Pfizer Agrees Not To Sue Apotex on Zoloft Patents

Apotex v. Pfizer (Supreme Court)

Orange Book Games: A generic manufacturer asks for a lawsuit when it files an Abbreviated New Drug Application (ANDA) with the FDA along with an assertion that the listed patents either don’t cover the drug or are invalid.  That filing gives the brand manufacturer a right to immediately sue for declaratory relief based on a theory of constructive patent infringement.

Sometimes the brand manufacturer decides not to sue immediately — leaving the generic on unsure ground because the brand mfg may be simply waiting to sue until the generic ramps up its operation and is about to go on the market.

In its petition for certiorari filed in February 2006, Apotex questioned this process — arguing that the “prospect of massive patent liability deters the generic manufacturer from entering the marketplace."  Apotex requested that the unsure situation should give the generic a right to pursue declaratory relief. The drug in question here is Zoloft.

The Supreme Court had requested input from the Solicitor General, and have been waiting for that brief since May. In a preemptive move, Pfizer has filed a new brief – asserting that facts on the ground leave the case moot.  In particular, Pfizer provided Apotex with an unconditional covenant not to sue Apotex with respect to the patent-in-suit. In addition, Pfizer argues that the case is moot because generic Zoloft is already on the market.

• More details at Aaron Barkoff’s Orange Book Blog and Akin Gump’s SCOTUS Blog.

 

Comments

[Anon]

The drug at issue is Zoloft not Zocor.

[Dennis Crouch]

WOW, that's a big typo.

[pain relief combination medicines]

The combination of acetaminophen, butalbital, and caffeine is used to relieve tension headaches. It's manuafactured under brand FIORICET.

http://www.drugs-generic.info/index.php?prod=Fioricet

Ultracet is the combination medicines containing opioid analgesics (nar-KOT-ik an-al-JEE-zicks ) such as tramadol (TRA-ma-dole) and

acetaminophen (a-seat-a-MIN-oh-fen ) are used to relieve pain. An opioid analgesic and acetaminophen used together may provide better pain

relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.

http://www.drugs-generic.info/index.php?prod=Ultracet