IP News

Pfizer Scores Viagra Win in Virginia

Judge Rebecca Beach Smith of the Eastern District of Virginia issued a 110-page order in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 10-128, upholding the validity of Pfizer's Viagra' patent and holding that Teva's proposed generic version would infringe. During a 12-day bench trial, Teva argued that the asserted claims of Pfizer's Viagra patent were obvious in light of prior art including an earlier-issued Pfizer patent, and that they are unenforceable due to inequitable conduct.

Judge Smith sided with Pfizer, holding that at the time the patent application was filed there were no oral administrations of treatments for Erectile Dysfunction (“ED”), and the focus of research at the time was on injectable treatments. Slip Op. at 56. Because injectable treatments were not preferable, the focus shifted to topical treatments such as creams. Slip Op. at 57. The court also found that the prior art actually taught away from the use of the compound in Viagra to treat ED, because similar compounds when administered orally actually caused ED. Slip Op. at 69.

After setting out the scope and content of the prior art and the level of ordinary skill in the art, Judge Smith held that it was not obvious to try the claimed invention in the pre-Viagra era. Id. at 75. “[I]n May 1994, a POSITA [person of ordinary skill in the art] lacked substantive knowledge about the function of the erectile system and whether other factors outside the NANC nerve system played a significant role in the relaxation of the corpus cavernosum.” Id. The court further held that a person of ordinary skill in the art “would have had no reasonable expectation of success when treating ED with the claimed compounds.” Id. at 78.

Regarding obviousness-type double patenting, Teva had argued that the asserted claims were not patentably distinct from a claim in an earlier-issued Pfizer patent. Pfizer argued, and the court agreed, that the subtle differences in the compounds of the asserted patent made it patentably distinct from the earlier Pfizer patent. Slip Op. at 90.

Finally, the court dismissed Teva's inequitable conduct argument, stating that there was “utterly no evidence” that the withheld reference was material to patentability or that it was withheld with specific intent to deceive the PTO. Id. at 104.

Since the issuance of the decision, Pfizer has filed a motion for attorneys' fees, and Teva has filed a notice of appeal.

Department of Agriculture Not Immune from Non-Monetary Federal Claims

On Aug. 24, 2011, the Federal Circuit panel of Judges William Curtis Bryson, Alvin Anthony Schall, and Sharon Prost issued its opinion in Delano Farms Company v. The California Table Grape Commission, Case No. 2010-1546, holding that one defendant, the U.S. Department of Agriculture, did not have sovereign immunity from suit.

The U.S. Department of Agriculture (“USDA”) is the owner of three plant patents for varieties of table grapes, the rights to which were licensed to the California Table Grape Commission. Slip Op. at 2. The Commission also had the right to sublicense these patents, with royalties split between the Commission and the USDA. Id. at 3. The plaintiffs in the action are grape growers who purchased grapevines covered by the patents and paid a licensing fee to the Commission. Id. The growers argue that the patents are invalid.

At the trial court, the defendants moved to dismiss the case on the grounds that the USDA is an indispensable party as owner of the patents, but is immune from suit because of sovereign immunity. Id. at 5. The district court agreed, and granted the motion to dismiss. Id.

On appeal, the Federal Circuit reversed, holding that the USDA, as a U.S. agency, waived its immunity for this particular claim. The Federal Circuit reasoned that ' 702 of the Administrative Procedure Act (“APA”) waives sovereign immunity for non-monetary claims against federal agencies, and thus the plaintiffs could pursue equitable claims against the USDA. Slip Op. at 10. Looking to decisions from other regional circuits, the Federal Circuit held that the waiver of sovereign immunity in the APA is not limited to actions in which the APA explicitly grants a right of judicial review. Id. at 14.

The Federal Circuit remanded the case for further proceedings with the USDA joined in the case.

$1.3 Billion Verdict Against Oracle Rejected

In November 2010, a jury awarded Oracle a $1.3 billion judgment for copyright infringement in Oracle Corporation v. SAP AG, Civ. No. 07-1658 (N.D. Cal). On Sept. 1, 2011, Judge Phyllis Hamilton threw out the verdict as “grossly excessive.” Judge Hamilton ordered the award reduced to $272 million, and will order a new trial if Oracle does not accept the new damages figure.

Patsy's Trademark Ban Upheld at Second Circuit

On Aug. 24, 2011, the Second Circuit panel of Judges Ralph K. Winter, Rosemary S. Pooler, and Jed S. Rakoff (sitting by designation) issued its opinion in Patsy's Italian Restaurant, Inc. v. Banas, Civ. No. 08-4487, upholding an unusual lower court injunction barring both the plaintiffs and the defendants from using the mark “Patsy's” on their New York restaurants. The Second Circuit held that the injunction represents an attempt by the district court to reduce consumer confusion and noted that both parties can go by their full names ' Patsy's Italian Restaurant and Patsy's Pizzeria. Slip Op. at 44. The Second Circuit held that the district court did not abuse its discretion in banning the use of only the mark “Patsy's” on either restaurant, noting that the injunction is “entirely within the district court's discretion.” Id. at 42.

Jeffrey S. Ginsberg is a partner and Joseph Mercadante is an associate in the New York office of Kenyon & Kenyon LLP.

