Case Briefing

Move to Missouri Denied

Defendants failed to show that a change of venue from New York to Missouri was warranted, as the bulk of the witnesses were nearer the New York venue than the Missouri court to which transfer was sought, and certain non-party witnesses living within 100 miles of the New York court were subject to subpoena under Fed. R. Civ. P. 45(c)(3) and could be compelled to appear by Fed. R. Civ. P. 45(c)(3)(A)(ii) in New York, but could not be compelled to appear in Missouri. Lynch v. National Prescription Administrators, 2004 U.S. Dist. LEXIS 3134 (S.D.N.Y. 2/27/04).

The trustee of the Health and Welfare Fund of the Patrolmen's Benevolent Association of the City of New York (PBA) and the Retiree Health and Welfare Fund of the PBA alleged breach of fiduciary duty. After defendant Pharmacy Benefit Manager acquired National Prescription Administrators (NPA) from plaintiff, plaintiff alleged that NPA and defendant breached their fiduciary duty by benefiting from various “pricing spreads” and “kickbacks” from the drug manufacturers.

The court denied defendants' motion to transfer to the Eastern District of Missouri pursuant to 28 USC ' 1404(a), noting that although defendant's headquarters are located in St. Louis and at least some records and witnesses relevant to the case may be found in Missouri, defendants didn't established that the convenience of the witnesses as a whole would be increased through transfer of venue. NPA employees comprise most of the key witnesses, many of whom reside in the New York/New Jersey area.

Patent Term Extension Covers Drug Product and Its Salt Esters

The U.S. Court of Appeals for the Federal Circuit reversed the judgment of the U.S. District Court for the District of New Jersey, which had held that Dr. Reddy's Laboratories did not infringe the extended term of Pfizer's U.S. Patent No. 4,572,909 (the '909 patent) claiming certain dihydropyridine compounds and their acid addition salts. Pfizer Inc. v. Dr. Reddy's Laboratories, Ltd., 2004 U.S. App. LEXIS 3784 (Fed. Cir. 2/27/04).

Pfizer obtained federal registration of an anti-hypertensive, anti-ischemic drug product whose active ingredient is amlodipine, as the besylate salt. In obtaining the registration, Pfizer submitted clinical data acquired using both amlodipine besylate and amlodipine maleate. Pfizer eventually selected the besylate salt for ease of tableting. The 17-year term of Pfizer's patent, which claims certain dihydropyridine compounds and their acid addition salts, including the compound having the common name amlodipine, and its salts, ended on Feb. 25, 2003. The patent was, however, extended for 1252 days, until July 31, 2006, measured as a portion of the time consumed by the federal regulatory approval process, as authorized by the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (the Hatch-Waxman Act).

In Pfizer's application to the PTO requesting term extension under 35 U.S.C. ' 156, it identified Norvasc' as the product for which regulatory approval had been obtained, and stated that Norvasc' was “further identified” as amlodipine besylate.

In December 2001 Dr. Reddy's filed a new drug application, known as a “paper NDA,” under 21 U.S.C. ' 355(b)(2), proposing to market amlodipine as the maleate salt, for the uses for which Pfizer had obtained federal approval, based on the data that Pfizer had provided to the FDA. Dr. Reddy's acknowledged that amlodipine maleate is covered by the claims of the '909 patent, but argued that the term extension applied only to the besylate salt because that is the registered product. The district court agreed with Dr. Reddy's.

On appeal, the Federal Circuit noted that 35 U.S.C. ' 156(f) defines “the drug product” as including “any salt or ester of the active ingredient.” The FDA has ruled, “The term 'active ingredient' as used in the phrase 'active ingredient including any salt or ester of the active ingredient' means active moiety.” Abbreviated New Drug Application Regulations: Patent Exclusivity Provisions, 59 Fed. Reg. 50,338, 50,358 (F.D.A. Oct. 3 1994). In addition, the FDA has defined “active moiety” as “the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt … responsible for the physiological or pharmacological action of the drug substance.” 21 C.F.R. ' 314.108(a). Because of these previous interpretations of statutory terms, the Federal Circuit found that the district court misconstrued the statute in holding that the extended patent term did not cover any amlodipine salts except the besylate. The court stated, “The act by its terms extended the term of the patent for the registered uses of the drug product including its salt esters. The 'rights derived' provision of '156(b) specifically limits the extension to 'any use approved for the product,' which means that other, eg, non-pharmaceutical uses, are not subject to the extension. That provision does not contain any limitation regarding the form of the product subject to the extension. In fact, ' 156(f) clearly provides otherwise, in defining the term 'product' as 'including any salt or ester of the active ingredient.'”

Thus, the court held that Dr. Reddy's attempt to limit the extension to the specific approved salt on the basis of the “rights derived” provision of ' 156(f) to the approved product was unsound, and concluded that the extended term of the '909 patent covers amlodipine and any salt or ester, as provided by ' 156(f) and as claimed in claims 1, 7, and 8 of the '909 patent. As the extension was not limited to the besylate salt of amlodipine, the judgment of non-infringement and ensuing dismissal was reversed.

Suicide Can't Be Blamed on Pfizer's Failure to Warn

The U.S. Court of Appeals for the Ninth Circuit has held that a product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the conduct of the prescribing physician. Motus v. Pfizer Inc. , 2004 U.S. App. LEXIS 1944 (9th Cir. 2/9/04).

