Table
of Contents
14
extension (for up to 5 years, but not beyond a total of
14 years from the date of product approval) as
compensation for patent term lost during the FDA
regulatory review process. The duration and extension
of the term of foreign patents varies, in accordance
with local law. For example, supplementary protection
certificates (SPCs) on some of our products have
been granted in a number of European countries,
compensating in part for delays in obtaining
marketing approval.
Regulatory exclusivity, which
may consist of
regulatory data protection and market protection, also
can provide meaningful protection for our products.
Regulatory data protection
provides to the holder of a
drug or biologic marketing authorization, for a set
period of time, the exclusive use of the proprietary
pre-clinical and clinical data that it created at
significant cost and submitted to the applicable
regulatory authority to obtain approval of its product.
After the applicable set period of time, third parties
are then permitted to rely upon our data to file for
approval of their abbreviated applications for, and to
market (subject to any applicable market protection),
their generic drugs and biosimilars referencing our
data. Market protection provides to the holder of a
drug or biologic marketing authorization the exclusive
right to commercialize its product for a set period of
time, thereby preventing the commercialization of
another product containing the same active
ingredient(s) during that period. Although the World
Trade Organization's agreement on trade-related
aspects of intellectual property rights (TRIPS) requires
signatory countries to provide regulatory exclusivity to
innovative pharmaceutical products, implementation
and enforcement varies widely from country to
country.
We also rely upon other forms of unpatented
confidential information to remain competitive. We
protect such information
principally through
confidentiality agreements with our employees,
consultants, outside scientific collaborators,
scientists whose research we sponsor and other
advisers. In the case of our employees, these
agreements also provide, in compliance with relevant
law, that inventions and other intellectual property
conceived by such employees during their employment
shall be our exclusive property.
Our trademarks are important to us and are
generally covered by trademark applications or
registrations in the USPTO and the patent or
trademark offices of other countries. We also use
trademarks
licensed from third parties, such as the
trademark FAMPYRA which we license from Acorda.
Trademark protection varies in accordance with local
law, and continues in some countries as long as the
trademark is used and in other countries as long as
the trademark is registered. Trademark registrations
generally are for fixed but renewable terms.
Our Patent Portfolio
The following table describes our patents in the
U.S. and Europe that we currently consider of primary
importance to our marketed products, including the
territory, patent number, general subject matter and
expected expiration dates. Except as otherwise noted,
the expected expiration
dates include any granted
patent term extensions and issued SPCs. In some
instances, there are later-expiring patents relating to
our products directed to, among other things,
particular forms or compositions, methods of
manufacturing or use of the drug in the treatment of
particular diseases or conditions. We also continue to
pursue additional patents and patent term extensions
in the U.S. and other territories covering various
aspects of our products that may, if issued, extend
exclusivity beyond the expiration of the patents listed
in the table.
Table of Contents
15
Product
Territory
Patent No.
General
Subject Matter
Patent
Expiration
(1)
TECFIDERA
U.S.
7,619,001
Methods of treatment
2018
U.S.
7,803,840
Methods of treatment
2018
U.S.
8,399,514
Methods of treatment
2028
U.S.
8,524,773
Methods of treatment
2018
U.S.
6,509,376
Formulations of dialkyl fumarates for use in the
treatment of autoimmune diseases
2019
U.S.
8,759,393
Formulations
2019
U.S.
7,320,999
Methods of treatment
2018
Europe
1131065
Formulations of dialkyl fumarates and their use for
treating autoimmune diseases
2019
(2)
Europe
2137537
Methods of use
2028
(3)
AVONEX and
PLEGRIDY
U.S.
7,588,755
Use of recombinant beta interferon for
immunomodulation
2026
PLEGRIDY
U.S.
7,446,173
Polymer conjugates of interferon beta-1a
2022
U.S.
8,524,660
Methods of treatment
2023
U.S.
8,017,733
Polymer conjugates of interferon beta-1a
2027
Europe
1656952
Polymer conjugates of interferon-beta-1a and uses
thereof
2019
Europe
1476181
Polymer conjugates of interferon-beta-1a and uses
thereof
2023
(4)
TYSABRI
U.S.
6,602,503
Humanized
recombinant antibodies; nucleic acids and
host cells; processes for production; therapeutic
compositions; methods of use
2020
U.S.
7,807,167
Methods of treatment
2023
U.S.
9,493,567
Methods of treatment
2027
Europe
0804237
Humanized immunoglobulins; nucleic acids;
pharmaceutical compositions; medical uses
2020
(5)
Europe
1485127
Methods of use
2023
FAMPYRA
Europe
1732548
Sustained-release aminopyridine compositions for
increasing walking
speed in patients with MS
2025
(6)
Europe
23775536
Sustained-release aminopyridine compositions for
treating MS
2025
(7)
ZINBRYTA
U.S.
8,454,965
Methods of treatment
2024
U.S.
7,258,859
Methods of treatment
2024
U.S.
9,340,619
Daclizumab HYP compositions
2032
Europe
1539200
Anti-IL-2-receptor antibody for use in a method of
treating a subject with MS
2023
SPINRAZA
U.S.
6,166,197
Oligomeric Compounds Having Pyrimidine Nucleotide(s)
2017
U.S.
6,210,892
Alteration of Cellular Behavior By Antisense Modulation
of MRNA Processing
2018
U.S.
7,101,993
Oligonucleotides Containing 2’-O-Modified Purines
2023
U.S.
7,838,657
SMA Treatment Via Targeting of SMN2
Splice Site
Inhibitory Sequences
2027
U.S.
8,110,560
SMA Treatment Via Targeting of SMN2 Splice Site
Inhibitory Sequences
2025
U.S.
8,361,977
Compositions And Methods For Modulation of SMN2
Splicing
2030
U.S.
8,980,853
Compositions And Methods For Modulation of SMN2
Splicing
2030
U.S.
9,717,750
Compositions and Methods For Modulation of SMN2
Splicing
2030
Europe
1910395
Compositions And Methods For Modulation of SMN2
Splicing
2026
Europe
2548560
Compositions And Methods For Modulation of SMN2
Splicing
2026
Footnotes follow on next page.