Litigation Details for Allergan USA, Inc. v. Aurobindo Pharma Ltd. (D. Del. 2019)

Allergan USA, Inc. v. Aurobindo Pharma Ltd. (D. Del. 2019)

Docket		Date Filed	2019-09-13
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	10,188,632; 8,691,860; 9,115,091; 9,364,489; 9,675,587; 9,789,125
Link to Docket	External link to docket

Details for Allergan USA, Inc. v. Aurobindo Pharma Ltd. (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-09-13	140	Opinion - Memorandum Opinion	the ʼ489 patent”), 9,789,125 (“the ʼ125 patent”), 9,675,587 (“the ʼ587 patent”), and 10,188,632 (“the ʼ632…terms in U.S. Patent Nos. 8,691,860, 9,115,091, 9,364,489, 9,789,125, 9,675,587, and 10,188,632.. Signed by…Crystalline Form Patents are the ʼ860 patent, the ʼ091 patent, the ʼ489 patent, and the ʼ125 patent. The Abuse-Deterrent… terms in U.S. Patent Nos. 8,691,860 (“the ’860 patent”), 9,115,091 (“the ʼ091 patent”), 9,364,489 (“…Abuse-Deterrent Patents are the ʼ587 patent and the ʼ632 patent. The parties agreed on the constructions	External link to document

Allergan USA, Inc. v. Aurobindo Pharma Ltd.: A Comprehensive Analysis of the Patent Litigation

The pharmaceutical industry is no stranger to complex patent litigation, and the case of Allergan USA, Inc. v. Aurobindo Pharma Ltd. (Case No. 1:19-cv-01727-RGA) is a prime example of the intricate legal battles that shape the landscape of drug development and market competition. This article delves into the details of this high-stakes lawsuit, exploring its implications for both the parties involved and the broader pharmaceutical sector.

Background of the Case

The litigation between Allergan USA, Inc. and Aurobindo Pharma Ltd. centers around Allergan's drug Viberzi® (eluxadoline), a medication used to treat irritable bowel syndrome with diarrhea (IBS-D). Allergan, along with co-plaintiffs Allergan Holdings Unlimited Company and Eden Biodesign, LLC, initiated the lawsuit in response to Aurobindo's efforts to market a generic version of Viberzi®.

The Hatch-Waxman Framework

This case falls under the purview of the Hatch-Waxman Act, which governs the approval process for generic drugs in the United States. The Act allows generic manufacturers to file Abbreviated New Drug Applications (ANDAs) to expedite the approval of generic versions of brand-name drugs.

This is a Hatch-Waxman case arising from the efforts of six companies to market generic versions of Plaintiffs' Viberzi® drug product.[5]

Key Patents at Issue

The lawsuit involves several patents owned by Allergan, including:

• U.S. Patent No. 8,691,860
• U.S. Patent No. 9,115,091
• U.S. Patent No. 9,364,489
• U.S. Patent No. 9,789,125
• U.S. Patent No. 9,675,587
• U.S. Patent No. 10,188,632

These patents cover various aspects of eluxadoline, including its composition, formulation, and methods of use.

Procedural History

The case was filed on September 13, 2019, in the United States District Court for the District of Delaware. Judge Richard G. Andrews presided over the proceedings, which involved multiple defendants beyond Aurobindo Pharma Ltd.

Consolidation of Related Cases

As is common in pharmaceutical patent litigation, several related cases were consolidated under the lead case number 1:19-cv-01727-RGA. This consolidation included actions against other generic manufacturers seeking to enter the market with their versions of eluxadoline.

Key Court Documents

Throughout the litigation, several important documents were filed, including:

1. The initial complaint
2. Amended complaints
3. Claim construction briefs
4. Summary judgment motions

Claim Construction

One of the critical phases in patent litigation is claim construction, where the court interprets the meaning and scope of the patent claims at issue.

Markman Hearing

A Markman hearing, named after the landmark case Markman v. Westview Instruments, was held to determine the proper interpretation of disputed claim terms. Judge Andrews issued a memorandum opinion on January 11, 2021, providing claim construction for various terms in the patents-in-suit[1].

