The litigation in Adverio Pharma GmbH v. Teva Pharmaceuticals USA, Inc. (Case No. 1:18-cv-00112) centered on patent infringement claims under the Hatch-Waxman Act involving Teva’s attempt to market a generic version of Adempas® (riociguat tablets). Adverio Pharma GmbH, Bayer AG, and Bayer Healthcare Pharmaceuticals Inc. alleged that Teva’s Abbreviated New Drug Application (ANDA) No. 211044 infringed U.S. Patent No. 7,173,037 (the ’037 Patent), which covers riociguat compounds and their use in treating cardiovascular conditions[1][2][13].
Background and Key Allegations
- Patent Claims: The ’037 Patent includes claims for riociguat compounds, pharmaceutical compositions, and methods of use[13]. Adverio and Bayer asserted that Teva’s generic product would infringe these claims[2][13].
- Teva’s Defense: Teva filed a Paragraph IV certification, contending the ’037 Patent was invalid, unenforceable, or not infringed[13]. Their defense focused on non-infringement and potential invalidity arguments, though specifics (e.g., obviousness, anticipation) were not detailed in the available filings[2][13].
Procedural Posture
- Complaint: Plaintiffs sought injunctive relief under 35 U.S.C. § 271(e)(4) to block FDA approval of Teva’s ANDA until patent expiration[2].
- Jurisdiction: The case was filed in the U.S. District Court for the District of Delaware, with Teva acknowledging jurisdiction for the purposes of the litigation[13].
- Stipulations: Teva did not contest infringement of certain claims (e.g., claims 1–4, 6, 7, and 10 of the ’037 Patent)[2] but challenged others through its Paragraph IV certification[13].
Legal and Strategic Implications
- Hatch-Waxman Dynamics: The case typifies brand-generic disputes under the Hatch-Waxman framework, where a Paragraph IV certification triggers litigation and a 30-month stay on FDA approval[2][13].
- Antitrust and Public Policy Concerns: While not directly raised here, parallel cases involving Teva (e.g., Teva v. Amneal) highlight broader concerns about patent listings delaying generic competition[9][12].
Outcome and Significance
The available documents do not disclose a final judgment. However, the litigation underscores the strategic use of Hatch-Waxman provisions by both brand manufacturers (to protect patents) and generics (to challenge them)[2][13]. The ’037 Patent’s validity and Teva’s infringement stance likely hinged on claim construction and prior art analysis, common flashpoints in pharmaceutical patent cases[13].
This case exemplifies the high stakes of Orange Book patent listings and the procedural complexities inherent in balancing patent rights with generic market entry[12][13].
“The Hatch-Waxman Act allows generic drug manufacturers to challenge branded drug patents through the filing of a Paragraph IV certification, but this also triggers automatic litigation and delays.” [12]
Key Takeaways:
- Patent holders must rigorously defend Orange Book listings to maintain market exclusivity.
- Generic manufacturers rely on Paragraph IV certifications to expedite challenges, though litigation risks remain significant.
- Courts must balance statutory patent protections with antitrust concerns over delayed generic access[9][12].
FAQs:
Q: What is a Paragraph IV certification?
A: A legal assertion by a generic manufacturer that a brand’s patent is invalid or not infringed, enabling ANDA approval[12].
Q: How does the 30-month stay affect generic entry?
A: It delays FDA approval of the generic until patent litigation resolves, preserving brand exclusivity[12].
Q: Why are Orange Book listings contentious?
A: Improper listings can prolong monopolies by triggering unwarranted litigation stays, as seen in Teva’s broader litigation history[9][12].
Citations: [1][2][9][12][13]
References
- https://fedcircuitblog.com/2024/11/01/argument-preview-teva-branded-pharmaceutical-products-rd-inc-v-amneal-pharmaceuticals-of-new-york-llc/
- https://insight.rpxcorp.com/litigation_documents/12773313
- https://www.cafc.uscourts.gov/opinions-orders/04-1186o.pdf
- https://www.justice.gov/d9/2024-10/usa_v._teva_-_settlement_agreement.pdf
- https://www.govinfo.gov/content/pkg/USCOURTS-mad-1_18-cv-12029/pdf/USCOURTS-mad-1_18-cv-12029-0.pdf
- https://www.naag.org/multistate-case/connecticut-et-al-v-teva-pharmaceuticals-usa-inc-et-al-no-219-cv-02407-e-d-pa-filed-in-mdl-05-30-2019/
- https://paragraphfour.com/uploads/cases18/dedc18cv1895C.pdf
- https://studicata.com/case-briefs/case/altana-pharma-ag-v-teva-pharms-usa-inc/
- https://www.cafc.uscourts.gov/opinions-orders/24-1936.OPINION.12-20-2024_2439730.pdf
- https://fedcircuitblog.com/2025/01/02/opinion-summary-teva-branded-pharmaceutical-products-rd-inc-v-amneal-pharmaceuticals-of-new-york-llc/
- https://www.legalmetric.com/samples/sample_ijr_patent.pdf
- https://www.jdsupra.com/legalnews/recent-decisions-and-ftc-challenges-6951264/
- https://paragraphfour.com/uploads/cases18/dedc18cv0112A.pdf
- https://www.cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf
- https://www.orangebookblog.com/hatchwaxman_litigation/page/7/
- https://www.robinskaplan.com/newsroom/insights/adverio-pharma-gmbh-v-alembic-pharms-ltd
- https://patentlyo.com/patent/2024/04/obviousness-pharmaceutical-treatment.html
- https://insight.rpxcorp.com/litigation_documents/12773233
