GENERICally Speaking Hatch Waxman Bulletin

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business.

Vol. 2, No. 3

Fall 2012

The Fall 2012 issue of the GENERICally Speaking email campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

Relevant court decisions highlighted in this issue:

  • GlaxoSmithKline PLC v. Hikma Pharm. Co. Ltd.
    Finding that the ANDA product did not infringe the asserted claims (literally or under the doctrine of equivalents) since propylene glycol is not a saccharide; the claims were sufficiently enabled.
  • Pfizer Inc. v. Teva Pharm. U.S.A., Inc.
    Court finds asserted patents valid and infringed, but only under doctrine of equivalents.
  • ISTA Pharm., Inc. v. Food and Drug Administration
    ANDA applicants may rely on labeling of non-marketed drugs for purposes of generic product labeling.

 

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz

Partner

Pronouns: he/him

Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
Induced infringement may be found when all of the claimed steps are performed, regardless of the number of entities needed to perform them.
When the prior art discloses a portion of the claimed range, the patent claim at issue is invalid as obvious; the motivation of a person of ordinary skill to combine prior art does not need to be the same as that of the patentee; inherency is considered in an obviousness analysis.
Issues of fact preclude summary judgment of anticipation as priority date of reference was disputed; issues of fact precluded summary judgment of indefiniteness, lack of written description and lack of enablement.
Patent not invalid for obviousness-type double patenting.
Because prior art shows that increased drug concentration caused irritation, it taught away from claimed invention that disclosed tripling prior art ranges, and therefore asserted claims were not obvious; no inequitable conduct; not invalid for lack of written description; no standing to sue as to non-exclusive licensee.
Finding that the ANDA product did not infringe the asserted claims (literally or under the doctrine of equivalents) since propylene glycol is not a saccharide; the claims were sufficiently enabled.
Reverse payment settlements are antitrust violations.
ANDA applicants may rely on labeling of non-marketed drugs for purposes of generic product labeling.
Patent claiming 25 micrograms ethinyl estradiol not invalid based on genus/species anticipation arguments and obviousness despite the fact that the prior art disclosed a range of 20-50 micrograms of ethinyl estradiol.
Safe harbor provision of Hatch-Waxman allows post-approval batch testing.
A court may issue an injunction requiring correction of an improper use code, but may not dictate the precise terms of the corrected code.
Court finds asserted patents valid and infringed, but only under doctrine of equivalents.
Federal Circuit affirms findings of validity and infringement under the doctrine of equivalents.
Because negative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation, finding of invalidity is reversed.
The burden for proving invalidity is clear and convincing evidence; it is not heightened if prior art references were before the Patent Office nor is it lowered if a patent issues erroneously.
Claim preclusion barred plaintiffs from asserting reexamined claims that were substantially similar to the original claims that plaintiffs asserted in a first ANDA litigation.

Vol. 2, No. 1

Spring 2012

Vol. 2, No. 2

Summer 2012

Vol. 2, No. 4

Winter 2012