Thursday, March 20, 2014

Obviousness is Difficult

In this week's class, we discussed about non-obviousness, one of the three elements required for a patent to be valid. As I was reading the article by Dennis Crouch on Patently-O, many of the tests for obviousness in the case was mentioned in class and certainly highlights the difficulty in proving non-obviousness.

In summary, the patent by Leo Pharmaceutical claiming a "storage stable and non-aqueous" pharmaceutical composition was challenged by Galderma R&D and initially invalidated, before the Federal Circuit reversed the decision after an appeal. The reason for the invalidation and reversal primarily stems about the obviousness point of the patent, which I will discuss in this post.

First, we need to know a bit more about the composition is that it combines Vitamin-D and corticosteroids by adding the claimed solvent, which then allows it to be storage stable, which means it can be stored for a period of time without degrading. The Board had found this to be obvious as it combined three prior art references. It was known in the references that it would be great to be able to combine Vitamin-D and corticosteroids, but they either discouraged the combination or combined them without making them storage stable. Thus, the Federal Circuit stated that it was actually not obvious since past research pushes them away from the invention.

The Federal Circuit also substantiated with the point that the invention only came after a decade of previous patents, which means it was a different problem to solve or it would have been solved much earlier. As such, the Chief Judge handling the appeal, Judge Rader, felt that older prior art should be seen as less credible. I certainly agree to this point. Had the earlier researchers first known of the problem or not steered clear of it, they would have been able to solve it since they were already researching about it.

Also, while the patent claimed a wide variety of solvents, there were many more potential solvents and it would not have been obvious that the claimed solvents would work without first trying many others which would not. This made a lot of sense in why the obviousness test is such a difficult test to ascertain, such that even the Board would make a mistake. In fact, I would say it in itself is one of the biggest problems! Most inventions and solutions we see are obvious on first sight, simply because they solve the problem. For example, when we tutor someone, we may know how to solve the problem just because we already know how. However, sometimes, we cannot even comprehend why the tutee does not get it. It is very difficult to put ourselves in their shoes unless we can time-travel to when we did not know the solution. That is certainly an interesting side topic to think about.

Sources:
http://patentlyo.com/patent/2013/08/judge-raders-obviousness-tutorial-including-the-conclusion-that-older-prior-art-is-less-credible-and-a-restatement-that-o.html
http://www.cafc.uscourts.gov/images/stories/opinions-orders/12-1520.Opinion.8-8-2013.1.pdf


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