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The patenting of human genes: The Myriad Case

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In May 2009 the Public Patent Foundation (PubPat) and the American Civil Liberties Union (ACLU) filed a law suit before the United States District Court for the Southern District of New York, against the U.S. Patent and Trademark Office (USPTO), Myriad Genetics and the University of Utah Research Foundation. The reason behind this action is that Myriad Genetics and Utah Foundation were granted patents by the USPTO on the human genes BRCA 1/2. These genes were demonstrated to have an important role in both breast and ovarian cancer.

According to the judgment of the District Court of New York and the Amicus Curiae of the U.S Government it is the first time that a U.S Court has addressed the issue of whether an isolated DNA molecule is patentable subject matter under 35 U.S.C §101. Previous judgments that upheld the validity of patents on biological products concerned challenges under  §§ 102 and 103.

The District Court of New York invalidated the patents held by Myriad on the basis of the “product of nature doctrine”. According to this doctrine, in order for an invention to be patentable it must have markedly different characteristics –distinctive form, quality or property- distinguishing it from anything that exists in nature, and have the potential for significant utility.

Myriad and the University of Utah appealed the aforementioned ruling and now the case lies before the Court of Appeals for the Federal Circuit. Today 20% of human genes are patented in the U.S. and hence the final judgment by the Federal Circuit can change the current practice followed in the U.S. Thus, the outcome of the case is extremely important since the patenting of DNA can have significant consequences on the future of research, medical science, public health and the economy.

Updates (19/09/2011).
On the 29th of July 2011, the long anticipated opinion of the U.S. Court of Appeals for the Federal Circuit on the Myriad case was published. The opinion, taken with a 2/3 majority (Judges Lourie and Moore being in favor of the patentability of isolated DNA, and Judge Bryson having a dissenting opinion) reversed the district Court’s conclusion on the patentability of DNA molecules.

The Court appeared reluctant to move away from a long-standing practice of the U.S.P.T.O. and denied to extend the “laws of nature” exception to include isolated DNA sequences. The Court concluded that any decision aiming to change a long-lasting practice of the PTO should come from the Congress and not from the Court.

Update (30/05/2012)

On Monday 26 March 2012, the U.S. Supreme Court ordered, by granting a Writ of Certiorari, that the judgment held by the U.S. Court of Appeals for the Federal Circuit on the Myriad case be vacated and remanded to the lower Court for further consideration.

The Writ of Certiorari is an extraordinary prerogative writ, which is granted at the discretion of a Superior Court in cases that would otherwise not have the opportunity to be reviewed. According to Rule 10 of the Rules of the Supreme Court of the United States, a petition for a Writ of  Certiorari will be granted only for compelling reasons, such as: if there has been an error in lower law proceedings, if the case concerns an unsettled question of Federal law or if there are conflicting opinions between courts.

In the Myriad case, the Supreme Court granted a Writ of Certiorari but only for a limited purpose. The Supreme Court here is only remanding the case to the Court of Appeals for the Federal Circuit in order that it be reconsidered  in the light of the  Mayo Collaborative services v Prometheus Laboratories case, on which the Supreme Court had ruled a week earlier.

This second case concerned two patents on diagnostic methods based on the use of thiopurine drugs to treat autoimmune diseases. More precisely , the patents set forth processes which include researchers’ findings in identifying correlations between metabolite levels and the likelihood of harm or ineffectiveness.  The U.S. Supreme Court ruled that correlations between the levels of metabolites concentrated in the blood and the likelihood that a thiopurine drug dosage may cause harm or prove ineffective was not in itself patentable. The Court concluded that the processes were mere observations on a natural phenomenon and were not sufficient to turn an unpatentable law of nature into a patentable application of such a law.

Although the Writ of Certiorari in the Myriad case concerns not the method claims but the product claims regarding the cDNA and isolated DNA, it is probable that the Mayo decision will have an impact on the outcome of Myriad. This is because both cases concern the patent eligibility of natural phenomena. If the U.S. Court of Appeals decides to interpret the Prometheus decision broadly, it will probably change
its previous decision and  state that the claims on cDNA and isolated DNA are patent-ineligible  because of their great similarity with what is occurring in nature.

On 30 April 2012, the Court of Appeals for the Federal Circuit, issued an order vacating its previous decision and asking the parties and the amici curiae to file briefs, by 15 June 2012, on the question: What is the applicability of the Supreme Court’s decision in
Mayo to Myriad’s isolated DNA claims and to method claim 20 of the ’282 patent?

The Myriad case may return to the Supreme Court for a final judgment.

