Law Commons^™

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

Certiorari, Universality, And A Patent Puzzle, Tejas N. Narechania

Michigan Law Review

The most important determinant of a case’s chances for Supreme Court review is a circuit split: If two courts of appeals have decided the same issue differently, review is substantially more likely. But practically every appeal in a patent case makes its way to a single court—the Court of Appeals for the Federal Circuit. How, then, does the Supreme Court decide whether to grant certiorari in a patent case?

The petitions for certiorari in the Court’s patent docket suggest an answer: The Supreme Court looks for splits anyway. These splits, however, are of a different sort. Rather than consider whether …

Understanding Nautilus's Reasonable-Certainty Standard: Requirements For Linguistic And Physical Definiteness Of Patent Claims, Gary M. Fox

Michigan Law Review

Patent applicants must satisfy a variety of requirements to obtain a patent from the U.S. Patent and Trademark Office (USPTO). The definiteness requirement forces applicants to describe their inventions in unambiguous terms so that other inventors will understand the scope of granted patent rights. Although the statutory provision for the definiteness requirement has been stable for many years, the Supreme Court’s decision in Nautilus v. Biosig Instruments altered the doctrine. The Court abrogated the Federal Circuit’s insoluble-ambiguity standard and replaced it with a new reasonable-certainty standard. Various district courts have applied the new standard in different ways, indicating the need …

The Supreme Assimilation Of Patent Law, Peter Lee

Michigan Law Review

Although tensions between universality and exceptionalism apply throughout law, they are particularly pronounced in patent law, a field that deals with highly technical subject matter. This Article explores these tensions by investigating an underappreciated descriptive theory of Supreme Court patent jurisprudence. Significantly extending previous scholarship, it argues that the Court’s recent decisions reflect a project of eliminating “patent exceptionalism” and assimilating patent doctrine to general legal principles (or, more precisely, to what the Court frames as general legal principles). Among other motivations, this trend responds to rather exceptional patent doctrine emanating from the Federal Circuit in areas as varied as …

Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff

Michigan Telecommunications & Technology Law Review

“Pay-for-delay” settlements, also known as reverse payments, arise when a generic manufacturer pursues FDA approval of a generic version of a brand-name drug. If a patent protects the brand-name drug, the generic manufacturer has the option of contesting the validity of the patent or arguing that its product does not infringe the patent covering the brand-name drug. If the generic manufacturer prevails on either of these claims, the FDA will approve its generic version for sale. Approval of a generic version of a brand-name drug reduces the profitability of the brand-name drug by forcing the brand-name manufacturer to price its …

After Myriad: Reconsidering The Incentives For Innovation In The Biotech Industry, Daniel K. Yarbrough

Michigan Telecommunications & Technology Law Review

35 U.S.C. § 101 allows a patent for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Recently, the Supreme Court issued several key decisions affecting the doctrine of patentable subject matter under § 101. Starting with Bilski v. Kappos (2011), and continuing with Mayo Collaborative Services, Inc. v. Prometheus Laboratories (2012), Association for Molecular Pathology v. Myriad Genetics (2013) and, most recently, Alice Corporation Pty. Ltd. v. CLS Bank International (2014), every year has brought another major change to the way in which the Court assesses patentability. In Myriad, the …

Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane

Articles

The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …

Wag The Dog: Using Incidental Intellectual Property Rights To Block Parallel Imports, Mary Lafrance

Michigan Telecommunications & Technology Law Review

Federal law grants owners of intellectual property rights different degrees of control over parallel imports depending on the nature of their exclusive rights. While trademark owners enjoy strong control over unauthorized imports bearing their marks, their protection is less comprehensive than that granted to owners of copyrights and patents. To broaden their rights, some trademark owners have incorporated copyrighted material into their products or packaging, enabling them to block otherwise lawful imports in contravention of the policies underlying trademark law. A 2013 Supreme Court decision has significantly narrowed the importation ban of copyright law, but there may be pressure to …

The Real Issue Behind Stanford V. Roche: Faulty Conceptions Of University Assignment Policies Stemming From The 1947 Biddle Report, Sean M. O'Connor

Michigan Telecommunications & Technology Law Review

The recent Supreme Court decision in Stanford v. Roche laid bare a faulty assumption of the federal research funding system. Government patent policy for federally funded research relies on "contractors"--the recipients of federal funding--to secure patent assignments from their employees. While this practice was routine for private firms and nonprofit research institutions, it was not for universities. This was in part based on the relationship of faculty and other researchers to universities that differed from industry employment relationships. The roots of this faulty assumption can be traced to the seminal 1947 Biddle Report. Detailed monographs drafted as appendices to the …

Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg

Articles

The Supreme Court’s decision last Term in Mayo v. Prometheus left considerable uncertainty as to the boundaries of patentable subject matter for molecular diagnostic inventions. First, the Court took an expansive approach to what counts as an unpatentable natural law by applying that term to the relationship set forth in the challenged patent between a patient’s levels of a drug metabolite and the indication of a need to adjust the patient’s drug dosage. And second, in evaluating whether the patent claims add enough to this unpatentable natural law to be patent eligible, the Court did not consult precedents concerning the …

