In this antitrust case, In re Wellbutrin SR Antitrust Litigation, Nos. 04-5525, 04-5898, 05-396 (E.D. Pa.), three classes of plaintiffs, representing direct and indirect purchasers of Wellbutrin SR, as well as Medical Mutual of Ohio, a "third-party payor for Wellbutrin SR," sued GlaxoSmithKline (GSK) for violating various state and federal antitrust laws. The plaintiffs allege that GSK pursued frivolous patent infringement litigation against several generic drug makers who filed ANDA's for Wellbutrin SR. In March of this year, the district judge presiding in the case denied GSK's motion to dismiss, finding that for the purposes of the motion, GSK's patent litigation was "sham litigation," and therefore not entitled to Noerr-Pennington immunity from the antitrust laws.
GSK developed Wellbutrin SR, a sustained release version of its popular Wellbutrin antidepressant, shortly after the last of its Wellbutrin patents expired in 1991. Wellbutrin SR contains bupropion, the active ingredient, and an excipient known as hydroxypropyl methylcellulose ("HPMC"). In 1993, GSK filed a patent application broadly covering any sustained release formulation of bupropion. However, the broad claims were rejected, and GSK thereafter narrowed the claims to cover only formulations containing HPMC. The Patent Office granted GSK a patent on the narrow claims.
Beginning in 1999, several generic drug makers, including Andrx Pharms., Eon Labs, Impax Labs, Excel Pharms., and Watson Labs filed ANDA's to market generic versions of Wellbutrin SR containing sustained release excipients other than HPMC. Accordingly, the generic drug makers filed paragraph IV certifications, alleging that they did not infringe GSK's formulation patent. GSK sued each company for patent infringement, thereby earning an automatic 30-month stay of generic approval. However, in separate decisions, the courts held that GSK's patent was not infringed. Subsequently, GSK was sued for antitrust violations based on GSK's unsuccessful Wellbutrin SR patent litigation.
GSK moved to dismiss the antitrust case on grounds that its patent infringement suits qualify for Noerr-Pennington immunity, which generally shields from antitrust liability those parties who petition the government for redress. The antitrust plaintiffs acknowledged that lawsuits are ordinarily protected activity under Noerr-Pennington, but argued that GSK's infringement actions are subject to the "sham litigation" exception because they were "objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits" and they concealed "an attempt to interfere directly with the business relationships of a competitor, through the use of the governmental process."
The district court agreed with the plaintiffs. In particular, the court found that "any reasonable litigant confronting the facts Plaintiffs alleged at the time the infringement suits were filed would have concluded that GSK would be estopped from claiming infringement by equivalence. Without a viable argument for infringement by equivalence, GSK could not reasonably have expected success on the merits." The court therefore found GSK's infringement suits "objectively baseless," and entered an Order denying GSK's motion to dismiss.
Last week, the district court denied GSK's motion to certify the Order for interlocutory appeal to the Federal Circuit, meaning the case now moves forward in the district court. Stay tuned . . . .
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