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The Leahy-Smith America Invents Act effectively repealed aspects of the Federal Rules of Civil Procedure by creating a new statutory section governing joinder of accused infringers and consolidation of actions for trial in most patent infringement cases. This new law codifies a substantial barrier to joinder and consolidation for trial. In so doing, it frustrates the promotion of liberal standards both for evaluating the sufficiency of pleadings and for evaluating the propriety of joinder of parties—two of the primary policies embraced by the drafters of the Federal Rules of Civil Procedure. Remarkably, Congress adopted the new statutory section despite the absence of any detailed scholarly analysis prior to its enactment regarding these issues, sparse legislative history analyzing perceived problems with the relevant Federal Rules of Civil Procedure, and the lack of any consideration of the new statutory section by the Supreme Court’s Advisory Committee on Civil Rules. This Article provides a comprehensive analysis of the reasons for the enactment of the new statutory section, the competing policies animating the Leahy-Smith America Invents Act and the Federal Rules of Civil Procedure, and the appropriate interpretation and application of the new law. Such analyses have, to date, been absent from the legal conversation.

This Note argues that modern-day patent litigation lacks sufficient consideration of public policy concerns. In order to remedy this, I propose three potential solutions that would broaden standing in patent declaratory judgment actions, thereby allowing more plaintiffs who are likely to raise such arguments to have their day in court. First, I discuss expanding standing within the Supreme Court’s MedImmune framework, which requires courts to apply a broad all-the-circumstances test in determining patent declaratory judgment standing. Within this test, I urge courts to consider (1) the degree to which a potential infringer raises important public policy concerns and (2) the extent to which the potential infringer has a unique economic incentive to challenge the patent-at-issue. Second, I consider altering the framework for standing in patent declaratory judgment actions based on a reassessment of the fundamental justifications for standing doctrine generally. Observing that the traditional justifications for a standing requirement—and the separation of powers justification in particular—do not apply in the context of patent declaratory judgment actions, I suggest that the Supreme Court might craft a new standing framework. Third, I explore the extent to which Congress might statutorily expand standing in such cases. I conclude by noting that the post-grant opposition procedure created by the America Invents Act—the patent reform legislation signed into law in September 2011—is insufficient to assuage unease regarding the lack of public policy arguments in patent litigation. Courts might therefore look to standing in order to address this problem.

Examining the Effect of the America Invents Act on the Patent Grace Period

This Note argues that the U.S. Patent and Trademark Office’s interpretation of the new grace period under the America Invents Act (AIA), 35 U.S.C. § 102(b)(1)(B), is overly narrow and that an alternative interpretation proposing a broader reading of the grace period is more appropriate. Evidence for a broader reading includes the effect of each interpretation on the administrative burden at the Patent and Trademark Office, speed of patent disclosure, innovative activity by specific inventor groups, and inventor behavior in patent races. This analysis shows that a narrow interpretation of the grace period creates greater administrative burdens, discourages disclosure, disfavors small inventors and universities, and may make blocking firms in a patent race virtually costless. In contrast, a broad grace period is simpler to administer, accelerates disclosure, supports innovation by small inventors and universities, and provides firms with a defensive maneuver in patent races.

The cost of prescription drugs, a function of the nexus of patent law and antitrust law, has recently been thrust into the spotlight. In the shadow of the Federal Trade Commission’s vigorous challenges to anticompetitive agreements between branded manufacturers and their potential generic competitors, a new player entered the administrative patent invalidity arena—noncompetitors, such as hedge fund managers, who, despite their reputation for seeking profit at all costs, asserted a seemingly puzzling altruistic interest in invalidating certain patents that prevent generic competitors from entering the market. In light of “abuse of process” accusations and calls for sanctions, this Note suggests that corporate law may facilitate an understanding of the role of noncompetitors in patent invalidation. Using the corporate law phenomenon of greenmail as an analogy, this Note argues that noncompetitors may actually facilitate competition and, as such, should be permitted to continue filing administrative patent challenges.

In response to widespread concerns about the extent to which “trolls” distort the patent process and other deficiencies in the patent system, Congress created two new administrative trial processes by which a third party may challenge the validity of a patent in a more streamlined and less costly way than through a civil trial. Unfortunately, the very features that made these administrative quasi-judicial proceedings efficient also make them ripe for anticompetitive abuse. This behavior is especially problematic when it comes to bargaining over licenses for patents recognized as a “standard” or deemed to be “essential” to a particular industry. In this context, instituting administrative trials to determine patent validity may actually create an inequality in bargaining strength that allows the potential licensee to extract rents from the patent holder—especially if that licensee possesses market power.

This Note explores the source and nature of these anticompetitive harms and recognizes that, as currently applied by the courts, antitrust law cannot be used to reach these abuses. Noerr-Pennington immunity shields firms from exposure to antitrust liability with respect to most government interactions, with only narrow exceptions for sham petitioning and litigating activity. In the patent context, these exceptions are far too narrow and make antitrust liability functionally unobtainable. In particular, this Note argues that the “sham litigation” exception to Noerr-Pennington should be expanded to encompass a wider range of litigation tactics—including instituting an administrative proceeding—to deter anticompetitive behavior that distorts both bargaining over patent licenses and the market more broadly.

Many biotechnology products are living organisms that are essentially “made” by a trial and error process of directing evolution in a laboratory. Decades ago, the Supreme Court in Chakrabarty settled the threshold question of patent eligibility for life forms, stating clearly that living things are patentable. Nevertheless, the fact that nature assists inventors so heavily in the process of inventing a useful new organism raises the question of whether such organisms meet patent law’s enablement requirement—that a patent application must teach a person of ordinary skill in the art how to make and use the invention without undue experimentation. This Note argues that the enablement requirement has been overlooked for patents to genetically engineered organisms, and proposes solutions for updating this requirement to properly incentivize the creation of socially beneficial living things, without allowing inventors to bar access to products of nature.

In FTC v. Actavis, the Supreme Court issued one of the most important antitrust decisions in the modern era. It held that a brand drug company’s payment to a generic firm to settle patent litigation and delay entering the market could violate the antitrust laws. Since the decision, courts have analyzed several issues, including causation, the role of the patent merits, and whether “payment” is limited to cash. But one issue—the pleading requirements imposed on plaintiffs—has slipped under the radar. This issue has the potential to undercut antitrust law, particularly because settlements with payment and delayed entry today typically do not take the form of cash. The complexity of non-cash conveyances increases the importance of the pleading stage.

For that reason, it is concerning that courts recently have imposed unprecedented hurdles. For example, the district court in In re Effexor XR Antitrust Litigation failed to credit allegations that a generic delayed entering the market because a brand promised not to introduce its own authorized generic that would have dramatically reduced the true generic’s revenues. The same judge, in In re Lipitor Antitrust Litigation, dismissed a complaint despite allegations that the generic delayed entry in return for the brand’s forgiveness of hundreds of millions of dollars in potential damages in separate litigation. This Essay first introduces the Supreme Court’s Actavis decision. It then discusses the pleading standards articulated by the Court in Bell Atlantic v. Twombly and Ashcroft v. Iqbal. Turning to the cases that applied excessively high pleading requirements, it focuses on the Effexor and Lipitor cases. Finally, it analyzes the settlement cases that applied a more justifiable analysis.

Michael A. Carrier, Pleading Standards: The Hidden Threat to Actavis, 91 N.Y.U. L. Rev. Online 31 (2016).