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

Genentech, Inc. v. Sandoz, Inc. (D. Del. 2019)

Docket		Date Filed	2019-01-14
Court	District Court, D. Delaware	Date Terminated	2022-04-19
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	SHILPA MEDICARE LIMITED
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; 8,084,475; 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
Attorneys	Oren D. Langer
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

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

Date Filed	Document No.	Description	Snippet	Link To Document
2019-01-14				External link to document
2019-01-13	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
2019-01-13	3		12/18/2027 8,420,674 12/18/2027 7,566,729 4/22/2029 7,635,707 4/22/2029…of 2 PageID #: 348 Asserted Patents and Expiration Dates: Patent No. Expiration 7,767,225… Supplemental information for patent cases involving an Abbreviated New Drug Application (ANDA) …Received Notice: 12/3/2018. Date of Expiration of Patent: See Attached.Thirty Month Stay Deadline: 4/15/… ) SUPPLEMENTAL INFORMATION FOR PATENT CASES INVOLVING AN ABBREVIATED NEW DRUG	External link to document
2019-01-14	183	Notice to Take Deposition	O. The “ ‘729 patent” refers to U.S. Patent 7,566,729, entitled “Modifying Pirfenidone… patent, ‘002 patent, ‘780 patent, ‘674 patent, ‘462 patent, ‘701 patent, and ‘947 patent collectively…InterMune Patents” refer to the ‘729 patent, ‘236 patent, ‘707 patent, ‘700 patent, ‘383 patent, ‘610 patent…” P. The “ ‘236 patent” refers to U.S. Patent 7,696,236, entitled “Method of Providing…” Q. The “ ‘707 patent” refers to U.S. Patent 7,635,707, entitled “Modifying Pirfenidone	External link to document
2019-01-14	226	Order - -Memorandum and Order	single term in U.S. Patent Nos. 7,566,729 (“the ’729 patent”), 7,635,707 (“the ’707 patent”), and 8,592,462… construction for a single term in U.S. Patent Nos. 7,566,729, 7,635,707, and 8,592,462. Plaintiffs' proposed…the ‘729 patent, claims 2, 8, and 10 of the ‘707 patent, and claims 18 and 23 of the ‘462 patent. (D.I. … “It is a bedrock principle of patent law that the claims of a patent define the invention to which …construing patent claims, a court considers the literal language of the claim, the patent specification	External link to document
2019-01-14	354	Redacted Document	obsessive compulsive disorder. See U.S. Patent Nos. 7,816,383, claim 6; 8,103,002, claims 3 and 9. To …infringement issues being litigated. One family of patents Plaintiffs assert claims methods of managing pirfenidone…January 2019 19 April 2022 1:19-cv-00078 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Genentech, Inc. v. Sandoz, Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Genentech, Inc., a subsidiary of Roche, and Sandoz, Inc., a division of Novartis, is a significant case in the pharmaceutical industry, particularly in the context of patent infringement and generic drug approvals. This article delves into the key aspects of the case, including the background, the patents in dispute, the court's decisions, and the implications of the outcome.

Background of the Case

The case, filed on January 14, 2019, in the U.S. District Court for the District of Delaware (Case No. 1:19-cv-00078), involves Genentech's allegations that Sandoz infringed on its patents related to the drug pirfenidone, which is used to treat idiopathic pulmonary fibrosis (IPF)[3][4].

The Patents in Dispute

Genentech asserted multiple patents in this litigation, primarily focusing on methods for managing side effects when using pirfenidone to treat IPF. These included:

• Liver Function Test (LFT) Patents: These patents claimed methods for monitoring liver function in patients treated with pirfenidone.
• Drug-Drug Interaction (DDI) Patents: These patents covered methods for managing interactions between pirfenidone and other drugs.
• Formulation Patents: Although not central to the initial litigation, a formulation patent (the ’637 patent) was later introduced, claiming a novel tablet formulation of pirfenidone[4][5].

Genentech's Claims and Sandoz's Defense

Genentech alleged that Sandoz's generic pirfenidone product would induce infringement of its patents. Specifically, Genentech argued that Sandoz's proposed label for its generic drug would encourage physicians to prescribe the drug in ways that would infringe Genentech's patents. Sandoz, however, maintained that its label only suggested non-infringing generic uses and did not require or recommend any specific dose modifications that would infringe the patents[1][5].

