Replies to post #146555 on Biotech Values

[north40000]

http://www.cafc.uscourts.gov/images/stories/opinions-orders/12-1062.pdf


Before RADER, Chief Judge, DYK and MOORE, Circuit Judges.
Opinion for the court filed by Circuit Judge MOORE. Dissenting opinion filed by Chief Judge RADER.[57 pages total: no wonder it took so long. I have not had time to read it yet
MOORE, Circuit Judge.
Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc., and Watson Pharma, Inc. (collectively, Amphastar) appeal the district court’s order denying the Emergency Motion to Dissolve or Stay the preliminary injunction entered in this case. Because the district court applied an unduly narrow interpretation of the Hatch-Waxman safe harbor, 35 U.S.C. § 271(e)(1), we vacate the grant of a preliminary injunction and remand for further proceedings consistent with this opinion.[more]

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RADER, Chief Judge, dissenting.
By definition, a patent defines a right to exclude. Consistent with property principles, an infringer of a valid patent is an unlawful trespasser. The remedy for trespassing, in this area of property law as well as others, is removal of the trespasser. Indeed even the Constitution acknowledges the patent owner’s right to exclude trespassers. U.S. Const. art. I, § 8, cl. 8. Thus, exceptions to the traditional property remedy amount to a get-out-of-jail-free card for the trespasser. Accordingly, such exceptions must occur only sparingly with awareness that this license allows the wrongdoer free reign to continue trespassing.
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[Rocky3]

Most importantly (from MNTA board):

"Under the correct interpretation of 35 U.S.C § 271(e)(1), Momenta’s admission that Amphastar’s testing is carried out to “satisfy the FDA’s requirements,” Appellee’s Brief at 40-41, makes it unlikely that Momenta will succeed on the merits of its infringement claim."
"The district court’s findings with respect to the irreparable harm, balance of the hardships, and public interest factors were all, to some extent, predicated on its erroneous conclusion that Momenta’s patent was likely infringed by Amphastar’s product.
"Because Momenta has not established a likelihood of success on its claim of infringement, the preliminary injunction must be vacated. On remand, the district court may want to consider whether Momenta’s admission that Amphastar’s use of the patented invention is to “satisfy the FDA’s requirements” makes this case amenable to summary judgment of non-infringement in favor of Amphastar."