It Ain’t Over ‘Til It’s Over – The ANGIOMAX PTE Battle Takes Yet Another New Turn

September 26, 2011

By Kurt R. Karst –      

With each stroke of the pens President Obama used to sign into law the Leahy-Smith America Invents Act, it seemed as though another nail was hammered into the coffin of any attempts to deny The Medicines Company (“MDCO”) a win in the company’s decade-long battle to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin).  Indeed, in what we thought might very well be our final blog post on the issue, we essentially said adieu to the case, but did leave some room open for something crazy to happen in the U.S. Court of Appeals for the Federal Circuit (where APP Pharmaceuticals, LLC (“APP”) has been duking it out with MDCO – see here and here) given all of the twists and turns that have occurred with the ANGIOMAX ‘404 patent PTE over the years.    

The ink from President Obama’s signature on the Leahy-Smith America Invents Act was hardly dry when MDCO, on September 19, 2011, sent a letter to the Federal Circuit notifying the Court of the enactment of Section 37 of the new law and asserting that Section 37 resolves the merits of the ongoing litigation with APP, for which oral argument had been set for October 5, 2011.  As we previously reported, Section 37, titled “Calculation of 60-Day Period for Application of Patent Term Extension,” amended the PTE statute at 35 U.S.C. § 156(d) as follows:

(a) IN GENERAL.—Section 156(d)(1) of title 35, United States Code, is amended by adding at the end 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 such permission on the next business day. 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.”.

(b) APPLICABILITY.—The amendment made by subsection (a) 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 the enactment of this Act.

In response to MDCO’s letter, APP, on September 20, 2011, filed a letter of its own, as well as a motion.  In both documents, APP requests the Court to order supplemental briefing on Section 37 and to postpone oral argument.  According to APP:

Even assuming Section 37 of the Act means what MDCO says (a question not yet briefed), Section 35 provides that it does not take effect for one year. Pub. L. 112-29 § 35, 125 Stat. 284, 341 (2011).  Unlike other provisions, Section 37 provides no other effective date. . . .

Moreover, and in any event, the amendment cannot constitutionally be applied here.  Among other reasons, Congress cannot revive a patent that has entered the public domain.

Allowing Congress to resurrect an expired patent would obviate the Constitution's "limited Times" provision and would not promote the progress of science.  U.S. Const. art. I, § 8, cl. 8.  "Congress may not … 'authorize the issuance of patents whose effects are to remove existent knowledge from the public domain, or to restrict free access to materials already available.'''  Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 146 (1989) (quotation omitted). . . .

Late last week, the Federal Circuit ordered that oral argument be postponed and that MDCO and APP simultaneously file supplemental briefs addressing the effect of Section 37 of the America Invents Act on the disposition of the case.