A recent filed by Myriad Genetics involving the alleged infringement of their controversial breast cancer screening tool has included the prestigious Toronto SickKids hospital as a co-plaintiff. This lawsuit has been a source of criticism for the hospital and has reinvigorated the debate on the merits of public-private research collaborations in health care innovation.

Aftermath of SCOTUS Ruling - Myriad Genetics Sues Archrival

This , the US Supreme Court rendered a landmark , ruling out the patentability of some genetic sequences in patents developed by Myriad Genetics for their breast cancer screening tests. (You can view some of the IPilogue’s extensive coverage of the international litigation around this issue , and .) The results of this decision and the invalidation of the Myriad patents were seen by many as a development that of breast cancer screening methods due to the possibility of cheap alternatives being produced without being hindered by patent licensing. A sound prediction, as , companies started releasing breast cancer screening tools at a lower cost than the Myriad products. A few weeks after the ruling, however, Myriad in the Utah District Court against Ambry Genetics, claiming that the company owned or licensed to Myriad that had not been a part of the US Supreme Court case. In response to the lawsuit, Ambry has recently Myriad for antitrust violations.

This case is interesting from a Canadian point of view since some of the patents at issue involve ownership agreements between Myriad and various public health organizations, . In the , it is stated that the public health organizations will lose "significant amounts of revenue" from lost royalties, and that the revenue stream from their ownership to date has brought in around $57 million. Although listing SickKids as a plaintiff in the lawsuit due to their ownership agreement, the story has nevertheless garnered . This lawsuit has been seen by some as an attack on affordable breast cancer screening for patients, with SickKids seemingly in a position that is opposite its role as a health care provider. Patent arrangements like the one between SickKids and Myriad can be seen as paradoxical; preventing patients from being able to access the medical discoveries that have been made possible by .

Public-Private Research Collaboration: A Complex Issue

Discussions arising from situations such as this ultimately stem from the relationship between public institutions and profit-seeking entities in health research collaboration. Analyses of the merits of such collaboration has reached conclusions in different fields and , but a recent seemed to suggest a statistically significant increase in pharmaceutical industry innovation from publically-funded scientific research.

Critics of these joint research ventures frequently cite the through a “tragedy of the anticommons” effect, where other research entities choose not to enter a field of innovation due to the fear of their production ultimately getting blocked by existing patents. Luigi Palombi, an Australian lawyer that has written a book about the Myriad breast cancer screening saga, criticized the SickKids incident and that “[i]t is our outrageous for any publicly funded research institution to be put in this situation” and that “[o]nce you have publicly funded institutions getting into bed with these guys, well then that raises a whole series of other questions and issues”. Other commentators, such as McGill University law professor Richard Gold, that "[t]here's always been a relationship obviously between industry and hospitals and universities. And it's not all bad because, of course, universities do basic research." Professor Gold also went on to state that he hopes public institutions “will be wiser in the way they set up their agreements in order to have a choice to whether to be involved in ligation". Although the majority of commentators seem to agree that SickKids is currently occupying an unfavourable position from its public involvement in the lawsuit, the debate on the merits of these joint health-care research ventures is certainly an unresolved issue.

The Future of Public-Private Health Research Collaboration in Canada

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, after discovering the exact location and sequence of the genes BRCA1 and BRCA2 – mutations of which may increase the risk of breast and ovarian cancer – was able to isolate these genes, enabling, inter alia, the identification of genetic predisposition to these cancers. Only a subset of nucleotides can code for amino acids and consequently generate a protein ("exons"), while other nucleotides ("introns")are not able to perform this function.  Myriad created synthetic DNA sequences (so-called "complementary DNA" or "cDNA"), in which the natural introns are removed and only the exons remain, providing significant advantages for genetic examinations and other scientific purposes. On this basis, Myriad obtained patents on isolated genes BRCA1 and BRCA2, as well as patents relating to their synthetic DNA sequences. After obtaining these rights, various stakeholders filed actions against Myriad and the , claiming the invalidity of patents based primarily on patent ineligibility of products of nature.  The case made its way through the District and Federal Courts, and all the way to the U.S. Supreme Court. (For some of the IPilogue's past coverage on this story, click and .)

