BIOLOGICAL PATENTS:

A biological patent is a patent relating to an invention or discovery in biology. It can be a composition of matter, a method for obtaining or using one or more thereof, or a product combining such things. Even when a natural biological substance itself is patented (apart from any associated process or usage), this has been permitted in the US as long as they are sufficiently "isolated" from their naturally-occurring states. Prominent historical examples of such patents on isolated products of nature include adrenaline, insulin, vitamin B12, and unmodified genes (the latter becoming its own notable controversy as of late).

HISTROY

The 1970s marked the first time when scientists patented methods on their biotechnological inventions with recombinant DNA. It wasn’t until 1980 that patents for whole-scale living organisms were permitted. In Diamond v. Chakrabarty, the U.S. Supreme Court established the patentability of living matter, provided it was truly "man-made." The subject for this particular case was a genetically-engineered bacterium that was specifically modified to help clean up and degrade oil spills.

Since that 1980 court case, there has been much patenting of biological matter. Companies and organizations, like the University of California, have patented entire genome. In 1998, the U.S. Patent and Trademark Office (PTO) issued a broad patent claiming primate (including human) embryonic stem cells, entitled "Primate Embryonic Stem Cells" (Patent 5,843,780). On 13 March 2001, a second patent (6,200,806) was issued with the same title but focused on human embryonic stem cells.

Recently, there has been a slowdown and backlash against patenting biological material worldwide.

CONTROVERSY

Some believe that natural occurrences are not invented and thus should not be patentable. This is especially true if the biological matter being patented can be found in humans, such as sequences of DNA, which invokes a range of political and ethical arguments. The legal reasons for the controversy can vary by different countries' standards for patentability. In the US, an invention must have some "utility" but not necessarily an identified industrial application. According to Nielson and Whittaker (2002), the “notion of ‘utility’ is less specific, it means it is useful”. Beyond utility/usefulness, the US also requires that inventions be new/novel and non-obvious.

Many outside the United States feel that the patenting of stem cells was rash and are seeking to reverse patent rulings. In December 2006, Germany made an important precedent when it annulled the validity of a stem cell patent. The German Federal Patent Court declared that anything made from human tissue cannot be patented. The European Patent Office has ruled that certain stem cell lines, derived from destruction of human embryos, were not to be granted a European patent. Worldwide, people are questioning the validity of stem cell patents. Wisconsin Alumni Research Foundation has sought to gain approval for its US patent in Europe without success.

The backlash against stem cell patents is also occurring in the United States, but to a lesser degree. Currently, an appeal against the patents is being processed by two non-profit organizations: The Foundation for Taxpayer & Consumer Rights and Public Patent Foundation along with molecular

biologist Jeanne Loring of the Burnham Institute. They are fighting the validity of the patents by arguing that two of the patents cover a technique published in 1992, already patented by an Australian scientist. Another claim is that the techniques tied up with the patents are rendered obvious under a 1990 paper and two textbooks.

Advocates who speak against biological patents suggest that the techniques and processes associated with the discovery could be patentable but not the actual biological matter itself. For example, an advocate against biological patent would suggest that a gene associated with cancer should not be patented, but the test used to detect the gene could be.

EFFECTS ON RESEARCH

Some believe that the increase in patenting biological information leads to inefficiency in research. Many scientists are coming up against patent thickets, which are masses of information that they must obtain permission (and often pay large fees to utilize) before they can ever work with the information. Michael Heller and Rebecca Eisenberg (2005) explain that there is a recent trend of patenting more and more steps along the research path. This creates a "tragedy of the anticommons," whereby "each upstream patent allows its owner to set up another tollbooth on the road to product development, adding to the cost and slowing the pace of downstream . . . innovation". A report shows that notwithstanding escalating funding, in the past half-decade biomedical innovation has slowed markedly. The number of drugs approved by the Food and Drug Administration has fallen below previous eras. The technologies approved, it continues, are less influential than previous innovations approved. The current trend of patenting what previously were thought of as basic science insights have raised the financial bar for other scientists wanting to use such insight. The overall trend of more patents may be slowing innovation.

