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 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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It����that Myriad has been retaining clinical data concerning BRCA1/2 mutations as trade secrets, stemming from their control over BRCA1/2 research. By claiming mutation information from clinical trials as proprietary, Myriad is failing to disclose valuable information that is secondary to their patent of the initial genes, and potentially impeding research on the genes that could result in life-saving developments. This brings concerns around the circumvention of the parameters and breadth of their initial patent, as well as the convolution of the patent as a means of shrouding their company data in trade secrecy.

Typically,��; in exchange for disclosure of the information surrounding the invention (which is in the interest of furthering innovation), patent holders are granted legal protection from others using their patented invention. Trade secrets do not afford legal protection, and anyone obtaining the secrets (typically excluding those under contract) may use them freely. Of the greatest concern is that even if the BRCA1/2 patents are invalidated in court in the Spring, Myriad will still be privy to the clinical data collected under the invalid patent. Such unconscionable use of the patent system directly violates the����on which the system was built.

The primary public health consideration in Myriad’s decision to retain clinical data as trade secrets is the����that has resulted from their retention of mutation information. This is a particularly great concern, as Myriad����with BRACAnalysis. By retaining clinical BRCA gene mutation information in America, but not releasing it publicly, Myriad has ensured that consumers utilizing their test will receive more reliable results. At present, it has been reported that as a result of the vast mutation data and algorithms that Myriad has collected since releasing the BRACAnalysis test, only 3% of mutations will be of unknown significance. This contrasts unknown variant rates of 20% using other tests, including those presently in use in Europe. This means that Americans utilizing Myriad tests have a significantly greater chance of having their genetic variants identified, which is essential to therapeutic counseling. Further, as a result of this trade secret ‘loophole’ in the American patent system, which mirrors our own in Canada, Myriad will possess an inherent competitive commercial advantage over European BRCA tests despite not holding a BRCA patent in Europe. By allowing this type of action, a dangerous precedent is set in the field of biotechnological research, where research facilities may use patents as swords in order to protect vast trade secrets and monopolize a market, contrary to the public interest.

Beyond commercial interests, the primary function of scientific research in society is to serve the public good. This is particularly true in the case of medical research, as the ultimate goal is to benefit patients and improve diagnostics, treatment, and preventative medicine. Patents have become��, in order to encourage innovation and provide commercial protection and incentive for researchers who make significant breakthroughs. However, in the United States, it has been shown that����as of 2005, with most “inventors” overstating their discoveries surrounding the code, while others were granted protection for genes that had not been “discovered” yet (e.g., mutated or isoforms, with no description of the genes).

In my opinion, Myriad Genetics is a company benefitting from relatively lackadaisical biotechnology patenting standards. In addition to holding a (thus far) valid patent on the two primary diagnostic genes for breast and ovarian cancer,����through��, which has been described as the most efficient breast cancer test commercially available. Holding the American patents for the BRCA genes has ensured that Myriad has been able to turn a profit after pouring millions of dollars into research and development, and has in turn improved the diagnostic potential of medical practitioners. However, with this advancement in medicine has come at great cost to the public. By creating geographical inequalities (resulting from the limited scope of Myriad’s services), Myriad is effectively compromising the therapeutic services provided to women worldwide, solely to advance their economic interests. Thus, despite creating an incredibly useful database of mutation information and algorithms, Myriad has effectively created a monopoly, and, in my view, has violated the promotion of innovation and discovery that the patent system is designed to serve.

Their��, combined with what is regarded as an unreasonably high cost for the BRCA testing has led to allegations that Myriad is engaging in����by compromising the interests of public health in order to turn a profit. In my opinion, while the patent system certainly serves as a means of providing financial restitution to researchers and facilities that take financial risks in the interests of innovation, there comes a point when the public interest is being jeopardized out of greed. Such compromise of the public interest, especially in a medical research context, is contrary to the spirit of the patent system, which is to provide information to the public to improve transparency in innovation.

