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Full-Text Articles in Law
Did The America Invents Act Change University Technology Transfer?, Cynthia L. Dahl
Did The America Invents Act Change University Technology Transfer?, Cynthia L. Dahl
All Faculty Scholarship
University technology transfer offices (TTOs) are the gatekeepers to groundbreaking innovations sparked in research laboratories around the U.S. With a business model reliant on patenting and licensing out for commercialization, TTOs were positioned for upheaval when the America Invents Act (AIA) transformed U.S. patent law in 2011. Now almost ten years later, this article examines the AIA’s actual effects on this patent-centric industry. It focuses on the five key areas of most interest to TTOs: i) first to file priority; ii) broadening of the universe of prior art; iii) carve-out to the prior commercial use defense; iv) micro-entity fees; and …
Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan
Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan
Articles
The Bayh-Dole Act of 1980 established a new default rule that allowed nonprofit organizations and small businesses to own, as a routine matter, patents on inventions resulting from research sponsored by the federal government. Although universities helped get the Bayh-Dole Act through Congress, the primary goal, as reflected in the recitals at the beginning of the new statute, was not to benefit universities but to promote the commercial development and utilization of federally funded inventions. In the years since the passage of the Bayh-Dole Act, universities seem to have lost sight of this distinction. Their behavior as patent seekers, patent …
Symbols, Systems, And Software As Intellectual Property: Time For Contu, Part Ii?, Timothy K. Armstrong
Symbols, Systems, And Software As Intellectual Property: Time For Contu, Part Ii?, Timothy K. Armstrong
Michigan Telecommunications & Technology Law Review
The functional nature of computer software underlies two propositions that were, until recently, fairly well settled in intellectual property law: first, that software, like other utilitarian articles, may qualify for patent protection; and second, that the scope of copyright protection for software is comparatively limited. Both propositions have become considerably shakier as a result of recent court decisions. Following Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014), the lower courts have invalidated many software patents as unprotectable subject matter. Meanwhile, Oracle America v. Google Inc., 750 F.3d 1339 (Fed. Cir. 2014) extended far more expansive copyright protection …
Expired Patents, Trade Secrets, And Stymied Competition, W. Nicholson Price Ii
Expired Patents, Trade Secrets, And Stymied Competition, W. Nicholson Price Ii
Articles
Patents and trade secrecy have long been considered substitute incentives for innovation. When inventors create a new invention, they traditionally must choose between the two. And if inventors choose to patent their invention, society provides strong legal protection in exchange for disclosure, with the understanding that the protection has a limit: it expires twenty years from the date of filing. At that time, the invention is opened to the public and exposed to competition. This story is incomplete. Patent disclosure is weak and focuses on one technical piece of an invention—but that piece is often only a part of the …
Patenting Frankenstein's Monster: Exploring The Patentability Of Artificial Organ Systems And Methodologies, Jordana Goodman
Patenting Frankenstein's Monster: Exploring The Patentability Of Artificial Organ Systems And Methodologies, Jordana Goodman
Faculty Scholarship
The conception of Frankenstein’s monster bridges the ever-narrowing divide between man and machine. Long before Congress codified Section 33(a) of the America Invents Act (“AIA”), Mary Shelley’s vague description of the monster’s creation has left people wondering: what defines a human organism? Through an analysis of patent law and scientific progress in the development of artificial organ systems, this paper explores the boundaries of patentable subject matter in the United States and attempts to clarify Congress’s determination that “no patent may issue on a claim directed to or encompassing a human organism.” Though patent law should incentivize development of artificial …
Rent-Seeking And Inter Partes Review: An Analysis Of Invalidity Assertion Entities In Patent Law, W. Michael Schuster
Rent-Seeking And Inter Partes Review: An Analysis Of Invalidity Assertion Entities In Patent Law, W. Michael Schuster
Michigan Telecommunications & Technology Law Review
This Essay is the first analysis of a recent entrant on the patent landscape: the Invalidity Assertion Entity (IAE). IAEs engage in rent-seeking by demanding payment from patent holders in exchange for not attempting to invalidate their patents through administrative action before the U.S. Patent and Trademark Office. The response to IAEs has been uniformly negative. Reflexive proposals have been raised in Congress (unsurprisingly) to terminate the IAE business model. In contrast to the common response to IAEs, this Essay discusses how profit-driven IAEs may generate socially beneficial externalities and why legislating to end the IAE business model is imprudent.
