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Allergan Wins Out in Combigan Generics Case

Allergan, a specialty pharmaceutical company, has been battling it out in court with fellow pharmaceutical maker Sandoz over the right to sell a generic version of Allergan's popular glaucoma drug, Combigan. Last week, the Federal Circuit reversed a district court's ruling that many of Allergan's patent claims were nonobvious under 35 U.S.C. §103.

While most of Allergan's claims were deemed obvious, the Federal Circuit court upheld a method claim because it arguably involves a nonobvious result. Sandoz is consequently barred from entering the market until the Combigan patent in question expires in 2022.

The most interesting part of the case, however, may be Judge Dyk's dissent, in which he argues that the method claim is invalid because it's merely a "discovered result of an existing method or use."

The patents at issue in the case were all related to Combigan, a glaucoma treatment consisting of brimonidine and timolol. The Federal Circuit court unanimously reversed the lower court’s determination that the composition patents were nonobvious. Both timolol and brimonidine had already been used in the claimed concentrations in a number of ophthalmic treatments.

While the composition-related claims were deemed invalid as obvious, Allergan’s method claim was another story. Allergan’s ‘149 patent describes “a method of reducing the number of daily topical ophthalmic doses of brimonidine administered topically to an eye of a person in need thereof for the treatment of glaucoma or ocular hypertension from 3 to 2 times a day without loss of efficacy.” In other words, Allergan claimed that applying the drops twice a day rather than the recommended three times a day is just as effective if timolol is added to the solution.

According to the court, it’s generally understood in the industry that when brimonidine is used twice a day, rather than three times, the treatment loses its efficacy in the middle of the day. This effect is known as the “afternoon trough.” The court found that the method claim was nonobvious since it couldn’t find any evidence in the prior art that would allow it to conclude that adding timolol to brimonidine would help eliminate the afternoon trough effect.

Judge Dyk took issue with the majority’s reasoning. In his dissent, the judge notes that “while a new and nonobvious method of using an existing (or obvious) composition may itself be patentable … a newly-discovered result or property of an existing (or obvious) method of use is not patentable.” He argues that “avoiding a loss of efficacy” isn’t a separate step or limitation, but a result of an existing method.

Finally, Judge Dyk cites the court’s decision in Bristol-Myers Squibb v. Ben Venue Labs, stating that “[n]ewly discovered results of known processes directed to the same purpose are not patentable.”

Do you agree with Judge Dyk’s argument? Does the ‘149 claim merely describe a property of the claimed method or is it a patentable method in its own right?

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