Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 7 of 7
Full-Text Articles in Law
Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq
Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq
Vincent J Roth Esq
Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …
Avoid Japanization, Nahoko Ono
Avoid Japanization, Nahoko Ono
Nahoko Ono
USPTO and academia are both recently keen to encourage further transparency of patent assignment recordation system. This article contends that excessive regulatory framework is likely to deter exploitation of patents as Japan fails to do so despite of its top-ranked patent producer in the world.
Standard Of Proof For Patent Invalidation In The U.S. And Japan, Yoshinari Oyama
Standard Of Proof For Patent Invalidation In The U.S. And Japan, Yoshinari Oyama
Yoshinari Oyama
In June 2011, the U.S. Supreme Court confirmed the standard of proof for patent invalidation in Microsoft Corp. v. i4i Limited Partnership, et al. The Court held that an invalidity defense to be proven by clear and convincing evidence rather than by a preponderance of the evidence and that burden is constant and never changes. Compared to the U.S. patent system, there is no heightened standard of proof required for patent invalidation in infringement suits in Japanese courts and the invalidation rate is high especially after Kilby cas in 2000, where the Japanese Supreme Court decided that a patentee could …
Prometheus' Revenge: Process Patent Ambiguity, Robert Devin Ricci
Prometheus' Revenge: Process Patent Ambiguity, Robert Devin Ricci
Robert Devin Ricci
In Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Supreme Court returned to historical roots to determine whether a process met the subject matter criteria requirement for patents. The decision to return to historical precedent demonstrates two things: 1) the Court is hesitant to adopt black letter tests for determining patent eligibility and 2) the Court doubts the future applicability of the transformation component of the machine-or-transformation test as technology progresses. Because the decision did not provide any true guidance or light as to how a process claim should be analyzed for subject matter eligibility, the eligibility of such patents …
Reframing Patent Remedies, Karen E. Sandrik
Reframing Patent Remedies, Karen E. Sandrik
Karen E. Sandrik
The strength of our patent system is waning. The Supreme Court recently opened the door for dramatic change by rejecting the long-standing presumption that a permanent injunction should issue upon the adjudication of a valid and infringed patent. Courts have since refashioned patent remedies to favor monetary liability for patent infringement, resulting in the restructuring of substantive rights for certain classes of patent holders. This shift to a liability rule means that a patent holder loses its right to require consent prior to the use of its patented technology. This is a troubling development. If a patent holder is unable …
Discordant Harmonization: Did The European Court Of Justice Interpret The Biotechnology Directive’S Exclusions To Patentability Too Broadly In Brustle V. Greenpeace?, Mark Nickas
Mark Nickas
Stem cell technology offers the hope of treating a variety of diseases for which no effective treatment is currently available. Development of most therapeutic technologies depends on the availability of patent rights, which offer the opportunity to recoup the substantial investment necessary for such inventions. The question of whether human embryonic stem cells (hESCs) are eligible for patent protection raises deep-seated questions of ethics, with compelling moral arguments on both sides. The European Union’s Biotechnology Directive, passed in 1998, excludes from patentability inventions that involve the use of human embryos as contrary to ordre public or morality. Since the enactment …
Patent Reversion: An Employee-Inventor's Second Bite At The Apple, Richard Kamprath
Patent Reversion: An Employee-Inventor's Second Bite At The Apple, Richard Kamprath
Richard Kamprath
In an attempt to more fully compensate employee-inventors without harming the return on investment of employers, a patent reversion is proposed in which the rights to the patent revert to joint ownership between the original inventor and the current owner. In Section I, the background of the relationship between employer and employee-inventor will be discussed in terms of patent rights. This section will outline the problems inherent in the pre-assignment status quo of these rights from employees to employers. Section II will begin with Part A, which is a review of previously proposed solutions to the under-compensation of employee-inventors. The …