Wednesday, November 17, 2004

Fed Cir vacates preliminary injunction given to Medpointe by DNJ

In a 2-1 vote, the Federal Circuit vacated a preliminary injunction earlier granted to Medpointe against High Tech Pharmacal.

A significant point in the decision concerned the effectiveness of a (1938) prior art reference, the anti-cough remedy Candettes. The Candettes product had all three of the claimed (cationic) ingredients of Medpointe's US 6,417,206, although with different counter-anions. Because the '206 patent claimed specific counter-anions not in Candettes, this became an obvious rejection (35 USC 103), not an anticipation (35 USC 102). There was motivation to move from the anions of Candettes to the claimed anions.

The major issue with the Candettes reference was the presence of a fourth major ingredient, ammonium chloride, and whether this simple compound [NH4Cl] was an "active" or "inactive" ingredient. Medpointe's position was that it was "active" and that there was a patentable invention in REMOVING ammonium chloride from the 1938 composition.

Claim 1 of the '206 used open-ended language, "comprising." The CAFC interpreted this as limiting the "active" ingredients to only the three listed by Medpointe. Although the topic didn't come up in the obviousness case, if the three ingredients do function as a cough remedy, they inherently do so, and did so in 1938 when Candettes was marketed. If it were clear that the counter-anion of the three active (cationic) ingredients did not affect the cough remedy, then this case could have been decided as an anticipation, not on obviousness grounds. In the case In re Donohue, the court found anticipation even though the prior art and claimed product differed in their chemical identity (through a reaction known to one of ordinary skill).

Yes, v. BarnesandNoble, 239 F3d 1343 (CAFC 2001) was cited in the case. Yes, the CAFC vacated a PI of the district court of New Jersey.

Chief Judge Mayer dissented. First, he disagreed with the finding that ammonium chloride was not an active ingredient. Second, he disagreed with the finding about tannates (the counter-anion in the patent). Finally, he took issue with the use of "the failure to break even" as a way to negate commercial success as a secondary factor to negate obviousness.

UPDATE. Apparently, there is a question over "what has to happen" for a preliminary injunction to be vacated. Medpointe seems to think there needs to be an order from the CAFC to DNJ, and that the DNJ has to lift the injunction.

from a press release-->
MedPointe Pharmaceuticals responded today [Nov. 22] to recent developments concerning its continued efforts to enforce its intellectual property rights covering its TUSSI-12(R)D product line.

MedPointe's TUSSI-12(R)D brand products are covered by U.S. Patent No. 6,417,206 ("the '206 patent"). MedPointe has previously successfully enforced this patent against certain manufacturers to prevent infringement, obtaining consent orders and preliminary injunctions from the U.S. District Court for the District of New Jersey that prevent these parties from offering to sell or selling generic versions of MedPointe's patented TUSSI-12(R)D products.

Although a panel of an appellate court on November 17, 2004 issued an opinion that the preliminary injunction against Hi-Tech Pharmacal Co., Inc., Amityville, NY, should be vacated, MedPointe believes that the preliminary injunction remains in full force and effect, unless and until the appellate court issues a mandate vacating it. Among other things, the preliminary injunction prevents Hi-Tech Pharmacal Co., Inc. from shipping, manufacturing, having manufactured, offering to sell, selling, or importing into the U.S. Tannate 12 D S, a generic version of MedPointe's TUSSI-12(R)DS brand suspension product.

On November 19, 2004, Hi-Tech Pharmacal Co., Inc. issued a press release stating that it "plans to begin shipments of its Tannate 12 D S cough and cold product in the near future" but that it "may still be subject to liability based on a claim of patent infringement for sales of Tannate 12 D S." MedPointe believes that Hi-Tech Pharmacal Co., Inc. remains bound by the preliminary injunction and may not ship, manufacture, have manufactured, offer to sell, sell, or import into the U.S. Tannate 12 D S, unless and until the District Court, acting on a mandate by the appellate court, lifts that injunction.

MedPointe believes that the panel opinion of the appellate court is in error, and agrees with the Chief Judge of the appellate court, who dissented from the panel opinion. MedPointe intends to petition for a rehearing to overturn the opinion and prevent the issuance of any mandate vacating the injunction.


Post a Comment

<< Home