The Federal Trade Commission (FTC) is seeking to apply its success before the U.S. Supreme Court to another type of patent settlement.
The agency has asked the U.S. District Court for the District of New Jersey to accept its amicus brief in In re Effexor XR Antitrust Litigation. The Federal Trade Commission brief argues in favor of applying the precedent established in FTC v. Actavis to a settlement agreement based on a “no-authorized-generic” commitment.
The Supreme Court ruled that “pay-to-delay” agreements, under which brand name drug companies make payments to would-be competitors who make generic substitutes to keep the generic substitutes out of the market, can be subject to anti-trust scrutiny.
In the instant case, Wyeth Pharmaceutical Co. agreed not to compete with an authorized generic version of the drug Effexor XR to induce Teva Pharmaceuticals USA Inc. to abandon its patent challenge and refrain from selling its generic version of Effexor XR for two years. Brand-name drug makers manufacture authorized generic drugs as a way to ward of generic sales, particularly during the 180-day exclusivity period reserved for the first-filing generic under the Hatch-Waxman Act.
The pharmaceutical companies argue that the settlement should be immune from antitrust scrutiny because delayed entry was secured by a non-compete agreement rather than cash. Meanwhile, the Federal Trade Commission argues that “accepting the defendants’ claim of immunity whenever patentees use vehicles other than cash to share the profits from an agreement to avoid competition elevates form over substance, and it would allow drug companies to easily circumvent the ruling in Actavis, at great cost to consumers.”
It is unclear if the court will accept the amicus brief. A ruling is expected this month.
If you have any questions about this case or would like to discuss the legal issues involved, please contact me, Fred Zemel, or the Scarinci Hollenbeck attorney with whom you work.
You Just Received a Federal Grand Jury Subpoena in New Jersey: Now What?
Receiving a federal grand jury subpoena is not something most businesses or individuals anticipate. While it can be concerning, a federal grand jury subpoena does not necessarily mean that you are being accused of wrongdoing. It does, however, mean that a federal criminal investigation is underway and that federal prosecutors believe you may possess information […]
Why Every Business Should Conduct an Annual Insurance Coverage Review
Most New Jersey business owners purchase insurance policies, file them away, and assume they are protected if a claim arises. Without a regular insurance coverage review, many companies discover gaps only after a lawsuit, cyberattack, property loss, or other significant event occurs. An annual insurance coverage review can help businesses identify potential risks, ensure their […]
Demand Letters & Cease and Desist Letters: When to Send One (and When Not To)
Businesses and individuals often encounter situations where another party breaches a contract, fails to pay a debt, or continues harmful conduct. In many such disputes, a precisely drafted demand letter or cease-and-desist letter serves as a powerful legal tool. It can frequently resolve the dispute and avoid litigation. While demand or cease-and-desist letters can resolve […]
Key provisions in your contracts, including those relating to indemnification, insurance, and defense, are essential to contract risk management. While sometimes considered “boilerplate,” these provisions play a pivotal role when determining which party is responsible for certain costs and liabilities. They must always be negotiated and drafted carefully. Indemnification Clauses Businesses should never overlook the […]
Portability of estate and gift tax enables a surviving spouse to inherit any unused portion of their deceased spouse’s federal estate and gift tax exemption. So, if one spouse doesn’t utilize their full exemption, the surviving spouse can effectively double their exemption amount with regard to estate tax liability. For married couples, portability offers a […]
Pet Trusts in New Jersey and New York: A Practical Estate Planning Tool
For many of us, pets are more than companions—they are members of the family. Yet they are often overlooked or inadequately provided for when it comes to estate planning. A pet trust offers a legally enforceable way to ensure that your animal continues to receive proper care if you become incapacitated or pass away. As […]
No Aspect of the advertisement has been approved by the Supreme Court. Results may vary depending on your particular facts and legal circumstances.
Sign up to get the latest from our attorneys!
Explore What Matters Most to You.
Consider subscribing to our Firm Insights mailing list by clicking the button below so you can keep up to date with the firm`s latest articles covering various legal topics.
Stay informed and inspired with the latest updates, insights, and events from Scarinci Hollenbeck. Our resource library provides valuable content across a range of categories to keep you connected and ahead of the curve.
Let`s get in touch!
Sign up to get the latest from the Scarinci Hollenbeck, LLC attorneys!
