District Court Upholds Johnson & Johnson's Topamax Patent, Keeping Mylan's Generic Off the Market

Ortho-McNeil Pharma. v. Mylan Labs. et al., No. 04-1689 (D. N.J. 2007)

Mylan Laboratories filed an ANDA in 2001 to market a generic version of Topamax (topiramate), Johnson & Johnson's blockbuster anticonvulsant drug, and asserted that the patent on Topamax was invalid due to obviousness.  As we previously reported, last October Judge Stanley R. Chesler of the U.S. District Court for the District of New Jersey preliminarily enjoined Mylan from selling generic Topamax, pending a final resolution of the case.  Now, Judge Chesler has granted J&J's motion for partial summary judgment of patent validity, finding that J&J's U.S. Patent No. 4,513,006 is not invalid as obvious.

Judge Chesler's opinion on summary judgment tracks his October opinion granting a preliminary injunction.  In both decisions, Judge Chesler applied the Federal Circuit's "motivation-suggestion-teaching" test for obviousness.  That test, which is currently under review by the Supreme Court in KSR v. Teleflex, requires evidence of a teaching, suggestion, or motivation to combine or modify prior art references before making a finding of obviousness.

The '006 patent covers the drug topiramate, pharmaceutical compositions containing topiramate, and a method of using topiramate to treat convulsions.  Topiramate is an inhibitor of fructose-1, 6-bisphosphatase (FBPase), a key enzyme in glucose metabolism.  Mylan asserted that the inventors sought to discover a FBPase inhibitor as a potential treatment for diabetes, and thereafter arrived at topiramate.  According to Judge Chesler, however:

Mylan has offered no evidence that there was a suggestion from any source to use FBPase inhibitors to solve the problem of controlling blood sugar in diabetic patients; the requirements of the the "motivation-suggestion-teaching" test have not been met.  Federal Circuit law requires "rigorous application" of this test in an obviousness analysis.  Mylan has not shown a genuine issue as to any material fact; rather, there is a complete failure of proof concerning an essential element of the nonmoving party's case.

The '006 patent will not expire until September 26, 2008.  If Mylan wishes to market its generic Topamax before then, it seems that it will have to appeal to the Federal Circuit.

UPDATES:

• March 22 J&J press release, announcing grant of permanent injunction against Mylan.

Comments

[Stewart]

September 2008 is almost here. Did J&J get pediatric exclusivity?