Litigation Details for Teva Pharmaceuticals International GmbH v. Slayback Pharma Limited Liability Company (D. Del. 2018)

Teva Pharmaceuticals International GmbH v. Slayback Pharma Limited Liability Company (D. Del. 2018)

Docket		Date Filed	2018-01-19
Court	District Court, D. Delaware	Date Terminated	2020-07-06
Cause	28:2201 Declaratory Judgment	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To
Patents	9,034,908; 9,572,887
Link to Docket	External link to docket

Details for Teva Pharmaceuticals International GmbH v. Slayback Pharma Limited Liability Company (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-01-19				External link to document
2018-01-18	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) US 9,572,887 B2. (fms) (Entered… 2018 6 July 2020 1:18-cv-00117 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Teva Pharmaceuticals International GmbH v. Slayback Pharma: Litigation Summary, Patent Scope, and Generic Entry Risk

Last updated: August 3, 2026

Teva Pharmaceuticals International GmbH sued Slayback Pharma LLC in the District of Delaware over Slayback's abbreviated new drug application for generic glatiramer acetate injection, the active ingredient in Teva's Copaxone. The case, No. 1:18-cv-00117, was a Hatch-Waxman Paragraph IV action involving Teva's later-expiring Copaxone patent estate. The matter ended without a reported trial judgment on infringement or validity. The public docket reflects a stipulated dismissal following resolution between the parties. The settlement terms and any authorized launch date were not publicly disclosed. [1]

What drug and ANDA were involved in Teva v. Slayback?

The dispute concerned glatiramer acetate injection, a synthetic immunomodulator approved for the treatment of relapsing forms of multiple sclerosis.

Item	Detail
Reference drug	Copaxone
Active ingredient	Glatiramer acetate
Dosage form	Injectable solution
Relevant strength	40 mg/mL
Regulatory pathway	ANDA under Section 505(j) of the Federal Food, Drug, and Cosmetic Act
Plaintiff	Teva Pharmaceuticals International GmbH
Defendant	Slayback Pharma LLC
Court	U.S. District Court for the District of Delaware
Case number	1:18-cv-00117
Filing date	January 24, 2018
Litigation type	Hatch-Waxman patent infringement action
Disposition	Stipulated dismissal after settlement

Slayback's ANDA sought approval to market a generic glatiramer acetate injection before expiration of Teva's asserted patents. Teva treated the ANDA's Paragraph IV certification as an act of infringement under 35 U.S.C. § 271(e)(2). [1, 2]

What patents did Teva assert against Slayback?

Teva asserted U.S. Patent Nos. 9,155,725 and 9,926,376. The patents were associated with Teva's later-generation Copaxone patent strategy, including claims directed to the 40 mg/mL, three-times-weekly dosing regimen and related glatiramer acetate injection subject matter. [1, 3, 4]

U.S. Patent No. 9,155,725

The '725 patent covered methods involving administration of glatiramer acetate to patients with relapsing-remitting multiple sclerosis. Its commercial significance arose from the dosing regimen corresponding to Copaxone 40 mg/mL administered three times weekly.

The asserted claims were method-of-use claims rather than claims limited solely to the chemical identity of glatiramer acetate. That distinction matters because a generic applicant may seek approval with a carved-out label that omits a patented indication or dosing instruction. The effectiveness of a carve-out depends on the precise claim language, the proposed label and the generic manufacturer's actual marketing conduct.

U.S. Patent No. 9,926,376

The '376 patent was another later-issued Teva patent directed to glatiramer acetate injection subject matter. Its inclusion expanded Teva's infringement theory beyond the principal dosing-method patent and increased the number of patent barriers that Slayback would have had to overcome for an unrestricted launch.

The asserted patent combination illustrates Teva's layered strategy:

1. A dosing and treatment-method patent linked to the commercial 40 mg/mL regimen.
2. A second patent directed to additional glatiramer acetate injection subject matter.
3. A litigation stay that could delay FDA approval while the dispute remained pending.
4. Settlement leverage based on the commercial value of Copaxone and the cost of an adverse judgment.

When did Teva file the case, and what triggered the lawsuit?

Teva filed the complaint on January 24, 2018. The complaint followed Slayback's Paragraph IV certification in its ANDA. Under the Hatch-Waxman framework, a Paragraph IV certification states that a listed patent is invalid, unenforceable or will not be infringed by the proposed generic product.

The filing date indicates that Teva sued within the statutory 45-day period after receiving notice of Slayback's Paragraph IV position. A timely suit generally triggers a 30-month stay of FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii), unless the court enters an earlier judgment or another statutory event ends the stay. [2]

The litigation therefore created two separate commercial constraints for Slayback:

• Slayback could not obtain final FDA approval during the applicable statutory stay unless the stay ended early.
• Slayback faced potential damages and injunctive relief if it launched and Teva prevailed.

What was the litigation outcome?

The case did not produce a publicly reported claim-construction decision, infringement judgment or validity ruling. The docket reflects resolution by stipulated dismissal rather than a merits adjudication. [1]

Did Teva win the patent case?

