Despite the continued reliance on the rhetorical device that modern invention is performed by individual inventors in their garages, few would disagree that today most patentable inventive activity occurs in corporate and university settings and that most individuals who would be labeled “inventors” in the twenty-first century are employees of a corporate entity. Yet, while copyright law’s work made for hire doctrine automatically vests employers with ownership of works made within their employees’ scope of employment, except in a few limited circumstances, patent law continues to require a written assignment of the rights to a patented invention. In order to resolve resulting issues and bring patent law into the twenty-first century, the Patent Act should be amended to borrow from the Copyright Act and adopt a principle similar to the work made for hire doctrine that would grant employers the rights to their employees’ inventions made within the scope of their employment.
The Patent Act’s omission to define inventorship leaves a paramount concept in a legal vacuum. Where courts have stepped in to fill the void, they have largely deferred to the inventor, and joint inventor, status articulated in the patent claims. This fixation fails to accurately reflect the contributions of those who, by common understanding, are inventors. In doing so, the patent system incentivizes not invention, as the Constitution and Congress conceived, but legal claims of invention, playing to the advantage of the legally sophisticated rather than the scientifically innovative. In this article Professor Fellmeth explores this fundamental disconnect, and proposes several legal solutions.
Caught in the Middle: Reducing the Uncertainty Created by the FDA and the Patent System for Genetic Diagnostic Test Makers
The scientific complexity of genetic diagnostic testing produces test results which are often flawed or difficult to interpret. Therefore, increased regulation of these tests is necessary to protect consumers and encourage patient reliance. However, increased regulation is accompanied by increased costs for genetic diagnostic test makers. If such costs are increased with no opportunity for test makers to recoup their investments, the proposed regulations will reduce public access to these genetic tests, and will reduce future innovation in this field. In similar industries, manufacturers can recoup regulatory costs through intellectual property protection—using a patent to prevent competitors from bringing identical products to market. Unfortunately, the law is unclear as to whether genetic diagnostic tests fall within patentable subject matter. Here I suggest five changes that would alleviate consumer concerns while spurring further innovation in the genetic diagnostic test industry: (1) Increase labeling and genetic counseling requirements for direct-to-consumer tests; (2) Provide for statutory data exclusivity (rather than patent protection) for tests that require clinical studies for FDA approval; (3) Create mandatory maximum approval times for certain classes of genetic diagnostic tests to reduce the regulatory burden on manufacturers; (4) Require that manufacturers and regulatory agencies solicit complaints directly from consumers; and (5) Require minimal new regulation for purely software-based genetic diagnostic tests.
As patent protection afforded outside the United States becomes increasingly lucrative, the time is ripe to consider recalibrating the duration of patent protection afforded within the United States. Wesley D. Markham takes an empirical approach to this policy-based issue. Specifically, he develops a new metric, the “global patent term” (GPT), and uses it to analyze the patenting strategies of three firms in three very different industries. Based on the results of these three case studies, he concludes that patent globalization is more lucrative in some industries than others. Accordingly, the United States should seriously consider technology-specific patent terms to ensure all firms receive appropriate incentives to innovate. This Article presents the key findings of Wesley D. Markham’s empirical study and is a condensed version of a longer paper reporting his research. The full paper is available at http://ssrn.com/abstract=1796030.
In March 2010, the U.S. District Court in the Southern District of New York held in the Myriad case that patent claims directed to isolated DNA molecules were invalid under 35 U.S.C. § 101 for failing to claim patent-eligible subject matter, relying heavily on the so-called “product of nature” doctrine. Instead of a chronological order, this Note reviews the legal history of the “product of nature” doctrine in a brand new analytical framework, analyzing the application of the “product of nature” doctrine to relevant cases based on whether the claimed subject matter is an element, a molecule, or a microorganism. This Note then proposes an appropriate test for applying the doctrine to patent claims directed to molecules. Retroactive application of the proposed test to moleculeclaim case law would have yielded results consistent with the vast majority of relevant cases. Application of the proposed test to the DNA-molecule claims-insuit in Myriad leads to a legal conclusion that the claimed DNA molecules are patent-eligible, contrary to the conclusion of the Myriad court. This Note also makes an effort to address certain issues in the court’s opinion, and to provide some practical tips to patent practitioners in drafting DNA molecule claims.
Since the financial crisis of 2008, many contractual partners who formerly looked rock solid have experienced major cash-flow problems. In addition, it has always been the case that in some fields of technology, such as biotech, a significant number of businesses are expected to fail. Thus, it is important to think through at the outset how a license might be treated by a bankruptcy court, and where possible, to structure the agreement accordingly. How to best do this will depend primarily on whether a party is the patentee or the licensee, and on the extent to which rights are transferred (i.e. whether the transaction results in a sale or merely a license agreement). As Jordan Markham argues, in the context of a bankruptcy proceeding, the patentee is generally better served by a greater, and a licensee by a lesser, transfer of rights.
Software Developers, On Guard!: Offering Software for Sale Can Trigger a Bar to Patentability Even If the Software Is Untested and Incomplete
Paul A. Ragusa and Jack Chen discuss the on-sale bar to patentability in the context of nascent software. They conclude that a simple investigation concerning whether software code was complete at the time of an offer for sale is insufficient to establish the critical date for the purposes under 35 U.S.C. § 102(b) (“Conditions for patentability”).