Download PDF

Abstract:

A gene patent grants the user ultimate control and exclusive rights over a gene i.e. specific sequence of DNA, the government to whoever is the first to claimed to have identified the gene provides this patent. Once the patent has been issued, the patent holder is allowed to decide how the gene is used in clinical situations, research and commercial settings as well for the next 20 years. In 2013, there was a case against Myriad Genetics and their gene patents, where the Supreme Court ruled that genes could not be patented in the United States on grounds of DNA being a ‘product of nature’. It was deemed that there was a lack of intellectual property, and hence a patent cannot be granted. Previous to this judgment, there were 4300 human gene patent claims that were all remanded due to this case, which allowed for maximum usage for commercial purposes as well as research.

This paper will discuss the evolution of biopharmaceutical litigation in the United States that led up to the Supreme Courts’ decision in Myriad Genetics. Following which a further examination of other countries position with respect to gene patenting, and how the judgment in Myriad has affected their various legal positions.

I. THE POSITION IN THE UNITED STATES

1.1 Funk Bros. Seed Co. v. Kalo Inoculant Co.

Funk Bros. Seed Co. v. Kalo Inoculant Co.[1]is one of the foremost cases that discusses biopharmaceuticals much before the topic had gained significance and is as much relevant till date as it discusses one of the most essential questions of patent eligibility. The position in the US prior to this case was any naturally occurring substance that may exist individually or mixed could not claim patentability. This position was laid down as a judicial exception to sections 101 and 102 of Title 35 of the US Code, that discuss the doctrine of patentability. This was exemplified in the judgment of Ex Parte Grayson[2]that further established that any substance occurring in nature would not be considered patentable, unless it was reformed or the basic qualities or properties of the original have been changed as per prevalent law.[3]

Different strains of bacteria are used with different plants as to exhibit inhibiting characteristics, but the bacteria are plant specific and a specific bacteria strain is required for each type of crop. Some bacteria was found to not show these inhibitive effects, and a patent was granted for a mixed culture of bacteria so they could be used for a wider variety of crops and the need to buy specific bacteria would be eliminated. Kalo started manufacturing the mixed culture kits for farmers and had a patent on them, which Funk infringed my creating their own kits and selling them. Kalo then took this matter to court, and the issue of whether a mixture of bacterial strains could even be patentable due to its naturally occurring position.

The Court held that it was not patentable, and established the logic of naturally occurring substances can’t be patented. The non-inhibiting characteristics of the bacteria were a phenomenon that occurred in nature, and was not created by man or the properties altered. The mere packaging of various non-inhibitive strains was found to be ineligible for a patent[4].

This judgment thereby established the test differentiating a discovery and actual creation of product from a discovery, which is considered just as crucial in gene patenting scenarios in present day.  The test questions the degree of human participation in creation of a product.

1.2 Diamond v. Chakrabarty

This case is said to be one of the most revolutionary in terms of starting the issue of biopharmaceutical litigation.[5]Chakrabarty had filed for a patent for genetically modified bacteria that was able to handle oil spills. His patent included three claims, the bacteria, process for production of bacteria, and the composition of a carrier to keep the bacteria in water.

The last two claims were considered eligible for patentability, however the US Patent and Trademark Office rejected the claim to patent the bacteria itself. They justified their decisions by relying on previous case law that has established that microorganisms or bacteria are products of nature, and naturally occurring substances cannot be patented, as they are not patentable subject matter.

The word “manufacture” in §101 provides for the limits places on patentability of naturally occurring substances and living organisms and was the enabling factor prior to this case to ensure that living organisms are not patent eligible as they do not have scope for being “manufactured” in the most basic sense. Moreover since 1899 the doctrine of non-patentability has been in practice, where there was a claim for a fine found in a tree, and this patent was denied as one cannot have exclusive rights over a ‘product of nature’[6]accordingly, one can see an entrenched case law and legal position regarding US patent law and naturally occurring substances[7]. Chakrabarty argued against this on two levels, first he claimed that this specific bacteria was a manmade product of his work, and did not exist in nature. He also argued that the organism had been discovered only after investing his labor, and cannot be simply discovered. The Court of Customs and Patent Appeals overturned the judgment of the USPTO, and accepted his arguments. On further appeal by the USPTO, the Supreme Court upheld the decisions made by the Court of Appeals.

