Litigation Details for Biogen International GmbH v. Par Pharmaceutical, Inc. (S.D.N.Y. 2017)

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Biogen International GmbH v. Par Pharmaceutical, Inc. (S.D.N.Y. 2017)

Docket		Date Filed	2017-06-30
Court	District Court, S.D. New York	Date Terminated	2017-11-08
Cause	35:271 Patent Infringement	Assigned To	Jesse Matthew Furman
Jury Demand	None	Referred To
Parties	BIOGEN MA INC.
Patents	7,320,999; 8,399,514
Attorneys	David Neal Wynn
Firms	Arent Fox LLP (NYC)
Link to Docket	External link to docket

Details for Biogen International GmbH v. Par Pharmaceutical, Inc. (S.D.N.Y. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-06-30				External link to document

Biogen International GmbH v. Par Pharmaceutical: Tecfidera Patent Litigation Summary, Case No. 1:17-cv-04984

Last updated: October 30, 2026

Biogen International GmbH v. Par Pharmaceutical, Inc., Case No. 1:17-cv-04984, was a Hatch-Waxman patent action concerning Par’s abbreviated new drug application for generic dimethyl fumarate delayed-release capsules, the generic equivalent of Biogen’s Tecfidera. Biogen asserted Tecfidera patents against Par after receiving a Paragraph IV certification. The case ended without a public merits decision, leaving no judicial ruling in this action on patent validity, infringement, or the precise terms of Par’s proposed market entry.

What drug and patents were involved in Biogen v. Par?

The dispute involved dimethyl fumarate, the active ingredient in Tecfidera, which FDA approved in 2013 for relapsing forms of multiple sclerosis. Biogen marketed Tecfidera as delayed-release capsules in 120 mg and 240 mg strengths.

Par’s ANDA targeted generic dimethyl fumarate delayed-release capsules. Biogen’s claims arose under the Hatch-Waxman Act, which permits a patent owner to sue after receiving an ANDA notice containing a Paragraph IV certification.

Key product and patent data

Item	Detail
Brand drug	Tecfidera
Active ingredient	Dimethyl fumarate
Dosage form	Delayed-release oral capsules
Approved strengths	120 mg and 240 mg
Reference sponsor	Biogen Idec Inc. and related Biogen entities
FDA approval	March 27, 2013
Generic pathway	ANDA under Section 505(j)
Litigation type	Hatch-Waxman patent infringement
Court	U.S. District Court for the Southern District of New York
Case	1:17-cv-04984
Plaintiff	Biogen International GmbH
Defendant	Par Pharmaceutical, Inc.

The patents associated with Tecfidera included patents directed to fumarate compounds and methods of treating multiple sclerosis. Publicly reported Tecfidera patent coverage included U.S. Patent No. 6,509,376 and later method-of-use patents, including U.S. Patent Nos. 8,399,514 and 8,759,393. The exact patent claims asserted against Par must be distinguished from the broader set of patents listed or litigated against other ANDA applicants.

What was the legal basis for Biogen’s lawsuit against Par?

Biogen sued after Par certified under Paragraph IV that one or more patents listed for Tecfidera were invalid, unenforceable, or would not be infringed by Par’s proposed generic product.

A Paragraph IV certification is an artificial act of infringement under 35 U.S.C. § 271(e)(2). The resulting lawsuit can trigger an automatic FDA approval stay of up to 30 months under 21 U.S.C. § 355(j)(5)(B)(iii), subject to statutory exceptions.

Biogen’s likely infringement theory was that Par’s proposed delayed-release dimethyl fumarate capsules would fall within patent claims covering:

• Dimethyl fumarate pharmaceutical compositions;
• Delayed-release oral dosage forms;
• Dosing regimens for multiple sclerosis;
• Methods of treating relapsing multiple sclerosis with dimethyl fumarate.

Par’s principal defenses would have included noninfringement, invalidity under Sections 102 and 103 of the Patent Act, and, where applicable, unenforceability.

What was the litigation timeline in Biogen v. Par?

The litigation followed the standard ANDA sequence.

Date or period	Event
2017	Par submitted or pursued an ANDA for generic dimethyl fumarate delayed-release capsules.
2017	Biogen received Par’s Paragraph IV notice.
2017	Biogen filed Case No. 1:17-cv-04984 in the Southern District of New York.
During the case	The parties litigated the patent dispute under the Hatch-Waxman framework.
Final disposition	The action was resolved without a publicly reported trial judgment on infringement or validity.

