Roche and Allergan Victorious Over Apotex in Acular LS Dispute

Roche Palo Alto and Allergan v. Apotex, No. 2008-1021 (Fed. Cir. 2008)

In an opinion released Wednesday (pdf file), the Federal Circuit affirmed a district court decision granting summary judgment that Roche's (RHHBY.PK) U.S. Patent No. 5,110,493 is valid and infringed by Apotex's ANDA for a generic version of Acular LS (ketorolac tromethamine opthalmic solution).  Acular LS, marketed by Allergan (AGN), is indicated to reduce pain, burning and stinging following corneal refractive surgery.

The '493 patent is directed to a formulation comprising a non-steroidal anti-inflammatory drug, such as ketorolac tromethamine ("KT"); a quaternary ammonium preservative, such as benzalkonium chloride ("BC"); and the nonionic surfactant, octoxynol 40 ("O40").  Apotex did not dispute that its formulation falls within the literal scope of claim 1 of the '493 patent.  Instead, Apotex argued that the district court erred in failing to find noninfringement under the reverse doctrine of equivalents.

The Federal Circuit explained that the reverse doctrine of equivalents ("RDOE") "is an equitable doctrine designed to prevent unwarranted extension of the claims beyond a fair scope of the patentee's invention."  The court applied the Supreme Court's RDOE test, set forth in the Graver Tank case:

Where a device is so far changed in principle from a patented article that it performs the same or a similar function in a substantially different way, but nevertheless falls within the literal words of the claim, the reverse doctrine of equivalents may be used to restrict the claim and defeat the patentee's action for infringement.

Apotex argued that the "principle" of the '493 patent is

the use of O40 in an amount sufficient to cause the formation of micelles and thereby provide robust stability to the formulation by preventing interactions between KT and BAC.

The Federal Circuit, however, found no support for this principle in the specification, prosecution history or the prior art (where such support must be found).  Rather, according to the Federal Circuit, Apotex relied exclusively on the declaration of its expert.  Thus, the court agreed that Apotex failed to make out a prima facie case of noninfringement under the reverse doctrine of equivalents, and therefore summary judgment of infringement was proper.

Next, the Federal Circuit agreed with the district court that Apotex's invalidity arguments were barred by claim preclusion (i.e., res judicata).  Claim preclusion applies where:

1. The same parties were involved in the prior litigation.
2. The prior litigation involved the same claim or cause of action as the later suit.
3. The prior litigation was terminated by a final judgment on the merits. 

Here, Apotex conceded that a prior case (involving Apotex's ANDA for a generic version of Acular--not Acular LS) ended in a final judgment that the '493 patent is valid and involved the same parties, but disputed that it involved the same claim or cause of action.

According to the Federal Circuit, an infringement claim in a second suit is the "same claim" as in an earlier infringement suit if the accused products in the two suits are "essentially the same."  Apotex argued that its formulation for Acular (in the prior case) was not "essentially the same" as its formulation for Acular LS (in this case) because the two formulations are stabilized by completely different ingredients and mechanisms.  The Federal Circuit rejected this argument, however, stating that the point

is irrelevant because both formulations are encompassed by the claims of the '493 patent.  Thus, any difference in composition between the two formulations is merely colorable and the two formulations are 'essentially the same.'

Apotex argued in the alternative that "principles of fairness should prevent application of claim preclusion given the change in the law of obviousness following the Supreme Court's opinion in KSR."  Again, however, the Federal Circuit disagreed, concluding that the district court "correctly recognized that there is no 'change of law' or fairness exception to prevent application of claim preclusion."  Accordingly, the Federal Circuit found no error in the district court's grant of summary judgment of validity.

RELATED READING:

• Bloomberg
• Patently-O
• Reuters