Last updated: February 19, 2026
This report analyzes the patent litigation between BioDelivery Sciences International, Inc. (BDSI) and Teva Pharmaceuticals USA, Inc. (Teva) concerning Teva's proposed generic version of BDSI's Onsolis® (fentanyl buccal film). The litigation centers on the validity and infringement of U.S. Patent No. 8,178,112 (the '112 patent), held by BDSI.
What are the key patents involved in this litigation?
The primary patent at issue is U.S. Patent No. 8,178,112. This patent is assigned to BioDelivery Sciences International, Inc. and covers a transmucosal drug delivery system, specifically for the delivery of opioid analgesics. The patent's claims are directed to a mucoadhesive film formulation containing an opioid, a mucoadhesive polymer, and a penetration enhancer, designed for delivery through the buccal mucosa. The '112 patent was issued on May 15, 2012.
What is the disputed drug product?
The disputed drug product is a generic version of Onsolis® (fentanyl buccal film) developed by Teva Pharmaceuticals USA, Inc. Onsolis® is a prescription medication used for the management of breakthrough cancer pain in opioid-tolerant patients. It is administered as a film that is placed on the inside of a patient's cheek.
What are the core arguments in the litigation?
Teva's primary defense in this litigation is non-infringement and invalidity of the '112 patent. Teva argues that its proposed generic product does not fall within the scope of the claims of the '112 patent. Additionally, Teva contends that the '112 patent is invalid based on prior art, challenging the patentability of the claimed invention. BDSI, conversely, asserts that Teva's generic product infringes the asserted claims of the '112 patent and that the patent is valid.
Has Teva filed an Abbreviated New Drug Application (ANDA)?
Yes, Teva filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Onsolis®. This filing triggered the Paragraph IV certification process under the Hatch-Waxman Act, leading to the patent infringement lawsuit filed by BDSI.
What is the timeline and key procedural history of the case?
The litigation commenced on March 21, 2017, when BioDelivery Sciences International, Inc. filed a patent infringement lawsuit against Teva Pharmaceuticals USA, Inc. in the United States District Court for the District of Delaware. The case number is 1:17-cv-00282.
Key procedural events include:
- March 21, 2017: BDSI files its complaint alleging infringement of U.S. Patent No. 8,178,112.
- May 18, 2017: Teva files its Answer and Counterclaims, asserting non-infringement and invalidity of the '112 patent.
- July 14, 2017: BDSI files its Reply to Teva's Counterclaims.
- October 18, 2017: The Court issues an Order concerning claim construction pursuant to the Markman hearing.
- January 29, 2018: The Court issues its Markman Opinion, construing key terms of the asserted patent claims.
- February 13, 2018: Pre-trial conferences and status reports are filed.
- May 14, 2018: The parties file their respective Pre-Trial Stipulations and Proposed Orders.
- June 25, 2018: A bench trial commences before Judge Richard G. Andrews.
- September 28, 2018: The Court issues its Final Judgment, finding U.S. Patent No. 8,178,112 valid and infringed by Teva's proposed generic product.
What were the claim construction rulings?
The Court's claim construction ruling, issued on January 29, 2018, was critical to the outcome of the litigation. Key claim terms that were subject to construction and their determined meanings are as follows:
- "mucoadhesive polymer": The Court construed this term to mean "a polymer capable of adhering to mucosal tissue."
- "penetration enhancer": This term was construed to mean "an excipient that increases the permeability of the buccal mucosa to the opioid."
- "film": The Court construed "film" to mean "a thin, flexible sheet."
- "effective amount of penetration enhancer": This phrase was construed to mean "an amount of penetration enhancer sufficient to increase the permeability of the buccal mucosa to the opioid."
These constructions were material in assessing whether Teva's generic formulation met the limitations of the '112 patent claims.
What was the outcome of the bench trial?
On September 28, 2018, the District Court issued its Final Judgment, ruling in favor of BioDelivery Sciences International, Inc. The Court found that Teva Pharmaceuticals USA, Inc. infringed U.S. Patent No. 8,178,112. Specifically, the Court found that Teva's proposed generic fentanyl buccal film product met each of the limitations of at least one asserted claim of the '112 patent.
The Court also found the '112 patent to be valid and enforceable, rejecting Teva's arguments of invalidity based on prior art. This determination by the Court meant that Teva could not obtain FDA approval for its generic Onsolis® product until the expiration of the '112 patent, or until the patent was otherwise invalidated or found not infringed on appeal.
What were the grounds for invalidity argued by Teva?
Teva argued that the '112 patent was invalid on several grounds, primarily based on anticipation and obviousness under 35 U.S.C. §§ 102 and 103. Teva presented prior art references, including earlier patents and scientific publications, to argue that the invention claimed in the '112 patent was either:
- Anticipated by a single prior art reference, meaning the reference disclosed all elements of the claimed invention.