This new development is expected to delay a final decision on the Myriad case for a period of 2 to 3 years. In the meantime Myriad will continue to benefit from the fruits
of its patents on genes BRCA 1 and 2.

Update (18/10/2012)

On the 16 th of August 2012, the Court of Appeals of the Federal Circuit ruled for a second time on the Myriad case. The Court upheld its previous position regarding the patentability of the two "isolated" human genes, BRCA1 and BRCA2,
concluding that isolated genes are markedly different from native genes, and are therefore patent eligible under Title 35, Section 101 of the United States Code (35 U.S.C. §101).

The Court opted for a narrow interpretation of the Mayo case. According to the Court, "
Mayo does not control the question of patent-eligibility of such claims. They are claims to compositions of matter, expressly authorized as suitable patent-eligible subject matter in § 101."

The Court of Federal Circuit appeared for another time reluctant to move away from a longstanding practice of the USPTO stating that: "
The Supreme Court has repeatedly stated that changes to longstanding practice should come from Congress, not the courts," and that "Courts decide cases; they do not draft comprehensive legal treatises."

Judge Bryson, in his partly dissenting opinion , stated that although the conclusion of the Mayo case was not decisive, it should be instructive for the case under consideration. He stated that as in the case of method claims the patented method should do significantly more than simply describe natural relations, "a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product". Moreover, he stated that by fearing a detachment  from a longstanding PTO practice, the Court implicitly gives  lawmaking authority to the PTO.

As expected the saga of the Myriad case is not yet over. The plaintiffs filed a petition for a writ of Certiorari on the 24 th of September 2012 before the Supreme Court seeking a review of the aforementioned decision. The Supreme Court may or may not take up the case. In the second scenario the judgement of the Appeals Court will become final.

Update (21/ 12/ 2012)

On Friday 30 November 2012 the US Supreme Court granted a second certiorari on the Myriad case. The Court limited the certiorari to
question one (1) presented by the petition - the question of whether human genes are patent eligible. The Court denied Certiorari on the other two questions, on the method claims and on the plaintiff’s  standing, and rendered the Appeals Court judgement of 16  August 2012 on those two issues final. Although it seems unlikely that the Supreme Court will reverse a decades long practice of the U.S.P.T.O., such a decision will clarify once and for all the question of whether human genes are patentable. It is possible though that the Court, in attempting not to interfere with the U.S.P.T.O. practice, will declare that human genes as such cannot be patented, but purified or isolated DNA can be.

Update (03/ 07/ 2013)

The long awaited judgment of the U.S. Supreme Court on whether patents on genes are valid was issued on Thursday June 13, 2013. The Court unanimously ruled that patents on genes, even when isolated, are not admissible since genes fall within the product of nature doctrine. Patents on synthetic DNA (cDNA), however, are admissible because cDNA does not naturally occur.

This landmark judgment is expected to open up the door to scientific research on genes and it changes the practice followed by the USPTO in the last few decades regarding gene patenting. On the same day the USPTO issued guidelines to its examiners calling on them to reject product claims that refer to naturally occurring nucleic acids or fragments, whether isolated or not, as a result of the Supreme Court judgment on the Myriad case.

The Court in its opinion, delivered by Justice Thomas, stated that Myriad’s act of isolating BRCA1 and BRCA2 genes must be characterized not as an invention but as a discovery. The Court stated that "Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes". It added that separating the gene from its surrounding is not an act of invention and that "groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry". The inclusion of the words "by itself" implies that products of nature may still be patented as long as they are altered and significant human intervention is proved.

Moreover, the Court emphasized that the prohibition on patents on naturally occurring things is not unlimited and that "all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas" and that "too broad an interpretation of this exclusionary principle would eviscerate patent law".

Indeed, the Court upheld patents on cDNA stating that, despite the fact that cDNA retains naturally occurring exons of DNA, the lab technician definitely creates something new when cDNA is made. However, the Court in a footnote stated that the current opinion concerned the inventiveness requirement for cDNA, but not the other two requirements of patentability, i.e. non-obviousness and inventive step.

The Supreme Court’s decision sets stricter standards for patentability regarding biotechnology inventions, but does not completely forbid patents on naturally occurring products. It remains to be seen to what extent the judgment will affect the biotechnology industry in the U.S.

Relevant judicial documents to the Myriad Case

Abstract of the documents

In the United States District Court for the Southern District of New York, 09-CV-4515-RWS; Brief for Amici Curiae, The International Center for Technology Assessment, The indigenous People Council of Biocolonialism and the Council of Responsible Genetics in Support of the Plaintiffs.

