Litigation Details for Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc. (D. Del. 2015)

Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc. (D. Del. 2015)

Docket		Date Filed	2015-02-19
Court	District Court, D. Delaware	Date Terminated	2019-12-05
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	Plaintiff	Referred To
Parties	PRAXAIR INC.
Patents	8,282,966; 8,291,904; 8,293,284; 8,431,163; 8,573,209; 8,573,210; 8,776,794; 8,776,795; 8,795,741; 8,846,112; 9,265,911; 9,279,794; 9,295,802
Attorneys	Margaux L. Nair
Firms	Morgan Lewis & Bockius LLP
Link to Docket	External link to docket

Details for Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc. (D. Del. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-02-19				External link to document
2015-02-19	1		23, 1999. THE PATENTS-IN-SUIT 13. United States Patent No. 8,282,966 (the “’966 patent,” copy attached…ANDA Product. COUNT I INFRINGEMENT OF U.S. PATENT NO. 8,282,966 39. Plaintiffs repeat and reallege paragraphs…’966 patent, the ’284 patent, the ’163 patent, the ’741 patent, the ’112 patent, the ’904 patent, the …’966 patent, the ’284 patent, the ’163 patent, the ’741 patent, the ’112 patent, the ’904 patent, the …’966 patent, the ’284 patent, the ’163 patent, the ’741 patent, the ’112 patent, the ’904 patent, the	External link to document
2015-02-19	131		ORDER CONSTRUING THE TERMS OF U.S. PATENT NOS. 8,282,966, 8,293,284, 8,431,163, 8,795,741, 8,846,…2015 5 December 2019 1:15-cv-00170 830 Patent Plaintiff District Court, D. Delaware	External link to document
2015-02-19	138		Decision in Inter Partes Review of U.S. Patent No. 8,846,112 B2 by Praxair Distribution Inc., Praxair…2015 5 December 2019 1:15-cv-00170 830 Patent Plaintiff District Court, D. Delaware	External link to document
2015-02-19	156		alleging infringement of U.S. Patent Nos. 8,282,966 ("the '966 patent"); 8,293,284 ("…#x27;802 patent, '911 patent, and '794 patent (collectively, "the new patents") issued… patent"); 8,776,794 ("the '794 patent"); 8,573,209 ("the '209 patent"…continuation of U.S. Patent No. 8,573,209, one of the patents-in-suit, and the '802 patent is a continuation…addition of the new patents. First, the new patents bear close relation to the asserted patents: the '911	External link to document
2015-02-19	158		Counts I-V regard U.S. Patent Nos. 8,282,966 ("the '966 patent"); 8,293,284 ("the…;the '284 patent"); 8,431,163 ("the '163 patent"); 8,795,741 ("the '…x27;741 patent"); and 8,846,112 ('"the '112 patent"). 1 (D.I. 36 at 3.) The specifications…specifications of all five patents are substantively identical. Each of these five patents claims a method of …Inc. alleging that the Defendants infringed ten patents by filing an Abbreviated New Drug Application;	External link to document
2015-02-19	167		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,265,911 B2; 9,295,802 B2; 9,279,794…2015 5 December 2019 1:15-cv-00170 830 Patent Plaintiff District Court, D. Delaware	External link to document

Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc.: A Comprehensive Litigation Summary and Analysis

Background and Context

Mallinckrodt Hospital Products IP Ltd., a subsidiary of Mallinckrodt plc, has been embroiled in a significant patent infringement dispute with Praxair Distribution Inc. The litigation revolves around Mallinckrodt's patents related to the use and administration of inhaled nitric oxide (iNO) for treating neonates with hypoxic respiratory failure.

Patents in Dispute

Mallinckrodt asserted several patents in this case, including:

• Heart Failure (HF) Patents: U.S. Patent Nos. 8,282,966, 8,293,284, 8,795,741, 8,431,163, and 8,846,112. These patents pertain to methods of administering iNO.
• Device and Method Patents: U.S. Patent Nos. 8,573,209, 8,776,794, 8,776,795, and others related to devices and methods for administering gas, including the DSIR (Delivery System Infrared) patents[4].

