United states securities and exchange commission



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Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
F- 67
With respect to some loss contingencies, an estimate of the possible loss or range of loss cannot be made 
until management has further information, including, for example, (i) which claims, if any, will survive dispositive 
motion practice; (ii) information to be obtained through discovery; (iii) information as to the parties' damages claims 
and supporting evidence; (iv) the parties’ legal theories; and (v) the parties' settlement positions. 
The claims and legal proceedings in which we are involved also include challenges to the scope, validity or 
enforceability of the patents relating to our products, pipeline or processes, and challenges to the scope, validity or 
enforceability of the patents held by others. These include claims by third parties that we infringe their patents. An 
adverse outcome in any of these proceedings could result in one or more of the following and have a material impact 
on our business or consolidated results of operations and financial position: (i) loss of patent protection; (ii) inability 
to continue to engage in certain activities; and (iii) payment of significant damages, royalties, penalties and/or 
license fees to third parties.
Loss Contingencies 
Qui Tam Litigation
On July 6, 2015, a qui tam action filed on behalf of the United States and certain states was unsealed by the 
U.S. District Court for the District of Massachusetts. The action alleges sales and promotional activities in violation 
of the federal False Claims Act and state law counterparts, and seeks single and treble damages, civil penalties, 
interest, attorneys’ fees and costs. Our motion to dismiss is pending. The United States has not made an 
intervention decision. An estimate of the possible loss or range of loss cannot be made at this time.
Securities Litigation
We and certain current and former officers are defendants in an action filed by a shareholder on October 20, 
2016 in the U.S. District Court for the District of Massachusetts alleging violations of federal securities laws under 
15 U.S.C §78j(b) and §78t(a) and 17 C.F.R. §240.10b-5 and seeking a declaration of the action as a class action 
and an award of damages, interest and attorneys' fees. An estimate of the possible loss or range of loss cannot be 
made at this time.
Other Matters
Abbreviated New Drug Application (ANDA) Litigation relating to TECFIDERA
In June, July, and September 2017 and January 2018, we initiated patent infringement proceedings pursuant to 
the Hatch-Waxman act in the U.S. District Court for the District of Delaware against Amneal Pharmaceuticals LLC, 
Aurobindo Pharma U.S.A., Inc., Caribe Holdings (Cayman) Co. Ltd. DBA Puracap Caribe, Puracap International LLC, 
Graviti Pharmaceuticals Pvt. Ltd., Hetero USA, Inc., Impax Laboratories, Inc., Prinston Pharmaceutical Inc., Slayback 
Pharma LLC, Teva Pharmaceuticals USA, Inc., Alkem Laboratories Ltd., Cipla Limited, Glenmark Pharmaceuticals Ltd., 
Lupin Atlantis Holdings SA, Macleods Pharmaceuticals, Ltd., MSN Laboratories Pvt. Ltd., Pharmathen S.A., Shipla 
Medicare Limited, Sun Pharma Global FZE, Torrent Pharmaceuticals Ltd., TWi Pharmaceuticals, Inc., Windlas 
Healthcare Pvt. Ltd., Accord Healthcare Inc., Par Pharmaceutical Inc., Sandoz Inc., Sawai USA, Inc. and Zydus 
Pharmaceuticals (USA) Inc. In addition, we initiated patent infringement proceedings pursuant to the Hatch-Waxman 
act against Stason Pharmaceuticals, Inc. in the U.S. District Court for the Central District of California, Zydus 
Pharmaceuticals (USA) Inc. in the U.S. District Court for the District of New Jersey, Accord Healthcare Inc. in the U.S. 
District Court for the Middle District of North Carolina, Par Pharmaceutical Inc. in the U.S. District Court for the 
Southern District of New York, Sandoz Inc. in the U.S. District Court for the District of Colorado and Mylan 
Pharmaceuticals Inc. in the U.S. District Court for the Northern District of West Virginia. 
The cases against Accord Healthcare Inc., Zydus Pharmaceuticals (USA) Inc. and Sandoz Inc. have been 
dismissed in the North Carolina, New Jersey and Colorado courts but will continue against those parties in Delaware. 
The cases against Par Pharmaceutical Inc. in both New York and Delaware have been dismissed because Par 
Pharmaceutical Inc.’s ANDA application has been withdrawn. The case against Stason Pharmaceuticals, Inc. in 
California has been dismissed, but the case against its partner Sawai USA, Inc. will proceed in Delaware. 
We expect a trial in the Delaware actions in December 2019, and a trial has been set in the West Virginia 
action in February 2020.