GENE PATENT: an example of Biological Patent

A gene patent is a patent on a specific isolated gene sequence, its chemical composition, processes for obtaining or using it, or a combination of such claims. Gene patents are a prominent subset of the broader category of biological patents. Patents on genes have only been granted on isolated gene sequences with known functions, and these patents cannot be applied to the naturally occurring genes in humans or any other naturally occurring organism. There are no patents on "your genes" and no one can own "your genes".

HISTROY

The United States has been patenting chemical compositions based upon human extractions for over 100 years. The first patent for such a chemical was granted on March 20, 1906 for adrenalin. Judge Learned Hand justified permitting patents on purified natural substances on the rationale that they can become substantially more useful than their non-extracted or less-pure states. Insulin followed adrenaline as the second patent in 1923. Vitamin B12 was also patented (by Merck), prior to which it was difficult for people with deficiencies to get sufficient doses.

But prior to the 1970s it was almost unheard of to submit an application to the United States Patent and Trademark Office (USPTO) for an organism. The United States Supreme Court in Diamond v. Chakrabarty clarified that as long as the organism is truly "man-made," such as through genetic engineering, then it is indeed patentable. As a rule, raw natural material is generally rejected for patent approval by the USPTO. It is only after a DNA product is isolated and purified (or modified) that a patent

is considered. Over three million gene related patents have been applied for in the United States alone. (All pending applications are made public at 18 months after filing unless otherwise requested by the applicant.)

As of 2010, 40,000 patents exist on an estimated 2,000 human genes, or about 20 percent.

CONTROVERSY

There is particular political and ethical controversy over whether these patents advance technology by providing scientists, companies, and universities with an incentive to create, or hinder technology via litigation or threat of litigation. There is also controversy over whether and to what extent companies controlling gene patents hinder basic and/or clinical research. Finally, there is controversy over the price of medical treatments and diagnostics that are protected by gene patents.

While there is some controversy concerning the patenting of isolated genes and the way those patents are used, and there is controversy concerning patents on the diagnostic uses of genes (the real source of dispute in the Myriad court case), there is less controversy about patents on genes that are used to manufacture therapeutic proteins (for example, the protein therapeutic drug candidate that is the subject of the early part of the movie 'Extraordinary Measures' was covered in part by a classic gene patent, US Patent 6,770,468 ). There is also little controversy concerning the role of gene patents in the chemical industry—for instance in the manufacture of enzymes used in consumer products or industrial processes. In descriptions and enactments of the controversy over "gene patents", it is rare to find references to these everyday uses of genes and gene patents.

Gene Patents ruled invalid by a U.S. federal court; ruling being appealedA complaint against Myriad Genetics and the US Patent and Trademark Office filed in 2009 by professional medical organizations, doctors, and patients, all represented by the American Civil Liberties Union, sought to invalidate and discontinue all patents for naturally-occurring genes, which have thus far been issued on the grounds that such genes are "isolated and purified" to a non-naturally-occurring state. Myriad owns some of its patents; some were licensed from University of Utah. Specific claims, but not all claims, in seven of Myriad's 23 patents on BRCA1 and BRCA2 were challenged in the complaint. The challenged claims covered the isolated genes as well as diagnostic methods.

Many people working in the patent field had predicted that the courts would throw out this case.

However, the case was accepted, and all the challenged claims were ruled invalid on March 29, 2010 by United States District Court Judge Robert W. Sweet, a judge in the U.S. District Court for the Southern District of New York.

The claims that had not been challenged still stand.

