We’re happy to bring our readers a post from a friend of the blog and one of our regular guest bloggers, Chris Ohly, a leading patent litigator in the US. This post concerns a recent US case that imposes heightened standards for pleading in complaints in patent cases. For those interested, Chris has also made available a more detailed version of this post along with related case materials here. As he states there, “Heightened pleading requirements will alter the course of all patent litigation, including suits for alleged infringement of pharmaceutical and biologic patents.”
Heightened Pleading Standards in US
In recent cases, in proposed legislation and in draft amendments to the Federal Rules of Civil Procedure, consideration has been given to the impact in patent litigation of the Supreme Court’s decisions in Bell Atlantic v. Twombly, and Ashcroft v. Iqbal. Courts have found constraint in the Federal Rules, refusing to apply the heightened standards of “notice pleading” mandated by Twombly and Iqbal. Substantial pressure has arisen to apply such heightened pleading standards in patent cases, as it is in other complex litigation. Elevated standards would alter the course of all patent litigation, including suits for alleged infringement of pharmaceutical and biologic patents.
In Macronix International, Ltd. v. Spansion, Inc., Civil No. 3:13cv679 (E.D.Va. March 10, 2014), the court dismissed a lengthy patent complaint, with leave to amend, applying the heightened pleading standards announced in Twonbly and Iqbal. In stern language, the court said:
“Satisfying the requirements of Twombly and Iqbal, of course, will require counsel to focus complaints only on viable claims. Thus, before filing a complaint, counsel must ascertain exactly what claims should alleged to be infringed and how they are infringed. That can be done with brevity and clarity if counsel know at the outset their theories of infringement and what can, and cannot, be said about allegedly infringing conduct. That, in turn, may well, indeed likely will, require expert assistance. And, it will mean taking great care when crafting a succinct, but sufficient, patent complaint. But, that is not asking too much.
Indeed, it is high time that counsel in patent cases do all of that work before filing a complaint. That, of course, will serve to winnow out weak (or even baseless) claims and will protect defendants from the need to prepare defenses for the many claims that inevitably fall by the way side in patent cases. That also will serve to reduce the expense and burden of this kind of litigation to both parties which, like the antitrust litigation in Twombly, is onerous. The current practice is to file a Form 18 complaint and then, using claim charts, prior art charts, discovery, and motions, to pare claims that ought not to have been brought or that cannot withstand careful scrutiny. That process has proven to be an increasingly expensive proposition for the parties and one that takes a tremendous toll on already strained judicial resources.
There is no logical reason to exempt patent complaints from the plausibility requirements that apply to all other federal complaints. If counsel will but accept the task, the expense of patent litigation and the burden on the courts will be reduced. If they will not, their cases will be dismissed and they may face sanctions. But neither is necessary.”
Macronix International, Slip Op. at 13 – 15.
Given the specific context in which Hatch-Waxman suits are commenced, heightened pleading requirements will be a useful and productive means of reducing the time and expense consumed in suits for alleged infringement of pharmaceutical patents.
A longer comment about the recent decision in Macronix International, together with supporting materials, can be found here:
https://drive.google.com/folderview?id=0B1kt-_MZDESXMExER1FndEk5QVE&usp=sharing
As always, the views expressed in this post are my own and do not necessarily reflect the views of any law firm, or of any of other attorneys or clients. Nothing in this post is intended to provide any form of legal advice.
