Patent cases and public controversies.

• Author: Rinehart, Amelia Smith

INTRODUCTION

A patent could be described as a private solution to a public problem--the government grants to an inventor a private exclusive right to his invention for a limited time in order to encourage the promotion of progress to benefit the public as a whole. (1) When someone infringes that private right, the patentee enforces his exclusive right in federal court by filing a civil action for patent infringement pursuant to 35 U.S.C. [section] 281. (2) But what happens when a member of the public wishes to challenge the merits of that private right? Some members of the public might like to practice the invention without consequence--this group could include competitors, hopeful market entrants, patent licensees, or even strangers to the patent owner. Other people might believe that the patent harms them and others (including the government sovereign itself) by restricting competition and limiting innovation or by offending on moral or ethical grounds. Because the traditional Article III inquiry in such cases revolves around the reciprocal (and often hypothetical) infringement case that could be brought by the patentee against the challenging party, conventional wisdom holds that the former group, the practicing public, would be welcome in federal court while the latter group, the non-practicing public, would not.

Despite improbable chances for justiciability, (3) several recent cases challenge this conventional wisdom, revealing a trend in patent litigation whereby members of the public bring suits to challenge patents, including Ass'n of Molecular Pathology v. Myriad Genetics, Inc. ("AMP"), (4) Mama Cares Foundation v. Nutriset Societe Par Actions Cimplifiee ("Mama Cares'), (5) and Organic Seed Growers & Trade Ass'n v. Monsanto Co. ("OSGTA"). (6) In these public patent litigations, the declaratory plaintiffs seek to invalidate patents on a variety of grounds. In AMP and OSGTA, the declaratory plaintiffs claim the patents--gene patents in AMP and genetically modified food patents in OSGTA--are invalid on statutory subject matter grounds. (7) In Mama Cares, the declaratory plaintiffs claim that the patents, directed toward ready-to-eat therapeutic food products and processes, are invalid on other grounds of patentability (e.g., lack of novelty, non-obviousness, or inadequate disclosure). (8) In each case, the declaratory plaintiffs are not presently infringing the patents--the Mama Cares plaintiffs and some AMP plaintiffs desire to infringe; all of the OSGTA plaintiffs fear inevitable infringement sometime in the future. In all three cases, public interest groups, such as the American Civil Liberties Union and the Public Patent Foundation, support the declaratory plaintiffs in their quest for invalidation. The Court of Appeals for the Federal Circuit ("Federal Circuit") twice approved of jurisdiction in AMP[degrees] but found the OSGTA controversy moot. (10) A district court dismissed Mama Cares for lack of jurisdiction. (11) Each court came to a decision on jurisdiction (and therefore justiciability) by referring to the likelihood (or lack thereof) of an infringement suit by the patent owner and by citing the same Supreme Court and Federal Circuit precedent. However, the courts' views of that precedent and the Supreme Court's policy preference to encourage patent challenges raise questions regarding justiciability in patent cases and in public law cases generally.

As discussed below, MedImmune, Inc. v. Genentech, Inc., the most recent case from the Supreme Court addressing declaratory judgment justiciability, instructs courts considering declaratory cases (including patent ones) to embrace the flexibility of Article III justiciability by simply asking whether a declaratory plaintiff has a sufficiently real and immediate legal dispute with the declaratory defendant. (12) A broad view of MedImmune's Article III jurisprudence in declaratory patent cases could facilitate public litigants challenging patents in courts. Such public patent litigation would further a strong public interest in challenging invalid patents--an interest that courts, including the Supreme Court, have championed for decades. (13) However, despite MedImmune's hint of flexibility in applying its stated standard of reality and immediacy, the question of Article III justiciability in lower courts focuses on identifying an underlying coercive action that could be brought by the declaratory defendant. (In other words, the request for anticipatory relief necessitates asking the declaratory plaintiff, "You anticipate what exactly?") In a declaratory patent case, the underlying coercive action for infringement reorients the Article III inquiry toward the patentee's intent to enforce his patent rights and the declaratory plaintiff's desire to exploit non-infringing activity. (14) Thus, a contextual reading of MedImmune (itself a licensing dispute) and its progeny reveals a narrower view of justiciability that reiterates our federal civil litigation system's commitment to private adjudication even in patent cases where the public stakes may be large.