In its decision, the U.S. Supreme Court  stated that:

a) Laws of nature, natural phenomena and abstract ideas are not patentable under ;

b) Isolation of genes without any creation or alteration of genetic information is not an act of invention. Despite the great scientific relevance of Myriad's discovery, the isolated BRCA1 and BRCA2 genes and their genetic information are merely a product of nature, and therefore are not patentable under § 101; and

c) Unlike the genes BRCA1 and BRCA2, cDNA molecules, consisting only of exons, are not naturally occurring, but a result of human inventiveness. Even if the nucleotide sequence of cDNA is dictated by nature, it is unquestionable that the lab technician creates something new when cDNA is made. Therefore, cDNA is distinct from the DNA from which it was derived, so that it is patentable under § 101.

The U.S. Supreme Court also distinctly pointed out that this case did not involve method patents, new applications of knowledge about BRCA1 and BRCA2, and alteration of order of naturally occurring nucleotides, thereby preventing any implication of this case to these endeavors.

As a consequence of the decision, Myriad no longer has exclusive rights to the BRCA1 and BRCA2 genes, thereby allowing competitors in the biotechnological sector to recreate and use them. This will have important implications both socially and economically.  Firstly, the free use of the genes by various companies increases the opportunity for development and innovation for identification and treatment of cancer and for the discovery of new functions for the genes. In this way, public health can potentially obtain a number of additional long-term benefits.  Secondly, due to the competition exerted by other companies, the price of tests for identifying susceptability to cancer is expected to be reduced. Currently, the price of a complete test is around , making the test an unfeasible option for many people. The real economic benefits of the decision, however, are still questionable because (1) Myriad's patent on the cDNA was upheld and (2) Myriad likely has a number of  related to mutations of the BRCA1 and BRCA2, guaranteeing it significant exclusivity in this sector.  It will be necessary to observe the development of the market in the coming months to draw more concrete conclusions.

Despite its advantageous practical effects, the decision deserves criticism for some inconsistencies. In order to support the non-patentability of the genes BRCA1 and BRCA2, the U.S. Supreme Court emphasized that since the genetic information of these genes was not created or changed by Myriad, it should be considered as a product of nature and, consequently, ineligible for patentability. In order to support their conclusions on the patentability of the cDNA, however, the Court did not apply the same logic. Although the elimination of introns does not occur naturally, the genetic information contained in exons is pre-existing and results from purely natural processes, and by the Supreme Court's logic applied to BRCA1 and BRCA2, should be considered non-patentable. Furthermore, even while recognizing the possibility that a molecule similar to cDNA may possibly occur naturally by an unusual and rare phenomena caused by viruses, the Court confirmed its patentability as a composition of matter (§ 101) without providing a reasoned analysis of their opinion. Finally, the Court suggested that if the patent claims were focused merely on the chemical composition of the molecules of BRCA1 and BRCA2 instead of the actual genetic information of these genes, patentability may be possible; a statement which does not seem to be well-supported by the judiciary in light of § 101 and of the law of nature exception. In short, the U.S. Supreme Court did not exactly establish a boundary between the concepts of "product of nature" and "the result of human inventiveness", and as a result there is still legal uncertainty with respect to biotechnological patents.

Apart from the criticisms, it is important to note that the decision in Myriad under U.S. law is opposite to the current law in the European Union. states that isolated DNA sequences are patentable. Many scholars dispute whether the scope of protection provided by these patents is absolute (comprising all applications of the chemical compound) or purpose-bound (comprising only the applications indicated by the patent applicant). On this, the European Court of Justice decided prima facie that the scope of protection of biotechnological patents is purpose-bound (see ). This difference in legal treatment in the EU is favorable to holders of patents related to DNA sequences, who can still enjoy legal protection in several European countries.