In this amici curiae brief there are some  rather interesting arguments against the granting of the patents for isolated DNA claimed by Myriad. The main arguments are: (1) violation of the “product of nature doctrine” and (2)  the negative social, environmental, cultural and scientific impact that the granting of such patents may have, namely: the violation of precepts of common heritage and of the Public Domain and Public Trust doctrines, the privatization of genetic information, the facilitation of the exploitation of indigenous peoples and consequential violation of Public International Law obligations and the creation of a  system that facilitates the violation of the basic right of patients for informed consent.

United States District Court, Southern District of New York (USDC SDNY), Case 1:09-cv 04515-RWS, 29/03/2010

In its judgment the USDC SDNY concludes that all claims of Myriad for obtaining patents on isolated DNA which contained all or portions of the BRCA1/2 gene sequence were invalid pursuant to 35 U.S.C §101. The Court bases its judgment on the “product of nature doctrine” according to which “products of nature do not constitute patentable subject matter absent a change that results in a fundamentally new product”.

In the U.S Court of Appeals for the Federal Circuit; Brief for the United States as Amicus Curiae in support of neither party; No.2010- 1406

In the Amicus Curiae the government of the U.S presents the arguments against the patenting of isolated but unmodified genomic DNA. The basis of the argument of the U.S is again the product of nature doctrine. The US maintains that mere isolation does not turn a product of nature into a manmade invention. It however disagrees with the District Court’s decision to “invalidate also the challenged composition claims that are directed solely to cDNAs”, since these are synthetic molecules that are engineered by scientists and therefore are not a product of nature.

In the U.S Court of Appeals for the Federal Circuit; Brief of Intellectual Property Owners Association (IPO) in support of neither party; No.2010- 1406

The IPO claims that isolated DNA qualifies as  patentable subject matter under 35 USC §101. The main arguments “pro" a patent on isolated DNA demonstrated by the IPO are: isolated genes do not exist in nature and therefore the “product of nature doctrine” does not apply, and that the ban on patenting isolated human DNA will have a negative impact on research, technology and innovation.

Appeal from the United States District Court for the Southern District of New York in Case No. 09-CV-4515

The Court of Appeal ruled that isolated DNA is a distinct chemical entity with different physical characteristics from the natural DNA. Furthermore, the Court referred to the settle expectations of the inventing community and underscored that the role of the Jury is to interpret the Law as given by the Congress. The Court further stated that the Congress did not indicate any opposition to the PTO’s 2001 “Utility examination Guidelines” which affirmed the agency’s position that DNA molecules are patent-eligible subject matter.

Regarding the Myriad’s method to compare or analyzing DNA sequences, the Court confirmed the District Court’s decision that such methods are not patentable. The Court stated that those methods are abstract mental processes and therefore fail to comply with the “machine or transformation” requirement according to which a process is patent eligible if it: 1) is tight to a particular machine or apparatus or 2) transforms a particular article into a different state or thing (PROMETHEUS LAB v. MAYO COLLABORATIVE). On the contrary, the Court reversed the district Court’s decision on the method of screening for potential cancer therapeutics, holding that that method is patent-eligible because it includes transformative steps that are central to the purpose of the process.

Certiorari Summary Dispositions

The Supreme Court of the U.S. granted a writ of Certiorari on 26  March 2012. The Court remanded the case to the Court of Appeals of the Federal Circuit for further consideration in light of the case Mayo Collaborative services v. Prometheus Laboratories.

Appeal from the United States District Court for the Southern District of New York in Case No. 09-CV-4515, Senior Judge Robert W. Sweet. Decided: August 16, 2012

The Court of Appeals of the Federal Circuit confirmed its previous ruling, according to which isolated DNA is patentable subject matter. The Court stated that: "isolated DNA is removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body."

Regarding the method claims, the Court followed its previous line stating that the methods of comparing or analyzing are not patentable whilst the method of screening of  potential cancer therapeutics is patent eligible.

Petition for a Writ of Certiorari

The plaintiffs filed a petition for Certiorari asking from the Supreme Court to rule over the patent eligibility of isolated genes under Section 101. The plaintiffs stressed the significance of having a final Supreme Court judgment, which  would clarify the applicability of Section 101 to discoveries in genetics, for the national economy, medical science and the public health.

ORDER LIST: 568 U.S.

The Court granted a certiorari on the question of whether human genes are patent eligible.

Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., June 13, 2013

The Supreme Court of the United States decided that genomic DNA is not patent eligible, whilst synthetic DNA, cDNA, is patent eligible.


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