Law Commons^™

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Articles

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

Forcing Patent Claims, Tun-Jen Chiang

Michigan Law Review

An enormous literature has criticized patent claims for being ambiguous. In this Article, I explain that this literature misunderstands the real problem: the fundamental concern is not that patent claims are ambiguous but that they are drafted by patentees with self-serving incentives to write claims in an overbroad manner. No one has asked why the patent system gives self-interested patentees the leading role in delineating the scope of their own patents. This Article makes two contributions to the literature. First, it explicitly frames the problem with patent claims as one of patentee self-interest rather than the intrinsic ambiguity of claim …

Structure From Nothing And Claims For Free: Using A Whole-System View Of The Patent System To Improve Notice And Predictability For Software Patents, Holly K. Victorson

Michigan Telecommunications & Technology Law Review

No uniform or customary method of disclosure for software patents is currently employed by inventors. This Note examines the issues that develop from software patent claims disclosed at various levels of abstraction, and the difficulties encountered by courts and the public when investigating the contours of the software patent space. While the courts have placed some restrictions on the manner in which software inventions are claimed, they are easily bypassed by clever patent applicants who desire to claim the maximum scope of their inventions. In the long run, however, a large “patent thicket” of overlapping and potentially overbroad inventions will …

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 …

Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork

Michigan Telecommunications & Technology Law Review

Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval …

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 …

An Explicit Policy Lever For Patent Scope, Anna B. Laakmann

Michigan Telecommunications & Technology Law Review

Since its inception in 1982, the Federal Circuit has declined to take an overt role in setting patent policy. Dan Burk and Mark Lemley have observed that the court instead implicitly engineers patent policy through selective application of its patentability rules, which operate as "policy levers." Recent decisions on the patentability of diagnostic and therapeutic methods illustrate a significant problem with this approach. By maintaining a façade of adjudicative rule formalism while tacitly manipulating its rules to approximate policy goals, the court perpetuates empirical uncertainty about the patent law's practical effects. This Article proposes that the Federal Circuit use the …

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 …

Toward A System Of Invention Registration: The Leahy-Smith America Invents Act, Jason Rantanen, Lee Petherbridge

Michigan Law Review First Impressions

The recently enacted Leahy-Smith America Invents Act (“AIA”) represents the most significant legislative event affecting patent law and practice in more than half a century. In addressing the AIA, scholars and policymakers have focused with an almost laser-like exclusivity on the AIA’s imposition of a first-to-file-or-first-to-publicly-disclose system, which replaces an over 200-year-old first-to-invent tradition. This myopia, we suggest, overlooks a part of the AIA that could hold a substantially greater potential to jeopardize American innovation, job creation, and economic competitiveness: the imposition of a mechanism for supplemental examination.

Insterstitial Exclusivities After Association For Molecular Pathology, Mary Mitchell, Dana A. Remus

Michigan Law Review First Impressions

The high profile cases Bilski v. Kappos and Association for Molecular Pathology v. United States Patent and Trademark Office have renewed public debate about the proper scope of patentable subject matter. The subject matter inquiry has traditionally been treated as a threshold inquiry in patent law, serving a gate-keeping function by defining the types of inventions that are eligible for patent protection. The Patent Office and courts have approached the subject matter inquiry both by determining whether an invention falls into a statutory category-processes, machines, manufactures, or compositions of matter-as well as by determining whether an invention falls into a …

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 …

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 …

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 …

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 …

Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg

Articles

In this Article, I consider the possibility of giving the USPTO input from currently active technological practitioners in evaluating the obviousness of claimed inventions. Such input could potentially serve three useful functions. First, it could improve the accuracy of USPTO decisionmaking by providing access to the perspective of actual practitioners as to the obviousness of inventions from the perspective of the hypothetical PHOSITA. Second, it could help the USPTO document the evidentiary basis for rejections that rest in part upon tacit knowledge within technological communities. Third, it could provide a quality control mechanism that would improve the credibility of USPTO …

Reaching Through The Genome, Rebecca S. Eisenberg

Book Chapters

The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg

Articles

Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.

The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg

Book Chapters

The sequencing of the human genome is a great scientific accomplishment that opens the door to further scientific inquiry of a sort that would otherwise be impossible. In addition to being passionately interested in the patent issues this research presents, as a legal scholar I have a long-standing interest in the role of intellectual property in interactions between the public and private senators and between universities and private firms in research science, with a focus on biomedial research. However, although the Human Genome Project has provided a rich terrain for exploring these issues, I am puzzled that intellectual property issues …

International And Comparative Law Perspectives On Internet Patents, Toshiko Takenaka