The public case record does not establish a Federal Circuit decision or a district-court merits opinion in this specific action. The absence of a merits ruling is commercially important. It means the case did not produce binding claim construction or validity precedent against either party.

Was the Biogen v. Par case dismissed or settled?

The case was resolved through a non-merits disposition rather than a publicly reported patent trial. The publicly available docket record does not disclose the complete economic or launch terms of the parties’ resolution.

In Hatch-Waxman litigation, a dismissal after Paragraph IV litigation commonly reflects a settlement, license, covenant not to sue, or another negotiated arrangement. The dismissal alone does not establish whether Par received:

• An early licensed launch date;
• A launch right contingent on another patent event;
• A royalty-bearing license;
• A supply or distribution arrangement;
• A license limited to particular strengths or formulations; or
• A nonexclusive launch authorization.

No public basis supports treating the case dismissal as an adjudication that Biogen’s patents were valid or that Par’s product infringed.

What the settlement means for generic entry

The settlement likely reduced immediate litigation risk for Par, but it did not necessarily eliminate all regulatory or commercial barriers. A generic launch could still depend on:

• FDA approval of Par’s ANDA;
• The expiration or judicial treatment of remaining Tecfidera patents;
• Any agreed launch restriction;
• Pediatric exclusivity;
• Other ANDA litigation involving the same patents;
• Commercial decisions by Par and its parent company.

The absence of publicly disclosed settlement terms limits any precise calculation of Par’s authorized launch date or the value transferred between the parties.

What was the Orange Book status of Tecfidera?

Tecfidera’s Orange Book protection included patents directed to the product and its use in multiple sclerosis. The principal patent family included the following patents:

Patent	General subject matter	Publicly reported relevance
U.S. 6,509,376	Fumaric acid esters and pharmaceutical use	Core composition and treatment coverage
U.S. 8,399,514	Treatment of multiple sclerosis	Method-of-use protection
U.S. 8,759,393	Treatment of multiple sclerosis	Later method-of-use protection

U.S. Patent No. 6,509,376 had a patent term extending into 2020, subject to applicable patent-term adjustments or extensions. The later method-of-use patents were reported to extend into 2028.

The Orange Book listing did not guarantee that every listed patent would survive validity challenges. It created the regulatory framework for Paragraph IV certifications and potential 30-month stays. Patent listing and patent enforceability are separate questions.

How strong was Biogen’s Tecfidera patent estate?

Biogen’s patent estate was commercially significant but legally uneven.

Composition and formulation coverage

The earlier Tecfidera patents provided broad protection around fumarate compounds and their pharmaceutical use. Those patents created the initial barrier to generic entry but approached expiration in the years following FDA approval.

Delayed-release formulation claims were important because Tecfidera’s product design depends on oral delivery that delays release of dimethyl fumarate. A generic applicant could attempt to design around specific formulation limitations, but an ANDA product must still satisfy FDA requirements for pharmaceutical equivalence and bioequivalence.

Method-of-use protection

The later method-of-use patents were more consequential for the product’s long-term exclusivity. Biogen relied heavily on the patent family covering treatment of multiple sclerosis with dimethyl fumarate.

In separate litigation against Mylan, the Federal Circuit affirmed a finding that claims of U.S. Patent No. 8,399,514 were invalid as obvious. The decision weakened Biogen’s ability to use that patent family as a long-term barrier against generic dimethyl fumarate. The ruling did not itself decide every patent asserted in every Tecfidera case, including the Par action, but it materially affected the strategic value of similar method-of-use claims. (Biogen International GmbH v. Mylan Pharmaceuticals Inc., 2021)

Overall strength assessment

Patent-estate factor	Assessment
Early composition protection	Strong commercial value, but expiration was relatively near the start of generic litigation
Delayed-release product protection	Important, but dependent on claim scope and ANDA formulation details
Method-of-use protection	High commercial value but exposed to obviousness challenges
Litigation leverage	Substantial before adverse validity rulings
Long-term durability	Reduced by invalidity findings in related litigation
Generic design-around risk	Material, particularly for formulation and dosing claims

Biogen’s estate was strongest as a coordinated regulatory and litigation package. Its durability was weaker when individual method-of-use claims were tested on the merits.

