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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The criticisms from Australia concerning the patenting of genes echo those expressed throughout the North American battle. The primary attack on assigning patents of genetic materials to a company surrounds the invention component of the patent. Australian patent lawyer and proponent for ‘free trade’ of genetic materials, , likens companies such as Myriad to ‘cartels’, emphasizing that the genes are not something that anyone has invented. that allowing gene patents will permit patents on any biological materials that are artificial, irrespective of their source.

In an extremely accessible and , the Court surveyed the biological principles necessary to consider gene patents (this comprises more than half of the decision, and I strongly recommend it to anyone without a strong background in biological or medical sciences). The Court accepted the arguments of Myriad’s Australian lawyers, who leaned heavily on the arguments put forward by Myriad in the (although it noted that due to differences in the patent legislation and jurisprudence the American case itself was neutral, benefitting neither party). It was held that:

(1)�� because the genes are not naturally occurring DNA or RNA as they exist within the cells of the human body (which are not patentable, per ), they are not precluded from being the subject of a valid patent, and

(2)�� the patent claims to the genes are indeed to a manner of manufacture as required by .

With respect to (1) above, the Court was very conscious of the legislative intentions in drafting s. 18 of the Patents Act. In para 112 of the decision, it was acknowledged that a proposal was brought and subsequently rejected that would have included isolated DNA and RNA in the s. 18(2) provision. As such, it was left to the Courts to deal with the issue of gene patenting by establishing jurisprudence.

The Court found that because the patented nucleic acid sequences for BRCA1 and BRCA2 are independent and isolated for native DNA, it is patentable. Furthermore, because the sequences could not exist in isolation without human intervention, the patented matter consists of “an artificial state of affairs” (see paras 101-110), a necessary condition for invention in the Australian legislation. Even if it has been removed from a biological cell, the Court held that it is reasonable to deem the isolation ‘artificial’, emphasizing the process of isolation rather than the extracted material.�� Addressing broader concerns, Myriad’s counsel also emphasized that��the screening process of the patent, which includes the diagnostic component of comparing normal and mutated genes, could not be used .�� However, in my opinion, this does not address the important issues of access to medicine and the potential detriment that the patents pose to scientific progress.

The present case was in the form of a lawsuit brought by a national organization representing cancer patients, , and a Brisbane cancer survivor concerned with the impact that the gene patents will have on breast cancer diagnosis and treatment. I share these concerns. Indeed, I have about Myriad’s monopolization of the market and the conflation of trade secrets and patents, so I would direct your attention there for this discussion. However, for those opposed to the patenting of genetic codes and the processes for isolating genes, this Australian decision certainly gives reason for concern. That said, Myriad’s victory down under may be short-lived, as Cancer Voices Australia announced on March 3, 2013 that they to the decision of the Federal Court.��

Ryan Heighton is a JD candidate at Osgoode Hall Law School.

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Earlier this month a United States District Court to dismiss a lawsuit brought forth against the USPTO, Myriad Genetics, and directors of the University of Utah Research Foundation. The suit had to do with patents covering the genes BRCA1 and BRCA2 (for which mutations have been associated with a higher risk of breast cancer) and their usage in genetic testing. The plaintiffs, composed of a broad range of individuals and organizations from researchers to individual women with breast cancer, claimed that the patents should be unenforceable and that the USPTO’s practices in allowing such gene patents are unconstitutional. For a good primer (pun intended for the molecular biology folks) on the lawsuit and the issues it raises, read Stephanie Anderson’s IPilogue article from this past summer .

In his , Justice Robert W. Sweet, a veteran judge of the Southern District of New 91��ɫ, separated his analysis into five major sections: the subject matter jurisdiction over the claims against the USPTO, the plaintiffs’ standing to sue the USPTO for constitutional violations, the plaintiffs’ standing to sue Myriad and the directors, the personal jurisdiction of the Court over the directors, and the adequacy of the allegations of constitutional violations. All of these issues were, perhaps surprisingly, decided in favour of the plaintiffs.

With respect to the first issue, the USPTO argued that the Court did not have subject matter jurisdiction over the claims because Congress had already created a “comprehensive scheme ... to govern patent grants”, which precludes the courts from getting involved. However, Sweet said that the cases brought up by the USPTO to substantiate its point only included claims that the Patent Act already provided a remedy for; but in this instance there is no “statutory scheme providing a remedy for persons who complain about the constitutionality of patents issued by the USPTO and/or the policies and practices of the USPTO”.

The plaintiffs’ standing to sue the USPTO for constitutional violations is quite interesting considering the potential wide-reaching consequences of such a precedent. Despite the USPTO arguing that there was no sufficient causal connection between its acts and the supposed injuries to the plaintiffs, Sweet ruled:

While the USPTO is correct that Myriad’s refusal to license its patent broadly contributes to Plaintiffs’ alleged injuries, the patents were issued by the USPTO, in accordance with its policies and practices. It is those policies and practices that the Plaintiffs allege are unconstitutional. The injury alleged is therefore “fairly traceable” to the USPTO.

This reasoning could potentially open up the floodgates. The constitutional rights claimed by the plaintiffs as being infringed include freedom of speech under the , and Congress’ power to “promote the progress of science and useful arts” under . Since anyone can claim to be restricted when certain acts become unlawful due to the new existence of a patent-holder’s rights, it seems to me that virtually anyone can then have standing to sue the USPTO for the issuance of any patent it grants.

Regarding the plaintiffs’ standing to sue Myriad and the individual directors of the University of Utah Research Foundation, Sweet determined that the case law dictated that to get standing in such a declaratory judgment case, there must be an affirmative act by the patentee protecting their product, and also “meaningful preparation to conduct potentially infringing activity” on the part of the plaintiff. The first condition was found to be met when threatening cease-and-desist letters were sent by the defendants. The second condition was met for the researcher plaintiffs because they were ready to immediately perform BRCA1 and BRCA2 genetic testing. For the non-researcher plaintiffs, Sweet said that there were no authorities put forward by the defendants to show that indirect contributory infringement is not sufficient for standing in a declaratory judgment action, and that the non-researcher plaintiffs’ solicitation of and contribution to the infringement of the researcher plaintiffs was enough. I would again have to say that this reasoning could further open the floodgates for declaratory judgment litigation by third parties whose rights are only affected in an indirect way.

The issue of the Court’s personal jurisdiction over the directors was not too interesting in comparison to the other parts of the judgment. It was held that even though the directors were located out of state, they entered into a licence agreement that allowed for the marketing of products and services in New 91��ɫ, and also sent cease-and-desist letters to uphold their rights in New 91��ɫ. It was found that these were sufficient connections to the state for the district court to have specific personal jurisdiction.

The adequacy of the allegations of constitutional violations ought to have been a particularly important aspect of the judgment in light of the general novelty of the claims being made. However, Judge Sweet only spent about three pages out of the 85-page decision discussing this. After bringing up case law that rules that a complaint must state a plausible claim for relief in order to survive a motion to dismiss, the judgment briefly went through the specifics of the plaintiffs’ complaint. It was then held that, “[t]he facts alleged in the Complaint are plausible, specific, and form a specific basis for Plaintiff’s legal arguments. Consequently, the pleading requirements as set forth in Iqbal are satisfied.” I suspect that Judge Sweet did not wish to delve too deeply into the substance of this lawsuit at this point in time.

This decision should probably be viewed as quite the victory for the plaintiffs, since they are likely facing an uphill battle. Considering the major implications that would follow if their claims are successful, this suit is definitely one to keep track of. The next step in the process is the hearing of arguments for and against the motion for summary judgment, which is scheduled to occur in just over a couple of weeks.

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