District Court Decision

U.S. District Judge Richard G. Andrews ruled in favor of Sandoz, finding that Genentech did not meet the burden of proof to establish patent infringement. The judge determined that Sandoz's label did not encourage or promote the infringement of Genentech's patented methods. Additionally, Judge Andrews found parts of Genentech's patents to be invalid because earlier publications made Genentech's innovations obvious[1].

Appeal to the Federal Circuit

Genentech appealed the district court's decision to the U.S. Court of Appeals for the Federal Circuit. The Federal Circuit affirmed the district court's holdings, upholding the invalidation of the LFT patents as obvious and confirming that Sandoz's generic product would not induce infringement of the LFT patents or directly infringe the DDI patents[2][5].

Key Findings and Rulings

• Invalidation of Patents: The court found that the claims of Genentech’s LFT patents were unpatentable as obvious.
• No Inducement of Infringement: The court ruled that the sales of Sandoz’s generic product would not induce infringement of the LFT patents.
• No Direct Infringement: The court also found that the sale of Sandoz’s generic product would not directly infringe Genentech’s DDI patents.
• Formulation Patent: The ’637 patent, which claims a novel tablet formulation of pirfenidone, was not part of the initial litigation but was later introduced. However, it did not change the overall outcome of the case[4][5].

Implications and Outcome

The outcome of this litigation has significant implications for both Genentech and Sandoz, as well as the broader pharmaceutical industry.

• Generic Drug Approval: The decision allowed Sandoz to proceed with the sale of its generic pirfenidone product, which began in May 2022 after final FDA approval[4].
• Patent Protection: The case highlights the challenges pharmaceutical companies face in protecting their intellectual property, especially when generic manufacturers seek to enter the market.
• Legal Precedents: The Federal Circuit's affirmation of the district court's decision sets a precedent for future cases involving similar patent infringement claims and the interpretation of patent validity.

Quotes and Insights from Industry Experts

"The decision underscores the importance of ensuring that patents are novel and non-obvious, as well as the need for clear and specific claims to prevent generic infringement."[4]

Statistics and Data

• Litigation Duration: The case lasted approximately 1,192 days from filing to the latest docket entry[3].
• Number of Patents: Genentech asserted twenty patents initially, with only claims from six patents presented at trial[4].

Highlight from the Original Source

"Sandoz’s label does not require that any one of the claimed dose modifications be undertaken, and the dose modification step in Sandoz’s label is ‘broader’ than those in the patented methods, as the label also suggests dose modification options (e.g., permanent discontinuation) not covered by the Asserted Claims." - Judge Richard G. Andrews[1]

Key Takeaways

• Patent Validity: The case emphasizes the importance of patent validity and the need for innovations to be novel and non-obvious.
• Labeling and Inducement: The decision clarifies that generic drug labels must be carefully crafted to avoid inducing infringement of patented methods.
• Generic Competition: The outcome allows for greater competition in the market for IPF treatments, potentially benefiting patients through lower drug costs.
• Legal Strategies: Pharmaceutical companies must strategically select which patents to assert and ensure that their claims are robust enough to withstand legal challenges.

FAQs

What was the main issue in the Genentech v. Sandoz litigation?

The main issue was whether Sandoz's generic pirfenidone product infringed on Genentech's patents related to methods for managing side effects when treating IPF.

Which court made the initial decision in this case?

The initial decision was made by U.S. District Judge Richard G. Andrews in the U.S. District Court for the District of Delaware.

What was the outcome of the appeal to the Federal Circuit?

The Federal Circuit affirmed the district court's holdings, upholding the invalidation of the LFT patents and confirming that Sandoz's generic product would not induce infringement of the LFT patents or directly infringe the DDI patents.

What is the significance of the ’637 patent in this case?

The ’637 patent, which claims a novel tablet formulation of pirfenidone, was not part of the initial litigation but was later introduced. However, it did not change the overall outcome of the case.

How long did the litigation last?

The litigation lasted approximately 1,192 days from filing to the latest docket entry.

Sources

1. BioSpace: U.S. Judge Tosses Genentech Lawsuit Against Sandoz
2. Justia: GENENTECH, INC. v. SANDOZ INC., No. 22-1595 (Fed. Cir. 2022)
3. RPX Insight: Genentech, Inc., et al. v. Sandoz, Inc., et al.
4. Robins Kaplan LLP: Genentech, Inc. v. Sandoz, Inc.
5. Justia: GENENTECH, INC. v. SANDOZ INC., No. 22-1595 (Fed. Cir. 2022)