Hence the decision of this case was that creating a living organism that doesn’t occur naturally amounts to “manufacture” as stated in §101, and are eligible for patenting if found to be functional and useful.

One should note the difference in the arguments in Funk and Chakrabarty with the context of the developing legal principle. In Funk, the bacteria was a naturally occurring substance, and combining different strains did not amount to human efforts or labor being invested. But in Chakrabarty, though the bacterium was a naturally occurring substance, it did not possess the ability to aid oil spills until worked upon by Chakrabarty. Hence, it is noted that human interaction and intervention is found to be an essential component in granting patents with respect to naturally occurring substances or living organisms.

1.3 Moore v. Regents of the University of California

While Moorecase is neither the most significant, nor a landmark decision given by the courts in the issue of gene patenting, it is one of the most noteworthy one where the plaintiffs argued for the absolute eradication of gene patenting.[8] It did not particularly deal with the issue of patentability of genes, nor could it considering the California Supreme Court does not have jurisdiction over the federal matter. What the case did deal with that is relevant to Myriad, is the ownership rights one could have over the cell lines obtained from patients.

Moore was diagnosed with leukemia and would go to UCLA Medical Centre to avail treatment; here the doctor had Moore’s consent to test his spleen after removal and his bodily fluids. The doctor found his cells to have certain properties that would benefit his research, and without his proper consent he asked Moore to visit periodically for tests and samples. The doctor then filed an application for a patent based on the cell line found in the samples obtained from Moore. He was awarded the patent, and was provided financial benefits through this patent. Once Moore gained knowledge of the improper use of his cells, he filed a suit against this.

The issue raised was whether one could claim right over one’s cells after they’ve been removed from his body or have been discarded. The court decided that they did not require Moore’s body for the research, so whether the outcome had commercial value is irrelevant. However the court did mention that for a doctor to do such research it is essential that they do not withhold such information from the client in case of economic gain. The major precedent this case had established was that cell lines obtained from a patient when living could still be patented, and these patents would be unassociated with the living persons body from where the cells were obtained from.

II. THE LANDMARK ‘MYRIAD CASE’

Association for Molecular Pathology v. Myriad Genetics[9](popularly known as the “Myriad case”) was a landmark judgment in the area of gene patenting. It specifically dealt with challenging claims in patents owned by Myriad Genetics that dealt with isolated DNA sequences, and procedures to diagnose cancer by observing any mutated DNA sequences, and procedures to identify the varies drugs by using these isolated DNA sequences. Before this judgment, the legal position in US was that patents on isolated DNA sequences as a composition of matter were accepted by the US Patent Office.

2.1 Facts and Issues

Myriad in association with the University of Utah had been isolating and sequencing the BRCA2 gene, and the first patent was then filed in 1995. Later on Myriad launched BRACAnalysis, which was able to detect BRCA1 and BRCA2 genes (genes that show breast cancer and ovarian cancer[10]. The business model of Myriad was such that investors put money on Myriad based on the premium price that would be attached to the 20-year patent that was a startup in 1994, for which the patents would be expiring in 2014. Gene patents are highly controversial as the licensees enforce them so strictly as to ensure ultimate exclusivity. For example, Myriad had sent University of Pennsylvania’s Genetic Diagnostic Laboratory cease and desist letters claiming patent infringement, and these letters requested the pathologists to stop their research and testing of patent samples for BRCA.[11]Due to such legal threats made to multiple parties, the Association for Molecular Pathology (AMP) has actively been fighting against the exclusive licensing of gene patents and has been the main plaintiffs for this case. Other parties who are the other plaintiffs along with AMP and University of Pennsylvania were researchers from various universities such as NYU, Columbia, Emory and Yale. The defendants in this case were mainly Myriad, Trustees of University of Utah and the US. Patent and Trademark Office.[12]

The main issues raised in this case where specific claims discussing isolated genes, methods to identify drug candidates and various diagnostic methods. These issues arose from seven of the 23 patents that Myriad has on BRCA1 and BRCA2[13].