Impact of Claim Construction

The court's interpretation of claim terms can significantly influence the outcome of the case, as it sets the boundaries for what the patents cover and, consequently, what actions may constitute infringement.

Invalidity Challenges

Defendants in patent infringement cases often challenge the validity of the asserted patents. In this case, several grounds for invalidity were likely raised.

Written Description and Enablement

One potential challenge to the patents' validity could have been based on insufficient written description or lack of enablement under 35 U.S.C. § 112.

Obviousness-Type Double Patenting

Another common invalidity argument in pharmaceutical patent cases is obviousness-type double patenting (OTDP). This doctrine prevents patentees from extending their patent monopoly by obtaining multiple patents on obvious variations of the same invention.

The district court granted Acadia's motion for summary judgment of no invalidity for obviousness-type double patenting.[7]

While this quote refers to a different case, it illustrates the type of OTDP challenges that are frequently raised in pharmaceutical patent litigation.

Infringement Analysis

The core of any patent infringement case is the analysis of whether the accused product or process infringes the asserted patent claims.

Literal Infringement

To prove literal infringement, Allergan would need to show that Aurobindo's proposed generic product contains every element of at least one claim of the asserted patents.

Doctrine of Equivalents

If literal infringement cannot be established, Allergan might argue infringement under the doctrine of equivalents, which allows for a finding of infringement when the accused product performs substantially the same function in substantially the same way to obtain the same result as the patented invention.

Safe Harbor Provisions

The Hatch-Waxman Act provides certain safe harbor provisions that protect generic manufacturers from infringement liability for activities related to seeking FDA approval.

Section 271(e)(1) Safe Harbor

This provision allows generic manufacturers to use patented inventions for purposes reasonably related to developing and submitting information to the FDA.

Section 121 Safe Harbor

In some cases, the safe harbor provision of 35 U.S.C. § 121 may protect patents from OTDP challenges.

The asserted patent was not a proper obviousness-type double patenting reference and the safe harbor of 35 U.S.C. §121 applied to protect the original application.[7]

Expert Testimony

Expert witnesses play a crucial role in patent litigation, particularly in complex pharmaceutical cases.

Technical Experts

Both sides likely engaged technical experts to testify on issues such as the interpretation of patent claims, the state of the art at the time of invention, and the similarities or differences between the patented invention and the accused product.

Economic Experts

Economic experts may have been called upon to address issues related to damages, market impact, and the commercial success of the patented invention.

Discovery Disputes

Large-scale patent litigation often involves extensive discovery, which can lead to disputes between the parties.

Protective Order

A stipulated protective order was proposed to govern the handling of confidential information exchanged during discovery[5].

Inadvertent Production

The protective order included provisions for handling inadvertently produced privileged information, reflecting the complex nature of document production in such cases[5].

Summary Judgment Motions

As the case progressed, both parties likely filed motions for summary judgment on various issues.

Invalidity Summary Judgment

Defendants may have sought summary judgment of invalidity based on prior art or other grounds.

Non-Infringement Summary Judgment

Aurobindo and other defendants might have moved for summary judgment of non-infringement, arguing that their proposed generic products do not infringe Allergan's patents.

Trial Proceedings

If the case was not resolved through summary judgment or settlement, it would have proceeded to trial.

Bench Trial

Patent cases are typically tried before a judge rather than a jury. Judge Richard G. Andrews would have presided over the bench trial.

Burden of Proof

Allergan, as the plaintiff, would bear the burden of proving infringement by a preponderance of the evidence, while the defendants would need to prove invalidity by clear and convincing evidence.

Potential Outcomes and Implications

The resolution of this case could have significant implications for both the parties involved and the broader pharmaceutical industry.

Market Exclusivity

If Allergan prevails, it could maintain market exclusivity for Viberzi® until the expiration of its patents, potentially extending into the 2030s.

Generic Entry

A victory for Aurobindo and other defendants could pave the way for earlier generic entry, potentially reducing drug costs for consumers but impacting Allergan's revenue stream.

Comparative Analysis with Similar Cases

To fully understand the significance of Allergan v. Aurobindo, it's helpful to compare it with similar patent litigations in the pharmaceutical sector.