Defining The Patent And Copyright Term: Term Limits And The Intellectual Property Clause, Edward C. Walterscheid
Defining The Patent And Copyright Term: Term Limits And The Intellectual Property Clause, Edward C. Walterscheid
Journal of Intellectual Property Law
No abstract provided.
An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel
Michigan Law Review
Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …
The New Novelty: Defining The Content Of “Otherwise Available To The Public”, Caroline A. Schneider
The New Novelty: Defining The Content Of “Otherwise Available To The Public”, Caroline A. Schneider
Journal of Legislation
The "Leahy-Smith America Invents Act" (America Invents Act) was enacted on September 16, 2011.1 The purpose of the Act was to provide greater harmony between the U.S. patent system and patent systems of our international trading partners.2 A patent gives an inventor a monopoly in the issuing country to make, use, and sell the invention for a limited term in exchange for the disclosure of how to make and use the invention. In the United States, the granting of monopolies for limited terms is justified mainly on utilitarian grounds. The patent system is seen as the best way to incentivize …
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Michigan Telecommunications & Technology Law Review
Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Yaniv Heled
Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …
Navigating A Post America Invents Act World: How The Leahy-Smith America Invents Act Supports Small Businesses, Melissa Cerro
Navigating A Post America Invents Act World: How The Leahy-Smith America Invents Act Supports Small Businesses, Melissa Cerro
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Interactive Methods And Collaborative Performance: A New Future For Indirect Infringement, Josh Rychlinski
Interactive Methods And Collaborative Performance: A New Future For Indirect Infringement, Josh Rychlinski
Michigan Telecommunications & Technology Law Review
An individual is liable for patent infringement if he infringes one or more patented claims either directly under 35 U.S.C. § 271(a) or indirectly under 35 U.S.C. § 271(b) or § 271(c). In 2012, the Federal Circuit clarified its interpretation of § 271(b) and § 271(c) in the case of Akamai v. Limelight. However, the court failed to address issues of “divided” direct infringement, where two or more entities combine and together complete each and every step of a method claim, but no single entity does all of the steps. This Note walks through the history of the judicial interpretation …
Surviving The America Invents Act’S Overhaul Of U.S. Patent Law - Startup And Small Business Perspectives, Ron D. Katznelson
Surviving The America Invents Act’S Overhaul Of U.S. Patent Law - Startup And Small Business Perspectives, Ron D. Katznelson
Ron D. Katznelson
No abstract provided.
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
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 …
The Impact Of Codification On The Judicial Development Of Copyright, Christopher S. Yoo
The Impact Of Codification On The Judicial Development Of Copyright, Christopher S. Yoo
All Faculty Scholarship
Despite the Supreme Court’s rejection of common law copyright in Wheaton v. Peters and the more specific codification by the Copyright Act of 1976, courts have continued to play an active role in determining the scope of copyright. Four areas of continuing judicial innovation include fair use, misuse, third-party liability, and the first sale doctrine. Some commentators have advocated broad judicial power to revise and overturn statutes. Such sweeping judicial power is hard to reconcile with the democratic commitment to legislative supremacy. At the other extreme are those that view codification as completely displacing courts’ authority to develop legal principles. …
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Book Chapters
This article reexamines the sources of exclusivity for drugs, considers their limitations, and evaluates exclusivity under the new biologics legislation in light of these limitations. The current overlapping legal protections for exclusivity in the pharmaceutical marketplace reflect a series of political compromises, repeatedly renegotiated to correct for unintended consequences in the previous version of the rules. Patents and patent challenges play a central role in this system of protection, and many of the patents at stake are ultimately held invalid in litigation. It is not easy to untangle a complex legal regime that allocates billions of dollars of profits. But …
Improving Patent Notice And Remedies: A Critique Of The Ftc's 2011 Report, Alan Devlin
Improving Patent Notice And Remedies: A Critique Of The Ftc's 2011 Report, Alan Devlin
Michigan Telecommunications & Technology Law Review
2011 was an eventful year for those interested in patent law. In March, the Federal Trade Commission ("FTC") released a report that urges the Patent and Trademark Office ("PTO") and courts to remedy perceived inadequacies underlying the U.S. patent system. The FTC observes that people of skill in the art routinely encounter difficulty in determining the meaning, and hence exclusive scope, of a patent's claims. Not only does this failure of notice stymie the efficient dispersion of technology throughout the economy, the FTC argues, but the judicial process can aggravate the problem by granting inappropriate remedies in patent-infringement cases. Then, …
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Michigan Telecommunications & Technology Law Review
Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …
Toward A System Of Invention Registration: The Leahy-Smith America Invents Act, Jason Rantanen, Lee Petherbridge
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.
