Motion to Dismiss Denied in Breast Cancer Case: The USPTO is a Defendant in a Case Challenging the Constitutionality of Patents Granted by the USPTO

 By Jake Meyer

November 1, 2009, Judge Sweet of the United States District Court in the Southern District of New York issued an opinion in Association for Molecular Pathology v. United States Patent and Trademark Office.  The plaintiffs in the case, which were previously blogged about here, challenge the constitutionality and validity of patents on the BRCA1 and BRCA2 breast cancer genes owned by Myriad.  The defendants -- the U.S. Patent and Trademark Office (USPTO), Myriad Genetics, and the Directors of the Utah Research Foundation -- moved to dismiss the case for standing and jurisdictional issues.  Judge Sweet denied all motions to dismiss, finding there was both standing and jurisdiction.

The inclusion of the USPTO as a defendant in this case is unique to this case, as the USPTO has never been a party to a lawsuit in which the constitutionality of patents issued by the USPTO were brought into question.  The USPTO moved to dismiss for lack of subject matter jurisdiction (the USPTO also moved to dismiss for lack of standing) arguing that it had a comprehensive statutory scheme in place to redress violations of the Patent Act.  However, the cases the USPTO cited involved claims that alleged statutory violations that the Patent Act provided a remedy for.  Judge Sweet found that there was no comparable statutory scheme that provided remedies for constitutional violations.  Judge Sweet found that there was subject matter jurisdiction over the USPTO citing the novel circumstances of the action, the absence of any remedy provided in the Patent Act, and the importance of the constitutional rights asserted by the plaintiffs.

In his opinion, Judge Sweet also commented on the importance of the issues before the court, stating that:

The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific innovation in biomedical research.   

Judge Sweet’s characterization of genes as "information" and "genetic identities" indicates that he views genes as more than just a physical chemical, which proponents of gene patents often argue.  The characterization of genes as "information" gives strength to the plaintiffs' argument that patents on genes patent information and therefore violate First Amendment rights to free speech.  The characterization of genes as our "genetic identities" also indicates that he may view human genes as personal and unique to all humans.  However, the statement does cut both ways as Judge Sweet also indicates that he will consider the "need to adopt policies to promote scientific innovation in biomedical research."  Judge Sweet may ultimately decide that patent protection on the BRCA1 and BRCA2 genes is needed to promote scientific innovation and that these concerns outweigh the concerns of allowing patents on the "information that serves as our genetic identities."

The opinion by Judge Sweet denying the defendants' motion to dismiss allows the case to continue forward.  On December 11, Judge Sweet will hold a hearing on the plaintiffs’ motion for summary judgment in which the plaintiffs asked for invalidation of the patents on the breast cancer gene sequences and the correlations between mutations in the genes and disease.  This case will be an interesting one to watch and presents unique and interesting issues involving patent law, constitutional issues and concerns with health care and technology.  In fact, the case has all ready resulted in a unique and interesting twist -- the USPTO is a party to a case challenging the constitutionality of patents granted by the USPTO.

This information comports with the brief filed in Association for Molecular Pathology v. United States Patent and Trademark Office by ISLAT Director Lori B. Andrews.

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