Judge Sweet's 152–page decision ruled that the challenged claims to the isolated gene sequences had been "improperly granted" because they claimed unpatentable subject matter; the claims to the diagnostic methods were found invalid under the recent In re Bilsky decision. Because the case could be decided

with patent law, Judge Sweet did not look at the challenge on First Amendment grounds and dismissed them without prejudice. In his decision handed down March 29, 2010, Judge Robert W. Sweet of the United States District court of the Southern District of New York, rejected the legal equivalency between 'chemical compositions' like purified adrenaline and DNA. In his opinion Judge Sweet said: "The information encoded in DNA is not information about its own molecular structure incidental to its biological function, as is the case with adrenaline or other chemicals found in the body...this informational quality (of DNA) is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as 'no different' than other chemicals previously the subject of patents....DNA, in particular the ordering of its nucleotides, therefore serves as the physical embodiment of laws of nature - those that define the construction of the human body…the preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are to unpatentable products of nature."

The decision could prove far-reaching for the biotechnology field.

However, on March 30, 2010, Myriad announced that it will appeal the decision.

INDIAN PATENT MECHANISM:-

BIOTECHNOLOGY PATENT FACILITATING CELL

Intellectual property protection plays an important role in gaining advantageous position in the competitive game for economic growth. India enjoys a large asset of R&D personnel and infrastructure facilities. Scientists and policy makers need information and facilities for protecting the products of intellectual power of Indian Scientists. As a step in this direction, a Biotechnology Patent Facilitation Cell was established by the Department of Biotechnology (DBT) in July’1999.  

Biotechnology Patent Facilitating Cell, a single window awareness -cum - facilitation mechanism, established under Department of Biotechnology, Ministry of Science and Technology, aims to create awareness and understanding about Intellectual Property Rights (IPRs) among scientists and researchers, by arranging workshops, seminars, conferences, etc. at all levels and for introducing patent information as a vital input in the process of formulation of R&D programmes in biotechnology and providing patenting facilities to biotechnologists in the country, for filing Indian and foreign patents on a continuous basis.  

Objectives

BPFC has been established with the following objectives:

Creating awareness and understanding among biologists and biotechnologists, relating to patents and the challenges and opportunities in this area including arranging workshops, seminars, conference, etc., at all levels.

Introducing patent information as a vital input in the process of promotion of R&D programmes in biotechnology and biology.

Providing patenting facilities to biologists and biotechnologists in the country for filing Indian and foreign patents on a sustained basis.

Keeping a watch on development in the area of IPR and make important issues known to policy makers, bio-scientists, biotech industry, etc.

Achievements

During few years of its existence, BPFC has carved out a unique identity of its own among the biologists and biotechnologists in the country; with several achievements in the field of technology development in the Indian context. BPFC has facilitated filing more than 100 Indian and international patent applications out of which more than 10 patents have been granted. BPFC now look forward to Industry for taking up of these technologies to the market and to the consumers.

Patents Granted so far Inventor Title of Invention International Patents Dr. Asis Datta,

SLS, JNU Seed storage protein with nutritionally balanced amino composition. (3 US Patents) Dr. Rup Lal

Department of Zoology,University of Delhi A Process for development of cloning vectors. (2 Patents, Europe, USA)

Dr. Debi P. SarkarDelhi UniversitySouth Campus A targeted drug delivery carrier (1 Patent, USA) A Process for Producing a targeted gene for drug delivery carrier(1 Patent, USA)

Prof. A. N. Maitra,Deptt. Of ChemistryUniversity of Delhi,' Particles of below 109 mm highly mono-disposed drug loaded… medical systems (1 Patent, USA)

Indian Patents Dr. Padma SridharDepartment ofMicrobiologyOsmania UniversityHyderabad       Process of producing Cephamycin-C by Solid state formation, Process for continuous production of Cephamycin-C by formation, Process of producing Cephamycin-C by submerged batch fermentation (3 Patents)

Dr. Rekha Hari Das, CBT, Mall Road, Near Jubilee Hall Process for Preparing transfer vector PCTB1 to PCTB4 for the purpose of expressing proteins for commercial use (1 Patent)  

Awareness Creation Series of national roving seminars are organized on “Patenting in Biotechnology” and “IPR in

Biotechnology” at various institutions and universities around the country, in collaboration with World Intellectual Property Organization (WIPO), Geneva, to enhance the awareness of the scientists about the inventions, process of patenting, issues in IPR in biotechnology and the strategic importance of the IPR in post-GATT era.

