Brief by: Wayne Xu
Case Name: Wyeth v. Lupin Ltd.
Case Cite: 505 F.Supp.2d 303
Facts: Wyeth owns three patents, all of which are entitled “Extended Release Formulation of Venlafxine Hydrochloride.†Wyeth uses the patents to manufacture and distribute EFFEXOR. Lupin is a generic drug company based in india. On September 30, 2006, Luppin filed an Abbreviated New Drug Application (“ANDAâ€) with the FDA seeking approval to market and manufacture a generic version of EFFEXOR. LPI acted as Lupin’s registered agent for the ANDA filing. LPI is the wholly owned U.S. subsidiary of Lupin. On January 30, 2007, Wyeth received notification from Lupin that it had filed the ANDA. Wyeth filed suit against Lupin and LPI on March 12, 2007.
LPI contends that inducement liability does not exist for entities that were not the named ANDA filers; LPI is not a named ANDA filer.
Procedural Posture: This court considers summary judgment filed by the Defendant.
How the ANDA process works: The ANDA process allows a generic drug company to seek expedited approval of an already approved drug. When filing the ANDA, the generic drug manufacture must certify its belief in the status of the patnet. The ANDA applicant certifies that the relevant patents are either “invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.†After filing the certification, the generic drug manufacture must notify the patentee, who then may decide whether to sue the applicant for infringement. If the ANDA applicant resides outside the U.S., the application is required to contain the name and address of, and be countersigned by, an attorney, agent, or other authorized official who resides or maintains a place of business within the US. LPI serves this role for Lupin.
Issue: Was there an induced infringement?
Rule: Whoever actively induces infringement of a patent shall be liable as an infringer. To be liable for inducement, the inducing party must know or have reason to know that the activities alleged would induce infringement, and specifically intend to aid in infringement.
Holding: As there was an induced infringement.
Reasoning / Analysis: The act of filing an ANDA is not by itself a sufficient act to produce infringement liability. In the cases that stated that (Allergan, Warner-Lambert), the Federal Circuit precluded inducement claims against ANDA applicants that were not seeking FDA approval for the uses claimed in the patent and the uses were not FDA-Approved. In contrast, LPI and Lupin are seeking to manufacture and distribute a generic version of Wyeth’s EFFEXOR capsules for their patented and FDA-Approved use. Therefore, liability attaches.
LIP actively induced infringement because it was actively involved in the ANDA submission process, aided and abetted the inducement of the patents-in-suit, and upon FDA approval, will infringe the patents-in-suit by making, using, offering to sell, selling and/or importing Lupin’s capsules.
Future Importance: The price on generic drugs imported from other countries may rise because of the increased safeguards that companies like LPI must undertake in order to make sure they do not “induce†infringement.
Case Name: Wyeth v. Lupin Ltd.
Case Cite: 505 F.Supp.2d 303
Facts: Wyeth owns three patents, all of which are entitled “Extended Release Formulation of Venlafxine Hydrochloride.†Wyeth uses the patents to manufacture and distribute EFFEXOR. Lupin is a generic drug company based in india. On September 30, 2006, Luppin filed an Abbreviated New Drug Application (“ANDAâ€) with the FDA seeking approval to market and manufacture a generic version of EFFEXOR. LPI acted as Lupin’s registered agent for the ANDA filing. LPI is the wholly owned U.S. subsidiary of Lupin. On January 30, 2007, Wyeth received notification from Lupin that it had filed the ANDA. Wyeth filed suit against Lupin and LPI on March 12, 2007.
LPI contends that inducement liability does not exist for entities that were not the named ANDA filers; LPI is not a named ANDA filer.
Procedural Posture: This court considers summary judgment filed by the Defendant.
How the ANDA process works: The ANDA process allows a generic drug company to seek expedited approval of an already approved drug. When filing the ANDA, the generic drug manufacture must certify its belief in the status of the patnet. The ANDA applicant certifies that the relevant patents are either “invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.†After filing the certification, the generic drug manufacture must notify the patentee, who then may decide whether to sue the applicant for infringement. If the ANDA applicant resides outside the U.S., the application is required to contain the name and address of, and be countersigned by, an attorney, agent, or other authorized official who resides or maintains a place of business within the US. LPI serves this role for Lupin.
Issue: Was there an induced infringement?
Rule: Whoever actively induces infringement of a patent shall be liable as an infringer. To be liable for inducement, the inducing party must know or have reason to know that the activities alleged would induce infringement, and specifically intend to aid in infringement.
Holding: As there was an induced infringement.
Reasoning / Analysis: The act of filing an ANDA is not by itself a sufficient act to produce infringement liability. In the cases that stated that (Allergan, Warner-Lambert), the Federal Circuit precluded inducement claims against ANDA applicants that were not seeking FDA approval for the uses claimed in the patent and the uses were not FDA-Approved. In contrast, LPI and Lupin are seeking to manufacture and distribute a generic version of Wyeth’s EFFEXOR capsules for their patented and FDA-Approved use. Therefore, liability attaches.
LIP actively induced infringement because it was actively involved in the ANDA submission process, aided and abetted the inducement of the patents-in-suit, and upon FDA approval, will infringe the patents-in-suit by making, using, offering to sell, selling and/or importing Lupin’s capsules.
Future Importance: The price on generic drugs imported from other countries may rise because of the increased safeguards that companies like LPI must undertake in order to make sure they do not “induce†infringement.