United states securities and exchange commission

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.

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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.

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