IP News

Federal Circuit Revisits Inequitable Conduct Ruling in OxyContin Case

On Feb. 1, 2006, in response to a petition for rehearing, the U.S. Court of Appeals for the Federal Circuit vacated the opinion in Purdue Pharma L.P. v. Endo Pharms. Inc., 410, F.3d 690 (Fed Cir. 2005) (affirming trial court's decision that Purdue's patents were unenforceable due to inequitable conduct), and issued a new opinion. In the new opinion, the Federal Circuit remanded to the trial court for further proceedings.

The three patents asserted by Purdue against Endo (U.S. Patent Nos. 5,656,295, 5,508,042, and 5,549,912) are directed to controlled release oxycodone medications for the treatment of moderate to severe pain. The “Detailed Description” section of the written description in each asserted patent begins with the following statement:

It has now been surprisingly discovered that the presently claimed controlled release oxycodone formulations acceptably control pain over a substantially narrower, approximately four-fold (10 to 40 mg every 12 hours ' around-the-clock dosing) in approximately 90% of patients. This is in sharp contrast to the approximately eight-fold range required for approximately 90% of patients for opioid analgesics in general.

Endo filed an Abbreviated New Drug Application (“ANDA”) with the FDA in September 2000, seeking approval to make and sell a generic version of Purdue's OxyContin formulation. At the same time, Endo notified Purdue that it had filed a paragraph IV certification asserting that Purdue's patents either would not be infringed by Endo's generic drug or were invalid. Purdue filed a patent infringement suit against Endo in October 2000. After an 11-day bench trial, the trial court found by a preponderance of the evidence that Endo's proposed generic drug products would infringe Purdue's patents. However, the trial court also found that Endo had shown by clear and convincing evidence that Purdue's patents were unenforceable due to inequitable conduct during prosecution of the patents. The trial court's determination was based on its finding that Purdue had repeatedly told the PTO that it had discovered the fourfold range for oxycodone while failing to inform the PTO that this discovery was based on “insight” without “scientific proof.”

In its revised opinion, the Federal Circuit first found that the trial court's decision that Purdue had failed to disclose material information was not clearly erroneous: “While Purdue never expressly stated that the discovery of the fourfold dosage range was based on the results of clinical studies, that conclusion was clearly to be inferred from the language used by Purdue in both the patents and prosecution history.” According to the Federal Circuit, the fact that Purdue's discovery was only based on “insight” was material because it was inconsistent with Purdue's statements suggesting otherwise. While the Federal Circuit found that Purdue's omissions were material, it also stated that the “level of materiality is not especially high.”

The Federal Circuit also examined the trial court's findings on intent. First, the Federal Circuit found that the trial court erred by relying on evidence that Purdue personnel believed it would be difficult to satisfy FDA labeling requirements. Second, the Federal Circuit concluded that the trial court had erred when it found that the level of materiality was high and inferred deceptive intent. In this case, the Federal Circuit stated that the materiality of the undisclosed information was “relatively low,” and therefore there is less of a basis for inferring intent. As a result of its findings, the Federal Circuit remanded the case so that the trial court can re-evaluate the evidence of record.

District Court Refuses to Enjoin Generic Makers of Allegra

Judge Joseph A. Greenway of the U.S. District Court for the District of New Jersey recently denied Aventis Pharmaceuticals, Inc.'s motion for a preliminary injunction in Aventis Pharms., Inc. v. Barr Labs., Inc., Nos. 01-3627, 03-487, 04-1064, and 04-1078, 2006 U.S. Dist. LEXIS 3355 (D.N.J. Jan. 30, 2006).

Aventis, joined by Merrell Pharmaceuticals, Inc., Carderm Capital L.P., and AMR Technology, Inc. (collectively “plaintiffs”), brought a motion for a preliminary injunction against Barr Laboratories, Inc., Teva Pharma-ceuticals USA, Inc., Ranbaxy Labora-tories Limited and Ranbaxy Pharma-ceuticals, Inc., and Amino Chemicals, Ltd. (collectively “defendants”) for marketing, making, using, or selling generic fexofenadine, the active ingredient in Allegra, a popular allergy medication. The patents-in-suit are owned by, or licensed to, Aventis, Merrell, Carderm, and AMR. Ranbaxy has manufactured fexofenadine for Barr, while Amino has manufactured fexofenadine for Teva.