Plaintiff claimed that her husband suffered from an adverse reaction to the drug Zoloft', leading him to commit suicide. She argued that Pfizer, as Zoloft's manufacturer, was liable because the company failed to provide adequate warnings to doctors of alleged side effects associated with the antidepressant. The district court granted Pfizer's motion for summary judgment, holding that plaintiff failed to establish a sufficient causal link between her husband's suicide and Pfizer's conduct. The Ninth Circuit affirmed, finding that warnings for the drug were intended to be read by the prescribing physician, not the end-user of the product. Because the physician in the present case testified that he didn't read the warning literature at all, a stronger warning would have had no effect on the decedent's care. Thus, even if the warnings should have been stronger, the lack of such a warning was not a proximate cause of decedent's suicide.

Move to Missouri Denied

Defendants failed to show that a change of venue from New York to Missouri was warranted, as the bulk of the witnesses were nearer the New York venue than the Missouri court to which transfer was sought, and certain non-party witnesses living within 100 miles of the New York court were subject to subpoena under Fed. R. Civ. P. 45(c)(3) and could be compelled to appear by Fed. R. Civ. P. 45(c)(3)(A)(ii) in New York, but could not be compelled to appear in Missouri. Lynch v. National Prescription Administrators, 2004 U.S. Dist. LEXIS 3134 (S.D.N.Y. 2/27/04).

The trustee of the Health and Welfare Fund of the Patrolmen's Benevolent Association of the City of New York (PBA) and the Retiree Health and Welfare Fund of the PBA alleged breach of fiduciary duty. After defendant Pharmacy Benefit Manager acquired National Prescription Administrators (NPA) from plaintiff, plaintiff alleged that NPA and defendant breached their fiduciary duty by benefiting from various “pricing spreads” and “kickbacks” from the drug manufacturers.

The court denied defendants' motion to transfer to the Eastern District of Missouri pursuant to 28 USC ' 1404(a), noting that although defendant's headquarters are located in St. Louis and at least some records and witnesses relevant to the case may be found in Missouri, defendants didn't established that the convenience of the witnesses as a whole would be increased through transfer of venue. NPA employees comprise most of the key witnesses, many of whom reside in the New York/New Jersey area.

Patent Term Extension Covers Drug Product and Its Salt Esters

The U.S. Court of Appeals for the Federal Circuit reversed the judgment of the U.S. District Court for the District of New Jersey, which had held that Dr. Reddy's Laboratories did not infringe the extended term of Pfizer's U.S. Patent No. 4,572,909 (the '909 patent) claiming certain dihydropyridine compounds and their acid addition salts. Pfizer Inc. v. Dr. Reddy's Laboratories, Ltd., 2004 U.S. App. LEXIS 3784 (Fed. Cir. 2/27/04).

Pfizer obtained federal registration of an anti-hypertensive, anti-ischemic drug product whose active ingredient is amlodipine, as the besylate salt. In obtaining the registration, Pfizer submitted clinical data acquired using both amlodipine besylate and amlodipine maleate. Pfizer eventually selected the besylate salt for ease of tableting. The 17-year term of Pfizer's patent, which claims certain dihydropyridine compounds and their acid addition salts, including the compound having the common name amlodipine, and its salts, ended on Feb. 25, 2003. The patent was, however, extended for 1252 days, until July 31, 2006, measured as a portion of the time consumed by the federal regulatory approval process, as authorized by the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (the Hatch-Waxman Act).

In Pfizer's application to the PTO requesting term extension under 35 U.S.C. ' 156, it identified Norvasc' as the product for which regulatory approval had been obtained, and stated that Norvasc' was “further identified” as amlodipine besylate.

In December 2001 Dr. Reddy's filed a new drug application, known as a “paper NDA,” under 21 U.S.C. ' 355(b)(2), proposing to market amlodipine as the maleate salt, for the uses for which Pfizer had obtained federal approval, based on the data that Pfizer had provided to the FDA. Dr. Reddy's acknowledged that amlodipine maleate is covered by the claims of the '909 patent, but argued that the term extension applied only to the besylate salt because that is the registered product. The district court agreed with Dr. Reddy's.

On appeal, the Federal Circuit noted that 35 U.S.C. ' 156(f) defines “the drug product” as including “any salt or ester of the active ingredient.” The FDA has ruled, “The term 'active ingredient' as used in the phrase 'active ingredient including any salt or ester of the active ingredient' means active moiety.” Abbreviated New Drug Application Regulations: Patent Exclusivity Provisions, 59 Fed. Reg. 50,338, 50,358 (F.D.A. Oct. 3 1994). In addition, the FDA has defined “active moiety” as “the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt … responsible for the physiological or pharmacological action of the drug substance.” 21 C.F.R. ' 314.108(a). Because of these previous interpretations of statutory terms, the Federal Circuit found that the district court misconstrued the statute in holding that the extended patent term did not cover any amlodipine salts except the besylate. The court stated, “The act by its terms extended the term of the patent for the registered uses of the drug product including its salt esters. The 'rights derived' provision of '156(b) specifically limits the extension to 'any use approved for the product,' which means that other, eg, non-pharmaceutical uses, are not subject to the extension. That provision does not contain any limitation regarding the form of the product subject to the extension. In fact, ' 156(f) clearly provides otherwise, in defining the term 'product' as 'including any salt or ester of the active ingredient.'”

Thus, the court held that Dr. Reddy's attempt to limit the extension to the specific approved salt on the basis of the “rights derived” provision of ' 156(f) to the approved product was unsound, and concluded that the extended term of the '909 patent covers amlodipine and any salt or ester, as provided by ' 156(f) and as claimed in claims 1, 7, and 8 of the '909 patent. As the extension was not limited to the besylate salt of amlodipine, the judgment of non-infringement and ensuing dismissal was reversed.