2
[xxxvii] Supra note 81.
[xxxviii]process of replacing or regenerating human cells, tissues or organs to restore or establish normal function
[xxxix] USPTO, application number 12/924891.
[xl]Bone cell delivery device, available at https://www.freepatentsonline.com/y2011/0256205.html (last visited on 13/07/2014)
[xli] “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”
[xlii] Before the 2005 Amendment.
[xliii]INTERPRETATION OF SECTION 3(D) IN THE INDIAN PATENTS ACT 2005:
A CASE STUDY OF NOVARTIS<https://www.nalsar.ac.in/IJIPL/Files/Archives/Volume%201/2.pdf> (last visited on 13/07/2014)
[xlv]Manisha Singh Nair, Selection Patents and Indian Patents Act Section 3(d), available at https://www.asialaw.com/Article/1970845/Selection-Patents-and-the-Indian-Patent-Act-Section-3d.html?Print=true&Single=true (last visited on 13/07/2014)
[xlvi]KD Raju, Interpretation of Section 3(D) in The Indian Patents Act 2005:A Case Study of Novartis, available at https://www.nalsar.ac.in/IJIPL/Files/Archives/Volume%201/2.pdf (last visited on 13/07/2014)
[xlvii] Biotechnology Patenting in India: Will biogeneries lead a sunrise industry to bio innovation?, (PITT LAW Legal Studies Research Paper Series, Working Paper no.2, 2008), at 27-28
[xlviii]Indrani Barpujari, The Patent Regime and Nanotechnology: Issues and Challenges, (2010) 15Journal of Intellectual Property Rights, at 206-213.
[xlix]W.P. No. 24754 of 2006 and W.P. No. 24759 of 2006.
[l]MihailRoco&William Bainbridge, Societal Implications of Nanoscience and Nanotechnology, (Dordrecht, Netherlands: Kluwer, 2001), at 1
[li]Behfar Bastani& Dennis Fernandez, “Intellectual property in nanotechnology”  Thin Solid Films 420-421, 472cited at Joel D’Silva,Pools, thickets and open source nanotechnology, E.I.P.R. 2009, 31(6), 300-306
[lii]Jeffrey Matsuura, nanotechnology regulation and policy worldwide(Artech House, 2006), at 20-21 cited at Joel D’Silva, Pools, thickets and open source nanotechnology, E.I.P.R. 2009, 31(6), 300-306.
[liii]Joel D’Silva, Pools, thickets and open source nanotechnology, E.I.P.R. 2009, 31(6), at 301.
[lvi]For example, the basic science and methods in nanotechnologies which would be required in order to further develop and exploit them. Also since much of the research is still in the nascent stage, patents granted are likely to be broad in scope. See Id.
[lvii]The concept of patent thickets where several own rights that would be collectively required to exploit a particular technology or application.
[lviii]Siva Vaidhyanathan, Nanotechnologies and the law of patents: A collision course in Geoffrey Hunt and Michael Mehta (eds),Nanotechnology: Risk, Ethics and Law (UK: Earthscan, 2006),at 225-226.
[lix] The paper found 357 granted patents by searching the Indian Patent Database. Further data was unavailable during the period of research.
[lx] Section 53, Patent Act 1970
[lxi] “The period for which an application for patent shall not ordinarily be open to public under sub-section (1) of section 11A shall be eighteen months from the date of filing of application or the date of priority of the application, whichever is earlier.”
[lxii] “A first examination report along with the application and specification shall be sent to the applicant or [his authorised agent ordinarily within six months from the date of the request for examination or six months from the date of publication, whichever is later]. In case other interested person files the request for examination, an intimation of such examination may be sent to such interested person.”
[lxiii] “The time for putting an application in order for grant under section 21 shall be twelve months from the date on which the first statement of objection is issued to the applicant to comply with the requirements.”
[lxv] See, sections 12 and 13, Patent Act 1970.