In my opinion, the decision by the U.S. Supreme Court is, to some degree, appropriate. The acknowledgment that the isolated genes occur naturally is correct; if the product itself is not a result of the human inventiveness, but only found in the nature, it is not an invention. This view excludes the patentability of DNA sequences and promotes development and innovation by competitors. If the isolation of genes constitutes an inventive step, the methods of isolation may be considered patentable, but not the chemical compound itself. The novelty of the isolated genes, however, is questionable since its existence is known before isolation. In spite of this, there remains some well-founded criticisms of the decision, which the Court will need to address them in future cases.

The decision of the U.S. Supreme Court in Myriad creates an important precedent for cases related to the patentability of biotechnological inventions in the USA and, considering its subject-matter, can serve as a model for improvement for legislatures and judiciaries in other countries.

Pedro Henrique Dias Batista is an IPilogue Editor and a PhD student at Ludwig Maximilian University of Munich.

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The case concerned whether Myriad’s patents, describing the composition of isolated DNA molecules and methods of isolating and analyzing genes used to detect certain types of breast and ovarian cancers, are patent eligible in light of the recent ruling of (Mayo). Patent eligibility in the United States is defined by . The United States Court of Appeals for the Federal Circuit had originally reviewed the patents in July 2011, before the United State Supreme Court’s holding in Mayo. During their original review, the Court found that Myriad’s composition based claims, the claims covering the actual isolated genes themselves, were patent-eligible. In contrast, Myriad’s patent claims covering comparison and analysis were almost all patent-ineligible. The original ruling was a 2-1 split decision with Justice Bryson stating in dissent that genes and their fragments were also patent-ineligible. The decision was appealed to the United States Supreme Court.

The Mayo decision was handed down nine months later, in March of this year. In this decision, covered in a guest blog on IP Osgoode , the Supreme Court ruled that the method claims found within Prometheus Laboratories’ patents were not eligible for patent protection because the claims were based on laws of nature, a patent-ineligible subject matter. In light of the Mayo decision, the Supreme Court remanded the Myriad case back to the Court of Appeals for reconsideration.   expected the Supreme Court decision to remove the legal foundation that the original Myriad ruling was built on, as human genes could be considered products of nature. Instead, the U.S. Court of Appeals for the Federal Circuit respectfully held that the Mayo decision would not alter their judgement against Myriad’s patents.

In the decision by the Court of Appeals, the majority relied on precedent established in (Chakrabarty) and (Funk Bros.) to help determine how patent-eligibility laws, specifically 35 U.S.C. § 101, should be interpreted in regards to Myriad’s composition patents. In Chakrabarty, the U.S. Supreme Court recognized bacteria engineered to break down different components of crude oil as patent-eligible. The Court found that because the claim was to a non-naturally occurring manufacture or composition of matter that was the product of human ingenuity, the claim was patent-eligible. In Funk Bros., the U.S. Supreme Court held that a grouping of unmodified bacteria was not patent-eligible as the aggregation of species did not make any of the species acquire a different property or use. Applying both of these precedents to the case at hand, the Court found that the composition patent claims, covering isolated human genes, were valid under 35 U.S.C. § 101 as they “are markedly different—have a distinctive chemical structure and identity—from those found in nature”. Although stating that the Mayo decision did not modify their holding, it should be noted that the Court of Appeals’ decision to hold the majority of Myriad’s method claims as patent-ineligible falls in line with the Mayo ruling. In Myriad, the Court of Appeals found that method claims that simply ‘analyze’ or ‘compare’ patent-eligible subject matter are not themselves patent-eligible as they only claim abstract mental processes. The only claim that escaped this judgement, claim 20 in U.S. Patent 5,747,282, included “transforming” the inputs of the method before analyzing, which in the Court’s eyes was more than simply applying a law of nature.

