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Articles 1 - 4 of 4
Full-Text Articles in Law
Addressing The Elephant: The Potential Effects Of The Patent Cases Pilot Program And Leahy-Smith America Invents Act, Randall R. Rader
Addressing The Elephant: The Potential Effects Of The Patent Cases Pilot Program And Leahy-Smith America Invents Act, Randall R. Rader
American University Law Review
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 …
What Should Be Patentable? A Proposal For Determining The Existence Of Statutory Subject Matter Under 35 U.S.C. Sec. 101, Andrew Beckerman Rodau
What Should Be Patentable? A Proposal For Determining The Existence Of Statutory Subject Matter Under 35 U.S.C. Sec. 101, Andrew Beckerman Rodau
Andrew Beckerman Rodau
The question of what type of inventions should be protectable under patent law is a controversial issue that has received significant attention. Recent Supreme Court decisions reject a bright line test in favor of a more-opened ended approach to determining patent eligibility. Unfortunately, this provides limited guidance to lower courts and consequently the issue remains unsettled. Most inventions fit within the statutory requirements defining patent-eligible inventions. This article will examine the scope of patent-eligible subject matter defined by patent law section 101. It will look at judicial interpretation of the statute including exceptions judicially engrafted onto the statute by the …
Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg
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 …