Snowball Effect: The Incidence of Premature Paragraph IV Certification Notice Grows

By Kurt R. Karst –      

It was just a little more than three months ago that we blogged on the topic of “premature notice” in the context of a Complaint filed by Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) against Par Pharmaceutical, Inc. (“Par”) concerning Par’s notice of a Paragraph IV certification contained in an ANDA Par submitted to FDA for a generic version of SAMSCA (tolvaptan) Tablets.  Since then, we’ve noticed an uptick in the number of premature notices being sent out by ANDA applicants.  (We neither take any credit, nor any blame for any increase in premature notices.)  Different notice recipients – i.e., NDA holders and patent owners – have chosen different ways to deal with those premature notices . . . unless, of course, the recipient is not even aware that it has received premature notice.     

By way of background, an ANDA applicant (or 505(b)(2) applicant) that certifies Paragraph IV to a patent listed in the Orange Book for the listed drug relied on, or RLD, must provide notice of that certification to the NDA sponsor and patent owner.  FDC Act § 505(j)(2)(B)(ii) governs the timing of sending that notice.  It states:

(ii) TIMING OF NOTICE.—An applicant that makes a [Paragraph IV] certification . . . shall give notice as required under this subparagraph—

(I) if the certification is in the application, not later than 20 days after the date of the postmark on the notice with which the Secretary informs the applicant that the application has been filed; or

(II) if the certification is in an amendment or supplement to the application, at the time at which the applicant submits the amendment or supplement, regardless of whether the applicant has already given notice with respect to another such certification contained in the application or in an amendment or supplement to the application.

Notice sent prior to FDA’s acceptance of an original ANDA is considered premature and ineffective.  Some NDA holders/patent owners have decided not to act on premature notice, as seems to be the case with VASCEPA (icosapent ethyl) Capsules, as recently reported by Amarin here on page 31 (and here as well).  Others, however, have sued for infringement after receiving premature notice, perhaps out of an abundence of caution.  Such an action, although without any regulatory significance insofar as FDA is concerned, could result in ANDA approval earlier than if notice was timely sent.  As the court in SB Pharmco Puerto Rico, Inc. v. Mutual Pharm. Co, Inc., 552 F. Supp. 2d 500 (E.D. Pa. 2008), pointed out: premature certification could lead to manipulation of the Hatch-Waxman scheme by “accelerat[ing] the timing provisions and litigation process well beyond the framework that Congress intended.”  

Of course, if patent infringement litigation initiated as a result of premature notice is nipped in the bud – i.e., if a case is dismissed before litigation arising from later and valid notice is initiated and made a part of the first case – then it all may be water under the bridge.  That seems to be the case with SAMSCA.  After Otsuka filed a Motion for Judgment on the Pleadings and the motion was briefed (see here and here), the district court issued an Order granting Otsuka’s request that Par’s notice be considered improper, null, void, and without legal effect, among other things.  In the meantime, FDA’s Paragraph IV Certifications List still does not indicate that the Agency has received (i.e., filed) and ANDA with a Paragraph IV certification for a generic version of SAMSCA.

A similar fact pattern is playing out in the U.S. District Court for the Eastern District of Texas, where Allergan, Inc. (“Allergan”) recently filed a Complaint against Watson Laboratories and Actavis Pharma alleging premature notice concerning generic RESTASIS (cyclosporine ophthalmic emulsion) 0.05%.  Allergan is seeking, among other things, a “Declaratory Judgment of False Paragraph IV Notification.”  Allergan filed suit notwithstanding receiving confirmation from FDA in a letter that Watson’s ANDA was not yet received.

Another interesting case is generic EFFIENT (prasugrel HCL) Tablets, 5 mg and 10 mg.  In that case, Par sent notice to Eli Lilly and Company (“Lilly”) in December 2013 “stating that Par had included within its ANDA” a Paragraph IV certification to certain patents listed in the Orange Book for EFFIENT.  At that time, FDA’s Paragraph IV Certifications List did not identify that FDA had received a Paragraph IV ANDA for generic EFFIENT.  Indeed, the list was not updated with such information until February 4, 2012, despited having been updated on January 6 and January 23, 2014 with information on other drugs.  Lilly filed a Complaint on January 23, 2014 alleging infringement; however, Lilly’s Complaint is silent with respect to premature notice.  Apparently Lilly was unaware that Par’s notice was prematurely sent. 

That apparent oversight seems to have been subsequently realized when Lilly filed a Complaint against Par and several other ANDA applicants on March 12, 2014.  According to the Complaint:

377. On or about December 9, 2013, Par sent Lilly, Daiichi Sankyo, and Ube a letter, dated December 9, 2013, and an attached memorandum (collectively, the “December Par Notification”) stating that Par had included within its ANDA a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ’703 and ’325 patents are invalid, unenforceable, and/or will not be infringed by the manufacture, use, importation, sale or offer for sale of the Par Products in the United States (“Paragraph IV Certification”).

378. Plaintiffs filed suit against Par Pharmaceutical in this judicial district on January 23, 2014, 1:14-cv-00109-SEB-TAB, and Par Pharmaceutical filed its Answer on February 28, 2014.

379. On or about January 31, 2014, Par sent Lilly, Daiichi Sankyo, and Ube a second letter, dated January 31, 2014, and an attached memorandum (collectively, the “January Par Notification”) repeating that Par had included a Paragraph IV Certification within the Par ANDA.

380. Unlike the December Par Notification, the January Par Notification represented that the FDA received the Par ANDA for substantive review.

381. Plaintiffs are therefore filing the instant Complaint against Par Pharmaceutical to preserve its right for a 30-month stay under 21 U.S.C. 355(j)(5)(B)(iii) and 21 U.S.C. 355(c)(3)(E)(ii) in response to the January Par Notification.

So what is FDA doing to halt the practice of a company sending out premature notice?  We’re not exactly sure yet . . . . but we think that some action is afoot.