Pfizer Inc. v. Dr. Reddy's Laboratories

9 Analyses of this case by attorneys

  1. We Received a Patent Term Extension - Now What?

    Pepper Hamilton LLPN. Nicole StakleffJune 3, 2017

    Additionally, innovators should consider employing strategies to attempt to mitigate the risk of a third party exploiting the inherent limitations of a PTE award.Endnotes1See Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291, 1300 (Fed. Cir. 2011).2See Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 597 F. Supp. 2d 462, 468-69 (D. Del. 2009) (holding that an interference may be declared during the extension period, as nothing in the legislative history indicates that 35 U.S.C. § 156 confers anything less than the full scope of a patentee's rights during the extension period).3See 35 U.S.C. § 156(b).4SeePfizer v. Dr. Reddy’s Labs., Ltd., 359 F.3d 1361, 1366-67 (Fed. Cir. 2004).5See 35 U.S.C. § 156(b)(1).6 An argument could be made that the Hatch-Waxman Act was an attempt to “establish a balance whereby the patent term extension is offset by facilitating generic entry when the extended term expires, yet preserving the innovation incentive.” See Pfizer, 359 F.3d at 1366.

  2. Federal Circuit Affirms Two District Court Decisions Concerning PTE Availability; Decisions Embrace an “Active Ingredient” Approach to PTEs

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstMay 10, 2010

    That provision states that the term of a patent claiming a drug shall be extended from the original expiration date of the patent if, among other things, “the permission for the commercial marketing or use of the product . . . is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.” Over the past few years, the U.S. Patent and Trademark Office (“PTO”) has heavily relied on decisions by the U.S. Court of Appeals for the Federal Circuit in Fisons v. Quigg, 8 U.S.P.Q.2d 1491 (D.D.C.1988), aff’d 876 F.2d 99 U.S.P.Q.2d 1869 (Fed.Cir.1989), and Pfizer Inc. v. Dr. Reddy’s Labs., 359 F.3d 1361 (Fed. Cir. 2004) (“Pfizer II”) to support the Office’s interpretation of the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active moiety” (i.e., the molecule in a drug product responsible for pharmacological action, regardless of whether the active moiety is formulated as a salt, ester, or other non-covalent derivative) rather than “active ingredient” (i.e., the active ingredient physically found in the drug product, which would include any salt, ester, or other non-covalent derivative of the active ingredient physically found in the drug product). In contrast, the Federal Circuit’s 1990 decision in Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir.

  3. Federal Circuit Upholds Patent Term Extensions in LEVAQUIN and METVIXIA Cases

    McAndrews, Held & Malloy, Ltd.May 10, 2010

    The Federal Circuit applied similar reasoning in the Photocure case:[A]s the '267 patent illustrates, the pharmacological properties of MAL differ from those of ALA, supporting the separate patentability of the MAL product. MAL hydrochloride is a different chemical compound from ALA hydrochloride, and it is not disputed that they differ in their biological properties, warranting separate patenting and separate regulatory approval, although their chemical structure is similar.Notwithstanding this reasoning, the PTO argued that pursuant to Pfizer v. Dr. Reddy's, 359 F.3d 1361 (Fed. Cir. 2004), the statutory term "active ingredient" does not mean the compound that is present in the approved drug, but instead it means the "active moiety" of the compound; that is, the part responsible for the pharmacological properties. The Federal Circuit, however, rejected the PTO's construction.

  4. Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc.

    Finnegan, Henderson, Farabow, Garrett & Dunner, LLPMay 10, 2010

    Id. at 8 (citing Pfizer Inc. v. Dr. Reddy’s Labs., Ltd., 359 F.3d 1361, 1366 (Fed. Cir. 2004)). However, because Lupin did not assert any nonpharmaceutical uses for levofloxacin, the Federal Circuit concluded that “[t]he district court did not abuse its discretion in issuing an injunction commensurate with the patent rights of exclusion.”

  5. Photocure ASA v. Kappos

    Finnegan, Henderson, Farabow, Garrett & Dunner, LLPAnthony D. Del MonacoMay 10, 2010

    The PTO attempted to distinguish Glaxo, arguing that Glaxo did not address the term “active ingredient.” The PTO instead relied on Pfizer Inc. v. Dr. Reddy’s Laboratories, Ltd., 359 F.3d 1361 (Fed. Cir. 2004), in which the underlying issue was whether infringement of an extended patent was avoided by changing the salt. The Federal Circuit in Pfizer held that the changed salt had no effect on the activity of the product, for the “active moiety” of the product was unchanged.