Training of Scientists In order to promote basic understanding of patents and other IPR-related issues among the Indian scientists, and to analyze issues in the area of patenting in biotechnology, department has initiated one-week refresher courses on IPR in biotechnology for officers and scientists at the National Law School of India University, Bangalore which will be held four times in a year. The four such courses were held during the last financial year. Through these training programmes it is intended to create awareness about the need for protection of intellectual property generated by the scientists in biotechnology and its identification, utilization, IPR regime in the country and outside, the procedures and nuances of writing

patent documents with description and claims and issues associated with the protection of live forms, international patenting, product patents etc.

Patenting Nanotechnology- the Challenges posed to the Indian patent regime

Introduction

The Indian patent regime, originating from as early as 1856, has morphed into one of the most competent mechanisms of the modern era. Having been subject to remodeling and amendments of sorts since its inception, the present Indian Patent Act stands fulfilling nearly all the requirements clamped down by the globalized patent regimes, as encapsulated in the TRIPS mandate, as also the Patent Co-operation Treaty, 1970. A patent refers to the protection accorded to any new and useful invention. The quintessence of the Patents Act lies in the norms laid down, to be satisfied in order for a patent to be granted for an invention. The invention should be novel, should involve some inventive step, and should possess some degree of industrial applicability. Filing of applications, framing provisional and complete specifications, redress of infringement grievances, grant of compulsory directions, secrecy directions and revocation of patents, among several other minor topics are found within the gamut of the Indian Patent Act.

In tandem with the changes in society, an operative change in technology has been witnessed. As newer avenues emerge, Science unfailingly throws challenge after challenge in the path of law, as each new mechanism knocks on the doors of the Intellectual Property system, seeking protection therein. Protecting some of these technologies are often grey areas in the Indian Patent system. One such avenue, which has kicked up much consternation, is the field of nanotechnology. The factor that makes nanotechnology unique is that it uses a process distinct from that of traditional forms of technology. Most  top  down  manufacturing  processes  take  the  help  of  the  top  down  process wherein  larger blocks are broken down into smaller ones.

There are two main ways of applying nanotechnology so far: one is the top-down approach, whereby structures are made smaller and smaller until they reach a nanometre scale using larger elements. The other approach is the bottom-up approach, by which elements at the Nanoscale are chosen and assembled to form some sort of matter or mechanism. This way of manipulating matter at the atomic level obviously bears the potential of enormous developments. Why nanotechnology? The extent of the scientific demand and commercial worth of the branch of science pertaining to nanotechnology warrants an examination into the feasibility of the present patent regime in protecting the inventions arising in the aforementioned branch of knowledge. Between 1997 and 2002, the quantum of nanotechnology patents had increased by an astounding 600%. World over, patent offices are clamoring to develop methods to deal with nanotechnology. The subject encompasses a plethora of other disciplines within its gamut, such as chemistry, biology, physics, computer science, material science, engineering, medicine and even electronics. It becomes imperative that a completely new paradigm be explored, to cull out effective patent protection mechanisms. The grey areas, phrased in the form of questions include the following:

Can these products be patented at all? Are these products and processes obvious, granted that molecular drugs and bulk metal catalysts

are known elements? Can the Indian patent Office do the needful with regard to protecting nanotechnology?

The promises of nanotechnology are large. Given what is at stake and the high expectations put on the burgeoning industry, it is imperative for the current patent doctrines to effectively respond to new technology. Nanotechnology investors face uncertainty about the extent of their patent rights. Patents with broad claims, that lack reference to scale, on traditional products, might allow traditional patent holders to exact royalties from their nanoscale counterparts. Furthermore, bargaining between the traditional and nanoscale manufacturers might break down because of the diverging valuations that the parties place on their assets.

