, 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.

The post Isolated Genes Are None Of Your Business! – SCOTUS Decides Myriad appeared first on IPOsgoode.

Is there a Material Difference Between a Gene that Has Been Isolated from a Human and One that Has Not?

As previously covered by the IPilogue (,��, and ), at issue is a pair of genes known as BRCA1 and BRCA2.  Mutations in these genes have been positively correlated with an increased risk in the development of breast and ovarian cancer in women.  The University of Utah owned the patent rights to both (1) the method of analyzing and comparing the isolated DNA sequences in order to detect mutation in the BRCA genes and (2) the composition of matter that included the genes themselves.  Myriad Genetics was the exclusive licensee of these patents and was responsible for chemically isolating that genetic sequence.  The bulk of the method patents were by the Federal Circuit Court and that decision is now final given the USSC’s refusal to revisit the issue.

Instead, the Court will focus on the main point of disagreement in . In that ruling, the 2-1 majority (which consisted of Judges Lourie and Moore) upheld their that isolated DNA molecules are indeed patentable subject matter. It is a of American patent law that substances found in nature are not patentable; however the USSC’s decision in  also established that a product of nature that is “markedly different from naturally occurring ones” with a “distinctive name, character and use” may be patentable as it is a “non-naturally occurring composition of matter”.  Because the native BRCA genes are chemically bonded to other genes and histone proteins, the majority concluded that breaking those bonds to isolate the BRCA genes turned the isolated genes into materials that are markedly different from the naturally occurring genes in humans and thus eligible for patent protection.

Judge Bryson dissented with the majority on this point stating: “There is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered”  (at 7 of Bryson’s ruling). Judge Bryson then goes on to compare the isolation of human genes with the extraction of newly discovered minerals from the earth’s crust.

“In this respect, the genes are analogous to the 'new minerals discovered in the earth' or the 'new plant found in the wild' that the SC referred to in Chakrabarty.  It may be very difficult to extract the newly found mineral or to find, extract, and propagate the newly discovered plant.  But that does not make those naturally occurring items the products of invention.”

Like some minerals, Bryson J argues, genes are hard to extract from their natural setting.  Also like minerals, genes can be used for purposes that would be infeasible if they remained in their natural setting.  Furthermore, the process of extracting minerals or the picking of plants, like the process of isolating genetic material, can result in some physical or chemical changes to the natural substance.  But such changes do not make extracted minerals or plant pickings patentable. Thus they should not have that effect for isolated genes.  In each case, merely isolating products of nature by extracting them from their natural location and making alterations attendant to the extraction process does not give the extractor the right to patent the products themselves.

Looks Like It’s Going to Be An Interesting Summer For The American Genetic Industry

It is expected that the Supreme Court will hand down its ruling in June of 2013. By granting this appeal, the Supreme Court may finally settle the central point of dispute in a series of lengthy rulings that have wound through the Federal Circuit since . Whichever way the USSC rules, it seems the summer of 2013 will be an interesting one for the American Genetic Industry.

Beatrice Sze is a JD Candidate at Osgoode Hall Law School.

The post Staying Abreast of an Isolating Issue: USSC to Rule on Patentability of Human Genes appeared first on IPOsgoode.

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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