“Undue difficulty in gaining patent protection will deter investment by reducing the prospect of a reasonable return. This is not in the interests of patients, or of industry. On the other hand, too free availability and excessive breadth of protection will give undue reward for prosaic contribution and may inhibit the speed of exchange of basic knowledge and the likelihood of development of useful products.”1
Genes are the physical units of heredity that parents automatically transfers to children. They are composed of a molecule termed deoxyribonucleic acid (DNA). DNA is composed of sequences of components known as nucleotides.3 Genes are cardinal as they consist of blueprints for the body engaged in formulating proteins. It is proteins that are responsible for growth of our bodies.4 Genes are chemical compounds qualified as compositions of subject matter to meet patent standards. Amongst the parameters of patentability determined by the US Patent Act, there are various exceptions as scrutinized by the courts. A naturally occurring or a preexisting substance of nature is not patentable, per se. However, the courts have ascertained that a product of nature may be patentable if significant artificial alterations are made. By isolating, purifying or otherwise altering a naturally occurring product, an inventor may obtain a patent on the product in its altered form.5 Thus, one cannot patent a naturally occurring gene or protein as it exists in the body, but one can patent a gene or protein that has been isolated from the body and is useful in that form as a pharmaceutical drug, screening assay or other application.6
The practice of granting patents on genes, although upheld by the courts, has come under criticism and scrutiny by some legal scholars, scientists and politicians. The subject of gene patenting includes several ethical, legal, and economic constituents. Although not mutually exclusive, brief understandings of several issues are as follows.
ETHICAL ISSUES INVOLVED IN GENE PATENTING
There is a notion that gene patents allow outsiders ownership of another person’s genetic constitute, often without their consent or knowledge.7 This concern has extended to complaints that patients no longer possess their own bodies and doctors are restrained from testing for various diseases.8 It is debated that patents obstruct access to testing process because gene-patent holders can ascertain any use of their gene and they can restrict a doctor from testing a patient’s blood for a particular genetic mutation and can forbid anyone performing research to enhance a genetic test or to come up with a gene therapy based on that gene.9 This comprehended constraint on research and testing options are the problems to antagonists of gene patents.10 Indeed patents on peculiar genetic information determines and limits the medical usefulness of the information and impedes or prevents far-flung research on the disease, the traditional pathway by which medical knowledge is encouraged, advanced and shared.11
However, some experts disagree. According to them, the courts have consistently taken the position that a person does not own any cells or tissue once they are outside the person’s body.12 There exist no such evidence of patients unable to utilize existing genetic tests because of patents. Rather, they maintain, it as a financial issue related with the monetary value of health care and/or an issue of profits for the doctor or clinical geneticist and pathologist wishing to administer tests patented by other inventors.13
Similarly it is established that there is little quantitative evidence so far as negative impact of patents on scientific research activity is concerned.14 The disclosure obligations of the patent system may better facilitate the objective of encouraging and advancing the diffusion of knowledge and eliciting social returns than the substantial legal alternative and trade secret protection.15
LEGAL ISSUES AFFECTING VALIDITY OF GENE PATENTING
Eminent jurists and academicians contend that genes are products of nature and hence discoveries and that do not meet the criteria necessary to obtain a patent.16 As contend the useful properties of a gene’s sequences are not ones that scientists have invented, but instead, are natural, inherent properties of the genes themselves.17 The fact that the gene has been isolated is considered a “technicality” by experts who subscribe to this view.18 Courts have upheld gene patents if they meet the essential requirements of the US Patent Act. According to some analysts, the law grants patents on discoveries despite what is repeatedly confirmed by the antagonists of gene patenting, patent law applies equally to “discoveries” as to “inventions.” In fact, Article 1, Section 8 of the U.S. Constitution explicitly pertains to “discoveries,” as does the Patent Statute:
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent.”19 As Bendekgey and Hamlet-Cox has pointed out, numerous biotechnology products are built upon compounds existing in nature including such therapies as interleukins, interferon’s and insulin.20 Similarly, a patent on penicillin was granted to Alexander Flemming who isolated and purified the drug from mold, a naturally occurring substance.21
The quality of the gene patents awarded by the USPTO has always been a concern for some experts. A study reveals that 38% of the claims contained in 74 patents on human genetic material were “debatable.”22 This research indicated that utility issues were identified as the most frequent and prevalent problem, accompanied by the required written description of the invention.23 It is also contended that gene patents do not meet the criteria of non-obviousness, because, through in silico analysis, the function of human genes can be anticipated on the grounds of their homology to other genes.”24
This analysis is not without criticism, as questions have been raised regarding the authors’ definition of “problematic” that is based upon the authors’ perspectives rather than court decisions. In addition, the data include patents awarded in the early 1990s when gene patenting was still developing and there was little experience and expertise on which to grant these patents.25 Such concerns over patent quality are not limited to gene patents. The debate over whether or not the USPTO is too lenient in awarding patents is current and is specifically intense as emerging industries develop and seek patents.