2.2 Arguments Raised

The plaintiffs argued that the claims must be declared invalid, as they are not considered patentable subject matter according to §101 of Title 35 of the United States Code. They argued that the isolated genes are not patentable products of nature, and that the various procedures and diagnostic methods are simple processes that can’t be considered real world transformations. They also claimed that the drug screening issues are just the basic procedures of science and are not unique or novel to claim its patentability. According to US Patent law one can claim for a patent if it is “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof”. However US patent law also says that if anything is a “naturally occurring article”, (defined in law) then one cannot claim a patent on it.[14]

Plaintiffs questioned the existence and nature of the patents assigned to Myriad and their usage of them, and argued against their limited research for the specific scientific processes. They argued that patients are also disadvantaged as Myriad made it almost impossible for one to obtain a second opinion from another physical issues of breast cancer or ovarian cancer. By preventing competition from obtaining similar testing apparatus, and being the sole testers for BRCA1/2 the cost for the patient to undergo these tests is also found to be expensive

Myriad’s defense for claiming that their patents are valid are that US Patent and Trademark Office (USPTO) grants patents for genes if they are “isolated sequences”, similar to the process of issuing patents for any other chemical compounds.This was on the basis that isolating the DNA sequence completely changes its nature and character than what is present when existing in the human body. The isolation of the genetic material is a chemical combination that would not exist in nature, but can only do so with specific processes. They also claimed that their diagnostic tests are patentable subject matter and are not basic scientific processes that they have a monopoly over, but are individual processes that are specific to isolating these DNA sequences[15].

2.3 Decisions of the Courts

2.3.1 United States District Court of Southern District of New York

Judge Sweet held that all the claims at question are invalid. The judgment extended to around 152 pages, and with relation that the question of isolated DNA sequences, he declared that though the DNA is in an ‘isolated’ form, it does not affect the basic fundamental quality of DNA[16], hence the patents discussion the ‘isolated DNA’ are found ineligible for patents according to 25 U.S.C of §101. The judges also found that comparisons of DNA sequences in these patents are random abstract processes similar to the decision in In Re Bilski[17]hence, not patentable. The judges also found that the drug screening claims and the processes involved with it are not patentable as they are simple and ‘basic scientific principles’ and one can’t claim exclusivity over them.

2.3.2 United States Court of Appeals for the Federal Circuit

Myriad appealed and the case was subsequently heard in the United States Court of Appeals for the Federal Circuit. The court overturned the decision made by the District Court in part, by reversing the fact that an isolated DNA sequence is not patentable, and that drug screening claims are patent ineligible. The court also affirmed its decision on the fact that it agreed with the District Court’s decision and claimed comparisons of DNA sequences are not patentable.[18] Judge Lourie wrote the majority judgment, and rationalized that isolated DNA is very different in terms of chemical composition from its existence in nature. Diamond v. Chakrabarty[19] was discussed here, and mentioned how it was decided that testing a genetically modified organism (GMO) is “markedly different” from how it is found to be existing in nature and it was held that GMO’s are patentable. Hence relying on that decision, he declared that since the DNA sequence of Myriad’s patents do not exist in nature alone, hence are patentable.

2.3.3 The Supreme Court’s Holding

Post Federal Circuit’s decision, AMP petitioned for writ of certiorari and asked for a review of case by the Supreme Court.[20] Following which the Supreme Court vacated the previous decision, and remanded the case back to them.[21] This decision by the Supreme Court was in context with the decision in Mayo Collaborative Services v. Prometheus Laboratories Inc.[22] In this case it was held that certain types of medical diagnostic patents including naturally occurring ones, are patent ineligible. The Supreme Court assumed the Federal Circuit would take into account this preceding, and remanded it such that it could be taken into light.