With the completion of the��, the United Nations identified the risk of abuse of advancing biotechnology, and the����took effect. Of particular importance is Article 12, which indirectly relates to gene patenting and freedom of research. It takes specific note of the unique nature of the genome, which is within all humans, and declares that the genome should be free to research in the interest of advancing bioscience and medicine. Additionally, and in my view damning to Myriad’s trade secrets and imposed geographical inequality, it declares that the benefits of advances in genetics and medical science be made available to all. Although this is not a binding legal document, it was carefully considered, is highly persuasive, and contemplates essential concepts in bioethics which may factor into the Supreme Court’s 2013 ruling.

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

The post Live and Let Die: Gene Patenting Plot Thickens as the Patent/Trade Secret Line is Blurred appeared first on IPOsgoode.

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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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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, representing the , stated, "We don't think people should have a monopoly just because they have discovered a gene." However, Olver does agree that treatments should be patentable:

"If they invent a treatment as a result, by all means."

On Monday, , breast cancer survivor and member of , spoke to the panel about patenting cures, not genes, as well. ''If someone owns a patent to one gene and someone else owns a patent to another gene associated with breast cancer, my question is, will they ever talk?'' she began, "If you discover a treatment or cure, then patent that. Don't patent the gene. Patent the cure."

Perhaps the era of gene patents is coming to an end.

Last year, of Melbourne requested that hospitals stop conducting breast cancer gene tests because the company owns the patent for the genetic mutation and the $2 100 screening test in Australia. The controversy surrounding Genetic Technologies is similar to a current situation here in North America. patent on the BRCA1 and 2 genes is currently under in the United States as well. This past May, a lawsuit was filed again the USPTO, Myriad Genetics, and the University of Utah Research Foundation by breast cancer patients as well as many prominent medical researchers across the United States. The plaintiffs introduced a novel argument by stating that gene patents are in violation of free speech rights and therefore are unconstitutional according to the First and Fourteenth Amendments to the US Constitution.

The University of Utah and Myriad genetics asked a New 91��ɫ federal judge to the high-profile case against them in mid July. They argue that the plaintiffs in the case cannot prove that they were injured by the patents granted to the university fifteen years ago. , "If the plaintiffs in this case have standing, then virtually anyone can challenge any patent at any time." The USPTO filed a motion asking for a dismissal as well. However, one could argue that because Myriad holds a patent for genes that are in every female's DNA, it would make sense that almost anyone could have standing to challenge their patent. As I have , one of the problems with some gene patents seems to be their overly-broad nature, which inevitably leads to conflicts such as the rights to breast cancer gene screening tests as outlined above. These are over-reaching implications that (likely) the USPTO and parallel organizations in other countries facing similar controversy did not desire.

Should cures for genetic diseases be patentable, but not the actual gene that causes or contributes to the disease? What if the cure involves genes, such as in gene therapy? Gene therapy is currently being considered for cancer treatment. Gene therapy is a procedure where the genetic mutation that is causing or contributing to an illness, such as in breast cancer, is changed. The mutant allele, or section of DNA, is replaced with a functional piece of DNA, thereby stopping the production of the "cancer-causing" proteins and thus halting the progression, or reversing the damage, of the disease.

is one example that has shown positive results in mouse ovarian and breast cancers and is being considered for human treatment. P53 gene therapy may even be effective against tumours that lack p53 mutations because p53 can also serve as a growth inhibitor in certain settings. Since cancer is caused by a proliferation of cell reproduction, p53 may stop this process from occurring. Right now, the main limiting factor of gene therapy for cancer treatment is the degradation of the vector by the host's immune system, which may be rectified in the near future with more research.

Is gene therapy distant enough from a standard gene patent that it should be patentable? Or is gene therapy still fundamentally using genetic information that, according to some people, is a product of nature and should not be patentable? As someone who is strongly in support of genetics, I believe that most diseases have, at their fundamental level, a root in genetics, and thus many cures for diseases will involve genetics to some degree. Whether this means that I think that cures for diseases such as breast cancer should be patentable, I am still unsure.

The patent debate was not always so complicated, as demonstrated by the famous comment of Dr. Jonas Salk who invented the polio vaccine. When journalist Edward R. Murrow asked who owns the polio vaccine patent, Salk replied, "Well, the people, I would say. There is no patent. Could you patent the sun?"

Well, almost, according to , which stated that "anything under the sun that is made by man" could qualify for patent protection.

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