Michigan Telecommunications & Technology Law Review

The Internet and e-commerce have created a borderless market. Goods and services sold on the Internet are subject to the patent statutes and regulations of all countries in which customers have access. Because the presence or absence of patent protection--or variations in that protection--hinders the movement of goods and services throughout the Internet, it is necessary to harmonize the protection afforded by Internet patents in their early stages of development. Among the three papers, however, only Professor Chiappetta touched upon the problem of compliance with the provisions in TRIPS. None of the papers paid attention to the feasibility of harmonizing …

Internet Business Model Patents: Obvious By Analogy, Margo A. Bagley

Michigan Telecommunications & Technology Law Review

This Article contends that part of the problem of Internet business model patents is the narrow view of analogous art employed by judges and USPTO examiners which largely excludes relevant "real-world" prior art in the determination of non-obviousness under § 103 of the Patent Act. Consequently, part of the solution lies in helping courts and the USPTO properly to define analogous art for a particular invention. To do so, judges and examiners must recognize the interchangeability of computer programming (i.e. "e-world" activities) to perform a function, with human or mechanical performance of the same function (i.e. "real world" activities). Such …

Defining The Proper Scope Of Internet Patents: If We Don't Know Where We Want To Go, We're Unlikely To Get There, Vincent Chiappetta

Michigan Telecommunications & Technology Law Review

Part I of this Article addresses the appropriateness of protecting Internet innovations under the current patent regime. It concludes that the doctrinal, historical and policy arguments require different outcomes regarding computing (patentable subject matter) and competitive arts (at best a difficult fit) innovation. Part II argues that the new electronic economy has given rise to a particular kind of competitive arts "market failure" (interference with first-to-move lead-time incentives) which must be addressed. It concludes, however, that tinkering with the existing patent or copyright regimes is not only complex, but poses significant risks, and should be avoided. Part III sketches the …

The Promise And Perils Of Strategic Publication To Create Prior Art: A Response To Professor Parchomovsky, Rebecca S. Eisenberg

Articles

In a provocative recent article in the Michigan Law Review, Professor Gideon Parchomovsky observes that a firm racing with a competitor to make a patentable invention might find it strategically advantageous to publish interim research results rather than risk losing a patent race. This strategy exploits legal rules limiting patent protection to technological advances that are new and "nonobvious" in light of the "prior art" or preexisting knowledge in the field. By publishing research results, a firm adds to the prior art and thereby limits what may be patented in the future. Parchomovsky posits that, before it is able to …

Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg

Articles

As public and private sector initiatives race to complete the sequence of the human genome, patent issues have played a prominent role in speculations about the significance of this achievement. How much of the genome will be subject to the control of patent holders, and what will this mean for future research and the development of products for the improvement of human health? Is a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claims to the genome on behalf of the many sequential innovators who elucidate its sequence …

Analyze This: A Law And Economics Agenda For The Patent System, Rebecca S. Eisenberg

Articles

Legal scholars and economists might enhance the value and impact of their work by making more effective use of each other's knowledge and capabilities. Legal scholars can offer a more nuanced understanding of the legal rules that underlie the patent system and the doctrinal levers that might be manipulated in furtherance of public policy goals. Economists bring to bear a set of analytical and methodological tools that could shed considerable light on what these doctrinal levers are doing and which of them we ought to be manipulating. Together, we have a better chance of asking the right questions and thinking …

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 …

Information Wants To Be Free, But The Packaging Is Going To Cost You, Gregory A. Stobbs

Michigan Telecommunications & Technology Law Review

The question is this: where do we draw the line between private ownership and the public domain? It is not a question of choosing between copyright and patent, of choosing between hardware and software, or of choosing between implementation and algorithm. It is a more fundamental question that reaches back to ancient human values and transcends our current fixation on computers and software. It helps to put things in perspective. When debating where we and the law are headed (as we are now), it helps to know where we have been. In this regard, do not assume that software patents …

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.

Intellectual Property At The Public-Private Divide: The Case Of Large-Scale Cdna Sequencing, Rebecca S. Eisenberg

Articles

The Human Genome Project provides fertile ground for studying the role of intellectual property at the wavering boundary between public and private research science. It involves a major commitment of both public and private research funds in an area that is of significant interest both to research scientists working in university and government laboratories and to commercial firms. It thus provides a wealth of new scientific discoveries that are simultaneously potential candidates for commercial development and inputs into further research. Its obvious implications for human health raise the stakes of getting the balance between private property and public access right, …

Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges

Articles

You have asked for our legal opinion on the patentability of inventions claimed in U.S. patent applications 07/716,831, filed June 21, 1991 (the '831 application, or .'831"), 07/837,195, filed September 25, 1992 ("'195"), and 07/952,911, filed February 12, 1993 (."911"), all filed in the name of Craig Venter and others and assigned to the National Institutes of Health "(NIH)." We understand that NIH has abandoned these patent applications and has no present intention of filing similar applications in the future, but that NIH remains interested in the patenting of human DNA sequences from a broader public policy perspective. We have …