Despite courts' doublethink (15) in declaratory patent cases like MedImmune--simultaneously promoting public patent challenges as a matter of patent policy and private litigation as a matter of law--these cases have not created an open door to federal court for public patent litigants. MedImmune's reminder that rigorous rules have no place in Article III justiciability determinations appears to be disregarded in the declaratory patent case. Post-MedImmune cases in the Federal Circuit and in lower courts insist upon a showing of affirmative acts from the patentee indicating an intention to enforce his patent and affirmative acts from the declaratory plaintiff indicating that she is "ready, willing and able" to infringe the patents at any time in order to establish the legally cognizable interest required for justiciability. (16) Declaratory patent plaintiffs who allege injuries outside of the traditional harm of patentees' threatened coercive actions for infringement (what the Federal Circuit refers to as "a restraint on the free exploitation of noninfringing goods" (17)) remain excluded from federal courts despite arguably presenting other injuries of sufficient immediacy and reality to warrant relief. In traditional cases where the patentee explicitly or implicitly threatens to bring an infringement suit against a declaratory plaintiff making meaningful preparations to infringe (or already infringing), courts reach the same results as under the older reasonable apprehension of suit test abrogated in MedImmune. (18) In cases involving privileged parties (like licensees or covenantees) or in cases involving a member of the public seeking to challenge the patent on public interest grounds, courts struggle to identify an underlying coercive cause of action for infringement based upon such affirmative acts by the patentee and declaratory plaintiff.

The growing interest in public interest patent litigation, as evidenced by cases like AMP and others, suggests that there is room for improvement in the jurisprudence of justiciability in declaratory patent cases. Moreover, MedImmune's long game--shifting the focus from a bright-line rule based upon the relative certainty of an infringement action to an adverse interests standard--suggests that public patent litigation could be encouraged as the best mechanism for challenging patents that may negatively impact society. Recognizing that members of the public have an interest in invalidating patents deemed costly for society as a whole and an even greater interest in the patent system's overall legacy of legitimacy in granting the right to exclude only when deserved, this Article proposes that MedImmune's doublethink be resolved by allowing certain members of the public standing to sue patentees in order to invalidate patents. A limited citizen's right to invalidate a patent would supplement the private right to invalidate that is afforded to alleged infringers and would improve the overall legitimacy of the patent system.

The Article proceeds as follows. Part I summarizes the evolution of the current standard for justiciability in declaratory patent cases, including the Supreme Court's MedImmune opinion and its progeny in the Federal Circuit and the lower courts. Part II discusses the growing trend of public interest patent litigation and the hurdles declaratory plaintiffs face on justiciability grounds despite courts' approval of patent challenges generally on policy grounds. Finally, Part III introduces a legislative reform that promises to afford justiciability for some members of the public without compromising Article III's emphasis on private adjudication.

1. THE EVOLUTION OF A JUSTICIABILITY STANDARD

   Federal courts have exclusive jurisdiction over all suits "arising under any Act of Congress relating to patents." (19) The majority of patent cases satisfy this jurisdictional requirement by arising under 35 U.S.C. [section] 281, which grants to a patentee the "remedy by civil action for infringement of his patent." (20) A patentee seeking to enforce the limited, exclusive rights secured by his patent may file suit against any party who makes, uses, sells, or offers for sale the invention claimed by the patent or who imports the invention into the United States. (21) Because patents enjoy a presumption of validity by statute, (22) a patentee need not establish that his patent meets the requirements for patentability in order to proceed with his infringement suit in federal court; proving ownership suffices for a civil action brought under 35 U.S.C. [section] 281. (23) Anyone sued by the patentee for infringement may challenge the validity of any patent claim in suit as an affirmative defense to liability. (24) If a defendant establishes with clear and convincing evidence that a patent claim is invalid, the claim cannot be infringed and will...