Patent Infringement As Criminal Conduct, Jacob S. Sherkow

Michigan Telecommunications & Technology Law Review

Criminal and civil law differ greatly in their use of the element of intent. The purposes of intent in each legal system are tailored to effectuate very different goals. The Supreme Court's recent decision in Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060 (2011), however, imported a criminal concept of intent--willful blindness--into the statute for patent infringement, a civil offense. This importation of a criminal law concept of intent into the patent statute is novel and calls for examination. This Article compares the purposes behind intent in criminal law with the purposes behind intent in patent law to …

Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg

Articles

In 1980, the Supreme Court gave a reassuring signal to the then-nascent biotechnology industry about the availability of patent protection for the fruits of its research when it upheld the patentability of a genetically modified living organism in Diamond v. Chakrabarty. Twenty-five years later, the Court seemed poised to reexamine the limits of patentable subject matter for advances in the life sciences when it granted certiorari in Laboratory Corporation v. Metabolite. But the Federal Circuit had not addressed the patentable subject matter issue in Laboratory Corporation, and the Court ultimately dismissed the certiorari p etition as improvidently granted. Five years …

The Accession Insight And Patent Infringement Remedies, Peter Lee

Michigan Law Review

What is the appropriate allocation of rights and obligations when one party, without authorization, substantially improves the property of another? According to the doctrine of accession, a good faith improver may take title to such improved property, subject to compensating the original owner for the value of the source materials. While shifting title to a converter seems like a remarkable remedy, this outcome merely underscores the equitable nature of accession, which aims for fair allocation of property rights and compensation between two parties who both have plausible claims to an improved asset. This Article draws upon accession-a physical property doctrine …

Teva V. Eisai: What's The Real Controversy, Grace Wang

Michigan Telecommunications & Technology Law Review

This Note examines the changing role of declaratory judgment actions in challenging patents upon generic entry and evaluates alternative regulatory schemes to the FDA's current system of patent enforcement in the drug approval setting. Part I reviews the Federal Circuit's recent decisions regarding generic drug entry, focusing on how the courts justify declaratory judgments in the current system and when a "controversy" exists to create Article III jurisdiction. Part II examines the complex system of regulating generic drug entry and how attempts to stop the exploitation of loopholes have resulted in a patchwork of regulation by various parties. It challenges …

Appellate Review Of Patent Claim Construction: Should The Federal Circuit Be Its Own Lexicographer In Matters Related To The Seventh Amendment, Eileen M. Herlihy

Michigan Telecommunications & Technology Law Review

The Federal Circuit stated in an en banc decision in Cybor Corp. v. FAS Technologies, Inc. that the construction of patent claims is "a purely legal issue," and is therefore subject to de novo review on appeal. The Cybor decision reaffirmed the position of the majority of the Federal Circuit which had been announced in its en banc Markman decision, and proclaimed that the de novo standard of review is supported by the Supreme Court's Markman decision, a Seventh Amendment opinion. However, Cybor included strong opposition to a de novo standard of review from some of the judges of the …

Pharma's Nonobvious Problem, Rebecca S. Eisenberg

Articles

This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …

Exclusion Confusion? A Defense Of The Federal Circuit's Specific Exclusion Jurisprudence, Peter Curtis Magic

Michigan Law Review

Specific exclusion has become a controversial limitation on the doctrine of equivalents, which is itself an essential and controversial area of patent law. The doctrine of equivalents allows a patentee to successfully claim infringement against devices that are outside of the literal reach of the language used by the patentee in her patent to describe what she claims as her invention. The Supreme Court has prescribed some of the outer limits of the doctrine of equivalents and articulated the underlying policy concerns that inform its analysis-noting that courts should balance protection of the patentee's intellectual property with the public's reasonable …

Making Sense Of Ksr And Other Recent Patent Cases, Harold C. Wegner

Michigan Law Review First Impressions

The recent Supreme Court review of KSR International Inc. v. Teleflex Inc., eBay Inc. v. MercExchange LLC, and Microsoft Corp. v. AT&T Corp. manifests the Court’s current interest in the patent jurisprudence of the Fed-eral Circuit. Now it is evident that the Court has a level of concern sufficient to guarantee the possibility of grant of certiorari—whereas formerly a case could rarely generate sufficient interest for review. For long-range impor-tance in patent law, KSR stands alone as the single most important Supreme Court patent decision on the bread and butter standard of “obviousness” in the more than forty years since …

Ksr's Effect On Patent Law, Stephen G. Kunin, Andrew K. Beverina

Michigan Law Review First Impressions

The Supreme Court in KSR International Co. v. Teleflex Inc. clarified its 1966 decision in Graham v. John Deere, avoiding the sea change to a synergy- based standard that many had expected—and perhaps feared. KSR has raised the bar set in Graham for seeking patent protection—by providing a flexible test for obviousness—while simultaneously making it easier for accused infringers to defend themselves. Moreover, KSR will change the strategies of both patent prosecutors and litigators. Before KSR, the Supreme Court’s last major decision on nonobviousness under 35 U.S.C. § 103 was Graham, in which the Court established three factual inquiries for …

