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European Biopharmaceutical Review

Patently Obvious


Jen Zarutskie, at Foley Hoag, explores why understanding obviousness is key to patenting later generation technologies

When one thinks of ‘inventions’ and ‘patents’, unprecedented advances and breakthroughs can come to mind. There are, of course, great patents that cover completely new technologies the likes of which the world has never seen before. However, as any area of technology matures, subsequent advances can seem to be much smaller than what is already known and published. That is not to say such advances are not useful and do not have great value; quite the contrary. Combining known therapies can often provide more potent treatments for the disease each component was developed to treat – they may even apply to different diseases entirely. Known genes may be discovered to have novel disease associations, and known protein sequences may be redesigned to afford better stability or novel or enhanced activity, for example. Thus, composition and method claims drawn to such later generation advances can be quite desirable.

To be patentable in the US, an invention must be ‘novel’, that is it cannot be patented if: “(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent,” or “(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country more than one year prior to the application for patent in the United States . . .” (1)

Generally, later generation advances in an area of technology meet the novelty requirement, as they are improvements of known technology or combinations of known technologies. However, even if the subject matter sought to be patented is not exactly described in the prior art, and involves one or more differences over the most similar technology already known, a patent may still be refused, if the differences are considered to be “obvious.” (2) Put another way, the subject matter sought to be patented must be sufficiently different from what has been used or described before in order for it to be considered “nonobvious” under US patent law. Patenting later generation advances can be challenging, but not insurmountable if one understands and applies the law.

CURRENT US LAW
The USPTO considers four factors in evaluating whether a claimed invention is obvious: 

  • The scope and content of the prior art

  • The differences between the prior art and the claimed invention

  • The level of one of ordinary skill in the art

  • Evidence of secondary considerations (3)

The obviousness of a claimed invention over the prior art is determined “at the time the invention was made” (4). The USPTO cannot therefore evaluate whether the invention is obvious in light of the prior art as it is understood at the time the claimed invention is being examined at the USPTO, but rather as it would have been understood by “one of ordinary skill in the art” at the point in time that the invention was conceived by the inventor. If it does not, the patent applicant can challenge an obviousness rejection on the grounds that the USPTO has “impermissively used hindsight” in formulating its rejection. One of ordinary skill in the art is a hypothetical person who is presumed to know the relevant prior art. (5) It is not the inventor him- or herself, a judge, a layman, those skilled in remote arts, or geniuses in the art at hand (6). The characterisation of one of ordinary skill in the art is based on various factors including the “educational level of the inventor... the sophistication of the technology, and the educational level of workers in the field” (7).


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Jen Zarutskie is an associate at Foley Hoag LLP. She is a US registered Patent Attorney and regularly prepares and prosecutes patent applications in the fields of biotechnology, bioinformatics, pharmaceuticals, biosensors, materials science and business methods. She also manages patent portfolios, performs patent due diligence in connection with transactions, drafts non-infringement, invalidity and clearance opinions, and drafts agreements for developing and commercialising pharmaceuticals and biotechnologies. Jen holds an AB in Chemistry from Bryn Mawr College, a PhD in Biological Chemistry from MIT and a JD from Boston University School of Law.
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