Alcon Research, Ltd. v. Apotex, Inc.

Case Name: Alcon Research, Ltd. v. Apotex, Inc., Case No. 1:09-cv-102-RLY-TAB, 2013 U.S. Dist. LEXIS 71432 (S.D. Ind. May 21, 2013) (Young, J.)

Drug Product and Patent(s)-in-Suit: Pataday® (olopatadine); U.S. Patent Nos. 6,995,186 (“the ’186 patent”) and 7,402,609 (“the ’609 patent”)

Nature of the Case and Issue(s) Presented: Apotex alleged inequitable conduct as against the ’186 patent and the ’609 patent. Alcon moved for summary judgment with respect to Apotex’s inequitable conduct affirmative defenses and counterclaims.

Pataday is an ophthalmic solution used for the treatment of allergic eye disease. Pataday, which contains olopatadine at a concentration of 0.2%, is covered by the ’186 and ’609 patents. Before the development of Pataday, Alcon developed and manufactured a similar drug called Patanol®. Patanol, with an olopatadine concentration of 0.1%, is covered by the U.S. Patent No. 5,641,805 (“the ‘’805 patent”). Patanol is administered to the affected eye at least twice a day, and Pataday, with twice the concentration of olopatadine, may be administered just once per day.

Olopatadine at 0.2% is not physically stable. Over time, precipitants such as crystals or other particles will form in the solution. The ’186 and ’609 patents claim the use of either of two polymers—polyvinylpyrrolidone (“PVP”) or polystyrene sulfonic acid (“PSSA”)—to enhance the physical stability of low viscosity solution compositions containing olopatadine.

During the prosecution of the ’186 patent application, the USPTO rejected the pending claims as either anticipated or obvious in view of the ’805 patent. To overcome this rejection, plaintiffs conducted experiments using a different polymer, polyvinyl alcohol (“PVA”), that served as the basis for a declaration submitted to the USPTO. Viscosity was measured three times using a Viscometer having an error rate of 5%. But the scientist only reported one of those data points without any recall as to why that particular data was singled out. The same declaration was submitted during the prosecution of the ’609 patent application.

Apotex’s claim was based on the omission of two pieces of information during prosecution of the asserted patents: (i) patentees reported only the viscosity data for Formulation J (PVA) that was favorable to patentability (2.1 cps), and intentionally failed to disclose the viscosity data for Formulation J that was unfavorable to patentability (2.0 cps); and (ii) patentees failed to disclose that the specific error rate for the viscometer is 5%. Had the patentee provided this information to the USPTO, said Apotex, Formulation J (PVA at 2.0 cps) would have fallen within the statistically valid viscosity range of between 1.995 and 2.205 cps—overlapping with the claimed viscosity range in the asserted patents. The court agreed and denied Alcon’s motion for summary judgment.

Why Apotex Prevailed: The parties agreed that the viscosity value for Formulation J (PVA) at 2.1 cps was material to patentability. Thus, the merits of Apotex’s inequitable conduct claims hinged on intent. As such, the court addressed the Federal Circuit’s decision in Therasense, and distinguished it with the instant motion.

Therasense, however, was an appeal from a bench trial, and sets forth the standard for proving inequitable conduct at trial. Indeed, the opinion is replete with references to “the evidence,” to “the burden of proof,” and to what is necessary to “prevail on a claim.” The court’s function in that instance is to determine the facts and apply the law to those facts. In marked contrast, this case is before the court on [Alcon’s] motion for summary judgment. To prevail, [Alcon] ha[s] the burden of establishing the absence of an essential element of [Apotex’s] case in accordance with the applicable standard of review.

In light of the above, the court found a reasonable trier of fact could conclude the testimony of Alcon’s witnesses—the prosecuting attorney, the scientist that conducted the viscosity experiments, and the declarant—were not plausible in light of their roles in the prosecution of the patent, the e-mail traffic amongst the three of them during the relevant time frame, and by the simple fact that neither of them could explain why the single data point was chosen over others, even though the scientist carrying out the experiments opined that both values were scientifically valid, nor why the Examiner was not informed of the potential error rate of 5%. A reasonable trier of fact could therefore conclude that in order to gain allowance of the asserted patents, Alcon’s witnesses, individually or in concert with one another, made a deliberate decision to withhold the 2.0 viscosity data of Formulation J from the Examiner, and/or made the deliberate decision to withhold the viscometer error rate of 5%.

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