Patent Injunctions And The Problem Of Uniformity Cost, Michael W. Carroll

Michigan Telecommunications & Technology Law Review

In eBay v. MercExchange, the Supreme Court correctly rejected the Federal Circuit's general rule requiring that a permanent injunction follow from a finding that a patent is valid and infringed. Recognizing that one size does not fit all in patent law, the Court returned traditional equitable discretion to the district courts. With this discretion, district courts can now deploy remedies for patent infringement that are sensitive to relevant differences among industries, technologies, and entities. This Essay sets the Court's rejection of a uniform remedial regime in a larger context concerning the role of uniformity in patent law. It then explores …

Ksr V. Teleflex: Predictable Reform Of Patent Substance And Procedure In The Judiciary, John F. Duffy

Michigan Law Review First Impressions

Though KSR International Co. v. Teleflex, Inc. is now widely acknowl-edged in the bar and the academy to be the most significant patent case in at least a quarter century, that view dramatically underestimates the impor-tance of the decision. The KSR decision has immense significance not merely because it rejected the standard of patentability that had been applied in the lower courts for decades, but also because it highlights many separate trends that are reshaping the patent system. This Commentary will touch upon four such trends that are clearly evi-dent in KSR. First, the case was a predictable continuation of …

The Supreme Court And The Federal Circuit: Visitation And Custody Of Patent Law, Rebecca S. Eisenberg

Articles

The U.S. Supreme Court’s relationship to patent law sometimes seems like that of a non-custodial parent who spends an occasional weekend with the kids. The custodial parent is, of course, the U.S. Court of Appeals for the Federal Circuit. The Federal Courts Improvement Act of 1982 consolidated intermediate appellate jurisdiction over patent law cases in this single court, which hears appeals from the U.S. Patent and Trademark Office (“PTO”), the U.S. District Courts, the U.S. Court of Federal Claims, and the U.S. In-ternational Trade Commission. Day to day it is the Federal Circuit that reviews contested decisions of the institutions …

Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm

Michigan Telecommunications & Technology Law Review

Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to a …

Arising Under Jurisdiction And Uniformity In Patent Law, Christopher A. Cotropia

Michigan Telecommunications & Technology Law Review

The law governing the Federal Circuit's appellate jurisdiction was brought into question in Holmes Group, Inc. v. Vornado Circulation Systems, Inc. The Federal Circuit's appellate jurisdiction over Vornado's appeal rested solely on Vornado's counterclaim alleging patent infringement by Holmes. Holmes's complaint sought a declaratory judgment of no trade dress infringement and did not include any patent law claims. While the Federal Circuit found appellate jurisdiction over Vornado's appeal based on the counterclaim of patent infringement, the Supreme Court disagreed. The Court focused on the language in 35 U.S.C. § 1338(a), which defines the Federal Circuit's appellate jurisdiction by the statute's …

Escaping The World Of I Know It When I See It: A New Test For Software Patent Ability, Brooke Schumm Iii

Michigan Telecommunications & Technology Law Review

The major thesis presented in this article is a focused standard of software patentability, in particular for pure computational methods or algorithms directed to the manipulation of numbers operating on a computer. The general philosophy is to compel inventors to narrow their claims to an algorithm expressed in terms of its utility and then to require that the particular utility or functionality be expressed in the claim as a limit on the claim, thus precluding the patent monopoly from being overbroad. As a corollary, any person is free to use or perhaps to patent the algorithm for a different utility …

Sofware Patents And The Information Economy, Michael Perelman

Michigan Telecommunications & Technology Law Review

Modern economists universally acknowledge that information is an essential component of productivity. Moreover, as they begin to focus more and more on the nature of information, their conception of information widens considerably.

The Patentability Of A Principle Of Nature, John B. Waite

Articles

The extent to which courts will go in conceding patentability to a natural law, or principle of nature, is evidenced in the case of Minerals Separation Co. v. Hyde, 37 Sup. Ct. -, decided by the Supreme Court, December 11, 1916. It has always been more or less an axiom of patent law that the discovery of a principle of nature does not entitle the discoverer to a patent for it. The case usually thought of first as authority therefor, is that of Morton v. New York Eye Infirmary, 5 Blatch. 116, 2 Fisher 320. The patentees in that case …

Limitations Upon The Use, After Sale, Of Patented Articles, John B. Waite

Articles

In the case of Motion Picture Patents Co. v. Universal Film Co., 37 Sup. Ct. 416, the Supreme Court has just rendered a decision which reverses the much discussed case of Henry v. Dick Co., 224 U. S. 1. The opinion was by a divided court, however, as three of the justices dissented, and Justice McREYNOLDS "concurred in the result" only. It can, therefore, hardly be said to settle the ultimate rule as in contradiction to that followed in Henry v. Dick Co., and discussion of the case is of something more than mere academic value. The facts were that …