A Rose ‘Whereby’ Any Other Name Would Smell as Sweet to a Petitioner

Posted by Ed Walsh on Nov 29, 2016

In Coalition for Affordable Drugs v. Pozen, Inc. (IPR2015-01718), the Board instituted a trial despite a failure of the petition to show that a final “wherein” clause of a method claim was met by the prior art. Rather, the Board reasoned that the “wherein” clause was likely to actually be a “whereby” clause, just by another name. Because a “whereby” clause stating the intended result of performing a method is not a limitation on the claim, failure to show that the result was known or even occurred in the prior art was not a basis to deny institution.

Here, the challenged patent described reducing the incidence of gastric ulcers in patients taking non-steroidal anti-inflammatory drugs (NSAID) by providing a combination of drugs in a unit dose form (i.e., a capsule). The unit dose combined a specific NSAID with a specific acid reducer. These drugs were coated differently to coordinate their release as the unit dose passed through a patient’s gastrointestinal tract.

The claims recited treating a patient with a unit dose form including those two drugs, and included three wherein clauses that qualified characteristics of the unit dose form.

A fourth wherein clause recited:

“wherein administration of the unit dose form is more effective at reducing the incidence of the NSAID-associated ulcers in patients taking [low-dose aspirin] LDA than in patients not taking LDA who are administered the unit dose form.”

The Board did not accept that the petitioner had shown that this result was known. The petitioner’s expert declaration was offered to prove this point, but was discounted because it merely parroted assertions in the petition that the references disclosed this result. Indeed, the patent owner argued that it was surprising and unexpected that its unit dose form was more effective at reducing ulcers in patients taking low-dose aspirin than in those not taking aspirin.

Nonetheless, the Board instituted, passing the case to trial. There was no dispute that all elements of the claim, except the final wherein clause, were shown in the prior art. There was also no dispute that there were suggestions in the art to use these elements together. Because determining whether that final wherein clause is a limitation would be highly fact-specific, it could not be resolved pre-institution, reasoned the Board. Accordingly, the petition, even without evidence of that greater efficacy, was adequate to make the threshold showing required for institution.

Just as Romeo in Shakespeare’s Romeo and Juliet found that it didn’t matter what you call a rose, the petitioner found that naming the clause a “wherein” or a “whereby” clause made no difference.

But, this play has a second act: the trial. Early next year, the Board will issue its final written decision. In finding that the petition made a threshold showing adequate for institution, the Board indicated that it would consider in its final written decision the fact-specific inquiry needed to determine whether the final wherein clause limits the method recited in the claim or can be ignored as merely a statement of intended results. Moreover, the Board expressed a willingness to delve into evidence that the stated result was surprising and unexpected, which might negate suggestions in the prior art to combine the claimed elements into unit dose form having the characteristics recited in the claims. Perhaps the petitioner should think of Shakespeare’s Julius Caesar instead of Romeo and Juliet, and “beware the Ides of March.”

Topics: Kyle Bass, BioPharma

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