Did Par file a Paragraph IV challenge to Tecfidera?

Yes. The case was a Paragraph IV Hatch-Waxman dispute involving Par’s proposed generic dimethyl fumarate product. Par’s certification put the relevant Tecfidera patents in issue and allowed Biogen to bring an infringement action before generic approval.

A Paragraph IV challenge does not mean the challenger will prevail. It indicates that the ANDA applicant alleges that the listed patent is invalid, unenforceable, or not infringed. The applicant may seek FDA approval before patent expiry if it succeeds in litigation, obtains a settlement license, or otherwise satisfies the statutory approval requirements.

What was the FDA regulatory status of generic dimethyl fumarate?

FDA approved Tecfidera in 2013 under the new drug application pathway. Generic dimethyl fumarate products were subsequently approved after patent and exclusivity barriers were addressed through litigation, settlements, or patent developments.

The central regulatory issues were:

1. Whether Par’s ANDA was sufficiently complete for approval;
2. Whether the 30-month stay applied and when it ended;
3. Whether unexpired listed patents blocked approval;
4. Whether any statutory or pediatric exclusivity remained;
5. Whether the proposed product met bioequivalence requirements.

FDA approval would not have resolved the patent dispute. An ANDA product can be approved while a patent dispute remains relevant, depending on the status of the stay and the statutory conditions governing approval.

Did biosimilar risk affect this case?

No. Tecfidera is a small-molecule drug, not a biologic. Par’s application proceeded under the ANDA pathway, not the Biologics Price Competition and Innovation Act biosimilar pathway.

The appropriate competitive risks were:

• Generic substitution;
• ANDA approval;
• Paragraph IV patent litigation;
• Formulation design-around;
• Authorized generic competition;
• Launch timing and price erosion.

Biosimilar concepts such as interchangeable biosimilar designation, reference-product exclusivity under the Public Health Service Act, and patent dance procedures were not applicable to Par’s Tecfidera challenge.

Which companies challenged Tecfidera patents?

Biogen faced multiple ANDA challengers concerning generic dimethyl fumarate. Publicly reported litigants included Par Pharmaceutical, Mylan and other generic drug companies.

Separate proceedings involving the same product do not produce identical outcomes. Each case can differ based on:

• The ANDA formulation;
• The Paragraph IV notice;
• The patents asserted;
• The proposed labeling;
• The parties’ settlement terms;
• Claim-construction positions;
• The timing of FDA approval.

The Mylan litigation was particularly important because the Federal Circuit affirmed invalidity of a key Tecfidera method-of-use patent. That ruling increased pressure on Biogen’s broader generic-defense strategy.

What patent litigation affected Tecfidera generic launch scenarios?

Tecfidera generic launch outcomes fell into four principal scenarios.

Immediate launch after invalidity or noninfringement ruling

A generic could launch before nominal patent expiration if the asserted patents were held invalid or not infringed and no other enforceable barrier remained.

Licensed early launch

Biogen could grant a launch license through settlement. The license might specify a date earlier than patent expiry while preserving the patent owner’s ability to avoid a formal adverse judgment.

Launch after patent expiry

If no enforceable patent blocked approval, generic companies could launch after the expiration of the relevant patent and any applicable regulatory exclusivity.

At-risk launch

A generic applicant could launch while appeal or residual patent issues remained. That strategy creates potential damages exposure under the patent laws and carries commercial risk if the patent owner later obtains relief.

The Par case ended without a public merits ruling, so it does not identify which scenario governed Par’s commercial strategy.

What commercial exposure did Biogen face?

Tecfidera was one of Biogen’s major revenue products. Generic entry threatened:

• Rapid price erosion;
• Loss of pharmacy substitution control;
• Conversion of patients to lower-cost generic products;
• Reduced negotiating leverage with payers;
• Lower net sales for the branded product;
• Revenue cannibalization from other fumarate products.

The commercial exposure was amplified because dimethyl fumarate is a small molecule administered orally and is comparatively suitable for conventional generic competition. Unlike biologic products, it does not face manufacturing complexity that would independently protect the brand from substitution.

Biogen’s later product portfolio, including Vumerity, also created lifecycle-management considerations. Any commercial migration from Tecfidera to another fumarate product could attract scrutiny under patent, regulatory, and antitrust theories, depending on the specific conduct.

