October 25, 2016

Case Name: Allergan Sales, LLC v. Sandoz, Inc., No. 12-cv-207-JRG, 15-cv-347-JRG, 2016 U.S. Dist. LEXIS 135088 (E.D. Tex. Sept. 30, 2016) (Gilstrap, J.) 

Drug Product and Patent(s)-in-Suit: Combigan® (brimonidine tartrate / timolol maleate ophthalmic solution); U.S. Patent No. 7,030,149 (“the ’149 patent”)

Nature of the Case and Issue(s) Presented: In 2008, Sandoz submitted an ANDA to the FDA seeking approval to make and sell a generic version of Combigan. Sandoz sent a Paragraph IV letter to Allergan and Allergan filed suit. Shortly before trial, Sandoz filed a stipulation of infringement that its ANDA met all of the limitations of claim 4 of the ’149 patent. The case proceeded to a bench trial on the issue of invalidity of the remaining asserted claims (including claim 4 of the ’149 patent), and the Court found the claims to be infringed, based on the stipulations, and not invalid. The Court enjoined Sandoz from making, using, offering to sell, or selling the products described in the ANDA within the United States until after the last of the expiration dates of the patents-in-suit, including the ’149 patent. The Federal Circuit affirmed the holding that claim 4 of the ’149 patent was not invalid, reasoning that Sandoz failed to present clear and convincing evidence that claim 4 of the ’149 patent would have been obvious.

While on appeal, Sandoz modified its ANDA in an effort to design around Allergan’s patents. The label of the proposed ANDA product at issue in the first case indicated use of the product “in patients with glaucoma or ocular hypertension.” Sandoz modified its ANDA to remove the indicated use of glaucoma; it sought approval only for the indicated use of its product in patients with ocular hypertension. On January 23, 2015, Sandoz sent a second Paragraph IV letter to Allergan, which notified Allergan of Sandoz’s modified ANDA.

Allergan sought summary judgment that Sandoz was precluded from challenging the validity of claim 4 of the ’149 patent under the doctrines of issue preclusion and claim preclusion and that Sandoz’ proposed ANDA product infringed claim 4 of the ’149 patent. Sandoz sought summary judgment that claim 4 of the ’149 patent was invalid and that its ANDA product did not infringe claim 4 of the ’149 patent. The court found that Allergan’s motion and Sandoz’s motion concerning invalidity should be denied, and that Sandoz’s motion for non-infringement should be granted-in-part and denied-in-part.

Why both parties prevailed: The court first addressed Allergan’s argument that issue preclusion barred Sandoz from re-arguing the validity of claim 4 of the ’149 patent because invalidity was a single issue for purposes of issue preclusion and it was the subject of the earlier district-court case and appeal. Sandoz responded by arguing that issue preclusion did not bar re-litigation of invalidity because the court changed the construction of claim 4. In the first case, the parties expressly agreed on the construction of the terms “brimonidine” and “timolol.” In the present case, Sandoz sought a different, broader claim construction, and the Court obliged on the basis that the prior constructions were not actually litigated in the first instance, given that the parties had mutually agreed to the resulting constructions. Thus, the validity of claim 4 had never been litigated under the court’s second claim construction.

The court similarly dismissed Allergan’s claim-preclusion argument. Sandoz’ section viii carve out, which omitted the words “glaucoma or” from the label, indicated that it was seeking approval from the FDA to “market the generic drug for a different method of use” from the methods of use claimed in Sandoz’ proposed ANDA product, the subject of the earlier litigation. “These differences are tangibly real and are more than merely colorable.”

Given no preclusive effect from the earlier litigation, Sandoz argued that claim 4 was invalid for lack of an adequate written description. Sandoz argued that claim 4 “covers a vast number of combinations of chemical compounds that the applicants did not invent, describe or disclose.” Allergan responded that there were genuine issues of material fact, and the court agreed. Sandoz’s expert opined that when properly construed, claim 4 “yields over 300 possible combinations of 0.2% brimonidine and 0.5% timolol.” According to Sandoz, the ’149 patent disclosed only one of those 300 possible combinations and thus was invalid for lack of written description. Allergan’s expert opined that there were only six combinations of brimonidine/timolol because there were only two pharmaceutically acceptable forms of brimonidine and three pharmaceutically acceptable forms of timolol. “This dispute represents a battle of the experts. As a result, there is a genuine dispute of material fact as to which forms of brimonidine and timolol are encompassed within the Court’s claim construction.”

Next, Sandoz argued that because Allergan had produced no evidence that Sandoz will practice the method described in claim 4, which requires an “administering” step, Sandoz was entitled to summary judgment of non-infringement with respect to Allergan’s claim of literal infringement. The court agreed. However, the court found that there were multiple genuine issues of material fact with respect to the issue of induced infringement, namely whether both Combigan’s and Sandoz’ proposed ANDAs product met the efficacy limitation contained in claim 4 and whether Sandoz possessed the requisite specific intent to induce infringement.