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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 …
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 …
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, …
Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel
Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel
Michigan Telecommunications & Technology Law Review
The possibility that small populations would see few medications developed for their conditions has [...] led the U.S. Congress to pass the 1983 Orphan Drug Act ("ODA"), giving firms special incentives to develop drugs for diseases afflicting fewer than 200,000 persons per year.[...][U]under the Act, drug makers receive seven years of exclusive marketing upon FDA approval of newly-developed drugs qualifying as "orphan drugs"--i.e., drugs for disorders affecting fewer than 200,000 persons.[...]Together, [the] provisions (a) increase the effective market size; and (b) reduce fixed (sunk) costs. In doing so, the Act provides a natural experiment for measuring the impact of increased …
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Michigan Telecommunications & Technology Law Review
In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Michigan Telecommunications & Technology Law Review
Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a …
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 …
Economic Espionage Act--Reverse Engineering And The Intellectual Property Public Policy, The, Craig L. Uhrich
Economic Espionage Act--Reverse Engineering And The Intellectual Property Public Policy, The, Craig L. Uhrich
Michigan Telecommunications & Technology Law Review
The publicity surrounding[...] incidents of industrial espionage resulted in a push for federal protections. In response to this pressure from U.S. industries, Congress passed the Economic Espionage Act of 1996 ("EEA"). The EEA protects trade secrets through the use of federal criminal sanctions." The EEA's provisions are introduced in Part I. Trade secrets are a form of intellectual property. Therefore, a basic understanding of intellectual property law is important to an analysis of the EEA. Part II of this Article provides an overview of the various forms of intellectual property. To be effective, the EEA must complement existing intellectual property …
Taking A Bite Out Of Circumvention: Analyzing 17 U.S.C. 1201 As A Criminal Law, Jason M. Schulz
Taking A Bite Out Of Circumvention: Analyzing 17 U.S.C. 1201 As A Criminal Law, Jason M. Schulz
Michigan Telecommunications & Technology Law Review
...information content providers who depend heavily on copyright law are growing increasingly wary of advances in digital technology that allow manipulation of their content and potentially diminish the effectiveness of their copyright protection. Technology firms, on the other hand, are looking more and more at developing products which provide low-cost, high quality access to content without restriction. Thus, as technologists work feverishly to find new ways to free up information, content providers are fighting just as hard to constrain access in order to prevent market-killing duplication and distribution of their works. These two codependent yet clashing interest groups recently met …
Plotting The Return Of An Ancient Tort To Cyberspace: Towards A New Federal Standard Of Responsibility For Defamation For Internet Service Providers, Christopher Butler
Plotting The Return Of An Ancient Tort To Cyberspace: Towards A New Federal Standard Of Responsibility For Defamation For Internet Service Providers, Christopher Butler
Michigan Telecommunications & Technology Law Review
Though the rapid development of the Internet has created a fertile ground for legal innovation, more often than not legislators and courts have sought to address this relatively new medium by attempting to squeeze it into precedents and paradigms better suited to older forms of communication, technology, and media. Part I of this article looks back at the courts' initial efforts at addressing defamation via the Internet. From the start the courts attempted to fit the role of the ISP into the common law's categorizing of print media as either "publishers" or "distributors" of information. One court's misstep in overextending …