Domestic Patents - Questions You Should Ask Your Patent Attorney - - BioPharm International

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Domestic Patents - Questions You Should Ask Your Patent Attorney


BioPharm International
Volume 1, Issue 8



Your research and development team has just shouted "Eureka!" after long and expensive years of research, exclaiming they have developed a next-generation pain reliever. What do you do next? This article explores and suggests your next steps and identifies pertinent questions to ask a patent attorney. The focus is on intellectual property; this article does not address the myriad regulatory issues that must be resolved.

The Initial Question: Do we have an invention?



Your team of scientists tells you that methyl acetylsalicylate or "methyl aspirin" appears to work in a manner similar to the original Aspirin product developed more than a century ago by Bayer, but with fewer negative side effects on the stomach lining (characteristics assumed for purposes of this article). You contact your patent attorney and ask if the new product is patentable in the US. The attorney says that to determine the patentability of the new compound, you need an assessment, a process that reviews the teachings of the prior art, i.e., the world's patent and non-patent literature as it exists before your patent application is filed. This assessment will determine if your technology is patentable according to the four statutory criteria for patentability, namely, whether your invention: (1) falls within a statutory class (is a process, machine, article of manufacture, composition of matter, or any improvement thereof), (2) is useful, (3) is novel (i.e., has not been invented before), and (4) is non-obvious (i.e., the differences between the subject matter for which the patent is sought and the prior art are such that this subject matter as a whole, would not have been obvious at the time the invention was made, to a person "having ordinary skill in the art" to which the subject matter pertains). The attorney will also help you affirm that the invention is not barred by any statutory provisions, such as the one-year time limit that requires the patent application to be filed within one year of the invention being sold, being part of a commercial sale, or being publicly disclosed.

You decide to pursue the assessment, and a few weeks later your attorney delivers a report that contains at least some of the following information. It likely will identify the invention and note that its active component appears to be salicylic acid, the hydrolysis product of the aqueous reaction upon entry into the body. The report also will point out that salicylic acid, while effective for pain relief, tends to burn the sensitive linings of the mouth, throat, esophagus, and stomach. It may include information that helps you understand why salicylic acid is the active ingredient in Compound W, an over-the-counter wart remover.



The report probably will identify the original Bayer Aspirin patent for acetylsalicylic acid, US patent 644,077, assigned to Farbenfabriken of Elberfeld Company (now Bayer).1 While your compound is different, i.e., it substitutes a methyl group for a hydrogen, the report will note that your invention has a very similar chemical structure to Bayer's original Aspirin composition. To be complete, the report probably also will identify other pain-reliever compositions, such as acetaminophen (Tylenol), ibuprofen (Advil, Motrin IB, and Nuprin), naproxen sodium (Aleve), and ketoprofen (Orudus KT) as prior art, and it will review each for any teaching that would lead a scientist in the field to make your substitution.


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