The patent process is an activity heading towards claims that certain technologies are not amenable to patenting or that patents granted do not meet the requirements of the Patent Act. Nevertheless, as patent inspectors or examiners build up expertise in a new field and develop prior art, the quality of patents generally increases.26
ECONOMIC ISSUES WITH RESPECT TO GENE PATENTING
Biotechnology industry leaders view patents as vital for protecting innovation. It is found that patents are considered the most effective and efficient method to protect inventions in the drug industry, particularly when biotechnology products are patentable.27 Some commentators note that patents are particularly significant in this sector because of the relative ease of imitating the finished product. Costs associated with imitating a product is extremely low relative to the innovator’s costs for discovering and developing a new compound.28
Antagonists of gene patents debate that they restrain additional research because there are no alternatives to a patented gene in diagnosis, treatment, and research,29 and owners necessitates licensing fees.30 However, despite the fact being some experts claim to be a negative result of financial considerations in the biomedical research community,31 others maintain that gene patents prevents the doctors and clinical geneticists from performing tests for profit, or in a way that vies with the patent holder, without reimbursement to the inventors of those tests.32
Some analysts assert that certain patents, particularly those on research tools33 in biotechnology, hamper the innovation process. It is posited that ownership of research tools may inflict significant transaction costs that may result in delayed innovation and possible future litigation.34 The most important research tools are fundamental research platforms that open up new and unknown areas of investigation that needs to foster development by researchers in this field.35
While acknowledging that patent protection on research tools has induced private investment in biotechnology and the development of new products and processes, Eisenberg writes that:
Patents on research tools threaten to restrict access to discoveries that, according to the firm beliefs of scientists trained in the tradition of open science, are likely to have the greatest social value if they are widely disseminated to researchers who are taking different approaches to different problems.36
But this averment was disputed that there was no such norm regarding open scientific access as opposed to intellectual property protection in biological science community.37 Experiences depicts that patents on inputs generally do not prevent the production of outputs and that the availability of intellectual property protection has expanded the resources available in the biotechnology community and led to its success.38 It is established fact that there is no evidence that gene patents have induced a decrease in research in the biomedical arena or in gene therapies.39
According to a recent analysis it was concluded that patents do not have substantial impact upon basic biomedical research and that none of random sample of academics reported halted a research project due to another’s patent on a research input, and only about 1% of the random sample of academics reported experiencing a delay or modification in their research due to patents.40 Indeed obtaining tangible research inputs appear to be more difficult because of cost, competition and time issues.41 As genes will continue to be patented and research in the field of biotechnology continues, the discussion surrounding the ethical, legal, and economic issues of gene patenting remains on-going in the public policy arena.
