BioMarin Reviews Status of Exon 51 Composition of Matter and Method of Use Patent Interference Cases against Sarepta Therapeu...
September 21 2016 - 8:54AM
BioMarin to Seek Review of Ruling in Composition
of Matter Patent Interference (No. 106,008)
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that it
intends to seek a review of the Patent Trial and Appeal Board
(PTAB) of the United States ruling in Interference No. 106,008,
related to composition of matter (COM) claims related to exon 51
skipping antisense oligonucleotides. BioMarin is completing
its review of the decision and the specific means it may use to
seek a further review.
BioMarin also notes that on September 29, 2015, the PTAB ruled
in BioMarin’s favor in Interference No. 106,013 directed to the
method of use (MOU) of exon 51 skipping antisense oligonucleotides
to treat Duchenne muscular dystrophy. BioMarin believes that
the ruling on the exon 51 COM is specific to those claims and is
not relevant to the appeal of the PTAB decision in the MOU
interference. BioMarin anticipates a final ruling from
the Federal Circuit Court of Appeals on the PTAB decision related
to the MOU patent in late 2017 or early 2018. If BioMarin is
successful in this appeal, it believes that EXONDYS 51™
(eteplirsen) would infringe the MOU patents.
Companion European PatentIn Europe, BioMarin’s
method patent EP 1 619 249 B1 was previously upheld in an amended
form after an opposition procedure initiated by AVI Biopharma (now
Sarepta) before the European Patent Office Opposition
Division. The upheld claims include the use of 14- to
40-mer antisense oligonucleotides directed to exon 51 in the
DMD gene as a potential therapy to treat DMD. Although
an appeal procedure is pending, BioMarin currently has an issued
and enforceable patent, which encompasses antisense oligonucleotide
product/product candidates directed to exons 51 and 46 in
Europe.
About Interference Proceedings in the U.S. A
patent interference is a proceeding conducted by the Patent Office
in instances where two parties claim patent rights to the same
subject matter. The U.S. patent system awards patents to the first
party to invent a particular technology. In an interference, the
Patent Office determines which party invented the technology first,
and awards the patent to that party, although a party may request
that the PTAB consider certain additional matters related to the
validity of a patent.
About the Allowed U.S. Patent Application
claims
U.S. Patent Application No. 14/198,992 (methods of use) belongs
to a portfolio of patents entitled “Modulation of exon recognition
in pre-mRNA by interfering with the secondary RNA structure” that
was exclusively licensed from the Leiden University Medical Center
(LUMC, Leiden, The Netherlands), also referred to as Academisch
Ziekenhuis Leiden . The inventor of this application and current
BioMarin employee, Dr. Judith van Deutekom, VP, Discovery in
Research & Development, was former head of the DMD Genetic
Therapy group at LUMC and is one of the pioneers in the development
of genetic therapies for muscular dystrophies.
U.S. Patent Application No. 13/550,210 (composition of matter)
belongs to the same portfolio of patents that includes the MOU ‘992
application. Thus, the U.S. Patent Application No. 14/198,992
(methods of use) and U.S. Patent Application No. 13/550,210
(composition of matter) have the same priority date.
About BioMarinBioMarin is a global
biotechnology company that develops and commercializes innovative
therapies for patients with serious and life-threatening rare and
ultra-rare genetic diseases. The company's portfolio consists of
five commercialized products and multiple clinical and pre-clinical
product candidates. For additional information, please visit
www.BMRN.com.
For additional information, please visit www.BMRN.com.
Information on BioMarin's website is not incorporated by reference
into this press release.
Forward-Looking StatementThis press release
contains forward-looking statements about the business prospects of
BioMarin Pharmaceutical Inc., including, without limitation,
statements about: the ongoing patent disputes in both Europe and
the United States and the scope of the patents and patent
applications. These forward-looking statements are predictions
and involve risks and uncertainties such that actual results may
differ materially from these statements. These risks and
uncertainties include, among others: future outcomes of patent
proceedings, and specifically any challenges to the validity of the
patent matters, and any appeals thereto; and those factors detailed
in BioMarin's filings with the Securities and Exchange Commission,
including, without limitation, the factors contained under the
caption "Risk Factors" in BioMarin's 2015 Annual Report on Form
10-K, as amended, and the factors contained in BioMarin's reports
on Form 8-K. Stockholders are urged not to place undue
reliance on forward-looking statements, which speak only as of the
date hereof. BioMarin is under no obligation, and expressly
disclaims any obligation to update or alter any forward-looking
statement, whether as a result of new information, future events or
otherwise.
BioMarin®, is a registered trademark of BioMarin
Pharmaceutical Inc.
Contact:
Investors:
Traci McCarty
BioMarin Pharmaceutical Inc.
(415) 455-7558
Media:
Debra Charlesworth
BioMarin Pharmaceutical Inc.
(415) 455-7451
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