Also of interest in the instant case was the conflict between the government’s role and the role of the United States Patent and Trademark Office (USPTO). The USPTO was a defendant, while the government, as amicus curiae, argued that that human-engineered DNA molecules are eligible for patent protection, but isolated and unmodified genomic DNAs, like those targeted by Myriad’s patents, are not. In their ruling, the majority stated a desire to defer the issue to Congress and to allow the USPTO to continue to issue patents relating to DNA molecules as they have been for 30 years. In dissent, Justice Bryson raised an argument that the government’s position undermines that of the USPTO and therefore the issue should not be deferred.

This is a very contentious decision as it involves the patent-eligibility of naturally-occurring human genes. There are strong that this subject matter should not be patentable, while others claim that the subject matter’s “” make it patent-worthy. The ACLU, who was represented in this case, has stated that the ruling “.” Myriad, however, and believes that their gene patents have not hindered research on the DNA sequences that they cover. It is that this case will be appealed to the United States Supreme Court.

Mark Bowman is a JD Candidate at Osgoode Hall Law School.

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In the , the Association for Molecular Pathology v Myriad Genetics (Myriad), Myriad Genetics alongside the University of Utah, isolated two genes, BRCA 1 and BRCA 2, which are associated with breast and ovarian cancers.  Furthermore, it developed a test that examines the DNA extracted from the genes  for mutations that signify risk of developing breast or ovarian cancer.  The patent of the two genes grants Myriad Genetics a monopoly on testing for mutations and thus prevents other laboratories from performing such tests.

An action brought by the American Civil Liberties Union and the Public Patent Foundation on behalf of various medical groups, patients and researchers that Prometheus’ patent on the human genes were invalid as they were products of nature, and the ensuing monopoly granted prevented women from garnering confirmatory tests. A United States District judge in New 91��ɫ conceded and the patents in 2010.  Nonetheless, this victory for the American Civil Liberties Union and association was short lived, as the Court of Appeal for the Federal Circuit the ruling, holding that the DNA isolated from the body was patentable since it was “markedly different” in a chemical structure from the DNA within the body.  On appeal to the Supreme Court, the case was remanded to the Court of Appeal for the Federal Circuit for review.

On review, the Federal Court will be required to resolve whether isolating genes BRCA 1 and BRCA 2 merely describes a law of nature or whether it is “.” As mentioned earlier, and pursuant to Section 101 of the , laws of nature, natural phenomena, and an abstract idea are not patentable.  This provision is one that is seemingly simple to grasp, however, upon further interpretation, becomes complicated and abstract.  Patents sought by individuals who are able to demonstrate that their particular invention involves a of an abstract idea or law of nature are entitled to patent protection.  Therefore, Section 101 patent analysis is oriented towards what constitutes an application.  In Prometheus, patent protection for the diagnostic test that looked for chemicals formed when drugs used to treat gastrointestinal diseases were broken down in the body was  since the test merely recited and applied a law of nature. The future success or failure of Myriad Genetics’ patent may be foreshadowed utilizing the lesson learned from Prometheus, with greater accuracy depending on the degree of alignment between both cases. 

Perspectives on whether the fate of the Prometheus patent foretells a grim tale for  Myriad are rather varied and stratified. lawyers and patent experts believe that the ruling in Prometheus is not easily transferable to the present case since Myriad’s patents are compositions of matter while Prometheus’ were methods of testing. Dr. Robert Cook-Deegan, director of the program on genome ethics, law and policy at Duke University the logic to be different since the present case is about a thing, as opposed to a method.  believe that the ruling in Prometheus is opposed to the rationale used by the appellate court to uphold Myriad’s patents.  Daniel Ravicher of the Public Patent Foundation opined, “the isolation of DNA is a trivial, well-understood step…A unanimous Supreme Court has now undeniably declared that a trivial noninventive transformation” is not sufficient to obtain patent protection.

Irrespective of outcome, both Prometheus and Myriad have generated useful dialogue about the ethical and economic challenges facing the Unites States patent system in an age of biotechnology and the increasing monetization and exploitation of genetics.

Tracy Ayodele is a JD Candidate at Osgoode Hall Law School.

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