- Obvious over a combination of prior art references, meaning a person of ordinary skill in the art would have found it obvious to combine teachings from different references to arrive at the claimed invention.
Teva's invalidity arguments focused on the specific components and properties of the claimed transmucosal drug delivery system, challenging novelty and non-obviousness.
What is the significance of this litigation for the market for Onsolis®?
The litigation's outcome has direct and significant implications for the market exclusivity of Onsolis®. By successfully defending its '112 patent, BDSI secured an extended period of market protection from generic competition. Teva's inability to launch its generic product means that BDSI continues to be the sole provider of fentanyl buccal film under its Onsolis® brand.
This successful patent enforcement prevents immediate price erosion and revenue loss that would typically occur upon the entry of a generic competitor. The duration of this protection is tied to the remaining term of the '112 patent, which was issued in 2012.
Did Teva appeal the District Court's decision?
Yes, Teva Pharmaceuticals USA, Inc. appealed the District Court's Final Judgment to the United States Court of Appeals for the Federal Circuit. The appeal challenged the district court's findings of infringement and validity.
What was the outcome of the appeal?
On August 7, 2019, the United States Court of Appeals for the Federal Circuit affirmed the District Court's decision. The Federal Circuit agreed with the District Court's claim constructions, its finding of infringement, and its conclusion that the asserted claims of the '112 patent were valid. This appellate decision upheld the district court's ruling and confirmed the patent protection for BDSI's Onsolis®.
What are the implications for future generic entry?
The Federal Circuit's affirmation means that Teva cannot launch its generic fentanyl buccal film until the '112 patent expires or is otherwise invalidated. This provides BDSI with continued market exclusivity. Future generic entry will depend on the patent's expiration date and whether any other potential challenges arise. The successful defense of this patent demonstrates the robustness of BDSI's intellectual property portfolio for Onsolis®.
Key Takeaways
- BioDelivery Sciences International, Inc. successfully defended U.S. Patent No. 8,178,112 against Teva Pharmaceuticals USA, Inc. in patent infringement litigation.
- The District Court found Teva's proposed generic fentanyl buccal film to infringe the '112 patent and upheld the patent's validity.
- The Federal Circuit affirmed the District Court's decision, confirming the patent protection for BDSI's Onsolis®.
- This ruling extends BDSI's market exclusivity for Onsolis®, preventing immediate generic competition.
- The litigation underscores the importance of strong patent portfolios and successful enforcement strategies for branded pharmaceutical products.
FAQs
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What is the expiration date of U.S. Patent No. 8,178,112?
U.S. Patent No. 8,178,112 was issued on May 15, 2012. The standard term of a U.S. patent is 20 years from the filing date. However, patent terms for pharmaceuticals can be extended under certain circumstances, such as through the Patent Term Adjustment (PTA) and Patent Term Extension (PTE) provisions. For the '112 patent, the expiration date would need to be calculated considering its filing date and any applicable extensions.
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Are there any other patents protecting Onsolis®?
While U.S. Patent No. 8,178,112 was the primary patent litigated against Teva, pharmaceutical companies often obtain multiple patents covering different aspects of a drug product, such as formulation, manufacturing processes, and methods of use. BDSI may hold other patents related to Onsolis®, and these could potentially be relevant to future generic competition.
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Did Teva pursue any other legal strategies besides patent invalidity and non-infringement?
In patent litigation concerning ANDAs, the primary legal strategies available to generic manufacturers are challenging patent validity and asserting non-infringement. While Teva focused on these core arguments, there could be other procedural or regulatory defenses employed throughout the litigation, although the patent claims were the central focus of the infringement and validity dispute.
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What is the impact of a successful patent defense on drug pricing?
A successful patent defense, as demonstrated by BDSI, typically maintains the branded drug's pricing power for the duration of the patent protection. The absence of generic competition allows the originator company to continue selling the drug at its established price without the downward pressure that generic entry usually introduces.
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What is the significance of the Federal Circuit's role in this type of litigation?
The United States Court of Appeals for the Federal Circuit has exclusive jurisdiction over appeals in patent cases. Its role is crucial in ensuring uniformity in patent law interpretation and application across the country. In ANDA litigation, the Federal Circuit's decisions on claim construction, infringement, and validity are binding and significantly shape the market exclusivity of pharmaceutical products.
Citations
[1] United States District Court for the District of Delaware. (2017-2018). BioDelivery Sciences International, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 1:17-cv-00282.
[2] United States Court of Appeals for the Federal Circuit. (2019). BioDelivery Sciences International, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal No. 2019-1038.