A CRITICAL ANALYSIS OF MYRIAD’S PATENT CASE
To understand the particular criticisms pointed against Myriad’s patents over the BRCA1 and BRCA2 genes, it is necessary to briefly examine and review the history of their identification. Over a number of years, scientists within and outside of Myriad found that the BRCA1 and BRCA2 genes lead the body to produce tumor suppressing proteins. These proteins when present reduce the probabilities that an individual will develop cancer. When there is mutation in one of these genes, the body ceases to produce the protein, thus increasing the risk of contracting breast or ovarian cancer. On the basis of above knowledge, Myriad and others applied for and obtained patents over the genes and associated diagnostic test.
The criticisms against Myriad’s patents are quintuple. First, experts claimed that what Myriad did was simply to identify the function and sequence of two preexisting genes. This, they claimed, was a discovery and not an invention as no human intervention was required for the genes to possess this function.42 Second, even if the act of sequencing a gene could be considered an invention in the abstract, the process of sequencing genes has now become so routine that act alone can no longer be considered to be inventive.43 Therefore, if at all the scientists did was just sequence a gene, the invention would be considered obvious and not patentable. Third, some contended that the problem with Myriad’s patents is that they cover all possible and potential functions even those unknown at the time of application of the genes and covered virtually all forms of diagnostic testing, even those not contemplated by the inventors. Id est, the scope of the patent claims was comprehensive and should have been restricted to a specific function.44
Fourthly, argument made was that Myriad’s patent over the diagnostic test should be rejected as it should fall within certain exemptions according to which methods of medical diagnosis and treatment cannot be patented.45 Fifthly, there was argument about whether Myriad’s patent actually could be used to prevent certain activity, most prominently, research aimed at developing or improving diagnostic tests in the clinical setting.46 Consequently in a lawsuit, Association for Molecular Pathology, et al., vs. United States Patent and Trademark Office, et al. was filed against Myriad Genetics and the U.S. Patent and Trademark Office by professional medical organizations, patients and doctors, represented by the American Civil Liberties Union. The complaint fundamentally challenged claims on specific isolated genes and diagnostic methods in seven of Myriad’s 23 patents on BRCA1 and BRCA2. It is worth mentioning that some patents are owned by Myriad and some of them were licensed from University of Utah. The plaintiffs wanted specific claims to be declared invalid on the grounds that they are not patentable subject matter and that the isolated genes are not patentable products of nature and that the diagnostic method claims are evolved thought processes that do not yield any actual transformations.
In a decision by Judge Sweet it was held that the challenged claims to the isolated gene sequences had been “improperly granted” because they claimed not patentable subject matter and hence the claims to the diagnostic methods were observed to be invalid with reference to the recent In re Bilski decision.47 As case could be decided with patent law the Court did not consider the challenge on First Amendment grounds and dismissed the same without prejudice.48
The Federal Circuit partly upheld and partly overturned the decision of District Court.49 The Federal Circuit annulled the District Court’s finding that the claims extending to isolated gene sequences are invalid and also invalidated some of the diagnostic claims;50 the Federal Circuit upheld the finding that the claims for the diagnostic methods that only compare or analyze sequences that have no transformative step and are therefore held invalid.51
Recently issue of validity of Myriad gene patents reached to US Supreme Court and the Court ordered an appeals court to take a new look at the lawsuit. In a short order the court vacated that ruling and ordered the Federal court to consider the case again in light of a landmark Supreme Court ruling that invalidated two of the Prometheus Laboratories Inc. patents on a medical diagnostic test for monitoring drug dosages in which it was held that companies cannot patent observations about a natural phenomenon.52 Recently, the U.S. Federal Circuit Court of Appeals upheld the Myriads right to patent “isolated” genes known as BRCA1 and BRCA2, which account for most inherited forms of breast and ovarian cancers. However, the court denied the company’s effort to patent methods of “comparing” or “analyzing” DNA sequences. The argument that genes BRCA1/2, do not meet the criteria for patentability is hoped in several respects. As national patent law in OECD countries distinctly holds that genes are patentable.53 It is debatable that International trade agreements such as the Agreement on Trade-Related Aspects of Intellectual Property Rights also necessitates this conclusion. The result is that the steps required to purify and isolate genes in order to sequence them are conjointly considered to be a sufficient intervention as to quality of the genes as inventions. As law does not explicitly make differentiation between the concepts of discovery and inventions, courts have held that particular categories of activity cannot be patented because they are ‘products of nature’.54 In this category are scientific principles such as the law of gravity and pure mathematical formulae. However, genes do not fall within these exclusions.