Nanotechnology- Learning the Ropes

Nanotechnology – the technology of the smallest objects – is slowly but surely progressing. The first products making use of nanotechnology are appearing on the market, amongst others: tennis racquets, ski wax, and sun burn crème. The European Patent Office has granted about 80,000 patents on inventions in the field of nanotechnology. Hitherto, European academic literature has had hardly any attention for the patenting of nanotechnology. This is remarkable in view of the fact that nanotechnology raises new and important questions of law, as well as questions relevant for the development of nanotechnology industry in Europe. Well-known examples of nanotechnology are nano-carbon tubes and bucky-balls for making extremely rigid constructions, quantum dots which can be applied as markers for labeling purposes, and dendrimers that may be used for drug delivery purposes. The EPO defines nanotechnology as follows:

"The term nanotechnology covers entities with a controlled geometrical size of at least one functional component below 100 nanometres in one or more dimensions susceptible to make physical, chemical or biological effects available which are intrinsic to that size. It covers equipment and methods for controlled analysis, manipulation, processing, fabrication or measurement with a precision below 100 nanometres."

The general definition is that Nanotechnology refers to the science, building, visualizing and manipulating at the nanometer scale. Put simply, nanotechnology is the science and technology of building things from the bottom, upwards- one atom, or one molecule at a time. It stands to be the diametric opposite of traditional industrial technologies, which operate from the top, downwards. Raw materials in quintessential forms of traditional industries are broken down and machined into precisely crafted products, by removing the unwanted segments of the same. It was introduced by Richard P.Feynmann, a 1965 Nobel Laureate, in a lecture entitled “There’s plenty of room at the bottom”                However, this method differs greatly from natural processes in one way or the other. Every object on earth consists of molecules, cells and miniscule organelles. Based on the particular configurations, a construction of these molecular structures can create objects of astonishing size, like the coral reef, or a redwood tree, or even the human brain. This approach produces results which would normally seem impossible. It is often seen that these processes are taken for granted. A simple example for this is the human body. It begins as a single cell, but evolves into a mature human being consisting of 75 trillion complexly arranged cells. The molecular machinery responsible for this amazing, feat of production is capable of such results because it performs operations in parallel.

This process, thus, serves as a kind of an “existence proof” for nanotechnology. Of course, putting these natural molecular machines to work is in effect, nothing new, as every living being does so constantly. But, where nanotechnology differs is, in the fact that it attempts to transcend the realm of the natural. Full fledged nanotechnology successfully exercises complete control over the physical structure of the matter, akin to what is done by a word processor over the form and content of textual matter.

Using nanotechnology, production would be carried out by large numbers of tiny devices, operating in parallel, in a fashion similar to molecular machinery already found in living organisms. These nanodevices wouldn’t have to be made out of protein or other substances extractable from the natural environment, but can be constructed out of whatever fashion is most suited to their task. Popularly known as ‘assemblers’, these miniscule devices would be capable of manipulating individual molecules rapidly and precisely. Instead of weaving cloth this method would seize individual atoms using selectively sticky manipulator arms, and then “plug” those atoms together until chemical bonding occurs. By repeating these steps according to a programmed set of instructions, a nanotechnologicial approach would be able to synthesize materials faster, and at a lower cost.

Besides such efficient and powerful manufacturing capabilities, there exist more sophisticated applications. For instance, specially designed nanodevices, the size of bacteria might be programmed to destroy arterial plaque, or fight cancer cells, or repair cellular damages caused by aging. Finishing with these tasks, the element shall be induced to self destruct, or remain in a surveillance mode, or cause, in some cases, to integrate with the body cells itself. In addition to treating diseases, the technology would be exceptionally useful in producing drastically enhanced mental, physical and sensory abilities. Substantial changes in human morphology would be possible and even copying thoughts and memories, and actually storing them, would soon be reality, thanks to nanotechnology.

