ILNews

Large 'pay-to-delay' payments may become history after U.S. Supreme Court ruling

Back to TopCommentsE-mailPrintBookmark and Share

A decision handed down by the Supreme Court of the United States Monday could end the practice of pharmaceutical companies paying competitors very large sums to keep their generics off the market.

By a 5-3 decision in Federal Trade Commission v. Actavis, Inc., 12-416, the court reversed the 11th Circuit Court of Appeals and remanded to the lower court for further proceedings.

The U.S. Supreme Court essentially held that a patent does not always trump antitrust laws. It ruled that reverse payments to generic companies to settle patent litigation are not always illegal under antitrust laws. They can be illegal when the anti-competitive harm from such agreements outweighs their benefits.

The case focused on “pay-to-delay” agreements that are common in the pharmaceutical industry. Under these settlement agreements, the brand-name pharmaceutical company pays generic drug manufacturers to forgo challenging the patent and refrain from launching their low-cost generic products.

Associate Justice Stephen Breyer wrote the majority opinion in which Associate Justices Anthony Kennedy, Ruth Bader Ginsburg, Sonia Sotomayor and Elena Kagan joined. Chief Justice John Roberts filed a dissent joined by Associate Justices Antonin Scalia and Clarence Thomas. Associate Justice Samuel Alito took no part in the case.

Throughout the majority opinion, there are repeated references to the “large, unjustified,” and the “unexplained large” reverse payments. Although the ruling does not bar these payments, it indicates that such settlements could be found illegal if they are greatly in excess of the expenses of litigation and more in line with profits the generic company would have realized it if had entered the market.

In turn, this could create a chilling effect on this practice, according to Donald Knebel, a partner at Barnes & Thornburg LLP and senior adviser to the Center for Intellectual Property Research at Indiana University Maurer School of Law in Bloomington.

“It’s hard for me to believe that pharmaceutical companies will continue to make very large payment of this kind set out in this case with the knowledge now that the FTC can challenge the payment as violation of antitrust law,” Knebel said.
 
The case involved the reverse payment agreements that Solvay Pharmaceuticals entered into with Actavis Inc., Paddock Laboratories and Par Pharmaceutical. In 2000, Solvay had secured a patent for its drug, AndroGel, a topical testosterone product.

Subsequently, Actavis and Paddock filed abbreviated New Drug Applications for their own generic products. Par joined with Paddock. In 2006, the patent-litigation parties all settled.

Under terms of the settlement, the generic manufacturers agreed to delay bringing their products to market. And Solvay agreed to pay millions of dollars to each company.

While the parties said the payments were compensation for other services the generic manufacturers promised to perform, the FTC asserted the services had little value. Rather, the true point of the payment was to compensate the generics for agreeing not to compete.

The District Court dismissed the case and the 11th Circuit Court of Appeals affirmed. However, the majority of justices disagreed, in part, that Solvay’s patent was not proven to be valid because the settlement ended the litigation.

Beyer pointed to United States v. Line Material Co., 333 U.S. 287, 308 (1948), that held a valid patent excludes all, except its owner, from the use of the protected process or product.

He went on to write, “And that exclusion may permit the patent owner to charge a higher-than-competitive price for the patented product. But an invalidated patent carries with it no such right. And even a valid patent confers no right to exclude products or processes that do not actually infringe.”

In his dissent, Roberts faults the majority’s reasoning.

“The majority today departs from the settled approach separating patent and antitrust law, weakens the protections afforded to innovators by patents, frustrates the public policy in favor of settling, and likely undermines the very policy it seeks to promote by forcing generics who step into the litigation ring to do so without the prospect of cash settlements.”
 

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in Indiana Lawyer editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by

facebook - twitter on Facebook & Twitter

Indiana State Bar Association

Indianapolis Bar Association

Evansville Bar Association

Allen County Bar Association

Indiana Lawyer on Facebook

facebook
ADVERTISEMENT
Subscribe to Indiana Lawyer
  1. I can understand a 10 yr suspension for drinking and driving and not following the rules,but don't you think the people who compleate their sentences and are trying to be good people of their community,and are on the right path should be able to obtain a drivers license to do as they please.We as a state should encourage good behavior instead of saying well you did all your time but we can't give you a license come on.When is a persons time served than cause from where I'm standing,its still a punishment,when u can't have the freedom to go where ever you want to in car,truck ,motorcycle,maybe their should be better programs for people instead of just throwing them away like daily trash,then expecting them to change because they we in jail or prison for x amount of yrs.Everyone should look around because we all pay each others bills,and keep each other in business..better knowledge equals better community equals better people...just my 2 cents

  2. I was wondering about the 6 million put aside for common attorney fees?does that mean that if you are a plaintiff your attorney fees will be partially covered?

  3. I expressed my thought in the title, long as it was. I am shocked that there is ever immunity from accountability for ANY Government agency. That appears to violate every principle in the US Constitution, which exists to limit Government power and to ensure Government accountability. I don't know how many cases of legitimate child abuse exist, but in the few cases in which I knew the people involved, in every example an anonymous caller used DCS as their personal weapon to strike at innocent people over trivial disagreements that had no connection with any facts. Given that the system is vulnerable to abuse, and given the extreme harm any action by DCS causes to families, I would assume any degree of failure to comply with the smallest infraction of personal rights would result in mandatory review. Even one day of parent-child separation in the absence of reasonable cause for a felony arrest should result in severe penalties to those involved in the action. It appears to me, that like all bureaucracies, DCS is prone to interpret every case as legitimate. This is not an accusation against DCS. It is a statement about the nature of bureaucracies, and the need for ADDED scrutiny of all bureaucratic actions. Frankly, I question the constitutionality of bureaucracies in general, because their power is delegated, and therefore unaccountable. No Government action can be unaccountable if we want to avoid its eventual degeneration into irrelevance and lawlessness, and the law of the jungle. Our Constitution is the source of all Government power, and it is the contract that legitimizes all Government power. To the extent that its various protections against intrusion are set aside, so is the power afforded by that contract. Eventually overstepping the limits of power eliminates that power, as a law of nature. Even total tyranny eventually crumbles to nothing.

  4. Being dedicated to a genre keeps it alive until the masses catch up to the "trend." Kent and Bill are keepin' it LIVE!! Thank you gentlemen..you know your JAZZ.

  5. Hemp has very little THC which is needed to kill cancer cells! Growing cannabis plants for THC inside a hemp field will not work...where is the fear? From not really knowing about Cannabis and Hemp or just not listening to the people teaching you through testimonies and packets of info over the last few years! Wake up Hoosier law makers!

ADVERTISEMENT