Litigation Details for Genentech, Inc. v. Lupin Ltd. (D. Del. 2019)

Genentech, Inc. v. Lupin Ltd. (D. Del. 2019)

Docket		Date Filed	2019-01-18
Court	District Court, D. Delaware	Date Terminated	2021-10-15
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	7,566,729; 7,635,707; 7,696,236; 7,767,225; 7,767,700; 7,816,383; 7,910,610; 7,988,994; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,753,679; 8,754,109; 8,778,947
Link to Docket	External link to docket

Details for Genentech, Inc. v. Lupin Ltd. (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-01-18				External link to document
2019-01-17	1		U.S. Patent No. 7,566,729 25. U.S. Patent No. 7,566,729 (“the ‘729 patent”), entitled…  U.S. Patent No. 7,767,700 29. U.S. Patent No. 7,767,700 (“the ‘700 patent”), entitled… U.S. Patent No. 8,013,002 35. U.S. Patent No. 8,013,002 (“the ‘002 patent”), entitled… U.S. Patent No. 8,383,150 41. U.S. Patent No. 8,383,150 (“the ‘150 patent”), entitled… U.S. Patent No. 8,609,701 47. U.S. Patent No. 8,609,701 (“the ‘701 patent”), entitled	External link to document
2019-01-17	22	Patent/Trademark Report to Commissioner of Patents	B2; 7,696,236 B2; 7,767,700 B2; 8,420,674 B2; 7,566,729 B1; 7,635,707 B1; 8,592,462 B2; 8,609,701 B2; … Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s): 7,767,225 B2;…2019 15 October 2021 1:19-cv-00109 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Genentech, Inc. v. Lupin Ltd.: A Comprehensive Analysis of the Patent Infringement Case

In the complex world of pharmaceutical patent litigation, the case of Genentech, Inc. v. Lupin Ltd. (1:19-cv-00109) stands out as a significant battle over intellectual property rights. This article delves into the intricacies of this legal dispute, exploring its implications for the pharmaceutical industry and patent law.

The Genesis of the Lawsuit

On January 18, 2019, Genentech, Inc. and InterMune, Inc. (collectively referred to as "Plaintiffs") filed a complaint against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively "Lupin" or "Defendants") in the United States District Court for the District of Delaware. The lawsuit centered around Lupin's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Genentech's drug Esbriet® (pirfenidone) 267 mg capsules.

The Drug at the Center of the Dispute

Esbriet® is a vital medication used for treating Idiopathic Pulmonary Fibrosis (IPF), a rare and fatal lung disease. The drug's importance in the medical field cannot be overstated, as IPF patients face a grim prognosis without effective treatment options.

IPF results in scarring of the lungs, which makes breathing difficult and prevents the heart, muscles, and vital organs from receiving enough oxygen to work properly. The disease can advance quickly or slowly, but eventually the lungs will harden and stop working altogether.[1]

The Legal Basis of the Complaint

The lawsuit was filed under the Hatch-Waxman Act, which governs the approval process for generic drugs in the United States. Genentech alleged that Lupin's ANDA infringed on multiple patents associated with Esbriet®.

Patents at Stake

The complaint listed several patents that Genentech claimed were infringed by Lupin's ANDA, including:

1. U.S. Patent No. 7,566,729
2. U.S. Patent No. 7,635,707
3. U.S. Patent No. 8,592,462
4. U.S. Patent No. 7,816,383
5. U.S. Patent No. 8,084,475
6. U.S. Patent No. 8,013,002
7. U.S. Patent No. 8,318,780
8. U.S. Patent No. 8,383,150
9. U.S. Patent No. 8,420,674
10. U.S. Patent No. 9,326,957

These patents cover various aspects of Esbriet®, including its formulation, methods of use, and manufacturing processes.

Lupin's Paragraph IV Certification

In its ANDA, Lupin included a Paragraph IV certification, asserting that the patents listed by Genentech in the FDA's Orange Book were invalid, unenforceable, or would not be infringed by Lupin's generic product.

The Significance of Paragraph IV Certifications

Paragraph IV certifications are a crucial aspect of generic drug applications. They allow generic manufacturers to challenge the validity of brand-name drug patents before their expiration, potentially bringing lower-cost alternatives to market sooner.

Genentech's Allegations of Infringement

Genentech's complaint alleged that Lupin's submission of the ANDA constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A). This provision of patent law considers the submission of an ANDA seeking approval to engage in the commercial manufacture, use, or sale of a patented drug before patent expiration as an act of infringement.

Types of Infringement Claimed

The plaintiffs asserted multiple types of patent infringement:

1. Direct infringement
2. Induced infringement
3. Contributory infringement

Each of these infringement types carries different legal implications and requires specific elements to be proven in court.

Lupin's Defense Strategy

While the specific details of Lupin's defense are not fully disclosed in the available documents, it's likely that their strategy centered around challenging the validity of Genentech's patents and arguing non-infringement.

The Importance of Patent Validity

In patent infringement cases, defendants often attempt to invalidate the asserted patents. This can be done by demonstrating that the patents fail to meet the requirements of patentability, such as novelty, non-obviousness, and enablement.

