Hatch-Waxman Disputes

Guarding your rights in the pharmaceutical marketplace

Forge IP is well-versed in the intricacies of Hatch-Waxman, both old and new, with over 15 years of experience in both Paragraph IV and non-Paragraph IV pharmaceutical patent litigation.  With specialized experience in ANDA litigation, we have deep insight into the regulatory, business, and legal issues facing clients in the fields of drug development, approval, and sales.  Counsel at Forge IP have litigated many pharmaceutical cases, just a few examples of which follow.

Pulmicort Respules®

AstraZeneca v. Breath Ltd., et al.
pulmicort 3Successfully defended Apotex in an action filed by AstraZeneca regarding its generic budesonide inhalation suspension, a nebulized corticosteroid for the treatment of asthma.  AstraZeneca filed the case as a declaratory judgment action (non-P4) due to a section viii carve out (two dosing method patents) and a later pop-up patent (formulation) and initially obtained a preliminary injunction.  All three patents were invalidated at trial and the Court of Appeals for the Federal Circuit, and several hundred million dollars in bonds were secured for lost sales during the term of the injunction.


Takeda Pharmaceutical Co., Ltd., et al. v. Sandoz, Inc.
ActosDefended Sandoz in action filed by Takeda regarding its generic pioglitazone tablets, a thiazolidinedione for improving blood sugar control in diabetics.  Takeda filed the case as a hybrid action, including Paragraph IV claims for patents directed to a combo product and DJ claims for method-of-use patents.  Obtained successful settlement during expert discovery.


Glaxo Group Ltd., et al. v. Sandoz, Inc.
ZofranDefended Sandoz in Paragraph IV action filed by GlaxoSmithKline regarding its generic ondansetron tablets, used for the prevention of nausea and vomiting during cancer treatment.  After taking over the case, initiated discussions with GSK and was able to draft an ANDA amendment to avoid infringement, resulting in a subsequent quick dismissal of the case.


Janssen Pharmaceutical, N.V., et al. v. Eon Labs Manufacturing, Inc.
SporanoxDefended sole first-filer Eon Labs in action filed by Janssen (J&J) regarding its generic itraconazole capsules for treating fungal infections.  Obtained judgment of noninfringement of the asserted formulation patent at trial, which was affirmed by the Court of Appeals for the Federal Circuit, resulting in 180 day exclusivity for Eon Labs.


Teva Pharmaceutical Industries, Ltd., et al. v. Apotex, Inc., et al.
CoregIn a generic vs. generic litigation, defended Apotex in an action filed by Teva regarding carvedilol tablets, a beta-blocker for treating heart failure and hypertension.  Teva filed a declaratory judgment action asserting four patents (polymorph, hydrate, processes).  Apotex took aggressive action early in the case, and secured a dismissal.

The above are just a few examples of the many Paragraph IV and related pharmaceutical  patent matters that Forge IP counsel has litigated, having developed expertise early in this niche area of patent law.

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