Litigation Details for ALLERGAN SALES, LLC v. SANDOZ, INC. (D.N.J. 2017)

ALLERGAN SALES, LLC v. SANDOZ, INC. (D.N.J. 2017)

Docket		Date Filed	2017-10-30
Court	District Court, D. New Jersey	Date Terminated	2022-01-28
Cause	35:271 Patent Infringement	Assigned To	Claire Claudia Cecchi
Jury Demand	Both	Referred To	Edward S. Kiel
Parties	HON. DENNIS M. CAVANAUGH
Patents	7,030,149; 7,320,976; 7,323,463; 7,642,258; 8,133,890; 8,354,409; 8,748,425; 9,474,751; 9,770,453; 9,907,801; 9,907,802
Attorneys	HECTOR DANIEL RUIZ
Firms	Eric I. Abraham
Link to Docket	External link to docket

Details for ALLERGAN SALES, LLC v. SANDOZ, INC. (D.N.J. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-10-30				External link to document
2017-10-30	1		formulation of Combigan®. The listed patents are U.S. Patent Nos. 7,030,149, 7,320,976, 7,642,258, 8,133,890…infringed U.S. Patent Nos. 7,030,149, 7,320,976, 7,323,463, and 7,642,258, and that those patents were not …latest of the expiration dates of U.S. Patent Nos. 7,030,149, 7,320,976, 7,323,463, and 7,642,258. …that the claims of the ’149 patent, ’258 patent, ’976 patent, and ’425 patent are invalid and/or will not… infringement of United States Patent No. 9,770,453 (the “’453 patent”) under 35 U.S.C. § 271(e)(2) and	External link to document
2017-10-30	112		the first patent from which issued in 2006, U.S. Patent No. 7,030,149 (the “’149 patent”). (Id. ¶¶…the “’801 patent”), and 9,907,802 (the “’802 patent). These patents all stem from a patent application… ’149 patent, the ’425 patent, and a third patent from the first litigation, the ’976 patent. 6 (Id…other patents, U.S. Patent Nos. 8,133,890 (the “’890 patent”) and 8,354,409 (the “’409 patent”) that…Allergan Patent Family beginning with the first patent of this family, the ’149 patent. The inequitable	External link to document
2017-10-30	166	Redacted Document	149 patent U.S. Patent No. 7,030,149 (Ex. 5) °976 patent U.S. Patent No. 7,320,976 (Ex. 6) °258 patent U.S…methods of treatment. (32); see U.S. Pat. Nos. 7,030,149, 7,323,463, 8,133,890, 8,354,409, 8,748,425, 9,770,453…Apr. 13, 2012) °453 patent U.S. Patent No. 9,770,453 (Ex. 1) °801 patent U.S. Patent No. 9,907,801 (Ex.…Ex. 2) °802 patent U.S. Patent No. 9,907,802 (Ex. 3) °463 patent USS. Patent No. 7,323,463 (Ex. 4) °149… U.S. Patent No. 7,642,258 (Ex. 7) °409 patent U.S. Patent No. 8,354,409 (Ex. 8) °890 patent U.S. Patent	External link to document

Allergan Sales, LLC v. Sandoz, Inc.: A Comprehensive Litigation Summary and Analysis

Case Overview

The litigation between Allergan Sales, LLC and Sandoz, Inc. involves a series of patent infringement disputes related to several of Allergan's pharmaceutical products. Here, we focus on the specific case related to Allergan's ophthalmic drug Combigan®, which is used to treat glaucoma and ocular hypertension.

Nature of the Case

In the case of Allergan Sales, LLC v. Sandoz, Inc. (Case No. 2:17-cv-10129), Sandoz filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Combigan®. Allergan responded by suing Sandoz for patent infringement, alleging that Sandoz's generic version would infringe several of Allergan's patents related to Combigan®[5].

Key Issues Presented

Patent Infringement and Validity

The primary issues in this case revolve around patent infringement and the validity of the patents in question. Allergan asserted that Sandoz's ANDA product would infringe its patents, while Sandoz argued that the patents were invalid due to obviousness.

Claim Construction and Limitations

A critical aspect of the case was the construction of the patent claims, particularly the "wherein" clauses. Sandoz argued that these clauses were not limiting and therefore did not contribute to the patentability of the claims. However, the district court and the Federal Circuit disagreed, finding that these clauses were indeed limiting and material to patentability. These clauses specified the inventive aspect of Combigan®, namely its ability to reduce daily administrations from three times a day (TID) to twice a day (BID) without a loss of efficacy and with reduced adverse events[5].

