By Kurt R. Karst –
The continuing court battle over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) could be derailed if a recent amendment added to the House version of the America Invents Act (H.R. 1249) is accepted when conferees from the House and Senate meet to iron out differences between their respective versions of the bill. (The Senate-passed version of the America Invents Act is S. 23 and does not include the PTE provision discussed below.)
The amendment, included in Part B of House Report 112-111 and sponsored by Representative John Conyers (D-MI), would amend the PTE law at 35 U.S.C. § 156 to add at the end of § 156(d)(1) the following flush sentence:
For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to receive permission on the next business dy. For purposes of the preceding sentence, the term "business day" means any Monday, Tuesday, Wednesday, Thursday or Friday, excluding any legal holiday under section 6103 of title 5.
The “applicability” section of the amendment states that language above “shall apply to any application for extension of a patent term under section 156 of title 35, United States Code, that is pending on, that is filed after, or as to which a decision regarding the application is subject to judicial review on, the date of enactment of this Act.” That, of course, describes MDCO’s situation.
By way of background, FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000, and MDCO submitted its PTE application to the U.S. Patent and Trademark Office (“PTO”) on February 14, 2001 – 62 days after NDA approval, including the December 15, 2000 date of approval. Under 35 U.S.C. § 156(d)(1), the submission of a PTE application must occur “within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use.” The PTO denied MDCO a PTE for the ‘404 patent and MDCO sued.
Currently, and as we previously reported, in February 2011, the U.S. Court of Appeals for the Federal Circuit denied MDCO’s Motion to Dismiss or, in the Alternative, to Bifurcate and Stay in Part ANDA sponsor APP Pharmaceuticals, LLC’s (“APP’s”) appeal related to Judge Claude M. Hilton’s August 3, 2010 decision in which Judge Hilton ordered the PTO to consider timely filed MDCO’s PTE application for the ‘404 patent under a next business day interpretation of the PTE statute. The Federal Circuit’s February decision was precipitated by Judge Hilton’s September 13, 2010 decision denying APP’s Motion to Intervene in the litigation without addressing standing (on the basis that APP should have sought intervention earlier, and that allowing intervention at that point would unfairly prejudice MDCO). APP appealed the decision to the Federal Circuit challenging not only the district court’s September 13th intervention decision, but also the underlying merits decision. Briefing in the case, in which ANDA sponsor PLIVA filed an amicus brief in support of APP, appears to have been completed.
The Conyers amendment to H.R. 1249 had previously passed by voice vote during a markup of the bill earlier this year by the House Judiciary Committee (see our previous post here), but was subsequently stripped from the bill in a managers amendment. Rep. Conyers’ H.AMDT.499 (A009) to H.R. 1249 restored the PTE language in the previously passed and stricken amendment. The amendment was agreed to in an after business hours, recorded vote of 223 to 198 (Roll no. 485) that occurred on June 23rd at 4:58 P.M., Eastern Time.
The Conyers amendment passed after some lively debate on the floor of the U.S. House of Representatives (see Congressional Record pages H4489-4490 here). Representative Conyers said that the amendment “addresses the confusion regarding the calculation of the filing period for [PTE] applications under the Hatch-Waxman Act,” that “[b]y eliminating confusion regarding the deadline for [PTE] applications, this amendment provides the certainty necessary to encourage costly investments in life-saving medical research,” and that the amendment is consistent with Judge Hilton’s August 2010 decision.
Rep. Ed Markey (D-MA) echoed Rep. Conyers’ comments and added that the amendment “promotes good government by ensuring that the Patent Office and the FDA adopt consistent interpretations of the very same statutory language.” Rep. Markey also commented that “[r]ight now, America’s next Lipitor or Prozac could be bottled up at the Patent Office and never made available because of uncertainty regarding the patent term extension process,” and that “[i]n order to uncork American innovation and invention, we need a patent extension process that is clear, consistent, and fair.” Similarly, Rep. Scott Garrett (R-NJ) commented that the amendment
will clarify that when the FDA provides the final approval after normal business hours, the 60-day clock begins on the next business day. So by doing this, by ensuring that patent holders will not lose their rights prematurely, what this amendment does is it will not only resolve a longstanding problem but will encourage the development of innovative new drugs as well.
(So does that mean that an after business hours approval by FDA does not become effective until the next business day?)
Not all of the House floor debate was in support of the Conyers amendment. Rep. Lamar Smith (R-TX) opposed the amendment, saying that it essentially codifies Judge Hilton’s August 2010 decision, “but it ignores the fact that this case is on appeal.” Rep. Smith further commented that:
We need to let the courts resolve the pending litigation. It is standard practice for Congress not to interfere when there is ongoing litigation. If the Federal Circuit rules against [MDCO], generic manufacturers of the drug could enter the marketplace immediately rather than waiting another 5 years. This has the potential to save billions of dollars in health care expenses. While the amendment is drafted so as to apply to other companies similarly situated, as a practical matter, this is a special fix for one company.
Instead of including the PTE provision in H.R. 1249, Rep. Smith said that “it would be more appropriate for this to be considered as a private relief bill,” which is a type of bill “designed to provide benefits to a specific individual or corporate entity.” Such bills have been introduced in the past seeking an extension of a patent term. For example, in the 111th Congress, H.R. 2508 was introduced to extend the term of U.S. Patent No. 5,180,715 for a period of 2 years. That patent, now expired, was listed in the Orange Book for ELMIRON (pentosan polysulfate sodium) Capsules.