Patenting Nanotechnology- Challenges posed to the Indian Patent Regime

Even though many patents on nanotechnological inventions have been granted, little has been written about how easy or how hard it is to obtain nanotechnology patents and which problems and peculiarities an applicant encounters. Therefore, the patentability of nanotechnology is here discussed in more detail. The analysis of nanotechnology patenting is a necessary input to the more fundamental questions concerning the patenting of nanotechnology. A patent is granted for any invention, based on any kind of a technology as given under A.27 of the TRIPS agreement, as long it satisfies the norms of novelty, inventive step and industrial application. Emerging technologies present newer challenges in the path of granting patents. The challenges posed are one too many to discuss in entirety, but a select few, in pertinence with the Indian patent regime are thus dealt with:

A. The nature of the technology itself

The TRIPS agreement mandates that patents shall be accorded to inventions based on any technology, whatsoever. However, it is unfortunate that India lags behind in this regard. The Indian patent regime is not accommodative towards the idea of granting patents to inventions in the field of biotechnology, and nanotechnology. The need of the hour is to patent these inventions, as the threat of infringement is imminent, particularly on account of the usefulness of the invention. Nanotechnology is not confined to a single field of endeavour but exploits the peculiar properties of matter at the nano-scale level, across a plethora of areas in   modern engineering.  It dabbles with fields such as semiconductor design, biotechnology, materials science, telecommunications, and textiles, even though the patent is held by a firm that works in only one of these industries.

Emerging technologies have always been at daggers drawn, with the issue of patentability. Huge amount of patents are being filed for already patented inventions, with the only difference being that they are mere improvements in that field. In the past when the software boom captured the commercial arena of technological use the patents were not allowed for software developments. Biotechnology was also not considered as patentable and many of the inventions therein were ineligible for patenting as they involved the human body, by virtue of the fact that they dealt with the human body.  This trend had changed after the case of Diamond v Chakraborty.  Here,  a genetic engineer Ananda Mohan Chakraborty had

developed a bacterium capable of breaking down  crude  oil  which  is  proposed  to  treat  in  oil  spills. Initially, the patent was rejected however subsequently the Supreme Court in a majority opinion held that a live human made micro organism is a patentable subject matter and is a manufacture therefore patentable under the Act and it was further observed in this case that any thing under the sun can be patentable.

The  World  Intellectual  Property  Rights  Organization  (WIPO)  identifies  certain complexities  regarding  nanotechnology. One  problem, which  is,  to  a  certain  extent,  shared with a number of other emerging technologies is that the granted claims are overly broad, due at  least  in part  to  a  lack of available prior art, which  could  allow patent holders  to  lock up huge areas of technology. In this context, there is also a perceived risk of overlapping patents.

B. Lack of technical knowledge

Few individuals are equipped with sufficient knowledge with regards to nanotechnology. Knowledge driven economies like Europe and the USA have also expressed their inabilities with regard to the subject. India isn’t far behind, where this issue is concerned. This lack of knowledge and understanding would hamper the advancement of the field. Either patents may simply Not be issued altogether due to the lack of knowledge, or, the construction of claims and their scope would be put through indiscriminate questioning because the examiners fail to grasp the nuances of the invention altogether.

Another consequence of the lack of knowledge is that the patents granted would be far too wide, or too loosely defined, making it difficult to enforce the granted patent. The Indian patent offices are not equipped with the individual and organizational structure, to deal with nanotechnology. While information on different technology, branches are made available to the patent offices, there is next to nothing on nanotechnology. Conquering ignorance in the field of nanotechnology is a major challenge to the Indian patent regime. Further, the gamble of not knowing the utility of an invention is a major challenge to the Indian Patent Regime.

C. Novelty and Identifying Prior Art

The broad scope of nanotechnology arises on account of the fact that manipulation of materials or particles at the atomic level applies to a wide array of fields. This multi-dimensional feature causes the identification of previously distinguishable technological fields. Identifying prior art itself, is a tedious task, posing another challenge to the Indian Patent Regime. This is especially so in the case of nanotechnology. The absence of a proper prior art database is the major drawback in the Indian patent regime. Since the crux of nanotechnology vests mainly on the size factor, a number of size related questions arise: how do nanoscale inventions relate to prior art that does not specifically relate to a nano size? Could such prior art anticipate a nanoscale invention? Could prior art that refers to micro or larger scale take away the novelty of a nano scale invention? Is size alone enough to confer novelty upon an invention? What happens if size ranges mentioned in a prior art document and a nano scale patent application overlap?  An invention is only anticipated if it has been described completely and inclusive of all its elements in the prior art. If the prior art refers only to the micro or larger scale the nano scale equivalent is generally not anticipated.

