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GENERICally Speaking - Vol. 2, No. 3

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of its quarterly publication regarding ANDA patent litigation issues and the generics business, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.

Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.

This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.

Relevant Court Decisions

  • Pozen Inc. v. Par Pharm., Inc.
    Federal Circuit affirms findings of validity and infringement under the doctrine of equivalents.
  • Santarus, Inc. v. Par Pharm., Inc.
    Because negative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation, finding of invalidity is reversed.
  • Akamai Technologies, Inc. v. Limelight Networks, Inc.
    Induced infringement may be found when all of the claimed steps are performed, regardless of the number of entities needed to perform them.
  • Eli Lilly & Co. v. Teva Parenteral Meds. Inc.
    Patent not invalid for obviousness-type double patenting.
  • Momenta Pharm., Inc. v. Amphastar Pharm., Inc.
    Safe harbor provision of Hatch-Waxman allows post-approval batch testing.
  • Alcon Research, Ltd. v. Apotex Inc.
    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.
  • Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd.
    A court may issue an injunction requiring correction of an improper use code, but may not dictate the precise terms of the corrected code.
  • Sciele Pharm. Inc. v. Lupin Ltd.
    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.
  • In re K-Dur Antitrust Litigation
    Reverse payment settlements are antitrust violations.
  • Senju Pharm. Co. v. Apotex, Inc.
    Claim preclusion barred plaintiffs from asserting reexamined claims that were substantially similar to the original claims that plaintiffs asserted in a first ANDA litigation.
  • Galderma Labs., L.P. v. Tolmar, Inc.
    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.
  • Janssen Pharm., Inc. v. Watson Labs., Inc.
    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.
  • Astrazeneca AB v. Hanmi USA, Inc.
    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.
  • 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.

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.

Print

GENERICally Speaking - Vol. 2, No. 3

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of its quarterly publication regarding ANDA patent litigation issues and the generics business, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.

Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.

This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.

Relevant Court Decisions

  • Pozen Inc. v. Par Pharm., Inc.
    Federal Circuit affirms findings of validity and infringement under the doctrine of equivalents.
  • Santarus, Inc. v. Par Pharm., Inc.
    Because negative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation, finding of invalidity is reversed.
  • Akamai Technologies, Inc. v. Limelight Networks, Inc.
    Induced infringement may be found when all of the claimed steps are performed, regardless of the number of entities needed to perform them.
  • Eli Lilly & Co. v. Teva Parenteral Meds. Inc.
    Patent not invalid for obviousness-type double patenting.
  • Momenta Pharm., Inc. v. Amphastar Pharm., Inc.
    Safe harbor provision of Hatch-Waxman allows post-approval batch testing.
  • Alcon Research, Ltd. v. Apotex Inc.
    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.
  • Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd.
    A court may issue an injunction requiring correction of an improper use code, but may not dictate the precise terms of the corrected code.
  • Sciele Pharm. Inc. v. Lupin Ltd.
    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.
  • In re K-Dur Antitrust Litigation
    Reverse payment settlements are antitrust violations.
  • Senju Pharm. Co. v. Apotex, Inc.
    Claim preclusion barred plaintiffs from asserting reexamined claims that were substantially similar to the original claims that plaintiffs asserted in a first ANDA litigation.
  • Galderma Labs., L.P. v. Tolmar, Inc.
    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.
  • Janssen Pharm., Inc. v. Watson Labs., Inc.
    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.
  • Astrazeneca AB v. Hanmi USA, Inc.
    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.
  • 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.

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.