Posts Tagged: "hatch-waxman"

At the request of the Federal Trade Commission, the Solicitor General of the United States petitioned the U.S. Supreme Court to review a recent federal appeals court ruling concerning the FTC’s case against a “pay-for-delay” agreement. The petition for certiorari, the mechanism for asking for the Supreme Court to review a case, argues that the agreement that postponed generic competition for the testosterone-replacement drug AndroGel is anti-competitive and should not be legal. But thanks to the byzantine legal rules created by the Hatch-Waxman Act, the brand name owner was doing nothing more than what seems to explicitly be authorized by the law.

Last week the Federal Circuit decided the case of Santarus, Inc. v. Par Pharmaceutical, Inc., which dealt with whether a drug covered by an Abbreviated New Drug Application (ANDA) infringed the patents owned by that patent owner relative to the proton pump inhibitors (PPI) product omeprazole. The big issue in the case is what might at first glance seem to be a rather innocuous statement relative to the support necessary in a patent specification for a negative claim limitation. But after reading the Newman dissent (which joins in the other aspects of the Court’s decision) it starts to become clear that this could be a much larger issue of significant consequence.

While the Supreme Court may have expanded the reach of the Hatch-Waxman “safe harbor,” the Medtronic and Merck cases only involved pre-marketing FDA approval activity. But the recent split Federal Circuit panel decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. has now (alarmingly in my view) further widened the applicability of this “safe harbor” beyond such pre-marketing FDA approval activity. In Momenta Pharmaceuticals, Judge Moore (writing for the majority joined by Judge Dyk) ruled that this “safe harbor” could also apply to post-FDA approval activity, even if that activity was at least arguably commercial in nature.

One of the most debated issues in patent and antitrust law today involves pharmaceutical patent settlements. Brand-name drug manufacturers pay generic firms to settle patent litigation and delay entering the market. How should the antitrust laws respond? The Cipro case presents an ideal vehicle for Supreme Court review. It involves a simple, undisputed payment from brand to generic to delay entering the market.

The plaintiffs had argued that defendants had in fact violated Section 1 of the Sherman Act when they settled their dispute concerning the validity of Bayer’s Cipro patent by agreeing to a reverse exclusionary payment settlement. Bayer agreed to pay the generic challengers, and in exchange the generic firms conceded the validity of the Cipro patent. The Second Circuit panel affirmed the granting of summary judgment, finding themselves confined by the previous Second Circuit ruling in Tamoxifen. The panel did, however, make the extraordinary invitation to petition the Second Circuit for rehearing in banc, citing the exceptional importance of the antitrust implications, the fact that the primary authors of the Hatch-Waxman Act have stated reverse payments were never intended under the legislation and the fact that the Second Circuit in Tamoxifen simply got it wrong when they said that subsequent generic entrants could potentially obtain a 180 exclusive period even after the first would-be generic entrant had settled.

In this release, the authors (Kaye Scholer LLP’s Patent Group) update and expand Pharmaceutical and Biotech Patent Law with new discussion of many topics, including double patenting, inequitable conduct, product by process claims, attorneys fees under Hatch-Waxman and more. Table of Contents Table of Authorities Below is a synopsis of the significant updates provided for the Fall of 2009.

Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the…

Earlier today, Judge Garrett Brown of the United States Federal District Court for the District of New Jersey, issued an Order and Findings of Fact and Conclusions of Law in the dispute between between Merck and Teva Pharmaceuticals.  Judge Brown found that the patent in question, US Patent No. 5,565,473, was valid and enforceable, and that the Teva’s Abbreviated New…

On Tuesday, March 10, 2009, Dr. Reddy’s Laboratories (NYSE:RDY) prevailed in a patent dispute with Astra Zeneca, receiving a summary judgment victory in the ongoing dispute before the United States Federal District Court for the Southern District of New York.  U.S. District Court Judge Colleen McMahon ruled that the Omeprazole Magnesium OTC Abbreviated New Drug Application (ANDA) filed by Dr. Reddy’s does not…

The Patent Docs are reporting that on February 3, 2009, Senator Herb Kohl (D-WI) introduced legislation into the Senate titled the Preserve Access to Affordable Generics Act, which would prohibit brand name drug companies from compensating generic drug makers for delaying the entry of generic drugs into the market.  This bill is in response to a lawsuit initiated by the FTC…

Despite the fact that an official announcement is not due until sometime later this morning, it seems likely that everyone already knows that President Barack Obama has selected Judd Gregg, the Senior United States Senator from New Hampshire, to be his Secretary of Commerce.  All the political pundits have offered expert commentary on why President Obama might choose a Republican Senator to…

The Federal Trade Commission has filed a complaint in federal district court challenging agreements in which Solvay Pharmaceuticals, Inc. paid generic drug makers Watson Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. to delay generic competition to Solvay’s branded testosterone-replacement drug AndroGel, a prescription pharmaceutical with annual sales of more than $400 million. “At a time of escalating health care costs,…