Reference can be made of United States Supreme Court decision in Diamond v. Chakrabarty55, in which the Court held that a genetically altered organism i.e. a bacterium that cleaned oil spills competent for patent protection, the patent office has been granting patents over genes, animals, plants and other products of biotechnology and court has held this to be sufficient to grant patent on inventions if alteration is substantial. While raw products of nature i.e things that exist in exactly the same form in nature are not patentable in the United States, the steps involved in isolating, purifying or modifying genes and gene sequences are sufficient to render the resulting product an invention as opposed to a discovery. According to statistic of OECD and World Survey of Genomics Research the USPTO granted over 5,000 DNA patents in 2002.56 In 2005, Fiona Murray and Kyle Jenson identified 4,270 US patents containing claims on human DNA sequences.57
In addition to being in principle patentable, genes also satisfy the US criteria of non-obviousness (inventiveness), novelty and utility (industrial application). Under US law, a genetic sequence will not meet the test for non-obviousness if both the structure of the protein resulting from the gene is recognized as well as the procedure to determine the sequence of a gene that results in a protein with that function.58 If put differently, if the protein is known and we know how to find the gene that corresponds to that protein, then the gene itself cannot be patented.59 In this regard the US Patent Office’s utility guidelines,60 released in 2001, states that the utility of an invention must be substantial, specific and credible. Genes satisfy this test if an organism produces a protein, with a clear function, from the gene.61
A second petition was moved to Supreme Court challenging the decision of the Federal court by 2-1 decision. The US Supreme court observed that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.”62 The court held that Myriad created an innovative method of altering genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. It is pertinent to mention that processes used by Myriad to isolate DNA were well understood, widely used, and fairly uniform. The court further stated that the present case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes and denied its opinion on the patentability of DNA in which the order of the naturally occurring nucleotides has been altered and held that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.
COMPARING NOVARTIS AND MYRIAD PATENT CASE
In a very recent case of Novartis A.G. v. Union of India63 wherein Supreme Court of India upheld the rejection of a patent application, in relation to Cancer saving drug, as coming within the folds of Section 3(d) of the Patents Act, 1970. Subsequently, three months later US Supreme Court in Association for Molecular Pathology v. Myriad Genetics has partly rejected a patent application over a naturally occurring gene sequence that significantly increases the chances of breast and ovarian cancer (BRCA1 and BRCA2)
Despite the facial difference between these two cases there are some inducing similarities which emerge when scrutinized closely. These cases are interestingly similar with reference to the context of their agitation and the limitation imposed on the patent eligibility standards and the broader social implications of these cases on public health and access to medicine. It is significant to mention that in both these cases the inventors of the claimed drugs have come out in support of the decisions to deny patent protection over their discoveries.
Considering the fact that the gene sequence in the study, BRCA1 and BRCA2, are known to significantly increase the risk of breast cancer and ovarian cancer, Myriad Genetics has actually attempted to monopolize the means of detecting cancer through tests. The women activists agitated that tests for breast and ovarian cancer was already prohibitive and would only further step-up if a patent was granted. Whereas in the case of Novartis, a patent has been claimed on minor modification to Glivec (a life saving cancer drug), and thus would cost several times more, than drugs that would have been produced by generic manufacturers, if patent was granted. Although the price of a drug cannot be a ground for a patent eligibility, but it does have exclusive monopoly of patent exploitation potential, when the three fold eligibility criteria patent i.e., novelty, inventive step and industrial application are not applied in an appropriate and prudent manner.
