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Case: 13-1206
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Document: 63-2
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v. LEE
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Document: 63-2
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v. LEE
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Exela Pharma Sciences, LLC v. Kappos, No. 1:12cv-469, 2012 WL 3638552 (E.D. Va. Aug. 22, 2012); Exela
Pharma Sciences, LLC v. Kappos, No. 1:12-cv-469, 2012
WL 6697068 (E.D. Va. Dec. 21, 2012) (Reconsideration
Decision).
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Case: 13-1206
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PCT implementing statute, 35 U.S.C. 351 et seq., requires the applicant to fulfill certain United States documentary and fee requirements within 30 months after the
filing of the foreign priority application, here by December
6, 2002. See 35 U.S.C. 371(c), (d); PCT art. 22. SCR
Pharmatop did not file the required materials by December 6, 2002, and consequently the United States application was deemed abandoned. On January 2, 2003 SCR
Pharmatop filed a petition to revive the application,
stating that the delay was unintentional, using the form
provided by the PTO for revival requests. The PTO
granted the petition on April 25, 2003. The application
was duly examined, and the 218 patent issued on January 31, 2006.
In August 2011 SCR Pharmatop and exclusive sublicensee Cadence Pharmaceuticals, Inc. (collectively
Pharmatop) sued Exela in the United States District
Court for the District of Delaware for infringement of the
218 patent. The suit was brought under the HatchWaxman Act, 35 U.S.C. 271(e)(2), in response to Exelas
notice and filing of an Abbreviated New Drug Application
and Paragraph IV Certification relating to Pharmatops
injectable acetaminophen-based drug Ofirmev.
On November 30, 2011 Exela filed the subject petition
in the PTO, under the APA and 37 C.F.R. 1.181, 1.182,
and 1.183, challenging the PTOs revival of the patent
application that led to the 218 patent. Exela argued that
unintentional delay was not an available ground for
revival of a U.S. patent application claiming priority
under the PCT-implementing statute as then in effect.
Exela pointed out that 35 U.S.C. 371(d) limited the
revival of such national stage applications to those in
which the non-compliance was unavoidable:
The requirements with respect to the national fee
. . ., the translation . . ., and the oath or declaration . . . shall be complied with by the date of the
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Case: 13-1206
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violation, patent misuse, and shop right have been recognized as defenses to patent infringement. With all respect, my colleague errs in stating that such major
substantive issues, each of which is a traditional defense,
cannot be so easily distinguished from an excuse for a
missed filing date. Conc. Op. at 5. If judges cannot easily
distinguish the significance of antitrust violation from a
missed date, we must try harder.
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There is no automatic right of appeal to the Supreme Court of the United States from judgments
of the Federal Circuit. You must file a petition for a writ of certiorari which the Supreme Court
will grant only when there are compelling reasons. (See Rule 10 of the Rules of the Supreme
Court of the United States, hereinafter called Rules.)
Time. The petition must be filed in the Supreme Court of the United States within 90 days of
the entry ofjudgment in this Court or within 90 days of the denial of a timely petition for
rehearing. The judgment is entered on the day the Federal Circuit issues a final decision in your
case. [The time does not run from the issuance of the mandate, which has no effect on the right
to petition.] (See Rule 13 of the Rules.)
Fees. Either the $300 docketing fee or a motion for leave to proceed in forma pauperis with an
affidavit in support thereof must accompany the petition. (See Rules 38 and 39.)
Authorized Filer. The petition must be filed by a member of the bar of the Supreme Court of
the United States or by the petitioner representing himself or herself.
Format of a Petition. The Rules are very specific about the order of the required information
and should be consulted before you start drafting your petition. (See Rule 14.) Rules 33 and 34
should be consulted regarding type size and font, paper size, paper weight, margins, page limits,
cover, etc.
Number of Copies. Forty copies of a petition must be filed unless the petitioner is proceeding in
forma pauperis, in which case an original and ten copies of the petition for writ of certiorari and
of the motion for leave to proceed in forma pauperis. (See Rule 12.)
Where to File. You must file your documents at the Supreme Court.
Clerk
Supreme Court of the United States
1 First Street, NE
Washington, DC 20543
(202) 479-3000
No documents are filed at the Federal Circuit and the Federal Circuit provides no information to
the Supreme Court unless the Supreme Court asks for the information.
Access to the Rules. The current rules can be found in Title 28 of the United States Code
Annotated and other legal publications available in many public libraries.