Teva V. Eisai: What's The Real Controversy, Grace Wang
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 …
Hatch-Waxmanizing Copyright, Michal Shur-Ofry
Hatch-Waxmanizing Copyright, Michal Shur-Ofry
Michigan Telecommunications & Technology Law Review
This Essay presents a novel proposal for counter balancing "copyright overspills." In the background of the discussion is the common reality of users succumbing to rights holders' attempts to license uses which are most likely fair uses or completely free of copyright protection. These practices have attracted considerable attention in recent literature. Most scholarly proposals in this context emphasize the need to clarify the contours of the fair use doctrine and to remove doctrinal ambiguities. Yet these initiatives are probably insufficient to overcome users' risk aversion in copyright markets due to an inherent structural imbalance within copyright law. While the …
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
Michigan Telecommunications & Technology Law Review
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Michigan Telecommunications & Technology Law Review
Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the …
Synopsis Of The Extraterritorial Protection Afforded By Section 337 As Compared To The Patent Act , Neil F. Duchez
Synopsis Of The Extraterritorial Protection Afforded By Section 337 As Compared To The Patent Act , Neil F. Duchez
Michigan Telecommunications & Technology Law Review
Unlike Section 271 of the Patent Act of 1952, "[s]ection 337 is a trade law which is not necessarily limited by the principles of domestic patent law." When examined more closely, Section 337 of the U.S. Tariff Act of 1930 in effect provides a patentee more protection from infringing foreign activity than Section 271. Accordingly, in many situations involving foreign acts, it may be more advantageous to enforce a U.S. patent at the International Trade Commission ("Commission") as opposed to a federal district court. The analysis discussed infra more closely examines those situations and provides the history behind the intended …
Now That The Courts Have Beaten Congress To The Punch, Why Is Congress Still Punching The Patent System?, Robert A. Armitage
Now That The Courts Have Beaten Congress To The Punch, Why Is Congress Still Punching The Patent System?, Robert A. Armitage
Michigan Law Review First Impressions
The U.S. House of Representatives began September by passing the Patent Reform Act of 2007. This bill, if enacted, would make major changes to U.S. patent law. Given the universally recognized need for improvements to the U.S. patent system, passing a patent reform bill in the House should have been easy. It was not. The Patent Reform Act of 2007 made it through the House only after a spirited debate. There were a host of complaints by House members that the bill was not ready for floor action. In the end, it passed the House by a relatively narrow margin, …
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
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.
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Allowing universities to patent the results of government-sponsored research sometimes works against the public interest.
Best Mode: A Plea To Repair Or Sacrifice This Broken Requirement Of United States Patent Law, Steven B. Walmsley
Best Mode: A Plea To Repair Or Sacrifice This Broken Requirement Of United States Patent Law, Steven B. Walmsley
Michigan Telecommunications & Technology Law Review
An inventor's obligation to disclose the best mode of her invention is strong consideration in the U.S. patent bargain, but the courts paradoxically define the scope of that obligation, thus rendering the enforcement of U.S. patents unreasonably unpredictable. If an inventor cannot reasonably foresee the scope of her obligation to disclose invention details, then she is subjected to the costs and risks of either overcompliance or undercompliance with the best mode requirement. The scope of the best mode requirement should either be reliably defined by an en banc ruling of the Court of Appeals for the Federal Circuit, or the …
Recognition Of Proprietary Interests In Software In Korea: Programming For Comprehensive Reform, Byoung Kook Min, Gary Sullivan
Recognition Of Proprietary Interests In Software In Korea: Programming For Comprehensive Reform, Byoung Kook Min, Gary Sullivan
Michigan Journal of International Law
This article will review the legal environment and major issues concerning software protection in the Republic of Korea, and will describe the existing applicable laws and regulations and the trend towards software protection in the region. In addition, the implications of Korea's pending accession to the Universal Copyright Convention will be analyzed. Finally, this article will conclude with a discussion of the current reforms and their implications for Korean international trade law.