What manufacturing and intellectual-property barriers applied to generic dimethyl fumarate?

The principal barrier was intellectual property, not an unusually difficult manufacturing process.

A generic applicant still had to demonstrate:

• Pharmaceutical equivalence;
• Bioequivalence;
• Appropriate enteric or delayed-release performance;
• Stability through shelf life;
• Consistent capsule content and dissolution;
• Compliance with current good manufacturing practices.

Biogen’s formulation claims could increase the cost of designing and validating a noninfringing product. But manufacturing complexity alone would not prevent an ANDA applicant from competing if the product could be made to meet FDA specifications.

The most durable barriers would have been claims that covered the commercial product without requiring narrow formulation features that could be avoided through routine design changes.

How does Biogen v. Par compare with Biogen v. Mylan?

Issue	Biogen v. Par	Biogen v. Mylan
Product	Generic dimethyl fumarate for Tecfidera	Generic dimethyl fumarate for Tecfidera
Legal pathway	Paragraph IV Hatch-Waxman action	Paragraph IV Hatch-Waxman action
Public merits ruling	No reported merits decision in the Par action	Federal Circuit affirmed invalidity of a key patent
Commercial result	Public case record does not disclose full settlement terms	Adverse validity ruling weakened Biogen’s patent position
Precedential effect	Limited to the case disposition	Material effect on the relevant patent family and generic-entry analysis
Strategic significance	Negotiated resolution preserved confidentiality	Judicial invalidity ruling increased generic launch pressure

The two cases should not be treated as interchangeable. The Mylan decision provides legal analysis of a key patent, while the Par action primarily provides evidence of Biogen’s enforcement strategy and the commercial importance of Tecfidera’s patent estate.

Key Takeaways

• Biogen sued Par over a Paragraph IV ANDA for generic dimethyl fumarate delayed-release capsules.
• The case concerned Tecfidera, a small-molecule multiple sclerosis treatment.
• The litigation ended without a publicly reported trial judgment on infringement or validity.
• The complete settlement or dismissal terms were not publicly disclosed.
• Tecfidera protection included composition, formulation and method-of-use patents.
• U.S. Patent No. 8,399,514 was later held invalid in separate litigation against Mylan, weakening Biogen’s long-term method-of-use protection.
• Generic entry risk was driven by patent expiry, Paragraph IV challenges, related litigation and negotiated launch rights.
• Biosimilar law was irrelevant because dimethyl fumarate is a small-molecule drug.
• The case remains relevant as evidence of Biogen’s strategy to defend Tecfidera against ANDA applicants, but it does not establish a judicial precedent on the merits.

FAQs About Biogen International GmbH v. Par Pharmaceutical

What was Par’s generic product in the Biogen lawsuit?

Par pursued an ANDA for generic dimethyl fumarate delayed-release capsules, the proposed generic equivalent of Tecfidera in the 120 mg and 240 mg strengths.

Did Biogen win the Par patent case?

There was no publicly reported merits judgment establishing that Biogen won on infringement or patent validity. The action ended through a non-merits disposition.

Was Tecfidera protected by method-of-use patents?

Yes. Biogen listed and asserted method-of-use patents covering treatment of multiple sclerosis with dimethyl fumarate. The strength of that protection was reduced after a key patent was held invalid in separate litigation.

Could Par launch before Tecfidera’s last patent expired?

Potentially. A Paragraph IV challenger can launch before patent expiry after prevailing in litigation, obtaining a license, or relying on another statutory route to approval. The public Par docket does not disclose the definitive launch terms.

Was Par’s challenge a biosimilar application?

No. Par’s product was a conventional generic drug application under the ANDA pathway. Biosimilar procedures did not apply.

References

Biogen International GmbH v. Mylan Pharmaceuticals Inc., 18-1166, 2021 WL 5150621 (Fed. Cir. Nov. 5, 2021).

Biogen International GmbH v. Par Pharmaceutical, Inc., No. 1:17-cv-04984, U.S. District Court for the Southern District of New York, docket record.

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355.

U.S. Food and Drug Administration. (2013). Tecfidera prescribing information.

U.S. Patent No. 6,509,376. Fumaric acid esters for the treatment of multiple sclerosis.

U.S. Patent No. 8,399,514. Treatment for multiple sclerosis.

U.S. Patent No. 8,759,393. Treatment of multiple sclerosis.