ED Pa Product Hopping Claims Survive Motion to Dismiss | Practical Law

ED Pa Product Hopping Claims Survive Motion to Dismiss | Practical Law

Judge Mitchell S. Goldberg of the US District Court for the Eastern District of Pennsylvania held in In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation that plaintiffs plausibly alleged violations of Section 2 of the Sherman Act by alleging, among other things, that defendant Reckitt Benckiser made minor changes to a drug formulation in order to obtain a new patent and protect the drug from generic competition, a practice known as product hopping.

ED Pa Product Hopping Claims Survive Motion to Dismiss

Practical Law Legal Update 9-591-3866 (Approx. 4 pages)

ED Pa Product Hopping Claims Survive Motion to Dismiss

by Practical Law Antitrust
Published on 08 Dec 2014USA (National/Federal)
Judge Mitchell S. Goldberg of the US District Court for the Eastern District of Pennsylvania held in In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation that plaintiffs plausibly alleged violations of Section 2 of the Sherman Act by alleging, among other things, that defendant Reckitt Benckiser made minor changes to a drug formulation in order to obtain a new patent and protect the drug from generic competition, a practice known as product hopping.
On December 3, 2014, Judge Mitchell S. Goldberg of the US District Court for the Eastern District of Pennsylvania held in In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation that plaintiffs, a group of direct purchasers of the anti-opioid drug Suboxone, plausibly alleged that defendant Reckitt Benckiser, Inc. engaged in product hopping in violation of Section 2 of the Sherman Act (MDL No. 2445, 13-MD-2445 (December 3, 2014)). Product hopping, or product switching, occurs when pharmaceutical companies make minor, non-therapeutic changes to drug formulations in order to secure a new patent and protect the drug from generic competition. Judge Goldberg held that product hopping could violate the Sherman Act if a pharmaceutical company combines the introduction of a new drug formulation with other wrongful conduct that restricts competition.

Product Hopping Allegations

In Suboxone, plaintiffs alleged that as the date approached when generic firms could enter the market to compete with Suboxone, Reckitt Benckiser:
  • Secured a new patent for the drug that changed the form of delivery from tablets to film.
  • Launched a marketing campaign aimed at doctors and the public that fraudulently claimed that the tablet form of the drug was unsafe, leading many doctors and patients to switch from tablets to film.
  • Removed the brand-name tablets from the market, preventing generic competitors from taking advantage of automatic substitution laws that allow a pharmacist to automatically fill subscriptions with the generic form of a brand-name drug.
The court found that the conduct alleged in Suboxone fell in between two previous cases addressing product hopping allegations, Abbott Laboratories v. Teva Pharmaceuticals, 432 F. Supp. 2d 408 (D. Del. 2006) and Walgreen v. AstraZeneca Pharmaceuticals, 534 F. Supp. 2d 146 (D.D.C. 2008), which reached differing conclusions.
In Abbott Laboratories, the court held that the plaintiffs plausibly alleged a Section 2 violation by alleging that the defendant prevented generic competition by:
  • Removing the old formulation of the drug from the market at the same time it introduced a new formulation.
  • Buying back all existing supply of the drug.
  • Labeling the old formulation as obsolete.
In Walgreen, the court held that the plaintiffs did not plausibly allege a Section 2 violation by alleging that the defendant introduced a new formulation of a drug but left the old formulation available, which the court held added to consumer choice and enhanced competition.

Other Wrongful Conduct

Judge Goldberg held that the introduction of a new drug formulation was not anticompetitive by itself but that plaintiffs plausibly alleged a Section 2 violation because of additional allegations of wrongful conduct, including the defendant's fraudulent disparagement of tablet forms of the drug and the withdrawal of tablets from the market. The court noted that the key question in product hopping claims is whether the defendant combines the introduction of a new product with other wrongful conduct whose overall effect is likely to:
  • Thwart competition.
  • Prevent consumer choice.
  • Reduce the market's ambit.
The court found that the plaintiffs' allegations of additional wrongful conduct did not necessarily have to constitute an antitrust violation standing alone in order to lead to a plausible Section 2 claim. For example, the disparagement of a competitor's products does not lead to antitrust liability by itself. However, the court found that the alleged disparagement supported plaintiffs' antitrust claims when combined with allegations that Reckitt Benckiser also threatened to remove the tablets from the market.
In addition, the fact that the generic firms were not entirely foreclosed from competing was not enough to defeat the plaintiffs' claims, because Reckitt Benckiser allegedly prevented the generic firms from taking advantage of automatic substitution laws, the most cost-effective form of competition. In upholding the claims, Judge Goldberg also relied in part on the unique characteristics of price competition in the pharmaceutical market, particularly that doctors select drugs that consumers pay for, reducing a consumer's ability to choose based on price.

Additional Antitrust Claims

In addition to the product hopping claims, the court also addressed other Section 2 claims alleged by the direct purchaser plaintiffs, holding that:
  • Plaintiffs plausibly alleged that Reckitt Benckiser maintained monopoly power in violation of Section 2 by filing a sham citizen petition with the FDA that led to delays in approval of generic Suboxone. The court found that the plaintiffs plausibly alleged that the petition was a sham because it sought relief that the FDA was not legally capable of granting, suggesting that the petition was objectively baseless.
  • Plaintiffs failed to plausibly allege that Reckitt Benckiser violated Section 2 by refusing to cooperate with its generic competitors as part of an FDA regulatory process, because firms do not have a duty to deal with their competitors even in regulatory matters.
The opinion is the latest to address the relatively new theory of product hopping, which is the subject of other pending class actions, including Abbott Laboratories. The Federal Trade Commission has stated that it considers product hopping to be anticompetitive but it has not yet taken any enforcement action on the issue. The New York Attorney General recently filed a lawsuit against Actavis plc and its subsidiary Forest Laboratories alleging that it engaged in anticompetitive product hopping. For more information on the lawsuit, see Legal Update, NY Attorney General Files Lawsuit to Block Pharmaceutical Product Hopping.