Actelion’s Preemptive Strike Over REMS and Biostudy Product Availability Draws Antitrust Counterclaims, Another Drug, and Another Company Into the Mix

By Kurt R. Karst –   

Things are heating up in litigation in the U.S. District Court for the District of New Jersey initiated by Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) in September 2012, which, according to Actelion, “concerns the fundamental right of a business to choose for itself with whom to deal and to whom to supply its products.”  As we prevously reported, Actelion is seeking declaratory relief that the company is under no duty or obligation to supply prospective ANDA applicants Apotex Corp. (“Apotex”) and Roxane Laboratories, Inc. (“Roxane”) with TRACLEER (bosentan) Tablets for purposes of bioequivalence testing and ANDA submission.  Because of the potential of the drug to cause serious side effects,  TRACLEER is approved with a Risk Evaluation and Mitigation Strategies (“REMS”) program with Elements To Assure Safe Use (“ETASU”) that limit distribution of the drug through certain pharmacies, practitioners, and health care settings.  Apotex and Roxane both sent correspondence to Actelion seeking TRACLEER sample for use in bioequivalence testing and threatening antitrust litigation, but Actelion refused to provide drug sample to the companies “maintaining its right to choose with whom it does business” and citing certain REMS compliance issues. Instead of waiting for that antitrust action to be filed, Actelion took a proactive approach and sued Apotex and Roxane, saying, among other things, that “Apotex and Roxane are seeking to force Actelion to supply them with product, turning well-settled law, not to mention basic free-market principles, on their head,” and that “Apotex’s and Roxane’s demands would also require Actelion to violate its regulatory obligations.” 

In recent court filings, both Apotex and Roxane have brought counterclaims alleging illegal and anticompetitive conduct by Actelion.  Apotex’s Counterclaim Complaint alleges that Actelion has abused its monopoly power in violation of Section 2 of the Sherman Act and the New Jersey Antitrust Act “by denying Apotex the ability to purchase Tracleer samples for bioequivalence testing and to submit an ANDA to FDA for a generic bosentan product.”  Apotex seeks declaratory and injunctive relief and treble damages, including that the court compel Actelion “to sell Apotex sufficient quantities of Tracleer at market prices so that Apotex can perform bioequivalence testing.” 

Interestingly, Apotex procured a version of TRACLEER marketed in Canada and asked FDA for the Agency’s views on using that drug product in bioequivalence testing instead of the U.S.-approved and marketed drug product.  FDA commented in correspondence to Apotex that the company’s bioequivalence studies “should be performed using the approved US product as the reference product,” and that “[i]t is not acceptable to use an approved Canadian drug product . . . .”

Roxane’s Counterclaim Complaint alleges violations of, among other things, Sections 1 and 2 of the Sherman Act and the New Jersey Antitrust Act, and seeks declaratory and injunctive relief and treble damages.  Roxane’s Counterclaim Complaint concerns not only TRACLEER, but another drug as well – Actelion’s ZAVESCA (miglustat) Capsules, which FDA approved on July 31, 2003 under NDA No. 021348 for mild to moderate Type I Gaucher disease in adults for whom enzyme replacement therapy is not a therapeutic option.  ZAVESCA is not subject to an ETASU REMS, but rather, is subject to a “restricted distribution” program adopted and implemented by Actelion.  According to Roxane:

Faced with [a] threat to its monopolies, Actelion engaged in a scheme to prevent Roxane from obtaining the FDA-mandated drug samples necessary to develop Roxane’s generic products, by prohibiting distributors to sell to Roxane and by refusing to sell to Roxane itself.  Through its actions, Actelion has unlawfully prevented Roxane from developing generic versions of these drugs.

Roxane requests that the New Jersey court enter a Judgment and Order declaring that Actelion’s conduct is unlawful and “enjoining and restraining Actelion from limiting distribution of Tracleer and Zavesca samples to Roxane through use of its REMS and/or restricted distribution programs or otherwise,” among other relief.

Another generic drug manufacturer, Actavis Elizabeth LLC (“Actavis”), is seeking to enter the case as a intervenor-defendant/counterplaintiff.  According to Actavis’ Motion to Intervene, “Actelion has refused to provide Actavis with any Tracleer samples on the grounds that the [FDC Act] does not require ‘that Actelion relinquish its right to choose with whom it does business.’”  Actavis’ Proposed Counterclaim Complaint, like the Apotex and Roxane Counterclaim Complaints, alleges violations of the Sherman Act and the New Jersey Antitrust Act and seeks declaratory and injunctive relief and treble damages.

With the increasing profile of this lawsuit and the possibility of a game-changing decision (for either Actelion or generic competitors), one must wonder whether or not the Federal Trade Commission (“FTC”) will eventually seek to chime in on the case.  The FTC has reportedly been investigating REMS and its effects on generic competition.  Is a proposed amicus brief being drafted?  We’ll see.  The FTC has been active as of late, with amicus briefs filed in antitrust lawsuits involving patent settlement agreements and “product hopping.”  As a side note, REMS reform was recently included as a policy recommendation in a report (page 24) from the National Coalition on Health Care on curbing health care costs.