Update on pleading standards in Hatch-Waxman cases


Sufficient complaints need only contain a "short and plain" statement showing entitlement to relief. Though this pleading standard seems simple, it at times can be challenging under the Hatch-Waxman Act. Motions to dismiss recently decided in two district courts with heavy Hatch-Waxman dockets the District of New Jersey and the District of Delaware provide further instruction on how to properly craft complaints and the kinds of factual allegations that should and should not be included in them to withstand motions to dismiss. --more-->

Novartis Pharmaceuticals, Corp. v. Wockhardt USA LLC

In Novartis Pharmaceuticals, Corp. v. Wockhardt USA LLC (D.N.J.), several generic defendants submitted ANDAs seeking FDA approval for generic versions of Reclast®, a product containing zoledronic acid. Zoledronic acid is used to treat various bone diseases. The patentees sued, asserting infringement of the U.S. Patent No. 8,052,987 patent which claimed methods of using zoledronic acid to treat osteoporosis under 35 U.S.C. 271(b), (c), and (e)(2).

Several generic defendants sought to dismiss that infringement claim because they were not seeking approval for their ANDA products to treat osteoporosis, as claimed in the '987 patent, but rather to treat Paget's disease, a bone disorder. The generic defendants submitted "section viii" statements with their ANDAs, which alert FDA that the applicant is not seeking approval for the method of use that is claimed in the Orange Book-listed patent. 21 U.S.C. 355(j)(2)(A)(viii). Along with the section viii statement, the generic defendant must "carve out" the claimed method of use from their product's label.

The district court dismissed the allegation of infringement of the '987 patent under 271(e)(2) because the defendants were not seeking approval of their products for a patented use. The patentee argued that the generics' labels were misleading and did not show their true intent to sell their products to treat osteoporosis. The district court held that the patentee had not "sufficiently plead or demonstrated how Certain Defendants' section viii certifications are misleading or improper. Plaintiffs provide only conclusory statements in support." Further, the district court took judicial notice of an FDA Response to Citizen Petition in which FDA concluded that it could approve ANDAs for a zoledronic acid product where the label omits osteoporosis indications. The district court found the Response supported the defendants' position that their labels are not misleading.

The district court also dismissed the inducement claim, rejecting the patentees' argument that the realities of the market that the amount of patients with Paget's disease is dwarfed by those with osteoporosis (just 0.3% of prescriptions written for Paget's disease) demonstrate that the generics' proposed labels invite infringement of the '987 patent. The district court found that the patentees "failed to identify any explicit direction or instruction" by the generic defendants to induce infringement.

The district court did retain jurisdiction over the contributory infringement claim. The patentees argued that the use of Reclast® to treat Paget's disease was "occasional" and did not rise to the level of a "substantial non-infringing use," and the court could not conclude otherwise at the pleadings stage.

Turning to a separate issue, the district court also dismissed a claim asserted against defendant Apotex, alleging that Apotex had acted in concert with another generic entity, Gland, to submit an ANDA. The patentee pleaded that Apotex mailed Gland's paragraph iv letter, but the court found that the patentee did not plead sufficient facts to show that Apotex was actively involved in preparing or submitting Gland's ANDA. Because that claim was dismissed without prejudice, the patentees could move to amend and reassert the claim if discovery uncovered supporting facts.

The district court's analysis in Novartis demonstrates a practical consequence of pleading under the Hatch-Waxman scheme: sometimes patentees may not know much more than the information provided in a generic company's paragraph iv statement before filing suit. As the district court suggests, facts unearthed during discovery may give rise to claims that may not have been supportable at the pleadings stage. Brand companies should therefore take care in preparing their case schedules by securing a deadline to amend pleadings without requiring a showing of good cause that is close to the end of fact discovery. They should also be diligent about obtaining the discovery they need to assert any additional claims like those dismissed above and extending any discovery or amendment deadlines, as necessary.

Cumberland Pharmaceuticals Inc. v. Ihnopharma, Inc.

In Cumberland Pharmaceuticals Inc. v. Ihnopharma, Inc. (D. Del.), the court dismissed Cumberland's patent infringement claims on the pleadings because Cumberland's Complaint admitted that Ihnopharma's generic product did not contain one of the required claim elements. Cumberland filed suit against Ihnopharma for infringement of U.S. Patent No. 8,148,356 after Ihnopharma submitted an ANDA to market and sell a generic acetylcysteine product, used to treat acetaminophen overdose patients. Every claim of the '356 patent included the limitation that the claimed formulations be "free from a chelating agent."

Ihnopharma moved to dismiss Cumberland's Complaint for lacking subject matter jurisdiction and failing to state a claim, and also moved for judgment on the pleadings pursuant to Fed. R. Civ. P. 12(c). In deciding the motion, the district court cited Cumberland's allegations in the Complaint that Ihnopharma's proposed generic product contains EDTA, and that EDTA is a chelating agent. The district court also examined the '356 patent, which was attached to the Complaint, and which identified EDTA as an example of a chelating agent. Both the Complaint and the '356 patent touted the claimed formulation as an improvement over the prior art formulations because the claimed formulation did not include a chelating agent.

The district court rejected Cumberland's argument that it was required to construe the term "chelating agent" before deciding the motion to dismiss, finding "[n]o formal process of claim construction is necessary in order to determine that 'free from a chelating agent' means that a claimed composition may not including a chelating agent." Based on Cumberland's admissions, the district court found that Ihnopharma's generic product does not infringe any claim of the '356 patent, and dismissed the Complaint.

The decision in Cumberland demonstrates that courts are willing to dismiss allegations that are contrary to the facts pled in the Complaint and the information contained in the patent. Patentees should take care in preparing the allegations set forth in their Complaint to ensure that those allegations are not inconsistent with potential theories of infringement. Patentees should not assume that courts will be unwilling to dive into the technology at the pleading stage, without the benefit of the claim construction process or expert testimony.