November 19, 2018
Originally posted 2017-02-27 12:08:57
Originally posted 2016-08-18 12:00:25.
By Kristen Daly | www.amdlawgroup.com
When determining the patentability of a product, one must ensure that the invention falls under the category of patentable subject matter. Included under patentable subject matter is a requirement for non-obviousness. Under USPTO patent laws and regulations, a patent for a claimed invention may not be obtained “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.” However, the criteria for what makes an invention obvious has been subject to debate; and the effects of the landmark Supreme Court case KSR International Co. v. Teleflex Inc. reach not only basic mechanical fields but the field of biotechnology and pharmaceuticals.
Prior to KSR v. Teleflex, obviousness was solely determined using a rigid analysis made up of two tests: the TSM test and the RES test. The TSM test stated that obviousness required a showing of suggestion, teaching or motivation to combine or modify prior art references while the RES test pushed for obviousness if someone skilled in the art would perceive a reasonable expectation of success via that combination or modification. However, as a result of KSR, these tests were determined to be too restrictive; they are still used but are no longer the only basis for obviousness analyses. The major conclusion from KSR was that the lower Federal Circuit was wrong in three ways: by holding that courts and examiners should only look at the problem the patentee was trying to solve, by assuming that a person of ordinary skill in the art attempting to solve a problem will be led only to those prior art elements designed to solve the same problem, and by concluding that a patent claim cannot be proven obvious merely by showing that the combination of elements was obvious to try. It may be helpful to view a technical case such as MacDermaid v. DuPont.
In MacDermaid v. DuPont, MacDermaid Printing Solutions sought to invalidate one of E.I. du Pont de Nemours’ patents on the basis of obviousness. MacDermaid argued that DuPont’s patent for making flexographic plates using heat instead of chemicals was obvious because it described the same technology and method of as at least two prior patents. However, DuPont argued that a person skilled in the art would not have believed that combining the technology would produce a useful result. In the end, regarding that patent, the judge rejected DuPont’s claims and declared that patent invalid; thereby allowing MacDermaid continued use of the printing technology.
With all of these decisions and changes, it is not hard to see how pharmaceutical patents may become easier to invalidity claims based on obviousness. Often times, pharmaceutical companies are able to obtain or extend patents on drugs by slightly altering one of the lead compounds. It may be argued that a skilled person would know that by only slightly changing a compound similar to that of a prior art reference, the same result would be achieved; so the “invention” would be declared as obvious. Similarly, most pharmaceutical research relies on combining drugs and compounds that are known in order to yield a drug that accomplishes a certain result; thereby making the combination “obvious to try”.
Should people be concerned about the heightened scrutiny of pharmaceutical patents that comes along with these changes or is this a welcomed event that’ll cause Big Pharma to rethink some of its policies? 35 U.S.C. §103(a) (2006).
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