Current Report Filing (8-k)
June 13 2017 - 5:17PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 12, 2017
Alder BioPharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-36431
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90-0134860
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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11804 North Creek Parkway South
Bothell, WA
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98011
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code: (425)
205-2900
Check the appropriate box below
if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Indicate by check mark whether registrant is an emerging growth company as defined in
Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☐
If an
emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
Submission of Statement Setting out Grounds of Appeal in Opposition Proceeding in
European Patent Office
On June 12, 2017, Alder BioPharmaceuticals, Inc. (Alder) submitted its statement setting out the grounds of
appeal (the Grounds of Appeal) with respect to the decision of the Opposition Division (OD) of the European Patent Office (EPO) in the opposition to Labrys Biologics Inc.s (owned by Teva Pharmaceutical
Industries Ltd.) (Teva) European Patent No. 1957106 B1 disclosed in Item 3. Legal Proceedings in Alders Annual Report on
Form 10-K
for the fiscal year ended
December 31, 2016. Alder previously filed its notice of appeal in the proceeding on March 31, 2017. Eli Lilly and Company and Teva have also appealed the ODs decision. Alder continues to firmly believe that the use claims that were
maintained and narrowed by the OD were nevertheless improperly granted by the EPO and upheld by the OD, and should be revoked in their entirety on appeal for the reasons set forth in the Grounds of Appeal.
This Form 8-K contains a
forward-looking statement relating to Alders belief that the referenced patent should be revoked in its entirety, which is based upon Alders current plans, assumptions, beliefs, expectations, estimates and projections, and involves
substantial risks and uncertainties. Actual results and the timing of events could differ materially due to these risks and uncertainties as well as other factors, which include, without limitation: the inherent uncertainty in legal proceedings
involving intellectual property and the possibility that such proceedings may result in outcomes that are unfavorable to Alder; the timing, scope and costs of legal proceedings involving intellectual property; Alders ability to obtain and
protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the sufficiency of Alders capital and other resources; market competition; and other factors discussed under the caption
Risk Factors in Alders
Form 10-Q
for the quarterly period ended March 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on April 27, 2017, and is
available on the SECs website at www.sec.gov. Additional information will also be set forth in Alders other reports and filings it will make with the SEC from time to time. The forward-looking statement made in this Form 8-K speaks only
as of the date of this
Form 8-K.
Alder expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect
any change in Alders expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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Alder BioPharmaceuticals, Inc.
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Dated: June 13, 2017
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By:
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/s/ James B. Bucher
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James B. Bucher
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Senior Vice President and General Counsel
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