Novelty is evaluated against the available prior art. The multidisciplinary nature of nanotechnology results in the bridging of different fields of application, which makes it difficult to cull out the element of novelty altogether. Since novelty depends on the extent of prior art, it is necessary for a strong database of prior art. The Indian patent database ought to be made stronger. Akin to the Traditional Knowledge Database (TKD), there ought to be one with fully updated information, pertaining to nanotechnology, in

India. If the prior art does not refer to size, could it be true that a nano scale invention can be anticipated? Is the novelty of the nano scale invention destroyed simply because it is covered by the terms of a prior art document? This is not necessarily the case. In the first place, the prior art is destructive of novelty if it contains an enabling disclosure.

 Even if a nano scale invention is covered by the terms of a prior art document, it may still be novel if the person skilled in the art cannot practice the invention without knowledge of the claimed invention or engaging in inventive activity. If it is not clear to the person skilled in the art how to manufacture a nano scale variant of the prior art invention, this could well be enough to preserve the novelty of the nano scale invention. While the patentability of nanotechnology invention can be questioned in certain cases, the existing patent law framework gives enough inroads to confer novelty upon most nano scale inventions. This mainly derives from applying well-known patent principles to nano scale inventions. 

D. Inventive Step

An invention must involve an inventive step, making it non-obvious to a person skilled in the art. Even if a nanoscale invention is novel over the prior art, the inventive step requirement must be met. The first question one would ask is as to whether in nanotechnology inventions, downsizing in itself is not an obvious step for the person skilled in the art to take. From the decision of the Technical Board of Appeal, USA in case T 0070/99 (about micro scale analytical devices), it can however be derived that mere downscaling does not give rise to an inventive step. On what grounds, then, could one deem the existence of an ‘Inventive step’ in a Nanotechnology invention? An inventive step may reside in the fact that other processes have to be used to arrive at the nano scale products than is the case with bigger products. The other processes must of course not be obvious to the person skilled in the art, confronted with the problem of producing at nano scale.

If there is an unexpected function at the Nanoscale, it could be construed as an inventive step. The crux is that the unexpected function must solve a problem stated in the patent. Such unexpected results have been known to occur in nanotechnology. Carbon nanotubes can, for instance, depending on their construction, carry a much bigger current per surface unit as opposed to traditional metal conductors. The unexpected function must not be a mere side or bonus effect. If there are good reasons for a person skilled in the art to go down the road of the invention, then the occurrence of the ‘unexpected’ bonus effect does not contribute towards inventiveness.

E. Industrial Application

For an invention to be patentable, it must be capable of use in any kind of industry. Since nanotechnology is still in its infancy and many applications have not progressed beyond the laboratory stage, one couldn’t possibly fathom the extent of plausible industrial application. The nature of nanotechnology inventions often points the way to their industrial applicability: nanotubes for making light and strong constructions, nano drug delivery systems, or nanotechnology used to create high electric conductivity are self-evidently industrially applicable. In India, the problem that nanotechnology presents is that it is a technology that is completely unknown and presents a picture of potentials that are yet to be explored. The  Indo-US  joint forum  on  science  and  technology  has  identified  this  area  of  intense  cooperation.  .F. Enablement Issues

The patents act requires an inventor to disclose the best way of manufacturing his invention, to enable a person skilled in the art to do the same, post expiry of the patent. A major problem posed by nanotechnology to the present patent regime, is that the scope of the invention and the field of knowledge

itself is far too wide. Expressing and explaining the contents of the invention in full detail is next to impossible. The quintessence of the criterion of ‘sufficiency of disclosure’ is thus encapsulated:

1. That the invention is disclosed in a way that allows it to   be practiced, and 2. That the (teaching of the) invention must be reproducible.

