Supreme Court KSR Decision and its Impact on Pharmaceutical Patents
KSR Int’l Co. v. Teleflex Inc.,550 U.S. __, 82 USPQ2d 1385 (April 30, 2007)
Parties: Petitioner (KSR Int’l) v. Respondent (Teleflex) Lower Court: The district court ruled in favor of KSR that the Teleflex’s patent is obvious over the prior arts. Appeal Court: The Court of Appeals for the Federal Circuit (CAFC) reversed the district court’s decision. (Teleflex, Inc. v. KSR Int’l Co., 119 Fed. Appx.290 (Fed. Cir. 2005)). Decision on 1/6/05. Question Presented at the Supreme Court: Whether the Federal Circuit erred in holding that a claimed invention cannot be held “obvious,” and thus unpatentable under 35 U.S.C. sec. 103(a), in the absence of some proven “’teaching, suggestion or motivation’ that would have led a person of ordinary skill in the art to combine the relevant prior art teachings in the manner claimed”? Ruling: In a unanimous decision, the Supreme Court reversed the CAFC’s “strict” application of the teaching, suggestion or motivation (TSM) test – where the suggestion to combine must be express or implied in the prior art and narrowly drawn to the claimed combination. Decision on 4/30/07. Impact: It is harder to demonstrate the nonobviousness for inventor and easier to challenge the patent for obviousness.
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Now you all heard about this Supreme Court decision on obviousness, I would like to discuss the decision and its potential impact on pharmaceutical patents, especially in the combination patents.
Although this case is not related to pharmaceuticals, its ruling will apply to all patents at both filing phase at USPTO and litigation phase. For more thorough legal discussion, please check at Patently-O blog (here and here). I would like to discuss the parts that may be more interested to the inventor of the pharmaceutical field.
For combination patent, one may need to demonstrate unpredictable result, teaching away from the prior art, or some synergy of the combination. If it is predictable, it probably is obvious. The Supreme Court states:
“The combination of familiar elements according to know methods is likely to be obvious when it does no more than yield predictable results.”
“[W]hen a patent claims a structure already known in the prior that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
“If a person of ordinary skill can implement a predictable variation, Section 103 likely bars its patentability.”
[A] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.”
“The question is not whether the combination was obvious to the patentee, but whether the combination was obvious to a person with ordinary skill in the art. Under the correct analysis, any need or problem known in the field of endeavor at the time of the invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.”
On October 10, 2007, USOTO issued examiner guidelines for determining obviousness under this KSR ruling, 72 Fed. Reg. 57526. Several examples were presented in supporting obviousness rejections as follows:
Combining prior art elements according to known methods to yield predictable results;
Simple substitution of one known element for another to obtain predictable results;
Use of known technique to improve similar devices (methods, or products) in the same way;
Applying a known technique to known device (method, or product) ready for improvement to yield predictable results;
“Obvious to try” – choosing from a finite number of identified, predictable solution, with a reasonable expectation of success;
Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations would have been predictable to one of ordinary skill in the art;
Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
There were two cases in pharmaceutical field mentioned in “Obvious to try” category.
Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007)
This case is direct to the Norvasc® (amlodipine besylate). At the time of the invention, amlodipine was known, as was the use of besylate anions. Pfizer discovered that besylate salt had better manufacturability (such as reduced stickiness), which is an unpredictable property, even though it has the same therapeutic property. The Federal Circuit held that there were only a finite number (53) of pharmaceutical acceptable salts to be tested for improved properties. This would be an acceptable number to form “a reasonable expectation of success.” I discussed this case in a separate blog.
Alza Corp. v Mylan Labs, Inc., 464 F.3d 1286 (Fed. Cir. 2006)
The Federal Circuit in this case invalided Alza’s patent on an extended-release formulation of Ditropan® (oxybutynin). Ditropan® is a highly water-soluble compound in a 24-hr formulation. In one prior art, it taught how to develop highly water-soluble compound in extended-release formulation. In another prior art, it taught how to develop a 24-hr extended-release formulation. The court found that because the absorption properties of oxybutynin would have been reasonably predictable at the time of the invention, there would have been a reasonable expectation of successful development of a sustained-release formulation of oxybutynin as claimed. The court was not swayed by arguments of lack of absolute predictability.
As we can see from these examples, it is getting harder to demonstrate the nonobviousness and easier to challenge the patent for obviousness.