Alza v. Mylan (Fed. Cir. 2006, 06–1019).
Alza holds the patent on a once-daily controlled release oxybutynin formulation used to treat urinary incontinence. (U.S. Patent No. 6,124,355). Alza’s formulation is sold as Ditropan XL®. Mylan wants to sell a generic version and challenged the patent, and the district court obliged by finding the patent invalid as obvious.
In affirming the obviousness finding, a unanimous decision penned by Judge Gajarsa presents its defense of the much criticized teaching/suggestion/motivation test (TSM Test) for obviousness that is currently on review before the Supreme Court in the Teleflex case.
The meat of the opinion begins with a reminder that the motivation test did not arise with Federal Circuit, but rather that the making of the CCPA. The 1943 case of Fridolph, for instance, instructs that when “considering more than one reference, the question always is: does such art suggest doing the thing the [inventor] did.”
Next, the opinion explains that the TSM test “has been developed consistent with the Supreme Court’s obviousness jurisprudence as expressed in Graham and the text of [Section 103(a)].” The court explains that the purpose of the proof portion of the TSM test test is to avoid the problem associated with hindsight. The theory is that obviousness “should be based on evidence rather than on mere speculation or conjecture.”
Many of the briefs in Teleflex argue that the TSM test is “rigid.” In Alza, the court disagreed, arguing that the test is flexible “because a motivation may be found implicitly in the prior art.” (emphasis in original).
We do not have a rigid test that requires an actual teaching to combine before concluding that one of ordinary skill in the art would know to combine references. This approach, moreover, does not exist merely in theory but in practice, as well. Our recent decisions in Kahn and in Cross Medical Products amply illustrate the current state of this court’s views.
In Kahn, the court emphasized the availability of implicit proof of a motivation to combine references, and in Cross Medical, the court found that motivation could come from “general knowledge.”
In this case, the patent holder Alza argued that back in 1995, there was no suggestion to try (or likelihood of success of) using controlled release pills because nobody thought that the formulation could be absorbed in the colon. Defendant Mylan relied on an expert witness who testified that back in 1995 there would have been a reasonable likelihood that a controlled release pill would work – and thus that there was a motivation to try it. Alza presented some references that suggested that controlled-release pills might not work, but those did not specifically discuss absorption of the type of molecule contained in Ditropan.
Based on the expert testimony, the lower court agreed that the TSM test had been satisfied and that the patent was invalid as obvious. The appellate panel affirmed on a clear error standard, finding that:
we cannot perceive clear error in the district court’s factual findings that while colonic absorption was not guaranteed, the evidence, viewed as a whole, is clear and convincing that a person of ordinary skill in the art would nonetheless have perceived a reasonable likelihood of success and that she would have been motivated to combine prior art references to make the claimed invention.
Obviousness affirmed.
***Under this case, an expert panel can be establised at the USPTO and decide on the obviousness question as it pertains to the TSMs of each case. Leave these technolgically clueless judges out of the loop and get some real ordinary skill in the art techies involved.***
So long as applicants have the opportunity to subject these “experts” to questioning to ascertain their credentials to be qualified as one having ordinary skill in the art (comparable to what the expert in the case was subjected to). Moreover, applicants should have their own opportunity to present evidence from their own experts as to what would have been obvious to one skilled in the art.
Finally, to mitigate the problem of hindsight reconstruction, perhaps the system should work as follows:
1) An examiner reviews the application and claims.
2) The examiner submits citations from the prior art to the “experts” to review, each citation should have a certain minimum length (such as one paragraph), and no maximum length. The citations can be to specific teachings as to limitations or teachings as to problems to be solved or whatever additional teachings/suggestions/motivations the examiner believes is relevant to the claimed invention. At least one reference should be labeled a “primary” reference. The examiner, however, cannot include any written analysis to avoid hindsight reconstruction contamination.
3) The experts puts together a number of proposed combinations/modifications based upon the art cited to the expert by the examiner.
4) If the expert is able to come up with the claimed invention, then the PTO has established a prima facie case of obviousness
If the expert cannot come up with the claimed invention, then the examiner should have one more opportunity to cite a supplemental set of references to another expert, and if the other expert doesn’t come up with the claimed invention, then the examiner should either find a 102 reference or an explicit teaching/suggestion/motivation within the prior art to support the 103 rejection.
I’ve always like definition of “obvious” as “easily discovered.” If, after citing specific paragraphs to experts by an examiner specifically tailored to establish factual support for an obviousness rejection, the experts cannot come up with claimed invention, then perhaps the invention was not obvious (i.e., easily discovered).
This system could be an optional procedure available to examiners if the examiner cannot establish obviousness by the traditional route (i.e., the test set forth by the Federal Circuit), so as to not put excessive burden on the patent office.
Any system that allows the expert to review the claims and specification prior to the establishing obviousness makes it too easy for the expert to establish obviousness. All the expert has to do is use the problem statement described by most applicants in their specification and assert that this problem would be solved by this certain combination.
Perhaps having the experts be subjected to questioning would be a little too much, but they would definitely have to establish their credentials as being an expert, and I believe these credentials should mostly be found in real outside work experience.
Under this case, an expert panel can be establised at the USPTO and decide on the obviousness question as it pertains to the TSMs of each case. Leave these technolgically clueless judges out of the loop and get some real ordinary skill in the art techies involved.
Tongue in cheek, of course, but perhaps the CAFC should file this decision as an amicus brief in KSR v. Teleflex.
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