2.3.4 Decision of The Federal Circuit (II)

The Federal Circuit did not change its previous decisions, and ruled in favor of Myriad in a 2-1 decision. The new judgment was found to be the same as the first decision.[23] With respect to the Mayo decision, Judge Lourie held the compositions claims must be purely copies of nature, whereas in this situation they are not so Judge Bryson dissented on the claim of patent-legibility of isolated DNA sequences, and took into consideration the Mayo ruling when giving his judgment. He wrote how a patent should have an inventive concept attached to it, and if it includes a product of natural it should be more than small changes to the product, and should be transformative. If the compositions of matter before and after the scientific procedures are the same, is it really enough invention to the product. He also discussed how merely breaking the covalent bond, and isolation of material that is naturally occurring does not make a product patent eligible[24].

2.3.5 Decision of the Supreme Court (II)

Another petition had been filed to the Supreme Court with regards to the second Federal Circuit division. Justice Thomas gave the majority opinion, except for Judge Scalia who concurred in part, and in total judgment.[25] Thomas held that DNA is naturally occurring and products of nature cannot be patented purely because they have been isolated. Thomas also held that DNA(complementary DNA that is completely synthesized but uses a strand of naturally occurring RNA) can be patentable as it not a product of nature, but a product of man’s creation.

It was finally held by the Supreme Court, that Myriad could not claim patents to isolate genes. The Court declared that the process of isolating genes found in nature does not provide it eligibility for patents.[26]

III. INTERNATIONAL POSITIONS ON GENE PATENTING

3.1 Position in Europe

Due to the decision made in the US with respect to Myriad, the European Community has a much more lenient approach to gene patenting, and has a more accepting mentality towards DNA patentability. In 1995 itself, with regards to the case of Relaxin[27], the European Patent Office declared that if a substance is occurring in nature, and a mere discovery is made, then one cannot patent that living organism or substance. However if it a new substance and has no acknowledgment of its existence, then it could be argued for to be patented. This decision was established in another case, Biotechnology Directive, as mentioned in Schedule A2 of the Patents Act, 1977(UK).[28] Here it states than any naturally occurring substance if isolated from its environment, or if created through any mechanical procedures, then one could attempt to claim a patent over it, though it was originally purely a product that arose from nature. The Supreme Court of the United States though had taken an opposing view of the European Community by saying isolating the genetic material from its origin does not make it a creation or eligible for a patent.

3.2 Position in Australia

In 2013, there was a case analogous to that of Myriad dealt with by the Federal Court of Australia called the Cancer Voicers[29] case. The legal position in Australia with regard to subject matter requirement for a patent is that the invention must be manufactured as per Section 6 of Statute of Monopolies.[30] The High Court previously mentioned that though there existed no literal test, there is an organic and historical one that has evolved based on precedents[31]. It questions whether there have been ‘a proper subject of letters patent according to the principles which have been developed for the application of s 6’[32]. Here, the Federal Court decided not to follow in the footsteps of the US Supreme Courts case of Myriad, and instead ruled that if there has been an isolation of genetic material from any form of research done on cell lines, and have changed the structure as well as its functionality, and attains a differing composition, then one could claim it satisfies the patent subject matter requirement.[33] The Court also added that it was not for the Court to decide whether for whatever reasons (socio, moral, political) that genes should or should not be patented, rather that was a question for Parliament to deal with.[34]

3.3 Position in India

Section 3(c) the Indian Patent Act, 1970 states that a discovery of a living organism or of a naturally occurring substance could not amount to a claim of an invention and can’t claim a patent for it.[35] Similarly, any genes that occur naturally cannot be patented. Unfortunately there is a lack of judicial decisions that deal with the issue of isolated synthesized DNA sequences.

However there are a few patents issued by the Indian Patent Office that deal with gene patenting that have arisen before the guidelines established in 2013.

• First, Patent No. 243799 also known as Genetically Stable JEV cDNA based on Japanese Encephalitis Virus.[36]

Here, a patent was granted to the corporation regarding a cDNA structure even though it was a mere by-product of naturally occurring genetic material, and it was not synthesized.

