PTO Challenged After Denying a Patent Term Extension Based on First Commercial Marketing or Use Grounds

By Kurt R. Karst –      

The U.S. Patent and Trademark Office (“PTO”) has been sued once again after denying a Patent Term Extension (“PTE”) request.  The latest case in a long line of lawsuits concerns U.S. Patent No. 5,206,248 (“the ‘248 patent”), which is listed in FDA’s Orange Book as a method-of-use patent covering Avanir Pharmaceuticals Inc.’s (“Avanir’s”) NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) Capsules, and that is scheduled to expire on March 27, 2012.  The Complaint, filed last week by Avanir and the Center for Neurologic Study in the U.S. District Court for the Eastern District of Virginia (Alexandria Division), alleges that the PTO’s December 20, 2011 decision denying Plaintiffs’ PTE application for the ‘248 patent (Docket No. FDA-2011-E-0269) violated the Administrative Procedure Act (“APA”).  Plaintiffs request that the court vacate and set aside the PTO’s decision and order the PTO to extend the term of the ‘248 patent for the full period required under the PTE statute at 35 U.S.C. § 156. 

FDA approved NUEDEXTA on October 29, 2010 under NDA No. 021879 for the treatment of pseudobulbar affect (“PBA”).  NUEDEXTA is the first and only FDA-approved treatment for PBA.  PBA is a neurological condition sometimes referred to as “emotional incontinence” that is characterized by sudden outbursts of involuntary crying and/or laughing in patients with underlying neurological disease or injury.  In addition to the ‘248 patent, NUEDEXTA is listed in the Orange Book as covered by two additional patents – U.S. Patent Nos. 7,659,282, which expires on August 13, 2026, and RE 38,115 (“the ‘115 patent”), which expires on January 26, 2016 – and a period of 3-year exclusivity (new combination) that expires on October 29, 2013.  (Plaintiffs submitted a second PTE application to the PTO with respect to the ‘115 patent – Docket No. FDA-2011-E-0268.  The PTO also denied that PTE application on December 20, 2011; however, the ‘115 patent is not identified in the Complaint.)

Under the PTE statute 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 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.”   While Plaintiffs acknowledge in their PTE application that “dextromethorphan-containing products have previously been sold in the United States,” they contend that “the approval of dextromethorphan hydrobromide in NUEDEXTA™” meets the “first permitted commercial marketing or use” prong of the PTE statute.  Specifically, according to the Plaintiffs in their PTE application:

The provision of law under which the dextromethorphan hydro bromide active ingredient in NUEDEXT A™ was subject to a regulatory review period is section 505 of the FFDCA as amended by the [1984 Hatch-Waxman Amendments].  To the best of Applicant's knowledge, dextromethorphan-containing products sold prior to 1962 were not subject to a “regulatory review period” as defined under section 156(g), and were permitted to be marketed under a provision of law different from the provision of law under which NUEDEXTA™ was studied, reviewed, and approved.  To the best of Applicant’s knowledge, dextromethorphan-containing products sold after 1962 have been marketed under the [FDA’s] Over-the-Counter Drug Review, and not under the provision of law under which NUEDEXTA ™ was studied, reviewed, and approved (35 U.S.C. § 156(a)(5)(A)).

Plaintiffs also proactively address in their PTE application the 1989 decision in Westwood v. Quigg, 13 U.S.P.Q.2d 2067 (D.D.C. 1989), which affirmed a PTE denial by the PTO for a drug that first came to market before 1962.  Plaintiffs maintain, however, “that Westwood was wrongly decided, is distinguishable, and would not withstand scrutiny today.  Among other reasons, the court erred in failing to apply the FFDCA as it existed at the time it was amended by the [1984 Hatch-Waxman Amendments].”