The instant dispute arose when Barr and Teva each filed Abbreviated New Drug Applications (“ANDA”) seeking approval to market generic versions of Allegra. In response, plaintiffs filed a number of lawsuits alleging infringement of multiple patents, including some patents not at issue in the present motion.

After the FDA granted Barr's and Teva's ANDAs on Aug. 31, 2005 and Sept. 1, 2005, respectively, Barr and Teva entered into an agreement to jointly market a generic version of fexofenadine. Under Barr and Teva's agreement, Barr would transfer its 180-day exclusivity period to Teva and secure necessary regulatory approvals for the drug, while, in exchange, Barr would receive a percentage of the gross profits from Teva's generic Allegra sales.

On Sept. 29, 2005, the court granted plaintiffs' application for an order to show cause why a preliminary injunction should not issue. Plaintiffs asked the court to enjoin Teva and Barr from marketing generic fexofenadine, alleging that such activity would actively induce infringement of U.S. Patent Nos. 6,037,353, 6,187,791, and 6,399,632 (collectively, the “method patents”), which relate to treatment methods using fexofenadine. Plaintiffs also asked the court to enjoin Barr, Teva, Ranbaxy, and Amino from making, using, or selling generic fexofenadine, alleging that such activity would infringe claim 7 of U.S. Patent No. 5,750,703 (the “process patent”), which relates to a process for manufacturing fexofenadine.

The court found that plaintiffs had not demonstrated a likelihood of success in establishing that Barr or Teva had infringed the process patent and that defendants had not raised a substantial question as to the validity of the process patent. Moreover, the court held that plaintiffs had shown a likelihood of success in proving infringement of the method patents, but that defendants had raised a substantial question of invalidity of the method patents. As a result, the court denied plaintiffs' motion.

Federal Circuit Revisits Inequitable Conduct Ruling in OxyContin Case

On Feb. 1, 2006, in response to a petition for rehearing, the U.S. Court of Appeals for the Federal Circuit vacated the opinion in Purdue Pharma L.P. v. Endo Pharms. Inc., 410, F.3d 690 (Fed Cir. 2005) (affirming trial court's decision that Purdue's patents were unenforceable due to inequitable conduct), and issued a new opinion. In the new opinion, the Federal Circuit remanded to the trial court for further proceedings.

The three patents asserted by Purdue against Endo (U.S. Patent Nos. 5,656,295, 5,508,042, and 5,549,912) are directed to controlled release oxycodone medications for the treatment of moderate to severe pain. The “Detailed Description” section of the written description in each asserted patent begins with the following statement:

It has now been surprisingly discovered that the presently claimed controlled release oxycodone formulations acceptably control pain over a substantially narrower, approximately four-fold (10 to 40 mg every 12 hours ' around-the-clock dosing) in approximately 90% of patients. This is in sharp contrast to the approximately eight-fold range required for approximately 90% of patients for opioid analgesics in general.

Endo filed an Abbreviated New Drug Application (“ANDA”) with the FDA in September 2000, seeking approval to make and sell a generic version of Purdue's OxyContin formulation. At the same time, Endo notified Purdue that it had filed a paragraph IV certification asserting that Purdue's patents either would not be infringed by Endo's generic drug or were invalid. Purdue filed a patent infringement suit against Endo in October 2000. After an 11-day bench trial, the trial court found by a preponderance of the evidence that Endo's proposed generic drug products would infringe Purdue's patents. However, the trial court also found that Endo had shown by clear and convincing evidence that Purdue's patents were unenforceable due to inequitable conduct during prosecution of the patents. The trial court's determination was based on its finding that Purdue had repeatedly told the PTO that it had discovered the fourfold range for oxycodone while failing to inform the PTO that this discovery was based on “insight” without “scientific proof.”

