Patenting Therapeutic Methods: Statutes and Strategies

2018 ◽  
Vol 24 (2) ◽  
Author(s):  
Seema Soni ◽  
Pratap Devarapalli

Patenting medical therapeutic methods has become one of the toughest tasks for inventors and scientists in some jurisdictions where these methods are excluded from patentable subject matter. There are recent amendments by different countries in relation to patentability aspects of Therapeutic methods. In this scenario, analysis of these recent amendments would provide a path for researchers in the field to identify whether their inventions are considered as patentable subject matter. Our analysis sheds some light on different statutes and regulations of major jurisdictions on the patentable subject matter and patentability aspects of therapeutic methods. Furthermore, we have identified that most of the jurisdictions restrict inventors in patenting therapeutic methods. However, some countries such as United States and Australia allow patents related to therapeutic methods. We think adapting different strategies that are provided in this article would help researchers, inventors and patent attorneys in patenting the inventions related to therapeutic methods. Moreover, while applying the provided strategies, it is suggested that inventors should draft the patent claims by keeping a note of different statutes and regulations of countries in which they are interested to file the patent applications.

2016 ◽  
Author(s):  
Dan Burk

In its recent patentable subject matter opinion in Alice Corp. v. CLS Bank Int'l, the United States Supreme Court articulated a two-step patent eligibility test that hinges on the presence of an "inventive concept" in the patent claims. This short essay considers the connection between the "inventive concept" requirement in the Alice Corp. test and the requirement of an "inventive step" or non-obviousness requirement for patentability, by relating the Supreme Court's holding to similar decisions considering patentable subject matter under the European Patent Convention.


2016 ◽  
Author(s):  
Dan Burk

By the summer of 2013, the United States Supreme Court should issue an opinion in Myriad v. AMP, a case dealing with the patentability of human genes, including "cDNA" molecules that are created in the laboratory. Opponents of gene patenting have argued that such molecules should be deemed unpatentable "products of nature" because, statistically, such molecules might sometimes be fortuitously created in human cells. But this argument improperly imports into patent law's section 101 subject matter analysis the doctrine of inherency from section 102's provisions on novelty. And, if inherency is to be imported into section 101, the proper standard for patentability would be the "public benefit" criteria that has been developed in section 102 consideration of inherency. Under the "public benefit" standard, Myriad's cDNAs would constitute patentable subject matter.


2016 ◽  
Author(s):  
Dan Burk

The opinion of the United States Court of Appeals for the Federal Circuit, In re Roslin Institute, rejecting patent claims to mammals cloned from somatic cells, was rendered about a month before the United States Supreme Court's decision in Alice Corp. v. CLS Bank International. The Alice opinion explicitly sets out the standard for determining whether an invention falls within statutory patentable subject matter. Thus one is thus left to wonder what the Roslin opinion might have looked like had it been decided only a few weeks later, after the Alice decision was published, with the benefit of the Supreme Court's further direction on patentable subject matter. In this essay I explore whether in hindsight the Alice standard might have dictated a different outcome in Roslin, suggesting how the two-part test articulated by the Supreme Court in Alice might apply to a "products of nature" analysis for cloned mammals. Drawing on that analysis, I then use the Roslin case as a vehicle to highlight certain issues with the Supreme Court's current subject matter jurisprudence as applied to biotechnology. By juxtaposing Dolly with Alice, it becomes clear that the Supreme Court has revivified a number of dormant biotechnology patent problems in the guise of subject matter analysis.


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