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


Domestic Patents - Questions You Should Ask Your Patent Attorney

BioPharm International
Volume 1, Issue 8

Based on the information uncovered during the patent and prior art search, your patent counsel informs you that your invention meets the statutory criterion for "novelty" because no exact matches have been found in the literature. The attorney must now analyze the information to determine if your invention is rendered "obvious" in light of any of the identified art — i.e., is it an obvious variation of what is taught in any of the documents the attorney has uncovered, and if so, can your invention still be patented, as it has provided "unexpected results"? This analysis involves a three-pronged factual inquiry to: (1) determine the scope and content of the prior art, (2) compare the prior art and your proposed claims to determine whether a patentable distinction has been made, and (3) make a comparison and determination, from the point of view of a person having ordinary skill in the particular art as to whether the invention would be obvious (this criterion typically is defined by the sophistication of the technology and industry being evaluated). Following the analysis, your patent attorney will render an opinion as to whether any teachings illustrated or disclosed in any of the previous patents teach or render the invention "obvious."

There may be other relevant issues to examine, called "secondary considerations." In many instances, these considerations are important items of evidence that the invention was not obvious in nature, and they are often viewed as a fourth factual inquiry. An exemplary list of these considerations includes:

  • Long felt, but unsatisfied need for, the invention while the needed implementing arts and elements had long been available
  • Commercial success of the invention causally related to the invention itself, rather than to companion factors such as advertising
  • Copying of the patentee's invention by competitors, as distinguished from their independent development thereof
  • Teaching by those skilled in the art, away from the technical direction pursued by the patentee
  • The unexpectedness, to those skilled in the art, of the results of the invention

For purposes of this article, it is assumed that all of the relevant art has been found, and that no evidence was discovered to suggest the value of switching to a methyl group to achieve similar pain relief without the associated negative effects. Your patent attorney will likely conclude that this invention is not an "obvious" variation of the prior art.

However, was your initial question —"Do we have an invention?"— the right one? Did your question lead to the maximum amount of information? The answer to your initial question will be "yes" or "no" and will include some amplification. While this response has value, of equal or greater importance is the scope of protection that your patent attorney expects to be able to secure. In other words is this an invention for which broad or narrow protection will be available? Such an analysis, while difficult to make, is exceptionally helpful to any decision-maker and may influence whether the invention is maintained as a trade secret or patented.

The Follow-Up Question: Now that I have the patent, am I able to use it?

Assuming your patent attorney was correct in concluding the invention is patentable, and you have just obtained your patent from the US Patent and Trademark Office, are you free to use the teachings and protection contained in the patent and market your product? While the answer intuitively seems to be "yes," reality unfortunately is quite different, and the initial answer is "maybe." Let's see why.

blog comments powered by Disqus



GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines
Source: BioPharm International,
Click here