• Secondly, Patent No. 246865 also known as An Expression Vector or Cloning Vector Encoding Filarial Parasite Polypeptide.

Here, the Patent Office gave a differing view with respect to a patent regarding similar cDNA case, their logic being that it was already occurring in nature. Later on these objections were taken back and a patent was issued.

Clearly it can be seen that even though the Act states naturally occurring substances cannot be provided patents or protection of exclusivity for use, there have been clear examples where the opposite was decided and isolated gene sequences were provided this protection.

Due to the non-uniformity of decisions by the Patent Office, there was a Guideline for Examination of Biotechnology Applications for Patent[37] that had come into existence. The intention of these guidelines was to ensure regularity and consistence in decisions and granting of patents with respect to Patent law and precedents.

The Guidelines specify that isolated gene sequences that naturally occur is merely a discovery and not an invention, and hence can’t be eligible for patents as said in Section 3(c) of the Indian Patent Act, 1970. Though these Guidelines are positive step in the right direction, one should be aware with rise of biotechnology in India, there is bound to be an increase in patents and litigation surrounding them. The Patent Office should be aware when granting patents as to avoid exclusivity over information that should be free to all for further inventions, as that would be a roadblock to further innovation and development.

IV. CONCLUSION

Now one could note that the Supreme Court judgment in this case could be considered as a ‘middle path’ decision, where they haven’t agreed with the anti-patenting activists, neither the capitalist side where companies own these biopharmaceutical patents. But it is pertinent to note that the court took a much subtler approach to this issue as compared to how the public has viewed it or how the media has portrayed it. Rather than taking an extreme approach on either side by prohibiting or authorizing gene patenting completely, they took a view that could be read and interpreted differently on a case-to-case basis, and establishing legal positions as to what would be considered patentable.

It can clearly be seen that the court took into question the various issues that arise and may arise with gene patenting and formed their decision on that such that future cases can be judged based on these principles, and keeping in mind the basic fundamentals of the laws of patents. As technology furthers and advances in various spheres of science, one finds it difficult to draw the line between nature’s involvement and the extent of it, and much subtler differences can be seen, and applying such a simple test may find difficult in the near future and cause a hindrance to the development of science and technology.[38]

