The Case or Controversy in AMP v. PTO - Patent Law Blog (Patently ...

By Dennis Crouch

A substantial number of patent lawsuits are declaratory judgment actions that involve a user asking a federal court to rule that it is not liable for patent infringement (either because the user does not infringe or because the patent is invalid/unenforceable). A preliminary issue in these cases is always a determination of whether a sufficient legal dispute exists (a case or controversy) between the parties. Under the U.S. Constitution (as interpreted), a federal court cannot pass judgment on cases that do not meet this threshold. When multiple plaintiffs are present (as in the Myriad case), the court must find at least one plaintiff-defendant relationship that meets this threshold or else the case must be dismissed for lack of standing.

In Myriad, the Federal Circuit ruled that the research of at least one individual (Dr. Ostrer) was hampered by Myriad's patent enforcement activities. Although the court found a controversy in this case, the language that it used to permit the case to continue is quite narrow.

Public Interest Patent Litigation: An important element of the Myriad case is that it has been driven largely by public interest groups operating with an agenda of denuding patents that they see as harmful to public health and fundamental liberties. These parties include the ACLU, PubPat, and the first-named plaintiff, the Association for Molecular Pathology (AMP). Those advocacy groups have no intention of using the patent themselves, but challenging the patent fits within their agenda of protecting the public. In its opinion here, the court holds that those organizations do not have standing in the case.

We ? reverse the district court's holding that the various plaintiffs other than Dr. Ostrer have standing to maintain this declaratory judgment action. Simply disagreeing with the existence of a patent on isolated DNA sequences or even suffering an attenuated, non-proximate, effect from the existence of a patent does not meet the Supreme Court's requirement for an adverse legal controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment. The various organizational plaintiffs in this suit in particular were not the target of any enforcement action or offered license agreements by Myriad and had made no preparation to undertake potentially infringing activities. They accordingly suffered no injury and thus lack standing to bring this action.

This result obviously makes it more difficult for public interest organizations to take this type of action in the future. However, the court provides a roadmap ? simply identify an individual with an actual controversy as the named plaintiff.

Patient / Health Insurance Plaintiffs: Another set of plaintiffs in this case are patients who would like to run the DNA test using an alternative laboratory ? either because they want a second opinion or because they want a cheaper test. The court also wrote that those patients likely lack standing to bring a declaratory judgment action in the absence of some affirmative act by the patentee against those defendants.

Certain patients also allege an injury based on their inability to gain access to affordable BRCA genetic testing because of Myriad's patent dominance of such services. While denial of health services can, in certain circumstances, state a judicially cognizable injury, Plaintiffs have not pressed this as an independent ground for standing. Moreover, we fail to see how the inability to afford a patented invention could establish an invasion of a legally protected interest for purposes of standing.

This quote from the court conforms well to the Supreme Court's recent copyright decision Golan v. Holder (2012). In that case, the court wrote that individuals do not have enforceable rights to use the "public domain."

In a sense, it appears that the court here strained to claim jurisdiction over the case, but was careful to attempt to avoid expanding the scope of declaratory judgment jurisdiction in the process.

Source: http://www.patentlyo.com/patent/2012/08/the-case-or-controversy-in-amp-v-pto.html

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