Myriad Genetics Inc. Wins the Human Gene Patent Case

A grant of Patent gives the sole right to the owner over any new invention or discovery. A patent is generally not granted over naturally occurring elements. In the case of The association for molecular pathology v. U.S. patent and trademark office the conflict was regarding a patent on the BRCA1 and BRCA2 genes (the judgment can be accessed at: http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf).

 

The case was decided finally on the 16th of August 2012 in the United States Court of Appeals by a three judge bench. The opinion of the court was divided in the ratio of 2:1 with Judge Bryson passing a partly dissenting opinion. The Supreme Court of U.S. returned this appeal to the Court of Appeals by vacating its earlier judgment for taking into consideration precedents like Mayo Collaborative Services v. Prometheus, Inc.

 

The arguments of the Appellant-plaintiffs are that the human genes are non- patentable matter as per § 101 (35 U.S.C. § 101 can be accessed at: http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_101.htm). These genes will be useful in determining the risk of a woman developing breast or ovarian cancer in her lifetime. The argument against granting the patent is that exclusive power to Myriad for testing of such diseases would lead to monopoly in testing these diseases and would hamper scientific research.  ACLU, challenging the patents, argued that “Human DNA is a natural entity like air or water. It does not belong to any one company.”

 

The majority decision of the court has set aside the district court’s decision to exercise declaratory judgment. Declaratory judgments offer reliefs which are not available otherwise (28 U.S.C. §§ 2201-220, accessible at: http://www.law.cornell.edu/uscode/text/28/2201). This was done so because one of the plaintiffs known as Dr. Harry Ostrer has a legal standing to challenge the validity of Myriad’s patents. The district court’s decision was reversed as the genes in question represent a non-naturally occurring composition of matter. Also the method claim for testing potential cancer via changes in cell growth rates of transformed cells was held not to be a patent-ineligible scientific principle. Circuit Judge Alan Lourie said: "Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature."

 

However, the court held Myriad claim to “comparing” or “analyzing” DNA as patent ineligible as it included no inventive or transformative step. The critics of this decision however still say that "This ruling prevents doctors and scientists from exchanging their ideas and research freely."