V. BIBLIOGRAPHY

1. Indian Patent Act, 1970
2. Patents Act, 1977 (U.K.).
3. Statute of Monopolies.
4. Funk Bros. Seed Co. v. Kalo Inoculant Co.
5. Ex Parte Grayson
6. Moore v. Regents of the University of California
7. Association for Molecular Pathology v. Myriad Genetics,
8. Re Bilski
9. The Relaxin case
10. Cancer Voicers
11. Diamond v. Chakrabarty
12. Mayo Collaborative Services v. Prometheus Laboratories Inc.
13. DJ Kevles, Ananda Chakrabarty wins a Patent (1994)
14. Ex Parte Latimer, available at http://www.patentlyo.com/files/1889deccommrpat123-ex-parte-latimer.pdf
15. Pepper Hamilton LLP, Myriad – ONE-YEAR LaterPepper Hamilton LLP, Available at: http://www.pepperlaw.com/publications/myriad-one-year-later-2014-06-20/
16. ‘Myriad Genetics | Products & Services | All Products’, Available at: https://www.myriad.com/products-services/all-products/overview/.
17. In Practice: Containing “Myriad,” The Recorder, Available at :http://www.therecorder.com/id=1202613995155/In-Practice-Containing-Myriad
18. Australian Associated Press, Patient wins high court challenge against company’s cancer gene patent, The Guardian, October 7, 2015, Available at: https://www.theguardian.com/society/2015/oct/07/patient-wins-high-court-challenge-against-companys-cancer-gene-patent
19. Indian Patents. 243799: http://www.allindianpatents.com/patents/243799-genetically-stable-jev-cdna-based-on-japanese-encephalitis-virus-jev
20. Indian Patent Office issues draft guidelines on examination of biotech applications, Available at, http://pharmabiz.com/NewsDetails.aspx?aid=73087&sid=1 (last visited Oct 13, 2016).
21. Amy Corderoy, Companies can’t patent genes, US court rulesThe Sydney Morning Herald, http://www.smh.com.au/technology/sci-tech/companies-cant-patent-genes-us-court-rules-20130614-2o836.html.
22. Amy Corderoy, BRCA1 gene patent ruling to be appealedThe Sydney Morning Herald, http://www.smh.com.au/national/brca1-gene-patent-ruling-to-be-appealed-20130304-2fg1f.html.
23. Amy Corderoy, Landmark patent ruling over breast cancer gene BRCA1The Sydney Morning Herald, http://www.smh.com.au/national/health/landmark-patent-ruling-over-breast-cancer-gene-brca1-20130214-2egsq.html
24. Reuters, Court Reaffirms Right of Myriad Genetics to Patent Genes, The New York Times, August 16, 2012, Available at: http://www.nytimes.com/2012/08/17/business/court-reaffirms-right-of-myriad-genetics-to-patent-genes.html
25. Carl Lumma says, Applying Mayo to Myriad: Latest Decision Brings No New News (Plus: Why the Final Myriad Decision Might Not Matter for Personalized Medicine), Available at: http://www.genomicslawreport.com/index.php/2012/08/17/applying-mayo-to-myriad-latest-decision-brings-no-new-news/#more-6807.
26. Plaintiffs (Again) File Certiorari Petition in Myriad Case, Patent Docs, Available at: http://www.patentdocs.org/2012/09/plaintiffs-again-file-certiorari-petition-in-myriad-case.html
27. Supreme Court has Granted Cert in the Myriad Case, Question: Are Human Genes Patentable, Patently-O, Available at: http://patentlyo.com/patent/2012/11/supreme-court-has-granted-cert-in-the-myriad-case-question-are-human-genes-patentable.html
28. Heidi Ledford, US government wants limits on gene patents, News (2010), Available at: http://www.nature.com/news/2010/101102/full/news.2010.576.html
29. ‘Supreme Court Remands Myriad Case‘, Patent Docs, Available at: http://www.patentdocs.org/2012/03/supreme-court-remands-myriad-case.html
30. John Schwartz & Andrew Pollack, Judge Invalidates Human Gene Patent, The New York Times, March 29, 2010, http://www.nytimes.com/2010/03/30/business/30gene.html.
31. US Patent and Trademark Office, Notice 1337 CNOG 487, available at http://www.uspto.gov/web/patents/patog/week53/OG/TOCCN/item-115.htm

[1]Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).

[2]Ex Parte Grayson, 51 USPQ 413 (Bd. App. 1941).

[3]US Patent and Trademark Office, Notice 1337, CNOG 487, available at http://www.uspto.gov/web/patents/patog/week53/OG/TOCCN/item-115.htm(last visited Oct 13, 2016).

[4]Id. at 132.

[5]Diamond v. Chakrabarty, 447 U.S. 303 (1980)

[6]Ex Parte Latimer, available at http://www.patentlyo.com/files/1889deccommrpat123-ex-parte-latimer.pdf(last visited Oct 13, 2016).

[7] DJ Kevles, Ananda Chakrabarty wins a Patent, 25 Hist Stud Phys BiolSci 111 (1994)

[8]Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990).

[9]Association for Molecular Pathology v. Myriad Genetics, (2015) HCA 35.

[10] ‘Myriad Genetics | Products & Services | All Products‘ , Available at: https://www.myriad.com/products-services/all-products/overview/. (last visited Oct 13, 2016).

[11]Supra, note 10.

[12]Ibid.

[13]John Schwartz & Andrew Pollack, Judge Invalidates Human Gene Patent, The New York Times, March 29, 2010, http://www.nytimes.com/2010/03/30/business/30gene.html  (last visited Oct 13, 2016).

[14]Supra, note 10.

[15]Ibid.

[16]Supra, note 10.

[17]Re Bilski, 88 U.S.P.Q.2d 1385.