The first requirement implies that the person skilled in the art on the basis of the disclosure can rework the invention without an undue burden. Reproducibility indicates that the result of the invention can be reached over and again and not just on the basis of chance or only with a smaller or larger degree of predictability. If the examining or opposition division has no way of knowing or inferring the practicability of a nanotechnology invention, let alone its practicability across an entire range, it may very well require the patent applicant or patentee to beef up its disclosure and provide more detailed instructions for the reworking of the invention. Additionally, the fact that the invention produces the claimed results in a repeatable way may pose problems for nanotech inventors. In nanotechnology, analytical methods, tools and metrologies are often not available to the person skilled in the art. Without these the reproducibility of an invention may be difficult to ascertain. An inventor would thus be obliged to disclose these in the patent in order to make his claims verifiable.

Suggestions- The measures to allow the patent regime to rise to the challenges

Till date, India has  been  very  laid back  in  terms of  research  and development  in  the  field of nanotechnology  even  though research  and  development  and  the  possible  commercial  benefits  of Nanotechnology are clear to all. The possible reasons for the same could be that at the  moment  the  true  characteristics  and  use  of  the  technology  has  not  been  properly understood. The other reason is that even though the Indo-US civil nuclear deal is one of the most  important  steps  for  the  energy  requirements  of  India,  but  the government has been  so busy  in  formulating policies  and  rules on  this  technology  that  little attention  is being paid to other technologies. The patent if properly granted facilitates more and more innovations in  the  field to which  the  invention belongs however  the growth  retards once the  patents  are  wrongly  granted  or  rejected.              At present the Indian Patent Act has no provision that even incidentally touches the field of nanotechnology. There have been no guidelines or regulations framed with respect to regulating this technology even though the TRIPS agreement specifically  provides that intellectual protection must be extended to all fields of science so that it encourages more research and innovations. The need of the hour is to firstly formulate a plan for increasing the research and development in the field of nanotechnology, secondly to provide for funding and special incentives for research in this field. One of  the methods or possible solution  to  the present problem of patenting Nanotechnology can be addressed by bringing amendments in the Indian Patent Act  that may  not  be  exhaustively  directed  to  nanotechnology  however  they must  have some  mechanism  to  recognize  the  field  of  nanotechnology  and  formulate  a comprehensive  regulatory  plan  that  deals with Nanotechnology  providing  for  research, possible hazards and a framework for regulating the same.

Sweeping changes ought to be brought, in the Indian Patent Regime, to rise to the occasion, and take on newer technologies with ease. A few of these suggestive measures may be put to use for the same:

Patent applications are to be examined by a team of examiners, as opposed to a single examiner, as multiple inspections would prove better in understanding the claims

Creation of a database of prior art, akin to the Traditional Knowledge Database. One single organized and centralized command centre must be established, for the sake of

nanotechnology patenting. This would ensure uniformity in patent claim interpretation.

Training to personnel on a periodical basis would help meet the challenge of lack of information on the subject.

Creating expanded prior art databases would be prudent mechanisms to help ascertain the elements of novelty and inventive step.

The patent offices must be open to accepting wider claims as the case shall prove, in order to accommodate technologies in their nascent stages.

Conclusion

Nanotechnology will be an important part of our lives, providing us with the ability to do things on an atomic and molecular scale. To succeed as a business, companies that develop new discoveries and uses for nanotechnology will need patent protection. With a carefully developed patent strategy, the Indian Patent Regime can successfully rise to the challenge thrown in by Nanotechnology. Though the grey areas are numerous to count, the same should not act as a bar to the grant of patents to the inventions arising out of nanotechnology. Laws are enacted for society, by society, and works in society. It would be unfortunate to allow our legal systems to remain redundant, while science and technology take giant leaps. Science depends on law, to protect its new creations. A development in law, is thus, not too much to ask in the light of an advancement in Science.

BIOLOGICAL PATENTS

AND

INDIAN PATENT MECHANISM

By

VARSHA SINGH

REG NO.: 20070002

B.Tech , Biotechnology (6 th Semester)

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