PHILADELPHIA – Companies trying to avoid pharmaceutical patent restrictions are increasingly resorting to a practice called “product hopping,” wherein the dug company makes non-medical changes to stifle competition, though it runs the risk of inviting litigation.

In September, a group of 35 states and the District of Columbia filed an antitrust suit in U.S. District Court for the Eastern District of Pennsylvania against Reckitt Benckiser Pharmaceuticals and MonoSol Rx, the makers of the Suboxone and Indivior opioid addiction drugs.

The case, named Wisconsin et al vs. Indivior, alleges the makers of the brand-name drugs tried to extend their patents by switching from a pill form to a dissolvable strip, claiming greater efficacy.

“Product hopping as an anti-competitive tactic can be effective because of the drug regulatory structure and patent law,” John E. Lopatka, the A. Robert Noll Distinguished Professor of Law at Pennsylvania State University, told the Pennsylvania Record.

Lopatka said companies that already possess patents can find clever ways to repackage their products without making substantial changes, though there are provisions in the regulatory process meant to stop the practice.

“Product hopping can occur when a brand drug manufacturer has a period of marketing exclusivity, either because it has a patent or what is called ‘orphan drug’ protection,” he said.

“When that period expires, generic drug manufacturers who obtained FDA approval through ANDAs (abbreviated new drug applications) could compete with the brand manufacturer, so long as the generic drug satisfies a state’s definition of therapeutic equivalence.”

He said the key phrase is “therapeutic equivalence,” which means just changing the original patented product in a small way may not meet that threshold.

“(Suppose) shortly before expiration, the brand manufacturer might somehow change the drug in a minor way, such as by changing the dosage form, and market the modified drug,” Lopatka said. “It might remove the old brand drug from the market entirely, or it might create incentives for doctors to prescribe the new drug rather than the old drug.”

According to a recent blog post written by Jason Drori, an attorney with Wisconsin-based Foley and Lardner, the Wisconsin case is just one in a growing number of product hopping suits.

“While the public spotlight on opioid abuse makes the Indivior case one of intense interest, allegedly anti-competitive conduct meant to thwart generic competition has formed the subject of a growing number of pharmaceutical antitrust suits,” Drori wrote.

“Such conduct, including ‘product hopping’ or ‘product switching,’ has piqued the interest (and frustration) of government agencies (e.g., Federal Trade Commission) and industry participants and stakeholders alike.”

Lopatka said more pharmaceutical antitrust cases are being brought today than 30 years ago.

“The regulatory structure that has given rise to many of the recent antitrust cases was created in 1984, with passage of the Hatch-Waxman Act," he said.

Lopatka said he’s not exactly sure why Pennsylvania was chosen as the location for the states to file the suit, but there must be some strategy in the site selection.

“Normally, when a plaintiff has a choice of filing an action in many federal district courts, the plaintiff will tend to choose a district in a federal circuit that has law favorable to the plaintiff. Other issues, such as convenience, may also affect the choice,” he said.

“The states likely view the federal court in Pennsylvania as both a natural and favorable forum for their case.”

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