United states securities and exchange commission

Table of Contents
16
(1)  In addition to patent protection, certain of our products are entitled to regulatory exclusivity in the U.S. and the E.U. expected 
until the dates set forth below:
Product
Territory
Expected Expiration
TECFIDERA U.S.
2018
E.U.
2024
PLEGRIDY
U.S.
2026
E.U.
2024
FAMPYRA
E.U.
2021
ZINBRYTA
U.S.
2028
E.U.
*
SPINRAZA
U.S.
2023
E.U.
2027**
*ZINBRYTA was not designated a new active substance at the time of its approval in the E.U. and is not automatically entitled to regulatory 
exclusivity. Regulatory exclusivity may, however, be available for independent development of known active substances. We intend to assert 
the protection of its data on this basis.
**SPINRAZA may be eligible for an additional two years exclusivity in Europe based on the orphan pediatric indication.
(2)  This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries 
to 2024. 
(3)  This patent was revoked in a European opposition. This decision is being appealed. The patent is subject to granted 
SPCs in certain European countries, which extended the patent term in those countries to 2029.
(4)  This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries 
to 2028.
(5)  Reflects SPCs granted in most European countries and pediatric extension in some countries.
(6)  This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries 
to 2026.
(7)  This patent is subject to granted SPCs in certain European countries, which extended the patent term in those countries 
to 2026.
The existence of patents does not guarantee our right to practice the patented technology or commercialize the 
patented product. Patents relating to pharmaceutical, biopharmaceutical and biotechnology products, compounds 
and processes, such as those that cover our existing compounds, products and processes and those that we will 
likely file in the future, do not always provide complete or adequate protection. Litigation, interferences, oppositions, 
inter partes reviews or other proceedings are, have been and may in the future be necessary in some instances to 
determine the validity and scope of certain of our patents, regulatory exclusivities or other proprietary rights, and in 
other instances to determine the validity, scope or non-infringement of certain patent rights claimed by third parties 
to be pertinent to the manufacture, use or sale of our products. We may also face challenges to our patents, 
regulatory exclusivities and other proprietary rights covering our products by manufacturers of generics and 
biosimilars. A discussion of certain risks and uncertainties that may affect our patent position, regulatory 
exclusivities and other proprietary rights is set forth in Item 1A. Risk Factors included in this report, and a discussion 
of legal proceedings related to certain patents described above is set forth in Note 21, Litigation, to our consolidated 
financial statements included in this report.

---

Table of Contents
17
Competition
Competition in the biopharmaceutical industry is 
intense and comes from many sources, including 
specialized biotechnology firms and large 
pharmaceutical companies. Many of our competitors 
are working to develop or have commercialized 
products similar to those we market or are developing 
and have considerable experience in undertaking 
clinical trials and in obtaining regulatory approval to 
market pharmaceutical products. Certain of these 
companies have substantially greater financial, 
marketing and research and development resources 
than we do.
We believe that competition and leadership in 
the industry is based on managerial and technological 
excellence and innovation as well as establishing 
patent and other proprietary positions through 
research and development. The achievement of a 
leadership position also depends largely upon our 
ability to maximize the approval, acceptance and use 
of products resulting from research and the 
availability of adequate financial resources to fund 
facilities, equipment, personnel, clinical testing, 
manufacturing and marketing. Another key aspect of 
remaining competitive within the industry is recruiting 
and retaining leading scientists and technicians. We 
believe that we have been successful in attracting and 
retaining skilled and experienced scientific personnel.
Competition among products approved for sale 
may be based, among other things, on patent 
position, product efficacy, safety, convenience/delivery 
devices, reliability, availability and price. In addition, 
early entry of a new pharmaceutical product into the 
market may have important advantages in gaining 
product acceptance and market share. Accordingly, 
the relative speed with which we can develop 
products, complete the testing and approval process 
and supply commercial quantities of products will 
have a significant impact on our competitive position.
The introduction of new products or 
technologies, including the development of new 
processes or technologies by competitors or new 
information about existing products or technologies, 
may result in increased competition for our marketed 
products or pricing pressure on our marketed 
products. It is also possible that the development of 
new or improved treatment options or standards of 
care or cures for the diseases our products treat 
could reduce or eliminate the use of our products or 
may limit the utility and application of ongoing clinical 
trials for our product candidates. We may also face 
increased competitive pressures as a result of 
generics and the emergence of biosimilars in the U.S. 
and E.U. If a generic or biosimilar version of one of 
our products were approved, it could reduce our sales 
of that product.
Additional information about the competition that 
our marketed products face is set forth below.
Multiple Sclerosis
TECFIDERA, AVONEX, PLEGRIDY, TYSABRI and 
ZINBRYTA each compete with one or more of the 
following products: 
Competing Product
Competitor
AUBAGIO (teriflunomide)
Sanofi
BETASERON/BETAFERON
(interferon-beta-1b)
Bayer Group
COPAXONE 
(glatiramer acetate)
Teva Pharmaceuticals
Industries Ltd.
EXTAVIA 
(interferon-beta-1b)
Novartis AG
GILENYA (fingolimod)
Novartis AG
GLATOPA (glatiramer
acetate)
Sandoz, a division of
Novartis AG
LEMTRADA
(alemtuzumab)
Sanofi
OCREVUS (ocrelizumab)
Genentech
REBIF 
(interferon-beta-1)
Merck KGaA (and co-
promoted with Pfizer Inc.
in the U.S.)
FAMPYRA is indicated as a treatment to improve 
walking in adult patients with MS who have walking 
disability and is the first treatment that addresses 
this unmet medical need with demonstrated efficacy 
in people with all types of MS. FAMPYRA is currently 
the only therapy approved to improve walking in 
patients with MS. 
Competition in the MS market is intense. Along 
with us, a number of companies are working to 
develop additional treatments for MS that may in the 
future compete with our MS products. One such 
product that was approved in the U.S. in 2017 and in 
the E.U. in 2018 is OCREVUS, a treatment for RMS 
and PPMS that was developed by Genentech. While 
we have a financial interest in OCREVUS, future sales 
of our MS products may be adversely affected if 
OCREVUS continues to gain market share, or if other 
MS products that we or our competitors are 
developing are commercialized. Future sales may also 
be negatively impacted by the introduction of generics, 
prodrugs of existing therapeutics or biosimilars of 
existing products and other technologies.

---