Not convinced by Plaintiffs’ arguments, the PTO denied the ‘248 patent PTE application after receiving notification from FDA that both the dextromethorphan hydrobromide and quinidine sulfate components in NUEDEXTA had each been approved for commercial marketing or use prior to the approval of NDA No. 021879.  Among other things, the PTO cites in its denial the Federal Circuit’s decision in Arnold P'ship v. Dudas, 362 F.3d 1338, 1341 (Fed. Cir. 2004), concerning a PTE denial for VICOPROFEN (ibuprofen and hydrocodone bitartrate), the Westwood decision, and a 2007 decision from FDA concerning PTE ineligibility for a patent concerning BiDil (isosorbide dinitrate and hydralazine hydrochloride) Tablets (a copy of which is attached to the PTO’s ‘248 patent PTE decision).  Referencing the BiDil case, the PTO states:

Applicant is mistaken in its reading of § 156(a)(5)(A).  As previously explained by FDA in a similar situation, FDA maintains that the phrase “provision of law” refers “to the statutory provision under which the regulatory review occurs for a particular class of products that is eligible for patent term restoration, regardless of whether that statutory provision is amended.”  The FDA stated there, and the USPTO concurs, that the phrase is unambiguous on its face.  However, as explained in the 2007 FDA letter, even if the phrase is ambiguous, this interpretation is permissible in light of legislative intent, public policy concerns, and applicable case law.  There is no suggestion in the legislative history that the phrase “first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred” as used in § 156(a)(5)(A) is intended to treat amended versions of section 505 as different provisions of law.  Rather, as explained by the FDA at page 6 of the 2007 FDA letter, to treat each different amended version of section 505 as a different provision of law would contravene the legislative intent of Congress by allowing the term of more than one patent to be extended if a product received more than one approval as a member of a particular class of products.

(Interestingly, a somewhat similar dispute arose a few years ago after the enactment of the QI Act concerning so-called “old” antibiotics.  In that case, Citizen Petitions were submitted to FDA arguing, among other things, that the plain language of the QI Act directs FDA to apply the relevant statutory provisions of the Hatch-Waxman Amendments as they were enacted in 1984, not as subsequently amended by Congress.  FDA ruled otherwise.  See our previous post here.)

In their Complaint, Plaintiffs first argue that “the PTO erroneously defined the relevant ‘product’ for purposes of 35 U.S.C. § 156 as either dextromethorphan alone or quinidine alone.”  “Taken by themselves,” contend Plaintiffs, “dextromethorphan is a cough suppressant and quinidine treats heart arrhythmias and neither dextromethorphan nor quinidine alone has any effect on PBA.  However, together in Nuedexta®, the dextromethorphan/quinidine is a wholly new active ingredient that treats PBA.  The ‘248 patent covers this use of dextromethorphan/quinidine.”  Second, Plaintiffs argue that “the PTO erroneously determined that dextromethorphan has previously been the subject of a ‘regulatory review period’ under the same ‘provision of law’ under which Nuedexta® was approved.”  Not only is the conclusion misplaced based on the dextromethorphan/quinidine argument, contend Plaintiffs, but the PTO’s denial violates the APA “even if dextromethorphan alone is considered the active ingredient in Nuedexta®.”  According to the Plaintiffs:

[I]t is undisputed that Nuedexta® was approved for commercial marketing under the version of [FDC Act § 505] in effect on October 29. 2010, which requires proof of efficacy as well as safety. . . .  It is also undisputed that all other dextromethorphan products were approved by FDA under the pre-1962 version of [FDC Act § 505], which required no proof of efficacy, and no “regulatory review period.”  Despite these undisputed facts, FDA arbitrarily and capriciously found that the pre-1962 dextromethorphan products have been the subject of a “regulatory review period” and denied Avanir’s request for a PTE.

After all, write Plaintiffs, for NDAs submitted prior to the enactment of the 1962 Drug Efficacy Amendments, “FDA neither ‘reviewed’ nor ‘approved’ these NDAs before the products could be marketed. Instead, by operation of the statute, NDAs became automatically effective 60 days after they were filed, unless the FDA determined that it needed more time to ‘study and investigate the application’” (citing FDC Act § 505(c) (1938)).

Strap yourself in for another exciting ride on the PTE litigation train.