Acadia Pharmaceuticals v. Aurobindo

In a related case, Acadia Pharmaceuticals successfully defended its patents against an OTDP challenge:

The district court granted Acadia's motion for summary judgment of no invalidity for obviousness-type double patenting.[7]

This outcome may have implications for how OTDP challenges are evaluated in pharmaceutical patent cases.

Ironwood and Allergan v. Aurobindo

In a separate matter involving Allergan and Aurobindo:

Ironwood and Allergan will grant Aurobindo Pharma a license to market a generic version of LINZESS in the United States beginning on August 5, 2030 (subject to U.S.FDA approval), unless certain limited circumstances, customary for settlement agreements of this nature, occur.[10]

This settlement demonstrates that litigation between these parties can sometimes result in negotiated agreements that balance patent protection with eventual generic entry.

Industry Impact and Future Trends

The outcome of Allergan v. Aurobindo and similar cases shapes the landscape of pharmaceutical patent litigation and influences strategies for both brand-name and generic drug manufacturers.

Patent Term Extensions

Cases like this highlight the importance of patent term extensions and other strategies that brand-name manufacturers use to prolong market exclusivity.

Generic Challenges

The increasing sophistication of generic challenges to pharmaceutical patents may lead to more complex litigation and potentially more settlements.

Key Takeaways

• The Allergan v. Aurobindo case exemplifies the complex interplay between patent law and pharmaceutical regulation under the Hatch-Waxman framework.
• Claim construction plays a pivotal role in determining the scope of patent protection and potential infringement.
• Invalidity challenges, particularly those based on obviousness-type double patenting, remain a key strategy for generic manufacturers.
• Safe harbor provisions provide important protections for generic manufacturers but are subject to careful interpretation by the courts.
• The outcome of such litigation can have far-reaching effects on market exclusivity, drug pricing, and patient access to medications.
• Settlements between brand-name and generic manufacturers often involve negotiated entry dates for generic products, balancing innovation incentives with competition.
• The pharmaceutical industry continues to navigate a complex legal landscape, with patent litigation serving as a critical battleground for market access and revenue protection.

Frequently Asked Questions (FAQs)

1. Q: What is the Hatch-Waxman Act, and how does it relate to this case? A: The Hatch-Waxman Act is a U.S. law that governs the approval process for generic drugs. It allows generic manufacturers to file Abbreviated New Drug Applications (ANDAs) to expedite generic drug approvals while providing certain protections for brand-name drug patents. This case arose from Aurobindo's ANDA filing for a generic version of Allergan's Viberzi®.

2. Q: What is obviousness-type double patenting (OTDP)? A: OTDP is a judicial doctrine that prevents patentees from extending their patent monopoly by obtaining multiple patents on obvious variations of the same invention. It's a common invalidity challenge in pharmaceutical patent litigation.

3. Q: How does claim construction impact patent infringement cases? A: Claim construction is crucial because it determines the scope and meaning of patent claims. The court's interpretation of claim terms sets the boundaries for what the patent covers, directly influencing whether an accused product or process infringes the patent.

4. Q: What is the significance of safe harbor provisions in pharmaceutical patent litigation? A: Safe harbor provisions, such as those in the Hatch-Waxman Act, protect generic manufacturers from patent infringement liability for certain activities related to seeking FDA approval. This allows generics to prepare for market entry before patent expiration.

5. Q: How do settlements in pharmaceutical patent cases typically work? A: Settlements often involve the brand-name company granting the generic manufacturer a license to enter the market with a generic version of the drug on a specific future date. This date is typically earlier than the patent expiration but later than the generic company's desired entry date, representing a compromise between the parties.

Sources cited:

1. https://law.justia.com/cases/federal/district-courts/delaware/dedce/1:2019cv01727/70028/140/
2. https://bd6f.s3.amazonaws.com/media/documents/96_-_RGA_PO_Dispute.pdf
3. https://www.finnegan.com/en/insights/blogs/prosecution-first/safe-harbor-protection-acadia-pharms-inc-v-aurobindo-pharma-ltd.html
4. https://investor.ironwoodpharma.com/press-releases/press-release-details/2018/Ironwood-and-Allergan-Announce-Settlement-with-Aurobindo-Pharma-Resolving-LINZESS-linaclotide-Patent-Litigation/default.aspx