The strongest similarity between Novartis and Myriad appear in their ability to impose limits on convincing the patent eligibility. In Myriad, the court had to interpret Article 101 which does not impose any restriction on the text of the patent eligibility with the law, such as Diamond v Chakrabarty, which ruled that the laws of nature, abstract phenomenon and substances natural are not patent eligible. Based on this the Court rightly pointed in Myriad that “revolutionary discovery, innovative or even a brilliant discovery do not satisfy the § 101 test. The Indian Supreme Court in Novartis case had to decide whether the drug claimed was an invention of Section 2 (j) of the Act, and even if so, whether it would be excluded from patent protection under section 3 (d). The court held that even if the drug can be an invention for the limited purpose of Article 2 (j), it could not pass the minimum requirements of section 3 (d), and that the Novartis had failed to demonstrate clearly how and if at all, the new version is a significant improvement compared with the known versions (Imatinib mesylate) of the same drug.
Although the present two cases seems to be similar but there exists considerable difference between the two as in Myriad decision was largely a product of the Chakrabarty decision, and this measure was easier to achieve in relation to the task of interpreting Section 2 (j) and 3 (d) of the Supreme Court of without any judicial precedent applicable. More importantly, Novartis and Myriad stand for different degrees of patent ineligibility. Myriad recognizes a smoother and more intuitive principle for the exclusion of patent protection and intact natural substances principle, while Novartis strengthens a contested against misuse of a patent in the pharmaceutical industry known as concept of “evergreening”. The question of the validity of such a practice has not been addressed by the Court and the exact scope of section 3 (d) was consciously left open. This will only ensure that the exclusions of patent eligibility under the Patent Act of 1970, and its equivalent in other countries continue to be the site of other patent disputes
“Those who would patent DNA sequences without real knowledge of their utility are staking claims not only to what little they know at present, but also to everything that might later be discovered about the genes and proteins associated with the sequence. They are, in effect, laying claim to a function that is not yet known or a use that does not yet exist. This may be in current shareholders’ interests. But it does not serve society well. 64
In light of Novartis and Myriad patent cases which draw attention to an often overlooked understanding of patent law. It is important to mention that the test of three fold criteria of patent eligibility is merely the starting point of patent eligibility and not a conclusive determination of patents. This helps countries to fashion patent law regimes where exclusionary principles for patent eligibility, may reflect the social and economic needs of the domestic population, instead of being bound by universally agreed principles that can rarely, if ever, be implemented in a universal manner. This however does not to serve as challenge or even a critique to the TRIPS regime, which itself informs the drafting and implementation of most domestic patent law regimes. This reminds patent offices and courts that TRIPS recognizes pursuant to Article 27(2), individual exceptions that countries may use to temper the application of the three fold criteria of patent eligibility.
The purpose of Patent law is to provide exclusive rights to the owner but such vested rights should not only be in consonance with law and public policy but should also look up that such patents are not granted at the cost of diluting rights of public at large. Therefore, while granting gene patents to owner’s welfare of both public at large and the patent owner should be taken into consideration which therefore will be mutually beneficial. Although this approach is not practically feasible to be implemented in all cases as the above two cases sets best examples but the courts should try that rights of either of the parties will ultimately affect the beneficiaries as consequences of having lesser patent inventions, eventually disappointing people from accessing those inventions for benefits.
About the Author
University of Petroleum and Energy Studies, Dehradun
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- A biotechnology research tool is a cell line, reagent, or antibody used in research.
- Rebecca S. Eisenberg and Richard R. Nelson, “Public vs. Proprietary Science: A Fruitful Tension?,” Daedalus, Spring 2002.
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- See Mayo Collaborative Services v. Prometheus( ) 628 F. 3d 1347, reversed. Also See. Myriad wins gene patent ruling from US appeals court, https://www.reuters.com/article/2012/08/16/us-myriad-patent idUSBRE87F12K20120816
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- United States Patent and Trademark Office, Utility Examination Guidelines (Washington, 2001), online at: https://www.uspto.gov/web/offices/com/ sol/notices/utilexmguide.pdf (last accessed September 1, 2008)
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- Civil Appeal Nos. 2706-2716 OF 2013
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