Table of Contents
BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
F- 68
Interference Proceeding with Forward Pharma
In April 2015 the U.S. Patent and Trademark Office (USPTO) declared an interference between Forward 
Pharma’s pending U.S. Patent Application No. 11/576,871 and our U.S. Patent No. 8,399,514 (the '514 patent). 
The '514 patent includes claims covering the treatment of MS with 480 mg of dimethyl fumarate as provided for in 
our TECFIDERA label. In March 2017 the USPTO ruled against Forward Pharma. Forward Pharma has appealed to the 
U.S. Court of Appeals for the Federal Circuit and the appeal is pending. For additional information regarding this 
matter, please read Note 7, Intangibles Assets and Goodwill, to these consolidated financial statements.
European Patent Office Oppositions
In 2016 the EPO decided to revoke our European patent number 2 137 537 (the '537 patent), which we have 
appealed. The '537 patent includes claims covering the treatment of MS with 480 mg of dimethyl fumarate as 
provided for in our TECFIDERA label. 
In January 2018 the EPO announced its decision revoking Forward Pharma’s European Patent No. 2 801 355, 
which was issued in May 2015 and expires in October 2025. Forward Pharma has stated that it expects to file an 
appeal to the Technical Board of Appeal of the EPO. The settlement and license agreement that we entered with 
Forward Pharma in January 2017 did not resolve the issues pending in this proceeding and we and Forward Pharma 
intend to permit the Technical Board of Appeal and the Enlarged Board of Appeal, as applicable, to make a final 
determination. For additional information regarding this matter, please read Note 7, Intangibles Assets and Goodwill, 
to these consolidated financial statements.
Patent Revocation Matter
Swiss Pharma International AG filed actions in the District Court of The Hague (on January 11, 2016), the 
German Patents Court (on March 3, 2016) and the Commercial Court of Rome (November 2017) to invalidate the 
Dutch, German and Italian counterparts of our European Patent Number 1 485 127 (“Administration of agents to 
treat inflammation”) ('127 patent), which was issued in June 2011 and concerns administration of natalizumab 
(TYSABRI) to treat MS. The patent expires in February 2023. The Dutch counterpart was ruled invalid and we have 
appealed. In November 2018 Bioeq gmbh (an entity associated with Swiss Pharma and Polpharma) brought an 
action in the Polish Patent Office seeking to revoke the Polish counterpart of the ‘127 patent. In January 2018 the 
German court announced that the German counterpart was invalid. No date for a hearing on the merits has yet been 
set in the Italian action.
'755 Patent Litigation
On May 28, 2010, Biogen MA Inc. (formerly Biogen Idec MA Inc.) filed a complaint in the U.S. District Court for 
the District of New Jersey alleging infringement by Bayer Healthcare Pharmaceuticals Inc. (Bayer) (manufacturer, 
marketer and seller of BETASERON and manufacturer of EXTAVIA), EMD Serono, Inc. (EMD Serono) (manufacturer, 
marketer and seller of REBIF), Pfizer Inc. (Pfizer) (co-marketer of REBIF) and Novartis Pharmaceuticals Corp. 
(Novartis) (marketer and seller of EXTAVIA) of our U.S. Patent No. 7,588,755 ('755 Patent), which claims the use of 
interferon beta for immunomodulation or treating a viral condition, viral disease, cancers or tumors. The complaint 
seeks monetary damages, including lost profits and royalties. Bayer had previously filed a complaint against us in 
the same court, on May 27, 2010, seeking a declaratory judgment that it does not infringe the '755 Patent and that 
the patent is invalid, and seeking monetary relief in the form of attorneys' fees, costs and expenses. 
Bayer, Pfizer, Novartis and EMD Serono have all filed counterclaims seeking declaratory judgments of patent 
invalidity and non-infringement, and seeking monetary relief in the form of costs and attorneys' fees. The trial against 
EMD Serono and Pfizer commenced in mid-January 2018 and is ongoing. A trial date against Bayer and Novartis has 
not yet been set.


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