The recent appeal of Alcon Research Ltd. v. Barr Labs., Inc., No. 2012-1340 (Fed. Cir. Mar. 18, 2014) touched on several of the patent-law issues you will encounter in ANDA cases: infringement, written description, and enablement.

Barr sought to market a generic version of Alcon’s glaucoma and ocular hypertension drug Travatan Z®.  Alcon filed suit based on the two Orange Book patents and two additional patents that were not listed in the Orange Book.  At trial, the parties only tried infringement and validity of the two patents that were not listed in the Orange Book.  The district court found Alcon had failed to prove infringement of either patent and that Barr had proven by clear and convincing evidence that both patents were invalid for lack of enablement and lack of an adequate written description under 35 U.S.C. § 112 ¶ 1.  Barr sought JMOL as to non-infringement of the Orange Book patents, despite the fact that neither party presented any evidence of those patents at trial.  The district court denied JMOL on these patents.  Both parties appealed to the Federal Circuit; Barr as to denial of its JMOL and Alcon as to non-infringement and invalidity.

Dealing with infringement first, the Federal Circuit affirmed.  Alcon’s sole evidence of infringement was testing on Alcon’s own product during development, but argued these results could be extrapolated to Barr’s ANDA product.  The Federal Circuit disagreed, noting that “district court found, and the parties do not dispute on appeal, that the composition of the generic product proposed in Barr’s ANDA is significantly different from the compositions tested in Alcon’s study.”  Therefore, Alcon’s test results “provided no basis from which to draw any reliable inferences regarding [infringement].”

However, the Federal Circuit was much kinder to Alcon on the invalidity issues, concluding that neither patent was invalid either due to lack of enablement or lack of adequate written description.  The Court concluded that the district court erred by failing to ask the most basic question on enablement:  did Barr make the threshold showing that experimentation is necessary to practice the claimed methods?  Answering in the negative, the Federal Circuit pointed to the broad scope of the claims, which required only an increase in chemical stability.  Given this very basic claim requirement, the Federal Circuit found that no experimentation was required.  The court contrasted a simple increase with limitations of a specific stability increase or an optimized value.  The fact that experts could see many variables at play that may impact chemical stability did not mean that any experimentation was required to simply increase chemical stability.

The Federal Circuit also rejected the district court’s written description analysis and Barr’s arguments in support of it.  The court noted “the critical inquiry is whether the patentee has provided a description that ‘in a definite way identifies the claimed invention’ in sufficient detail that a person of ordinary skill would understand that the inventor was in possession of it at the time of filing.’”  Stated another way, “the written description is about whether the skilled reader of the patent disclosure can recognize that what was claimed corresponds to what was described; it is not about whether the patentee has proven to the skilled reader that the invention works, or how to make it work, which is an enablement issue.”  The court faulted Barr for failing to adduce any evidence of what an ordinarily skilled artisan would have understood from the disclosure of the two challenged patents.  This failure of any proof, let alone proof by clear and convincing evidence, required reversal as to lack of adequate written description.

Finally, the Federal Circuit quickly rejected Barr’s cross appeal as to denial of its JMOL for non-infringement of the two patents that were not tried.  Noting that Barr never filed a counterclaim for a declaratory judgment on those two patents and that “neither party ever put forward any arguments or evidence on the merits of infringement or validity,” the Federal Circuit concluded that these two patents “were no longer in the case as of the time of trial and [the district court] did not abuse its discretion in essentially deeming Alcon’s complaint as amended to remove them.”

Among the most interesting issue in this case, as often happens, occurred in a footnote.  Footnote 2 states in full, “Neither party raises or challenges the propriety of asserting patents that were not listed in the Orange Book against a generic manufacturer based on the filing of an ANDA, and we accordingly do not reach that issue.”  It is an interesting question, but one is not likely to come up often enough to get resolved on the merits.