Case Name: Novartis Pharms. Corp. v. Accord Healthcare Inc., C.A. No. 18-1043-LPS, 2019 U.S. Dist. LEXIS 104969 (D. Del. June 24, 2019) (Stark, J.)
Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod capsules); U.S. Patent No. 9,187,405 (“the ’405 patent”)
Nature of Case and Issue(s) Presented: Plaintiff moved for a preliminary injunction to enjoin the launch of generic fingolimod. Having considered the parties’ briefing and having conducted an evidentiary hearing and heard oral argument, the court granted plaintiff’s motion.
Why Novartis Prevailed: The court first addressed the issue of Novartis’s likelihood of success on the merits. At the outset, infringement was not contested for purposes of the preliminary injunction motion. Defendants did raise three invalidity challenges: (i) anticipation by Kappas 2006; (ii) lack of adequate written description; and (iii) lack of enablement or utility. While noting that defendants’ invalidity arguments were not frivolous, and that they very well may withstand summary judgment or even prove correct after trial, at the preliminary stage, the court found that “defendants are not at all likely to prevail at trial on invalidity.” First, the court reasoned that defendants had proposed the wrong POSA. Novartis’s definition, which is a team that includes not just a clinician, but also a pharmacologist, is more correct. That is because the patent contains parts that would be best understood by a pharmacologist even though the claims are principally directed to treatment and therefore to a clinician. Next, the court found that that the Kappas 2006 reference did not disclose the ’405 claim limitations of treatment and no loading dose. Kappas 2006 disclosed a test; it was an hypothesis. Therefore, it did not disclose and did not anticipate the treatment limitations of the asserted claims. It was also undisputed that Kappas 2006 was silent on the matter of a loading dose. The court moved on to defendants’ written-description defense and found that defendants were unlikely to persuade the court at trial that the inventors of the ’405 patent were not in possession of the claimed invention at the time of the application. The court reasoned that a patent did not need to tell the full story or really even any story about how the inventors came to their invention, and it need not state things that a POSA would already know, including the prior art. Therefore, much of the defendants’ attack on the supposed lack of adequate written description was really “legal irrelevancies.” Finally, the court addressed the lack of enablement or utility defense, on which little was written about in the briefs. Ultimately, the court found that Novartis had adequately demonstrated, supported by the USPTO’s findings, that when read in its full cotext, a POSA would understand the patent to preclude a loading dose.
Turning next to the issue of irreparable harm, the court found that Novartis had met its burden to show that there was a reasonable likelihood that in the absence of a preliminary injunction, one or more and up to six generics would undertake an at-risk launch in August 2019, and as a result, Novartis would suffer immediate and substantial harm that could not be remedied by money damages even if Novartis were to ultimately prevail at trial and obtain a permanent injunction. These harms included the likely massive and immediate price erosion in the market for oral treatment of relapsing-remitting multiple sclerosis. After what might be as long as one year of generic competition by the time this case were to go to trial and a decision would be issued, Novartis would not be able to raise the price back to where it was currently, or to where it would have been at that post-trial date in the absence of defendants’ at-risk infringement.
Finally, the court addressed the issues of the balance of harms and the public interest and found that both of those factors favored a preliminary injunction. Defendants stood to lose the opportunity to earn on the order of $50 million collectively by not being able to compete over approximately the following year, whereas Novartis would irreparably lose a market in which they sold approximately $1.8 billion of drugs each year. That balance clearly favored Novartis. Moreover, the public had an interest in protecting valid patent rights and in maintaining incentives for the massive investments required for drug development.
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