VIAGRA Patent Decision Gives Rise to Dispute Over ANDA Approval, Concern About 180-Day Exclusivity Forfeiture; Court Rigidly Applies Patent Statute

By Kurt R. Karst –      

A recent decision out of the U.S. District Court for the Eastern District of Virginia that Teva Pharmaceuticals USA, Inc.’s (“Teva’s”) generic version of Pfizer Inc.’s (“Pfizer’s”) VIAGRA (sildenafil citrate) Tablets would infringe Orange Book-listed U.S. Patent No. 6,469,012 (“the ‘012” patent), which expires on October 22, 2019, and that the ‘012 patent is valid and enforceable, spawned an interesting Hatch-Waxman dispute between the companies.  Teva is reportedly a first applicant eligible for a period of 180-day exclusivity. 

The court’s August 16, 2011 judgment stated:

IT IS ORDERED AND ADJUDGED that Teva Pharmaceuticals USA, Inc.'s Motion to Dismiss for Lack of Standing is GRANTED IN PART, and Pfizer Ireland Pharmaceuticals Co. is DISMISSED from this litigation; that judgment is entered for Pfizer Inc. and Pfizer Ltd. on the Amended Complaint and Amended Counterclaim, in accordance with the Court’s Opinion and Final Order which found that Pfizer Inc. and Pfizer Ltd. did not commit inequitable conduct in the prosecution of United States Patent No. 6,469,012; that Teva Pharmaceuticals USA, Inc.’s proposed generic equivalent of Viagra would INFRINGE United States Patent No. 6,469,012, and that United States Patent No. 6,469,012 is VALID and ENFORCEABLE.

Shortly after the court entered its judgment, Pfizer filed a motion to amend the judgment to add that the effective date of the approval of Teva’s tentatively approved ANDA No. 077342 shall be no earlier than October 22, 2019 when the ‘012 patent expires.  According to Pfizer, “[t]o give effect to the Opinion and Final Order,” the court should, consistent with 35 U.S.C. § 271(e)(4)(A), amend its judgment to add that the effective date of approval of ANDA No. 77-342 shall be no earlier than the date of the expiration of the ‘012 patent on October 22, 2019.

Under the patent statute at 35 U.S.C. § 271(e)(4), certain remedies are available for “acts of infringement” based on the submission of an ANDA containing a Paragraph IV certification.  Specifically, 35 U.S.C. § 271(e)(4)(A) states that for such acts of infringement, “the court shall order the effective date of any approval of the drug . . . product involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed.” 

Teva, which did not consent to Pfizer’s motion, and which has since appealed the court’s decision to the U.S. Court of Appeals for the Federal Circuit, argued in its opposition brief, that the court’s judgment should be amended to include the following provision:

the effective date of the final approval of Teva Pharmaceuticals USA, Inc.’s Abbreviated New Drug Application No. 77-342 shall be no earlier than the date of the expiration of United States Patent No. 6,469,012, or the date of a decision by the United States Court of Appeals for the Federal Circuit that Claims 25 and 26 of United States Patent No. 6,469,012 are invalid or unenforceable, whichever date is earlier.

According to Teva, FDC Act § 505(j)(5)(B)(iii)(II)(aa), which states that “if the judgment of the district court is appealed, the approval shall be made effective on – (AA) the date on which the court of appeals decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity),” contemplates approval in accordance with Teva’s proposed provision. 

Moreover, Teva states that the company is “entitled to final approval of its ANDA if the [Federal Circuit] decides that Claims 25 and 26 of the ‘012 patent are invalid or cannot be enforced,” and that “[i]f the Federal Circuit invalidates or holds Claims 25 and 26 unenforceable in some other case, there is no reason why Teva should have to delay marketing its proposed sildenafil ANDA product to persuade this Court that the Federal Circuit’s decision should be given effect.” 

Why is Teva concerned?  Because of the failure-to-market 180-day exclusivity forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I), and specifically the “later of” subitem (bb) event.  Under FDC Act § 505(j)(5)(D)(i)(I)(bb)(AA), 180-day exclusivity eligibility can be forfeited on the date that is 75 days after “a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed” in a patent infringement lawsuit involving the exclusivity-qualifying patent(s) and either a first applicant or any subsequent applicant that has a tentatively approved ANDA for the drug.  “If for any reason, including lack of FDA approval, Teva fails to begin marketing its ANDA product within 75 days of such a Federal Circuit ruling, Teva would forfeit its 180-day period of generic exclusivity,” says the company in its brief.  Pfizer, for its part, says in its reply brief that Teva failed to justify any departure from the court using the language at 35 U.S.C. § 271(e)(4)(A) in an amended judgment.

The court, in its decision granting Pfizer’s motion and denying Teva’s request, says that it was not persuaded that a departure from the statutory language at 35 U.S.C. § 271(e)(4)(A) is warranted. 

Teva points to 21 U.S.C. § 355(j)(5)(B)(iii)(II)(aa) as contemplating an earlier effective date for approval of an ANDA, specifically the date of a subsequent Federal Circuit decision in its favor.  However, 21 U.S.C. § 355(j)(5)(B)(iii)(II) does not seem to be in conflict with 35 U.S.C. § 271(e)(4)(A); indeed, the section goes on to expressly cite 35 U.S.C. § 271(e)(4)(A), stating ‘if the judgment of the district court is not appealed or affirmed, the approval shall be made effective on the date specified by the district court in a court order under [35 U.S.C. § 271(e)(4)(A)].’ . . .  The two statutes seem to be sufficiently harmonized and turn on the outcome of the appeal of the present case.  But 21 U.S.C. § 355(j)(5)(B)(iii)(II) cannot be read to instruct that the court can, let alone should, prospectively impose any effective date for an ANDA under 35 U.S.C. § 271(e)(4)(A) earlier than the one expressly proscribed by statute. [(Emphasis in original)]

While the court notes Teva’s concern about 180-day exclusivity forfeiture, that concern does not, according to the court, provide sufficient reason for the court to depart from the statutory language of 35 U.S.C. § 271(e)(4)(A) – even if the court has discretion to authorize an effective date for ANDA No. 077342 earlier than October 22, 2019.