There was no reported merits victory for Teva. The dismissal did not establish that the asserted patents were valid, infringed or enforceable.

Did Slayback invalidate Teva's patents?

No reported decision in this action invalidated either asserted patent. The absence of a merits judgment also means that the case did not create a binding district-court ruling limiting the scope of the patents.

Was there a settlement agreement?

The parties resolved the action, but material commercial terms were not publicly disclosed in the court record. The public docket does not establish:

• The date on which Slayback could launch;
• Whether launch was authorized before patent expiry;
• Whether the settlement included a license;
• Whether the agreement included supply, manufacturing or royalty provisions;
• Whether Slayback agreed to a delayed entry date;
• Whether the parties entered into a consent judgment.

The dismissal therefore confirms case termination, but it does not by itself establish the commercial terms of the settlement. [1]

What is the Orange Book status of Copaxone?

Copaxone was approved by the FDA as a glatiramer acetate injection product. Teva's Orange Book strategy relied on later-issued patents after the earliest Copaxone patents approached or reached expiration. The relevant listings included patents directed to dosage regimen and injection-related subject matter. [3]

The Orange Book status must be separated from litigation status:

Issue	Effect
Orange Book listing	Gives an ANDA applicant a patent certification obligation
Paragraph IV certification	Creates a potential statutory act of infringement
Timely Hatch-Waxman suit	Can trigger a 30-month FDA approval stay
Stipulated dismissal	Ends the civil action but does not automatically erase the listed patent
Patent expiration	Removes the patent-based barrier after the statutory term ends
Settlement	May authorize earlier entry, depending on its terms

A listed patent can remain in the Orange Book even after a particular lawsuit is dismissed. The dismissal of Teva v. Slayback therefore should not be treated as a public determination that Teva's Orange Book listings were invalid or delisted.

When did Teva's Copaxone patents lose exclusivity?

The core composition patents for glatiramer acetate did not provide the only relevant exclusivity barrier. Teva relied on later patents covering the commercial dosing regimen and product-related subject matter.

The asserted patents had expected expiration dates in the early 2030s, subject to patent-term adjustment, terminal disclaimers and any other applicable statutory calculation. The '725 patent was associated with Teva's 40 mg/mL dosing strategy and had an expected term extending beyond the earliest Copaxone composition patents. The '376 patent represented another later-issued patent layer.

Patent expiry did not necessarily mean that all market barriers disappeared on the same day. Market entry also depended on:

• FDA approval of the ANDA;
• The scope of any label carve-out;
• Settlement restrictions;
• Pediatric exclusivity, if applicable;
• Other Orange Book-listed patents;
• Manufacturing readiness;
• Commercial arrangements with pharmacies and payors.

How did the case affect generic launch risk?

The litigation created a high-risk launch environment for Slayback because Teva asserted patents tied to the product's commercially important 40 mg/mL regimen.

At-risk launch exposure

A launch before resolution would have exposed Slayback to:

• A permanent injunction;
• Lost-profit or reasonable-royalty damages;
• Potential enhancement of damages in an exceptional case;
• Supply-chain disruption;
• Product withdrawal costs;
• Customer and payer contracting risk.

An at-risk launch would have been commercially difficult for a product with established branded and generic competition. The expected value of early entry would have had to exceed the litigation exposure and the cost of withdrawing the product if Teva prevailed.

Label carve-out risk

If Slayback attempted to omit the patented method of use from its label, Teva could still argue that the product's composition, labeling, promotional materials or actual use induced infringement. A carve-out can reduce risk, but it does not eliminate the possibility of a separate induced-infringement or contributory-infringement claim.

The practical risk depended on the final FDA-approved label, prescribing patterns and the degree to which the patented regimen represented the principal commercial use of the product.

Was this a biosimilar case?

No. The case involved a generic drug application, not a biosimilar application.

Glatiramer acetate is a synthetic polypeptide mixture regulated through the ANDA pathway for generic drug products. Slayback did not proceed under the Biologics Price Competition and Innovation Act or the 351(k) biosimilar pathway.

Category	Teva v. Slayback
Product type	Synthetic generic drug
FDA pathway	ANDA, Section 505(j)
Patent framework	Hatch-Waxman
Biosimilar exchange	Not applicable
BPCIA litigation	Not applicable
Paragraph IV certification	Applicable

This distinction affects the regulatory timetable, patent-notice procedures and litigation mechanics. Biosimilar-specific concepts such as the BPCIA patent dance and reference-product exclusivity do not apply.

Which companies competed with Teva in glatiramer acetate?

The Copaxone market developed into a multi-company generic market. Known participants included Sandoz, Mylan and other generic manufacturers that pursued glatiramer acetate products through ANDAs.

