The Dolcera Blog

Test of enablement - “Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.”  Source
I have always considered the CAFC judgments as one of the best repository to learn intellectual property. I happened to come across a very interesting case.
Janssen Enablement Alzheimers (pdf) - This case (relating to US Patent No. 4,663,318) goes to prove the necessity of writing very detailed specifications backed with strong experimental data for claims to be upheld in the court of law. In this case, Janssen claimed use of a certain drug ‘galanthamine’ for treating Alzheimers. At the time of submitting the patent for review, the inventor who later on licensed the granted patent to Jansen, did not have sufficient experimental data proving direct probable linkage to use of galanthamine for Alzheimers treatment. USPTO examiner also cited this point, yet issued the patent (this part is weird). Eventually, the claims of this patent were held invalid due to an ‘enablement’ clause - in simple terms, enablement here means the specification did not directly support the claims of the inventor.
The discussions were also adverting to the utility requirement which prevents mere ideas from being patented. As noted in Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997), “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.
Being an inventor myself, this case intrigues me that if we find a novel use for a patented compound, we can get a patent for it. From a business perspective, I feel that it would be prudent that pharmaceutical firms keep track of formulation patents/method of use patents filed by competitors over its own molecule portfolio. This is on the assumption that the competitors are trying to find novel uses of a compound patented by the inventing pharmaceutical firm. If successful, the competition would need to pay royalties to the patent holder of the novel compound (assuming the patent holder is willing to license it on fair terms).
For the patent searching fraternity, the hypothesis of determining patent quality based on disclosed experimental data is quite sound. However, it becomes difficult to retrieve if the experimental data paragraphs are added during the later stages of patent prosecution. The US PAIR information workaround to access the office actions will be of little help especially if the number of patents to be examined is large.

Tweet  Delicious  Digg  Facebook