  6. The Stage is Set . . . . Federal Circuit to Hear Oral Argument Regarding PTE Eligibility

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstSeptember 3, 2009

    Both cases concern the proper interpretation of 35 U.S.C. § 156(a)(5)(A), which states that the term of a patent claiming a drug shall be extended from the original expiration date of the patent if, among other things, “the permission for the commercial marketing or use of the product . . . is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred” (emphasis added). In recent PTE determinations, the U.S. Patent and Trademark Office (“PTO”) has heavily relied on decisions by the U.S. Court of Appeals for the Federal Circuit in Fisons v. Quigg, 8 U.S.P.Q.2d 1491 (D.D.C.1988), aff’d 876 F.2d 99 U.S.P.Q.2d 1869 (Fed.Cir.1989), and Pfizer Inc. v. Dr. Reddy’s Labs., 359 F.3d 1361 (Fed. Cir. 2004) (“Pfizer II”) to support the Office’s interpretation of the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active moiety” (i.e., the molecule in a drug product responsible for pharmacological action, regardless of whether the active moiety is formulated as a salt, ester, or other non-covalent derivative) rather than “active ingredient” (i.e., the active ingredient physically found in the drug product, which would include any salt, ester, or other non-covalent derivative of the active ingredient physically found in the drug product). In contrast, the Federal Circuit’s 1990 decision in Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir.

  7. VA District Court Grants PhotoCure’s Summary Judgment Motion Challenging PTO’s “First Permitted Commercial Marketing” Interpretation for METVIXIA PTE

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstApril 2, 2009

    Specifically, under 35 U.S.C. § 156(a)(5)(A), the term of a patent claiming a drug shall be extended from the original expiration date of the patent if, among other things, “the permission for the commercial marketing or use of the product . . . is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred” (emphasis added). In recent PTE determinations, the PTO has heavily relied on decisions by the U.S. Court of Appeals for the Federal Circuit in Fisons v. Quigg, 8 U.S.P.Q.2d 1491 (D.D.C.1988), aff’d 876 F.2d 99 U.S.P.Q.2d 1869 (Fed.Cir.1989), and Pfizer Inc. v. Dr. Reddy’s Labs., 359 F.3d 1361 (Fed. Cir. 2004) (“Pfizer II”), to support the Office’s interpretation of the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active moiety” (i.e., the molecule in a drug product responsible for pharmacological action, regardless of whether the active moiety is formulated asa salt, ester, or other non-covalent derivative) rather than “active ingredient” (i.e., the active ingredient physically found in thedrug product,which would include any salt, ester, or other non-covalent derivativeof the active ingredient physically found in the drug product). In contrast, the Federal Circuit’s 1990 decision in Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir.

  8. PTO Denies PTE for PRILOSEC OTC; SYMBICORT PTE Decision Likely to Follow Suit; Litigation Seems a Likely Possibility

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstJanuary 4, 2009

    tatute at 35 U.S.C. § 156, the term of a patent claiming a drug shall be extended from the original expiration date of the patent if, among other things, the PTE application is submitted to the PTO by the owner of record within 60 days of NDA approval (specifically, the statute states that a PTE application “may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use” (emphasis added)), and if “the permission for the commercial marketing or use of the product . . . is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.” In recent PTE memoranda, the PTO has heavily relied on decisions by the U.S. Court of Appeals for the Federal Circuit in Fisons v. Quigg, 8 U.S.P.Q.2d 1491 (D.D.C.1988), aff’d 876 F.2d 99 U.S.P.Q.2d 1869 (Fed.Cir.1989), Pfizer Inc. v. Dr. Reddy’s Labs., 359 F.3d 1361 (Fed. Cir. 2004), and Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir. 1990) to support the Office’s interpretation of the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active moiety” (i.e., the molecule in a drug product responsible for pharmacological action, excluding any salt, ester, or other non-covalent derivative) rather than the entire molecule (i.e., the active moiety in a drug product, including any salt, ester, or other non-covalent derivative).

  9. PhotoCure Sues PTO after the Office Denies a PTE for METVIXIA; Lawsuit Challenges PTO’s “First Permitted Commercial Marketing” Interpretation

    Hyman, Phelps & McNamara, P.C.July 28, 2008

    PhotoCure’s lawsuit comes on the heels of several recent PTO decisions denying a PTE based on the “first permitted commercial marketing” criterion.Under the PTE statute at 35 U.S.C. § 156(a)(5)(A), the term of a patent claiming a drug shall be extended from the original expiration date of the patent if “the permission for the commercial marketing or use of the product . . . is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.”In recent PTE memoranda, the PTO has heavily relied on decisions by the U.S. Court of Appeals for the Federal Circuit in Fisons v. Quigg, 8 U.S.P.Q.2d 1491 (D.D.C.1988), aff’d 876 F.2d 99 U.S.P.Q.2d 1869 (Fed.Cir.1989), Pfizer Inc. v. Dr. Reddy’s Labs., 359 F.3d 1361 (Fed. Cir. 2004), and Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir. 1990) to support the Office’s interpretation of the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active moiety” (i.e., the molecule in a drug product responsible for pharmacological action, excluding any salt, ester, or other non-covalent derivative) rather “active ingredient” (i.e., the active moiety in a drug product, including any salt, ester, or other non-covalent derivative).