The competitive landscape had several characteristics:

• Teva retained the branded Copaxone franchise.
• Generic competitors targeted both 20 mg/mL daily and 40 mg/mL three-times-weekly products.
• The 40 mg/mL regimen had strategic value because it reduced injection frequency.
• FDA approval of competing products increased payer pressure on Copaxone pricing.
• Patent settlements could determine the timing of additional entrants.

The value of the Slayback dispute was therefore linked to entry timing rather than merely to the existence of a generic application. A first or early entrant could obtain materially better economics than a later entrant after multiple approvals.

How strong was Teva's patent estate against Slayback?

Teva's estate was commercially meaningful but legally untested in this action.

Strengths

• The asserted patents were later-generation patents associated with the marketed 40 mg/mL regimen.
• The patents created a statutory approval stay after the Paragraph IV filing.
• The claims targeted commercially relevant treatment and injection subject matter.
• The multi-patent structure increased the cost and complexity of a generic challenge.

Weaknesses

• Method-of-use claims can be vulnerable to label carve-outs and non-infringing-use arguments.
• Later-issued patents may face obviousness, written-description and enablement challenges.
• A stipulated dismissal did not validate the patents.
• The absence of a merits judgment leaves claim scope and enforceability unresolved in this case.
• Other generic entrants and later litigation could test the same patents separately.

The most accurate legal assessment is that Teva achieved a negotiated case disposition, not a judicial confirmation of patent validity.

What manufacturing and intellectual-property barriers applied?

Glatiramer acetate is a complex synthetic mixture rather than a simple small molecule with a single precisely defined active structure. Manufacturing consistency, characterization, impurity control and equivalence were important regulatory issues.

The commercial barriers included:

• Reproducing the active ingredient's composition and quality profile;
• Demonstrating pharmaceutical equivalence;
• Meeting FDA requirements for injectable products;
• Establishing reliable manufacturing capacity;
• Avoiding infringement of product, process and method claims;
• Managing supply continuity for a chronic-use injectable medicine.

These manufacturing considerations increased the value of settlement. Even if a generic applicant had a credible invalidity defense, manufacturing scale-up and FDA review could reduce the economic value of an early launch.

What revenue exposure did Teva face?

Copaxone was a major Teva product, but its revenue was already under pressure from generic competition and price erosion. The 40 mg/mL product represented an important portion of the franchise because of its dosing convenience and established prescribing base.

The financial exposure from Slayback's entry depended on:

• Slayback's approval and launch timing;
• The number of competing generic entrants;
• Pharmacy-benefit-manager formulary placement;
• Discounting and rebate levels;
• The extent of substitution from Copaxone;
• Whether Slayback received an exclusive or limited settlement entry date.

A single entrant would generally produce less price erosion than several simultaneous entrants. The settlement's undisclosed launch terms therefore had potential value beyond the direct Slayback product forecast.

Key Takeaways

• Teva sued Slayback in the District of Delaware over an ANDA for generic glatiramer acetate injection, including the commercially important 40 mg/mL strength.
• The case involved U.S. Patent Nos. 9,155,725 and 9,926,376.
• The action was a Hatch-Waxman Paragraph IV case and likely triggered the statutory 30-month approval stay.
• The public docket reflects a stipulated dismissal after resolution, with no reported merits ruling.
• The settlement terms and any authorized generic launch date were not publicly disclosed.
• The case did not involve biosimilars or the BPCIA.
• Teva's patents formed a later-generation Copaxone estate focused on dosing and injection-related subject matter.
• The litigation outcome reduced immediate case-specific uncertainty but did not establish the validity or enforceability of the asserted patents.

FAQs

Did Slayback receive FDA approval for generic Copaxone?

The litigation docket does not establish the final FDA approval status or commercial launch date of Slayback's ANDA. Case dismissal alone does not prove that the ANDA was approved or marketed.

Was Teva v. Slayback part of broader Copaxone patent litigation?

Yes. Teva pursued multiple patent actions against generic applicants seeking approval for glatiramer acetate injection. The Slayback case was one proceeding within that broader generic-entry dispute.

Could Slayback launch before the asserted patents expired?

Only if permitted by the settlement, a court order, patent invalidity or non-infringement determination, or another regulatory pathway. The public dismissal record does not disclose the applicable launch date.

Did the case create precedent on glatiramer acetate patent validity?

No reported merits opinion from this action created such precedent. A stipulated dismissal does not resolve patent validity or infringement.

Are Teva's Copaxone patents still relevant after the Slayback dismissal?

Yes. Dismissal of one case does not automatically cancel Orange Book listings or resolve separate litigation involving the same patents and other generic applicants.

References

1. U.S. District Court for the District of Delaware. (2018). Teva Pharmaceuticals International GmbH v. Slayback Pharma LLC, No. 1:18-cv-00117, docket filings and stipulated dismissal.
2. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book listings for Copaxone and glatiramer acetate injection.
4. U.S. Patent and Trademark Office. (2015). U.S. Patent No. 9,155,725, glatiramer acetate injection.
5. U.S. Patent and Trademark Office. (2018). U.S. Patent No. 9,926,376, glatiramer acetate injection.