Pfizer Scores Viagra Win in Virginia

Judge Rebecca Beach Smith of the Eastern District of Virginia issued a 110-page order in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 10-128, upholding the validity of Pfizer's Viagra' patent and holding that Teva's proposed generic version would infringe. During a 12-day bench trial, Teva argued that the asserted claims of Pfizer's Viagra patent were obvious in light of prior art including an earlier-issued Pfizer patent, and that they are unenforceable due to inequitable conduct.

Judge Smith sided with Pfizer, holding that at the time the patent application was filed there were no oral administrations of treatments for Erectile Dysfunction (“ED”), and the focus of research at the time was on injectable treatments. Slip Op. at 56. Because injectable treatments were not preferable, the focus shifted to topical treatments such as creams. Slip Op. at 57. The court also found that the prior art actually taught away from the use of the compound in Viagra to treat ED, because similar compounds when administered orally actually caused ED. Slip Op. at 69.

After setting out the scope and content of the prior art and the level of ordinary skill in the art, Judge Smith held that it was not obvious to try the claimed invention in the pre-Viagra era. Id. at 75. “[I]n May 1994, a POSITA [person of ordinary skill in the art] lacked substantive knowledge about the function of the erectile system and whether other factors outside the NANC nerve system played a significant role in the relaxation of the corpus cavernosum.” Id. The court further held that a person of ordinary skill in the art “would have had no reasonable expectation of success when treating ED with the claimed compounds.” Id. at 78.

Regarding obviousness-type double patenting, Teva had argued that the asserted claims were not patentably distinct from a claim in an earlier-issued Pfizer patent. Pfizer argued, and the court agreed, that the subtle differences in the compounds of the asserted patent made it patentably distinct from the earlier Pfizer patent. Slip Op. at 90.

Finally, the court dismissed Teva's inequitable conduct argument, stating that there was “utterly no evidence” that the withheld reference was material to patentability or that it was withheld with specific intent to deceive the PTO. Id. at 104.

Since the issuance of the decision, Pfizer has filed a motion for attorneys' fees, and Teva has filed a notice of appeal.

Department of Agriculture Not Immune from Non-Monetary Federal Claims

On Aug. 24, 2011, the Federal Circuit panel of Judges William Curtis Bryson, Alvin Anthony Schall, and Sharon Prost issued its opinion in Delano Farms Company v. The California Table Grape Commission, Case No. 2010-1546, holding that one defendant, the U.S. Department of Agriculture, did not have sovereign immunity from suit.

The U.S. Department of Agriculture (“USDA”) is the owner of three plant patents for varieties of table grapes, the rights to which were licensed to the California Table Grape Commission. Slip Op. at 2. The Commission also had the right to sublicense these patents, with royalties split between the Commission and the USDA. Id. at 3. The plaintiffs in the action are grape growers who purchased grapevines covered by the patents and paid a licensing fee to the Commission. Id. The growers argue that the patents are invalid.

At the trial court, the defendants moved to dismiss the case on the grounds that the USDA is an indispensable party as owner of the patents, but is immune from suit because of sovereign immunity. Id. at 5. The district court agreed, and granted the motion to dismiss. Id.

On appeal, the Federal Circuit reversed, holding that the USDA, as a U.S. agency, waived its immunity for this particular claim. The Federal Circuit reasoned that ' 702 of the Administrative Procedure Act (“APA”) waives sovereign immunity for non-monetary claims against federal agencies, and thus the plaintiffs could pursue equitable claims against the USDA. Slip Op. at 10. Looking to decisions from other regional circuits, the Federal Circuit held that the waiver of sovereign immunity in the APA is not limited to actions in which the APA explicitly grants a right of judicial review. Id. at 14.

The Federal Circuit remanded the case for further proceedings with the USDA joined in the case.

$1.3 Billion Verdict Against Oracle Rejected

In November 2010, a jury awarded Oracle a $1.3 billion judgment for copyright infringement in Oracle Corporation v. SAP AG, Civ. No. 07-1658 (N.D. Cal). On Sept. 1, 2011, Judge Phyllis Hamilton threw out the verdict as “grossly excessive.” Judge Hamilton ordered the award reduced to $272 million, and will order a new trial if Oracle does not accept the new damages figure.

Patsy's Trademark Ban Upheld at Second Circuit

On Aug. 24, 2011, the Second Circuit panel of Judges Ralph K. Winter, Rosemary S. Pooler, and Jed S. Rakoff (sitting by designation) issued its opinion in Patsy's Italian Restaurant, Inc. v. Banas, Civ. No. 08-4487, upholding an unusual lower court injunction barring both the plaintiffs and the defendants from using the mark “Patsy's” on their New York restaurants. The Second Circuit held that the injunction represents an attempt by the district court to reduce consumer confusion and noted that both parties can go by their full names ' Patsy's Italian Restaurant and Patsy's Pizzeria. Slip Op. at 44. The Second Circuit held that the district court did not abuse its discretion in banning the use of only the mark “Patsy's” on either restaurant, noting that the injunction is “entirely within the district court's discretion.” Id. at 42.

Jeffrey S. Ginsberg is a partner and Joseph Mercadante is an associate in the New York office of Kenyon & Kenyon LLP.