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Full-Text Articles in Law
The Patent Option, Daniel J. Gervais
The Patent Option, Daniel J. Gervais
Vanderbilt Law School Faculty Publications
There is a shift in the shape of intellectual property (IP) tools used to strengthen and lengthen the right of pharmaceutical companies to exclude others from making and marketing their products. Patents have traditionally been the tool of choice. Over the past two decades, however, pharmaceutical companies have increased their degree of reliance on a right known as “data exclusivity.” This right, which now exists in most major jurisdictions, is the right to prevent third parties from relying on the clinical trial data submitted by another pharmaceutical company to obtain marketing approval for a bioequivalent or biosimilar product. The right …
Patenting The Unexplained, Sean B. Seymore
Patenting The Unexplained, Sean B. Seymore
Vanderbilt Law School Faculty Publications
It is a bedrock principle of patent law that an inventor need not understand how or why an invention works. The patent statute simply requires that the inventor explain how to make and use the invention. But explaining how to make and use something without understanding how or why it works yields patents with uninformative disclosures. Their teaching function is limited; one who wants to understand or figure out the underlying scientific principles must turn elsewhere. This limited disclosure rule does not align with the norms of science and tends to make patent documents a less robust form of technical …
Patenting Around Failure, Sean B. Seymore
Patenting Around Failure, Sean B. Seymore
Vanderbilt Law School Faculty Publications
Many patents cover inventions that do not work as described. Fingers often point to the U.S. Patent and Trademark Office (Patent Office), which is criticized for doing a poor job of examining patents. But the story is more complicated for at least three reasons. First, from an information standpoint, the Patent Office is at a clear disadvantage because the inventor has little incentive to disclose failure because it might compromise patentability. Second, an inventor is not required to actually make everything that is claimed (or verify that everything that is claimed actually works) before filing a patent application. Third, inventors …
Reinvention, Sean B. Seymore
Reinvention, Sean B. Seymore
Vanderbilt Law School Faculty Publications
It is axiomatic that once an invention has been patented, it cannot be patented again. This aligns with the quid pro quo theory of patents — the public would receive nothing new in exchange for the second patent. Enforcing this rule is done through the novelty requirement, which bars a patent if the invention is already known. But the rule is hard to justify if the original patentee reneged on the quid pro quo by inadequately disclosing how to make and use the invention. The inadequate disclosure suggests that the original inventor did not invent anything and the public received …
Foresight Bias In Patent Law, Sean B. Seymore
Foresight Bias In Patent Law, Sean B. Seymore
Vanderbilt Law School Faculty Publications
Much of patent reform has focused on efforts to make it harder to obtain and enforce low-quality patents. The most straightforward way to achieve this goal is to raise the substantive standards of patentability. What is often ignored in discussions about raising patentability standards is that high-quality inventions can slip through the cracks. What is more troubling is that sometimes this happens because of bias. This Article draws attention to foresight bias, which occurs when a decision-maker lets over-pessimism and an oversimplified view of the future influence the patentability determination. Foresight bias leads to a patent denial regardless of the …
Atypical Inventions, Sean B. Seymore
Atypical Inventions, Sean B. Seymore
Vanderbilt Law School Faculty Publications
Patent law is constantly evolving to accommodate advances in science and technology. But, for a variety of reasons, some aspects of patent doctrine have not evolved over time leading to a growing disconnect between the patent system and certain technical communities. Particularly vulnerable to the ill effects of this disconnect are "atypical" inventions, which this Article definesas those in which either (1) a technical aspect of the invention or the inventive process does not conform to an established legal standard in patent law or (2) the technical underpinnings of the invention depart from well-established scientific paradigms. An example of the …
Rethinking Novelty In Patent Law, Sean B. Seymore
Rethinking Novelty In Patent Law, Sean B. Seymore
Vanderbilt Law School Faculty Publications
The novelty requirement seeks to ensure that a patent will not issue if the public already possesses the invention. Although gauging possession is usually straightforward for simple inventions, it can be difficult for those in complex fields like biotechnology, chemistry, and pharmaceuticals. For example, if a drug company seeks to patent a promising molecule that was disclosed but never physically made in the prior art, the key possession question is whether a person having ordinary skill in the art (PHOSITA) could have made it at the time of the prior disclosure. Put differently, could the PHOSITA rely on then-existing knowledge …
Heightened Enablement In The Unpredictable Arts, Sean B. Seymore
Heightened Enablement In The Unpredictable Arts, Sean B. Seymore
Vanderbilt Law School Faculty Publications
A bedrock principle of patent law is that an applicant must sufficiently disclose the invention in exchange for the right to exclude. The essential facet of the disclosure requirement is enablement, which compels a patent applicant to enable a person having ordinary skill in the art (PHOSITA) how to make and use the full scope of the claimed invention without undue experimentation. Enablement problems may arise when the applicant claims an invention broadly with a dearth of supporting data or examples. This is problematic in unpredictable fields like chemistry because a PHOSITA often needs a specific and detailed teaching in …