[18]In Practice: Containing “Myriad,” The Recorder, Available at,  http://www.therecorder.com/id=1202613995155/In-Practice-Containing-Myriad (last visited Oct 13, 2016).

[19]Diamond v. Chakrabarty, 447 U.S. 303.

[20] ‘Supreme Court Remands Myriad Case‘, Patent Docs, Available at: http://www.patentdocs.org/2012/03/supreme-court-remands-myriad-case.html (last visited Oct 13, 2016).

[21]Heidi Ledford, US government wants limits on gene patents,  Nat. News (2010), Available at: http://www.nature.com/news/2010/101102/full/news.2010.576.html (last visited Oct 13, 2016).

[22]Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289 (2012)

[23]Reuters, Court Reaffirms Right of Myriad Genetics to Patent Genes, The New York Times, August 16, 2012, Available at: http://www.nytimes.com/2012/08/17/business/court-reaffirms-right-of-myriad-genetics-to-patent-genes.html (last visited Oct 13, 2016).

[24]Carl Lumma, Applying Mayo to Myriad: Latest Decision Brings No New News (Plus: Why the Final Myriad Decision Might Not Matter for Personalized Medicine), Available at: http://www.genomicslawreport.com/index.php/2012/08/17/applying-mayo-to-myriad-latest-decision-brings-no-new-news/#more-6807. (last visited Oct 13, 2016).

[25]Plaintiffs (Again) File Certiorari Petition in Myriad Case, Patent Docs, Available at: http://www.patentdocs.org/2012/09/plaintiffs-again-file-certiorari-petition-in-myriad-case.html (last visited Oct 13, 2016).

[26]Supreme Court has Granted Cert in the Myriad Case, Question: Are Human Genes Patentable, Patently-O, Available at: http://patentlyo.com/patent/2012/11/supreme-court-has-granted-cert-in-the-myriad-case-question-are-human-genes-patentable.html (last visited Oct 13, 2016).

[27]Relaxin, (1995) EPOR 541.

[28] Schedule A2, Patents Act, 1977 (U.K.).

[29]Cancer Voicers, (2013) FCA 65.

[30]§ 6, Statute of Monopolies.

[31]Australian Associated Press, Patient wins high court challenge against company’s cancer gene patent, The Guardian, October 7, 2015, Available at: https://www.theguardian.com/society/2015/oct/07/patient-wins-high-court-challenge-against-companys-cancer-gene-patent (last visited Oct 13, 2016).

[32]Amy Corderoy, Companies can’t patent genes, US court rulesThe Sydney Morning Herald, Available at:http://www.smh.com.au/technology/sci-tech/companies-cant-patent-genes-us-court-rules-20130614-2o836.html. (last visited Oct 13, 2016).

[33]Amy Corderoy, BRCA1 gene patent ruling to be appealedThe Sydney Morning Herald, Available at: http://www.smh.com.au/national/brca1-gene-patent-ruling-to-be-appealed-20130304-2fg1f.html (last visited Oct 13, 2016).

[34]Amy Corderoy, Landmark patent ruling over breast cancer gene BRCA1The Sydney Morning Herald, Available at, http://www.smh.com.au/national/health/landmark-patent-ruling-over-breast-cancer-gene-brca1-20130214-2egsq.html (last visited Oct 13, 2016).

[35]§ 3(c), Indian Patent Act, 1970.

[36]Indian Patents: 243799, Available at: http://www.allindianpatents.com/patents/243799-genetically-stable-jev-cdna-based-on-japanese-encephalitis-virus-jev (last visited Oct 13, 2016).

[37]Indian Patent Office issues draft guidelines on examination of biotech applications, Available at,  http://pharmabiz.com/NewsDetails.aspx?aid=73087&sid=1 (last visited Oct 13, 2016).

[38] James D. Watson’s brief in support of neither party to the Court of Appeals for the Federal Circuit in The Association for Molecular Pathology v. Myriad Genetics.

Cite as: Ravali Gurram, Gene Patenting – Myriad Case Critique, 1 Int’l J. of Legal Sci. and Inno. 2 (2019)