The Role of the FDA in ANDA Disputes

The Food and Drug Administration (FDA) plays a crucial role in ANDA disputes. While the FDA doesn't adjudicate patent disputes, its approval process for generic drugs is intertwined with patent litigation under the Hatch-Waxman Act.

The Orange Book and Patent Listings

The FDA's Orange Book, officially known as Approved Drug Products with Therapeutic Equivalence Evaluations, lists patents associated with approved drugs. Generic manufacturers must address these listed patents in their ANDA submissions.

Esbriet® capsules and the use of Esbriet® capsules in accordance with its FDA-approved label are covered by one or more claims of the Asserted Patents. The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") lists the Asserted Patents in connection with Esbriet® capsules.[1]

The Potential Impact on the Pharmaceutical Industry

Cases like Genentech v. Lupin have significant implications for the pharmaceutical industry. They highlight the tension between brand-name drug manufacturers seeking to protect their investments in research and development, and generic manufacturers aiming to bring more affordable options to market.

Balancing Innovation and Accessibility

The outcome of such cases can influence the delicate balance between incentivizing pharmaceutical innovation through patent protection and ensuring access to affordable medications through generic competition.

Legal Precedents and Their Influence

While not directly related to this case, other recent Federal Circuit decisions provide context for how courts approach ANDA litigation. For instance, in H. Lundbeck A/S v. Lupin Ltd., the court clarified important aspects of contributory infringement in the context of "skinny" labels.

The H. Lundbeck A/S v. Lupin Ltd. Case

In this case, the Federal Circuit emphasized that "substantial noninfringing use" in contributory infringement refers only to uses that do not infringe the patent in question, not other patents held by the plaintiff.

The Federal Circuit clarified that "substantial noninfringing use in section 271(c) refers to uses that do not infringe the patent in question, not other patents."[3]

The Complexities of ANDA Litigation

ANDA litigation is notoriously complex, often involving intricate scientific and legal arguments. The Genentech v. Lupin case exemplifies this complexity, with multiple patents and various types of infringement claims at play.

The Role of Expert Testimony

In such cases, expert testimony often plays a crucial role in helping the court understand the technical aspects of the patents and the alleged infringement. Both sides typically present expert witnesses to support their arguments.

Potential Outcomes and Their Implications

The outcome of this case could have far-reaching implications for both Genentech and Lupin, as well as the broader pharmaceutical industry.

Possible Scenarios

1. If Genentech prevails, it could maintain market exclusivity for Esbriet® for a longer period.
2. If Lupin succeeds, it could pave the way for earlier entry of generic pirfenidone into the market.
3. The parties could reach a settlement agreement, potentially allowing Lupin to enter the market at a negotiated future date.

The Broader Context of Pharmaceutical Patent Litigation

The Genentech v. Lupin case is part of a larger trend of pharmaceutical patent litigation that has significant implications for healthcare costs and patient access to medications.

The Cost of Drug Development

Brand-name pharmaceutical companies often cite the high costs of drug development and clinical trials as justification for strong patent protection. According to a 2016 study by the Tufts Center for the Study of Drug Development, the average cost to develop and gain marketing approval for a new drug is estimated at $2.6 billion.

Key Takeaways

1. The Genentech v. Lupin case highlights the complex interplay between patent law and pharmaceutical regulation under the Hatch-Waxman Act.

2. The dispute centers around Lupin's attempt to market a generic version of Genentech's Esbriet®, a crucial treatment for Idiopathic Pulmonary Fibrosis.

3. Multiple patents are at stake, covering various aspects of Esbriet®'s formulation, use, and manufacture.

4. The case exemplifies the tension between protecting pharmaceutical innovation and ensuring access to affordable medications.

5. The outcome could have significant implications for both the specific drug market and broader trends in generic drug availability.

FAQs

1. Q: What is an Abbreviated New Drug Application (ANDA)? A: An ANDA is an application for a generic drug approval for an existing licensed medication or approved drug. It contains data that provides for the review and ultimate approval of a generic drug product by the FDA.

2. Q: What is a Paragraph IV certification? A: A Paragraph IV certification is a statement in an ANDA asserting that the patent for the brand name drug is invalid, unenforceable, or will not be infringed by the generic drug for which the ANDA applicant seeks approval.

3. Q: How does the Hatch-Waxman Act relate to this case? A: The Hatch-Waxman Act governs the process by which generic drugs can enter the market. It allows generic manufacturers to challenge brand-name patents before they expire through Paragraph IV certifications.

4. Q: What is the significance of the FDA's Orange Book in ANDA litigation? A: The Orange Book lists patents associated with approved drugs. Generic manufacturers must address these listed patents in their ANDA submissions, making it a crucial reference in patent infringement cases.

5. Q: How might the outcome of this case affect patients? A: The outcome could impact the availability and pricing of pirfenidone treatments for Idiopathic Pulmonary Fibrosis. If Lupin prevails, it could lead to earlier availability of lower-cost generic options. If Genentech wins, it could maintain market exclusivity for Esbriet® for a longer period.

Sources cited: [1] https://insight.rpxcorp.com/litigation_documents/13204814 [3] https://www.fr.com/insights/thought-leadership/blogs/the-federal-circuit-weighs-in-on-hatch-waxman-skinny-label-infringement-dispute/