The recent decision from the New Jersey District Court in Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Civ. No. 16-02290 (WHW)(CLW) (D.N.J. April 24, 2017) provides an interesting look at the boundaries of using the filing of an Abbreviated New Drug Application (“ANDA”) as an artificial act of infringement for purposes of creating a case or controversy and the consequences that may result from making unfounded infringement claims.


On April 22, 2016, Par sued Luitpold alleging infringement of U.S. Patent Nos. 9,119,876 and 9,295,657 after receiving notice from Luitpold about the filing of an ANDA directed to a generic version of Par’s Adrenalin® product. Luitpold moved for judgment on the pleadings asserting that the product specified in its ANDA did not infringe, and that Par’s claims were impermissibly based on speculation that the FDA would require Luitpold to amend its ANDA formulation at some point in the future in a way that would cause the ANDA product to infringe the asserted patents.

While it is understood that the Hatch-Waxman infringement inquiry is prospective, looking to “the product that is likely to be sold following ANDA approval,” Ferring B.V. v. Watson Labs., Inc.-Florida, 764 F.3d 1401, 1408 (Fed. Cir. 2014), the court in an earlier decision (Dkt. No. 109) rejected Par’s overly broad interpretation of “the product that is likely to be sold,” which was based on assumed amendments to the ANDA that had not yet occurred. Relying on the notion that “drug manufacturers are bound by strict statutory provisions to sell only those products that comport with the ANDA’s description of the drug” (Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002)), the court refused to look at what the future formulation might be. Instead, the court resolved that because Luitpold’s proposed ANDA product as presently defined did not meet the limitations of the asserted patents, there was no basis for Par’s infringement claims. In doing so, the court specifically refused to consider the issue of infringement by looking to drug formulations that were not yet in existence and refused to consider Par’s speculative infringement claims.

In the recent follow-on decision (Dkt. No. 139), the court granted Luitpold’s motion for attorneys’ fees, awarding $207,482.50 in fees and $4,580.93 in costs based on an exceptional case finding on grounds that Par’s Complaint lacked any factual or legal basis for asserting infringement.

When Must A New Paragraph IV Certification Be Provided

In reaching its decision, the court provided some guidance that is useful for drug companies to be aware of for future Hatch-Waxman litigation.

First, the court discounted Par’s argument that it was necessary to file suit to preserve the ability to assert patent infringement against Luitpold on any later-amended ANDA products. The court explained this was unnecessary because of safeguards that would require an ANDA filer, such as Luitpold, to provide a new Paragraph IV Certification and notice to Par if it amended its formulation. Specifically, 21 C.F.R. §§ 314.96(d) provides that an amendment to an ANDA is required to contain a patent certification or a recertification for a previously submitted paragraph IV certification if approval is sought for amendments:

  1. To add a new indication or other condition of use;
  2. To add a new strength;
  3. To make other than minor changes in production formulation; or
  4. To change the physical form or crystalline structure of the active ingredient.

Thus, the court in Par suggested that it was unnecessary for Par to file suit upon receipt of the first Paragraph IV Certification to obtain the 30-month stay where all agreed that the ANDA product did not infringe. The court’s reference to the safeguards suggests that Par should have waited if, and until, Luitpold actually amended its formulation, which would have forced Luitpold to provide a new Paragraph IV Certification. Under that scenario, Par would have received another opportunity to file suit triggering the 30-month stay of FDA approval.

In noting the safeguards in place for Par, the court referenced BenVenue Labs., Inc. v. Novartis Pharmaceutical Corp., 146 F. Supp. 2d 572 (D.N.J. 2001), where the court refused to enable the 30-month stay to be reset under very different circumstances. There, the court found that it properly had jurisdiction over the initial litigation, and although the later amendment changed the manufacturing process, an amended Paragraph IV Certification was not required. The court in BenVenue explained that “[i]t is important to remember that the purpose of the 30-month stay is not necessarily to extend the patent holder’s monopoly, but to create an adequate window of time during which to litigate the question of whether a generic will infringe the patented product, without actually having to introduce the generic product to the market.” Id. at 579.

The circumstances in BenVenue were quite different from what happened in Par, where there was not even a basis for Par’s original Complaint. However, both cases show the deference of courts to the statutory provisions that trigger the need for a new Paragraph IV Certification. Accordingly, under Par’s theory that Luitpold would eventually have to amend its ANDA to change the formulation, it would have been reasonable for Par to expect that the FDA would have required a new Paragraph IV Certification that would have provided a basis for a new infringement suit.

Broad Discovery Requests Directed to Other Related Products

Part of the court’s calculus of attorneys’ fees in Par involved consideration of the nature of Par’s discovery requests directed to its speculative claim, in what it described as abusively engaging in overly broad discovery in the process. In particular, Par sought discovery on Luitpold’s injectable epinephrine compositions, including past, current and “contemplated” formulations, and also regarding all formulations regardless of whether they were reasonably related to the limitations of the asserted patents. Not only did the court find the discovery requests overly broad, they were also needless in view of Luitpold’s response to an interrogatory swearing that Luitpold “had not changed its drug formulation, had not added any antioxidant, and had not conducted any testing using sodium bisulfite or any other bisulfite component.” (Dkt. No. 139 at 8.)

The court’s reaction to these requests signals a lack of tolerance for discovery that attempts to go beyond the narrow scope of the drug product at issue. In view of Par, requests seeking documents relating to all past, current and contemplated products “whether or not they contained ingredients that would infringe,” (Dkt. No. 139 at 7), and all documents whether or not they contained the material used in the patents-in-suit, are likely to be viewed as improper fishing expeditions. Similarly, the decision in Par demonstrates the court’s unwillingness to permit discovery that is not tied to the particular patent issues. As such, Par is a cautionary tale about the permissible boundaries of discovery and shows that some courts will not tolerate attempts to use patent litigation as a pretext for investigating the business practices of a competitor.