[lxvi] Jack B. Hicks et. al., Patenting Nanotechnology: Is there really plenty of room at the bottom?, available at https://www.wcsr.com/resources/pdfs/nano030310.pdf (last visited on 13/03/2014)
[lxviii] The research conducted by the paper has observed the average time taken for nano patents are 7.2 years
[lxix]Prashant Reddy, P.H. Kurian – the Patent Office’s ‘Knight in Shining Armour’ – resigns as the Controller General, June 18, 2011, available at https://spicyipindia.blogspot.in/2011/06/ph-kurian-patent-offices-knight-in.html (last visited on 13/07/2014)
[lxxii] Annual report 2009-2010, THE OFFICE OF THE CONTROLLER GENERAL OF PATENTS, DESIGNS, TRADE MARKS AND GEOGRAPHICAL INDICATION, available at https://ipindia.gov.in/cgpdtm/AnnualReport_English_2009_2010.pdf (last visited on 13/07/2014)
[lxxvi] State Intellectual Property Office of the P.R.C (SIPO), Grants for Three Kinds of Patents Received from Home and Abroad (year), January 2010-December 2010, available at https://english.sipo.gov.cn/statistics/gnwsqnb/2010/201101/t20110125_570600.html (last visited on 13/07/2014)
[lxxvii]2010 SIPO annual report
[lxxviii]SIPO recruited 1,671 people in total, among which 194 were for preliminary examination and flow management, 1,371 for substantive examination of invention patents, 29 for patent reexamination and invalidity examination, and 77 for administrative work. In addition, SIPO recruited 2,168 people to assist the examination process. See, 2010 SIPO annual report
[lxxix]Subramaniam Vuth, Lagging behind the dragon on IPR, Tata Review, December 2011, at 106,107 available at https://www.tata.com/pdf/tata_review_dec_11/review_laggin_behind_ipr.pdf (last visited on 13/07/2014)
[lxxx]Shamnad Basheer, Outsourcing Indian Patent Searches to CSIR: Insourcing Conflict?,February 12, 2011, available at https://spicyipindia.blogspot.in/2011/02/outsourcing-indian-patent-searches-to.html (last visited on 13/03/2014);see also, Sumathi Chandrashekaran, Out Now: the MoU between CSIR and IPO, February 08, 2012, available at https://spicyipindia.blogspot.in/2012/02/out-now-mou-between-csir-and-ipo.html (last visited on 13/07/2014)
[lxxxi] “The new patent applications shall be classified in groups formed as per the field of technology and International Patent Classification (IPC) by the Examiner/ Assistant Controller”; see, Patent Office Procedures 2009,1st July 2009, available at https://ipindia.nic.in/PatentOfficeProcedure/PatentOfficeProcedure_2009.pdf (last visited on 13/07/2014)
[lxxxii]European Patent Office, Nanotechnology and patent, available at https://documents.epo.org/projects/babylon/eponet.nsf/0/623ECBB1A0FC13E1C12575AD0035EFE6/$File/nanotech_brochure_en.pdf (last visited on 13/07/2014)
[lxxxiii] John Josef Molenda, The importance of defining novel terms in patenting nanotechnology inventions, 1 Nanotech. L. & Bus. 174 (2004), at 174.
[lxxxiv] Texas Digital Systems, Inc. v. Telegenix Inc., 308 F.3d 1193 (Fed. Cir. 2002)
[lxxxv] Webster’s II New Riverside Dictionary provides the definition of ‘crystal’ as “ A 3-dimentional structure made up of atoms, molecules or ions arranged in basic units that are repeated throughout the structure” while Microsoft Encarta Dictionary defines ‘Crystal’ , in chemistry, as “a solid containing an internal pattern of atoms, molecules, or ions that is regular, repeated, and geometrically arranged” and in electronic engineering, “a crystalline substance that has semiconducting or piezoelectric properties and is used as an electronic component, or the electrical device using it.”
[lxxxvi]Subodh Mahanti, Intellectual Property Rights (Part I: Patent System), available at https://www.vigyanprasar.gov.in/dream/may2001/intelleactual.htm (last visited on 13/07/2014)
[lxxxvii]Section 53, Patent Act 1970.
[lxxxviii]20-n (n=3 years) = 17 years.
[lxxxix] “The American Inventors Protection Act of 1999 amended 35 U.S.C. § 154(b) to expand the list of administrative delays which may give rise to patent term adjustment…..The “patent term guarantee” set forth in the American Inventors Protection Act of 1999 establishes three main bases for adjusting the term of a utility or plant patent: (1) if the USPTO fails to take certain actions within specified time frames; (2) if the USPTO fails to issue a patent within three years of the actual filing date of the application; or (3) for delays due to interference, secrecy order, or successful appellate review.” see, Karin L. Tyson & Robert W. Bahr, Patent Term Guarantee Overview, April 7,2009, available at https://www.uspto.gov/patents/law/aipa/pta/patent_term_guarantee.jsp (last visited on 13/07/2014)
[xc] Article 67, Patent Act (Act No. 121 of 1959)
[xci] Jack B. Hicks et al, Patenting Nanotechnology: Is there really plenty of room at the bottom?, available at https://www.wcsr.com/resources/pdfs/nano030310.pdf (last visited on 13/07/2014)