In its revised opinion, the Federal Circuit first found that the trial court's decision that Purdue had failed to disclose material information was not clearly erroneous: “While Purdue never expressly stated that the discovery of the fourfold dosage range was based on the results of clinical studies, that conclusion was clearly to be inferred from the language used by Purdue in both the patents and prosecution history.” According to the Federal Circuit, the fact that Purdue's discovery was only based on “insight” was material because it was inconsistent with Purdue's statements suggesting otherwise. While the Federal Circuit found that Purdue's omissions were material, it also stated that the “level of materiality is not especially high.”

The Federal Circuit also examined the trial court's findings on intent. First, the Federal Circuit found that the trial court erred by relying on evidence that Purdue personnel believed it would be difficult to satisfy FDA labeling requirements. Second, the Federal Circuit concluded that the trial court had erred when it found that the level of materiality was high and inferred deceptive intent. In this case, the Federal Circuit stated that the materiality of the undisclosed information was “relatively low,” and therefore there is less of a basis for inferring intent. As a result of its findings, the Federal Circuit remanded the case so that the trial court can re-evaluate the evidence of record.

District Court Refuses to Enjoin Generic Makers of Allegra

Judge Joseph A. Greenway of the U.S. District Court for the District of New Jersey recently denied Aventis Pharmaceuticals, Inc.'s motion for a preliminary injunction in Aventis Pharms., Inc. v. Barr Labs., Inc., Nos. 01-3627, 03-487, 04-1064, and 04-1078, 2006 U.S. Dist. LEXIS 3355 (D.N.J. Jan. 30, 2006).

Aventis, joined by Merrell Pharmaceuticals, Inc., Carderm Capital L.P., and AMR Technology, Inc. (collectively “plaintiffs”), brought a motion for a preliminary injunction against Barr Laboratories, Inc., Teva Pharma-ceuticals USA, Inc., Ranbaxy Labora-tories Limited and Ranbaxy Pharma-ceuticals, Inc., and Amino Chemicals, Ltd. (collectively “defendants”) for marketing, making, using, or selling generic fexofenadine, the active ingredient in Allegra, a popular allergy medication. The patents-in-suit are owned by, or licensed to, Aventis, Merrell, Carderm, and AMR. Ranbaxy has manufactured fexofenadine for Barr, while Amino has manufactured fexofenadine for Teva.

The instant dispute arose when Barr and Teva each filed Abbreviated New Drug Applications (“ANDA”) seeking approval to market generic versions of Allegra. In response, plaintiffs filed a number of lawsuits alleging infringement of multiple patents, including some patents not at issue in the present motion.

After the FDA granted Barr's and Teva's ANDAs on Aug. 31, 2005 and Sept. 1, 2005, respectively, Barr and Teva entered into an agreement to jointly market a generic version of fexofenadine. Under Barr and Teva's agreement, Barr would transfer its 180-day exclusivity period to Teva and secure necessary regulatory approvals for the drug, while, in exchange, Barr would receive a percentage of the gross profits from Teva's generic Allegra sales.

On Sept. 29, 2005, the court granted plaintiffs' application for an order to show cause why a preliminary injunction should not issue. Plaintiffs asked the court to enjoin Teva and Barr from marketing generic fexofenadine, alleging that such activity would actively induce infringement of U.S. Patent Nos. 6,037,353, 6,187,791, and 6,399,632 (collectively, the “method patents”), which relate to treatment methods using fexofenadine. Plaintiffs also asked the court to enjoin Barr, Teva, Ranbaxy, and Amino from making, using, or selling generic fexofenadine, alleging that such activity would infringe claim 7 of U.S. Patent No. 5,750,703 (the “process patent”), which relates to a process for manufacturing fexofenadine.

The court found that plaintiffs had not demonstrated a likelihood of success in establishing that Barr or Teva had infringed the process patent and that defendants had not raised a substantial question as to the validity of the process patent. Moreover, the court held that plaintiffs had shown a likelihood of success in proving infringement of the method patents, but that defendants had raised a substantial question of invalidity of the method patents. As a result, the court denied plaintiffs' motion.