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August 20, 2008


"AstraZeneca protected its Prilosec® franchise at great cost, but it is reasonable to ask, to what end and for what benefit? It doesn't appear to be an easy question to answer."


A very astute question to ask as this litigation went on for about 9 years to reach this point. For us looking for precedent on various issues on Hatch-Waxman and other patent subjects, it does provide quite a bit stuff to use.


This is most outrageous and senseless decision to come out of the CAFC for years. The CAFC panel has without the blink of any eye restated the long settled meaning of "reduction to pratice". The CAFC has now decided that "safety and effeciay" testing of Phase III trials required for FDA approval, may well be a necessary in order for a drug to be considered "reduced to practice".

This opinion yells in the face of countless prior CAFC decisions which state just the opposite. Testing for FDA approval is by far a much higher standard than what is required for "reduction to practice"


Dear EG:

I'm sure AstraZeneca doesn't intend the usefulness of the case to be how it helps the rest of us understand Hatch-Waxman, but you may be right, in the end that may be its greatest (maybe only) legacy.

Thanks for the comment.

Dear Bruce:

I think the basis for the court's decision is that the claim is for an (oral) pharmaceutical preparation/formulation. The problem with the decision differs a little between the two patents in suit. The '230 patent affirmatively recites functional features of the claimed structural elements (like "enhanced stability") that could be said to be uncertain until the results of the trials were known. If that limitation was given patentable weight, then whether the invention was reduced to practice could depend on those results.

Keep in mind, Judge Jones has handled these cases from their inception, and has ruled that omeprazole is "extremely difficult to formulate." If the CAFC gave that determination weight (and deference as a factual finding), it supports the idea that the inventors didn't know whether the formulation would work until they tested it in a sufficient number of people to have the clinical trial results.

This analysis works less well in the case of the '505 patent, but perhaps the court didn't think there was much profit in distinguishing between two expired patents. Given that Impax and Apotex could enter the market in October 2007, the entire case has an historical taint to it that might have affected the decision.

Insofar as anyone tries to use this case to equate Phase III clinical trials with reduction to practice as a general rule, I agree with you - at best this is a special case that should be distinguished on the facts. It will be interesting to see if any enterprising PTO examiners try to use this case to require Phase III trials to satisfy Sec. 101 or 112 requirements.

Thanks for the comment.

The really troubling aspect of this decision is that the CAFC panel is essentially taking the DC's "findings of facts" which the DC used in its determination of "experimental use" and is extrapolating those facts to the CAFC's determination of lack of "reduction to practice".

The DC "found" that the Phase III trials were intended to prove "safety and effeciacy", thus supporting a ruling on experimental use. But the CAFC is now using those findings of "saftey and effeciacy testing" to prove that there was a lack of reduction to practice.

This is pure judicial mischief. Obviously, the parties were fully focused on "experimental use" not on "reduction to practice". But now comes the CAFC to cherry pick findings to support its very different approach for affirming the ruling of the DC.

But the CAFC think that the formulation would have survived Phase II if it hadn't met a threshold FDA requirement for safety and effeciacy? of course there was RTP.

More troubling is how the CAFC has being conflating the SCOTUS Pfaff decision that relates to the "on sale bar" with the "public use bar". The Supreme Court in Pfaff held that the on-sale bar only applied when the invention was ready for patenting. It further held the RTP would generally imply that invention was ready for patenting. But they never said that this same rule applies to the "public use" bar. Obviously, the concept of "use" clearly suggests that the invention was RTP'd. You cannot "use" a drug if it wasn't RTP'd.


I don't disagree, but the claim is not to a drug per se, but rather to a particular formulation having certain properties. IF, and it's a big if, the CAFC was saying the inventors would only know if the claimed invention worked for its intended purpose after the results of the clinical trials were in, then the panel had a rational basis for its decision.

But you are correct that the issue was experimental use and not on sale, and this panel certainly seems to have these concepts confused. However, the decision cites Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005) (“the ready for patenting component of Pfaff’s two-part test [is] another necessary requirement of a public use bar.”) This is the lynchpin that joins the "ready for patenting" requirement with the public use bar. Think of the old corset case, or even the City of Elizabeth experimental use case. You could argue that you can't drive down a road until the road has been reduced to practice, but that use was not an invalidating public use because the inventors needed to know whether the road was ready for patenting (to put it in this panel's parlance).

You are right that this decision is ripe for abuse, but there is a logic in it.

Thanks for the comment.


I hadn't thought before about the issue of whether the Pfaff "ready for patenting" prong applied to "public use" versus "on sale". But the "ready for patenting" prong would seem reasonably to apply to "public use" here in the context of whether the clinical studies were needed to confirm that the formulation would work. Otherwise, you put a drug company in the dilemma of filing for a patent to avoid the clinical study being a "public use", only to find out later in the clinical that it didn't work as formulated.

You may recall the 2004 case of SmithKline Beecham Corp. v. Apotex Corp. where the Federal Circuit initially put a significant cloud over whether clinical studies were “experimental” and thus not a “public use.” The Federal Circuit there ruled that the clinical testing: (1) only measured the safety and efficacy of the patented drug as an antidepressant; (2) was not needed to define what was claimed, i.e., the drug itself; and (3) was therefore not “experimental,” but was instead an invalidating “public use.” Fortunately for SmithKline, the Federal Circuit vacated this panel decision en banc.

Surprisingly, the Federal Circuit in Omeprazole didn't refer to this SmithKline case, but it certainly illustrates why some reasonable latitude should be given to the drug manufacturer not to rigidly treat clinical studies as a potential "public use".

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