Court Decisions and Rulings

District Court Ruling

The district court granted Allergan a preliminary injunction, finding that the "wherein" clauses were claim limitations and that Allergan had shown a likelihood of success on the merits. The court determined that these clauses were essential to the patentability of the invention, as they defined the specific benefits of the drug's administration regimen[5].

Federal Circuit Appeal

Sandoz appealed the district court's decision to the Federal Circuit. The Federal Circuit affirmed the district court's finding, upholding the preliminary injunction. The appellate court concurred that the "wherein" clauses were limiting and material to patentability, thus supporting the validity of Allergan's patents[5].

Issue Preclusion and Claim Preclusion

In a related aspect of the litigation, the court addressed issues of issue preclusion and claim preclusion. Sandoz argued that the validity of certain claims had already been litigated in a previous case and should not be re-litigated. However, the court found that the claim construction had changed, allowing for a re-evaluation of the validity under the new construction. Additionally, Sandoz's attempt to carve out certain uses from its ANDA label was deemed insufficient to avoid infringement claims, as it sought approval for a different method of use that still overlapped with Allergan's patented claims[1].

Induced Infringement

The court also considered the issue of induced infringement. While Sandoz was granted summary judgment on literal infringement due to the lack of evidence that Sandoz would practice the method described in the patent, the court found genuine issues of material fact regarding induced infringement. This included whether Sandoz's proposed ANDA product met the efficacy limitation contained in the patent claims and whether Sandoz had the specific intent to induce infringement[1].

Consequences and Implications

The outcome of this litigation has significant implications for both Allergan and Sandoz. The affirmation of the preliminary injunction prevents Sandoz from marketing its generic version of Combigan® until the expiration of Allergan's patents. This decision underscores the importance of precise claim construction in patent litigation and the potential for "wherein" clauses to be considered limiting and material to patentability.

Key Takeaways

• Patent Claim Construction: The construction of patent claims, especially "wherein" clauses, can be crucial in determining patent validity and infringement.
• Issue and Claim Preclusion: Changes in claim construction can allow for re-litigation of validity issues, and carve-outs in ANDA labels must be substantial to avoid infringement claims.
• Induced Infringement: Evidence of specific intent and meeting efficacy limitations are critical in determining induced infringement.
• Preliminary Injunctions: Courts may grant preliminary injunctions based on the likelihood of success on the merits, particularly when claim limitations are material to patentability.

Frequently Asked Questions (FAQs)

Q: What was the main dispute in the Allergan Sales, LLC v. Sandoz, Inc. case? A: The main dispute was over patent infringement related to Sandoz's attempt to market a generic version of Allergan's ophthalmic drug Combigan®.

Q: How did the court interpret the "wherein" clauses in the patent claims? A: The court found that the "wherein" clauses were limiting and material to patentability, defining the specific benefits of the drug's administration regimen.

Q: What was the outcome of the Federal Circuit's review of the preliminary injunction? A: The Federal Circuit affirmed the district court's decision to grant the preliminary injunction, upholding the validity of Allergan's patents.

Q: What role did issue preclusion and claim preclusion play in the case? A: The court allowed re-litigation of validity issues due to changes in claim construction and found that Sandoz's ANDA label carve-outs were insufficient to avoid infringement claims.

Q: What are the implications of this case for generic drug manufacturers? A: The case highlights the importance of careful claim construction and the potential for preliminary injunctions to delay generic drug market entry.

Sources Cited

1. Robins Kaplan LLP Law Firm, "Allergan Sales, LLC v. Sandoz, Inc." - https://www.robinskaplan.com/newsroom/insights/allergan-v-sandoz
2. Robins Kaplan LLP Law Firm, "Allergan, Inc. v. Sandoz, Inc." - https://www.robinskaplan.com/newsroom/insights/allergan-inc-v-sandoz-inc
3. Robins Kaplan LLP Law Firm, "Allergan, Inc. v. Sandoz Inc." - https://www.robinskaplan.com/newsroom/insights/resources-legal-updates-generically-speaking-hatch-waxman-bulletin-2014-generically-speaking-spring-2014-allergan-inc-v-sandoz-inc2
4. Finnegan, "Allergan Sales, LLC v. Sandoz, Inc." - https://www.finnegan.com/en/tools/allergan-sales-llc-v-sandoz-inc1.html
5. The National Law Review, "Patentability Addressed in Allergan Sales v. Sandoz Suit" - https://natlawreview.com/article/when-wherein-clause-limiting-when-it-s-material-to-patentability