Patent Case Ruling Allows For Launch Of Generic Pepcid Complete

The U.S. District Court for the Southern District of New York invalidated a key patent for Johnson & Johnson/Merck's Pepcid Complete , opening the door for Perrigo to enter the market with a private-label equivalent.

Drawing on a recent Supreme Court case, Judge William H. Pauley III struck down Merck's '340 formulation patent concerning the use of the H2 blocker famotidine in the production of Pepcid.

J&J/Merck sued Perrigo for patent infringement in February 2005 after the private-labeler submitted an abbreviated new drug application with a Paragraph IV certification to FDA to manufacture and market an equivalent of the famotidine/antacid combination.

The patent covers a solid oral dose of impermeable coated famotidine (H2 blocker) granules and aluminum/magnesium hydroxide. The coating on the drug protects it from degrading upon contact and masks the bitter taste of famotidine.

Judge Pauley determined the formulation protections are obvious and "the '340 patent does no more than combine predictable results."

He referred to the Supreme Court's April 30 ruling in the patent infringement case KSR International vs. Teleflex. That ruling broadened the test used by the U.S. Appeals Court for the Federal Circuit to determine the obviousness of a patent.

Previously, a party seeking to invalidate a patent had to establish a clear reason for combining known elements in order to satisfy the federal court's test for obviousness. But the Supreme Court stated that approach may be too "rigid" in determining whether an invention would have been obvious to one skilled in the art.

The high court recommended federal court reviews include an "expansive and flexible approach" to "identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does."

Based on that approach, Judge Pauley determined Perrigo did not infringe the Pepcid patent and "the patent itself was invalid," a Perrigo spokesperson told "The Tan Sheet."

Judge Pauley added the obviousness of the '340 patent "is underscored by the Pepcid Complete NDA, which states: 'Taste masking of famotidine is necessary in a chewable tablet due to the bitterness of the drug substance.'"

J&J/Merck responded that its Pepcid patents are applicable and should be enforced under federal law, and it will therefore "vigorously" defend its patent.

"We are disappointed that the court found the ['340] patent invalid and we'll appeal the court decision. We believe the patents protecting Pepcid Complete are valid and enforceable and would be infringed by the introduction of any generic version of Pepcid Complete," a J&J/Merck spokesperson told "The Tan Sheet." The firm declined to elaborate on when the company plans to file its appeal or what aspect of the decision might be vulnerable to further legal action.

Perrigo's October 2004 ANDA sought approval to market Famotidine Complete, its generic version of Pepcid Complete, in tablets containing 10 mg of coated famotidine in one layer and 165 mg of magnesium hydroxide in a separate layer (¹ 'The Tan Sheet' Oct. 2, 2006, In Brief).

The June 5 ruling positions the company for a new product launch expected to occur in fiscal 2008, which starts July 1, according to Perrigo.

"Famotidine Complete's introduction to the store brand market provides an important new product in the gastrointestinal category to our retail and wholesale customers while providing significant savings for the consumers," Perrigo President and CEO Joseph Papa said.

Perrigo estimates Pepcid Complete's annual sales are about $90 million, but it is unclear how its own version of the acid indigestion drug will affect the market. "We haven't gone to market yet, so we don't know what the market will end up being," the firm said.

Should it win an appeal, Perrigo said it would launch its product with 180-days of marketing exclusivity afforded to firms that are the first to successfully challenge a pharmaceutical patent listed in the FDA's Orange Book according to provisions under the Hatch-Waxman Act of 1984.

- Robert W. Mitchell ([email protected])