Appeals Court Affirms Validity of Collegium’s Belbuca® Patents
December 22 2022 - 8:00AM
Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading,
diversified specialty pharmaceutical company, today announced that
the Federal Circuit has upheld the judgment of the U.S. District
Court for the District of Delaware that certain claims of the
patents protecting Belbuca® are valid.
In addition to upholding the District Court’s
judgment regarding the validity of certain claims in the 8,147,866
patent, expiring in 2027 (the “’866 patent”), and 9,901,539 patent,
expiring in 2032 (the “’539 Patent”), the Federal Circuit vacated
the District Court’s findings of invalidity with respect to certain
claims of the ‘866 patent and the 9,655,843 patent (both expiring
in 2027) and remanded such claims for reconsideration by the
District Court.
Alvogen conceded infringement of all claims at
issue in the litigation, and accordingly, Collegium expects that,
by virtue of the Federal Circuit’s decision, Alvogen will be barred
from entering the market with its product until 2032.
“We are very pleased with the Federal Circuit’s
decision, which reinforces the strength of the patents supporting
Belbuca, and we look forward to continuing to supply this
innovative and differentiated product to appropriate patients,”
said Shirley Kuhlmann, General Counsel and Chief Administrative
Officer of Collegium.
About Collegium Pharmaceutical,
Inc.
Collegium is a diversified, specialty
pharmaceutical company committed to improving the lives of people
living with serious medical conditions. Collegium’s headquarters
are located in Stoughton, Massachusetts. For more information,
please visit the Company’s website
at www.collegiumpharma.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. We may, in some cases, use terms such as
"believes," "potential," "expects," "plans," "intends," "may,"
"could," "might," "should" or other words that convey uncertainty
of future events or outcomes to identify these forward-looking
statements. Examples of forward-looking statements contained in
this press release include, among others, statements related to our
expectations relating to the timing and nature of generic
competition for our products. Such statements are subject to
numerous important factors, risks and uncertainties that may cause
actual events or results, performance, or achievements to differ
materially from the company’s current expectations. Actual results
may differ materially from management’s expectations and such
forward-looking statements in this press release could be affected
as a result of various important factors, including risks relating
to, among others, the outcome of any current or future patent
infringement litigation that may be brought by or against us, and
the regulatory status of our products and their generic
competitors. These and other risks are described under the heading
"Risk Factors" in our Annual Reports on Form 10-K and Quarterly
Reports on Form 10-Q and other filings with the SEC. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation
to update our forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
Investor Contact:Dawn
Schottlandt Argot Partnerscollegium@argotpartners.com
Media Contact:Marissa
SamuelsCorporate Communications
communications@collegiumpharma.com
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