I was browsing through some previous cases where nonobviousness plays a critical role and found a compelling example written a couple days before my birthday last year by Dennis Crouch from the University of Missouri School of Law. This case highlights some very interesting qualities about nonobviousness but most of all stresses its prevalent and essential role in determining patentability.
Leo Pharmaceutical Products filed a patent claiming a "storage stable and non-aqueous" invention to treat skin conditions. Before this solution was developed, an existing and well known treatment was the combination of Vitamin-D and a corticosteroid, except no one had been able to manufacture its storage stable form due to sensitive pH requirements. Initially the Board deemed the patent invalid due to obviousness in prior art. On appeal, the Federal Circuit reversed its verdict.
The PTO decision was tricky and the case became a relatively important obviousness case in the patent world. Basically, the Board found the patent claims obvious due to three prior art references- someone skilled in this "art" in the pharmaceutical industry would have taken the existing combination of Vitamin D and corticosteroids and added a solvent to it to achieve storage stability.
But why did the Federal Circuit reversed the Board's decision? While there is reasonable obviousness in design, the Board failed to accredit the patentee (Leo) for identifying the problem in the first place- that a stable form should be designed. The prior art did not recognize the problem and therefore never attempted to create a solution that solved the storage stability problems.
The blog post then goes into more detail about Judge Rader's interpretation of old prior art's relation to obviousness in this case. But our key takeaway in this intriguing case is that its seems the patent was ultimately validated on the grounds of nonobviousness in functionality.
I would be interested in exploring whether discovering new functions for existing designs is a patentable area. I had brought this up previously in comments about the Myriad case whereby a genetics lab's patent claim was rejected- while they found a new way to diagnose breast cancer by isolating breast cancer genes, which had never been done before, the courts could not award them a patent. There is a fine line here, where nonobviousness is a key factor, between patenting natural phenomena (the isolated genes) and new methodology, which is what I perceive in the Leo vs Rea case.
I definitely agree with your post that it seems interesting the court invalidated the claim on grounds of obviousness of the functionality. This situation does focus on the issue of judicial authority which seems to be commonly disputed in patent claims today.
ReplyDeleteThe formal power that judicial systems such as the Supreme Court has should be cautiously used. The misuse of the power lead to minimizing the drive for inventors to develop creative solutions and patent them. It would not be helpful for patent regulations to be obeyed on fear. The current patent system should be evaluated based on expert and formal authority to provide better decisions.
I also agree. The situation regarding obviousness brings controversy because it's so subjective. Even though the patent is approved at first, it could be invalidated later. I mean, in this case, why would we want to file a patent in the first place? I agree that something must be done. There were several articles which seemed to bolster my claim because many patents were invalidated after even though it was approved previously.
DeleteHi Melissa,
ReplyDeleteI think that your blog post covers a really interesting example regarding where the line between obviousness and nonobviousness is blurred. Specifically, I liked how you pointed out that in this case, the invention's nonobviousness was granted as a result of prior art's lack of problem definition, which is a subtlety that we hadn't yet talked about in class. I was wondering if you had any insight into other areas of obviousness that we haven't talked about yet in class?
I agree that subtleties in prior art make it difficult to fully distinguish between obviousness and non-obviousness. This blurred line enables skillful lawyers to tip cases in their clients' favor, and allows patent trolls the opportunity to create and exploit bad quality patents.
DeleteYou write some excellent, thoughtful posts--please don't fall behind!
ReplyDeleteProf Lavian: thank you for your encouragement! I apologize for the short break. I will be updating lots of new content today and I'm glad you enjoyed reading my thoughts! I'll be focusing on some economic interests regarding patents in this weekend's posts.
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