Plaintiff, Ferring B.V., filed a patent infringement action against Watson Laboratory, Inc. (“Watson Labs”) for tranexamic acid tablets sold under the trademark Lysteda. Watson Labs applied to the FDA for permission to manufacture and sell generic tranexamic acid tablets. Watson Labs filed a counterclaim and answer, including an assertion that the patent-in-suit was invalid. Ferring moved to dismiss the counterclaims for invalidity and to strike invalidity as an affirmative defense.
The district court began its analysis by noting that “[a]s a matter of both fairness and efficiency, it seems improper to permit a defendant to force a plaintiff to choose between ambush at trial and needless preparation for a myriad of potential affirmative defenses consistent with a single broad affirmative defense in the answer. The purpose behind the contemporary reading of Rule 8(a) is to prevent a plaintiff from extorting a settlement from a defendant through the prospect of an expensive, detracted discovery process predicated on threadbare claims that would be seen to be legally insufficient if the circumstances of the alleged wrongdoing were even read, much less put to proof.”
In its answer, Watson Labs asserted that the claims of the patents-in-suit were invalid for failing to comply with 35 U.S.C. §§ 101, 102, 103 and/or 112. The district court found that this pleading was insufficient. “This affirmative defense would probably be sufficient with respect o sections 101, 103, and 112 of the Patent Act if it were pled in the conjunctive (so that Ferring was on fair notice that it had to prepare to meet each of these defenses and would not waste its time preparing to meet some defenses that defendant does not intent to assert), but it is pled in the disjunctive, and even if pled in the conjunctive it would not be sufficient with respect to section 102, which alone contains several distinct theories of invalidity. If it were pled in the conjunctive, Ferring would properly be on notice that Watson Labs intended to argue that the ‘739 patent is invalid for being unpatentable subject material, see 35 U.S.C. § 103, and for containing insufficient specification, see id. § 112. But it is plead in the disjunctive, so Ferring is not on notice which of these legal theories Watson Labs truly intends to invoke. Also, Watson Labs’s invocation of § 102 would not be an “affirmative state[ment]” of any particular defense even if it had been pled in the conjunctive, because § 102 includes various theories of prior use, prior patent, abandonment, and invention by another.”
Accordingly, the district court granted the motion to strike the affirmative defense of invalidity for leave to amend and also granted the motion to dismiss the counterclaim for invalidity, with leave to amend, because it did not include “any facts whatsoever making invalidity plausible as required by Rule 8(a).”
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District courts are increasingly more willing to strike affirmative defenses or grant motions to strike counterclaims that are not sufficiently plead. Accordingly, it is important–to avoid motions to strike and motions to dismiss–to plead more than just the sections of the Patent Act to justify an invalidity defense.
The authors of www.PatentLawyerBlog.com are patent trial lawyers at Jeffer Mangels Butler & Mitchell LLP. We represent inventors, patent owners and technology companies in patent licensing and litigation. Whether pursuing patent violations or defending infringement claims, we are aggressive and effective advocates for our clients. For more information contact Stan Gibson at 310.201.3548 or SGibson@jmbm.com.