Litigation Timeline and Key Events

• Initial Lawsuit (2015): Mallinckrodt sued Praxair in the District of Delaware, alleging that Praxair's proposed ANDA (Abbreviated New Drug Application) product, Noxivent, infringed Mallinckrodt's HF patents and device claims of the DSIR patents[2][4].
• District Court Ruling (2017): The district court held that the HF patents were ineligible under 35 U.S.C. § 101 for lacking patent-eligible subject matter. It also found that the DSIR patents were not infringed by Praxair's proposed NOxBOXi device[2][4].
• PTAB Proceedings: Concurrently, Praxair petitioned the PTAB (Patent Trial and Appeal Board) to institute an Inter Partes Review (IPR) of one of the method patents (U.S. Patent No. 8,846,112), arguing that the claims were obvious. The PTAB found most claims obvious, and the Federal Circuit later upheld this decision, declaring all claims of the '112 patent unpatentable as obvious[1][4].
• Federal Circuit Appeal: Mallinckrodt appealed the district court's decision to the U.S. Court of Appeals for the Federal Circuit. The Federal Circuit heard oral arguments and ultimately affirmed the district court's ruling that the HF patents were ineligible under § 101 and vacated in part the ruling on the DSIR patents[2][4].

Subject Matter Eligibility Under § 101

The core issue in this litigation was whether the HF patents met the subject matter eligibility criteria under 35 U.S.C. § 101. The Federal Circuit applied the two-part test established by the Supreme Court in Mayo v. Prometheus and Alice Corp. v. CLS Bank.

• Step 1: Directed to a Natural Phenomenon: The court determined that the HF patent claims were directed to natural phenomena, specifically the observation that iNO gas can cause adverse events in patients with left ventricular dysfunction (LVD)[2][5].
• Step 2: Inventive Concept: The court found that the claim limitations, including identifying, determining, and administering steps, were routine and conventional in the art. The "excluding" step, which involved withholding iNO treatment from patients with LVD, was not considered sufficient to transform the claim into patent-eligible subject matter. The court held that this step merely restated the natural law and did not add an inventive concept[2][5].

Pre-emption and Selective Administration

Mallinckrodt argued that the claims did not have a large pre-emptive effect because they allowed for other treatments of appropriate and inappropriate patients. However, Praxair countered that the claims would prevent others from performing the diagnostic portion followed by treatment with iNO or alternative treatments, making the claims too pre-emptive[1].

Device Patents and Infringement

In addition to the method patents, Mallinckrodt also asserted that Praxair's NOxBOXi device infringed the DSIR patents. However, the district court found that these patents were not infringed. On appeal, the Federal Circuit addressed the construction of the term "verify" in the DSIR patents and whether Praxair's proposed gas cylinder infringed these patents. The court partially vacated and remanded the district court's decision on these issues[2][4].

Conclusion and Implications

The litigation highlights the challenges in obtaining and maintaining patents for methods that are closely tied to natural phenomena. The Federal Circuit's decision underscores the importance of demonstrating an inventive concept beyond the natural law itself to meet the subject matter eligibility criteria under § 101.

Key Takeaways

• Subject Matter Eligibility: Patents must demonstrate an inventive concept beyond natural phenomena to be eligible under § 101.
• Routine and Conventional Steps: Claims that involve only routine and conventional steps in the art are unlikely to be patent-eligible.
• Pre-emption: Claims that have a significant pre-emptive effect on future innovations may be deemed ineligible.
• Device Patents: The construction of terms in device patents can significantly impact infringement determinations.

Frequently Asked Questions (FAQs)

Q: What was the main issue in the Mallinckrodt v. Praxair litigation? A: The main issue was whether Mallinckrodt's patents related to the administration of inhaled nitric oxide (iNO) were eligible for patent protection under 35 U.S.C. § 101.

Q: Why were the HF patents deemed ineligible? A: The HF patents were deemed ineligible because they were directed to natural phenomena and did not contain an inventive concept sufficient to transform the claimed phenomena into a patent-eligible application.

Q: What role did the PTAB play in this litigation? A: The PTAB reviewed the obviousness of one of the method patents (U.S. Patent No. 8,846,112) and found most claims obvious, a decision later upheld by the Federal Circuit.

Q: How did the Federal Circuit rule on the DSIR patents? A: The Federal Circuit partially vacated and remanded the district court's decision on the DSIR patents, addressing issues related to the construction of the term "verify" and infringement.

Q: What are the implications of this case for future patent applications? A: This case emphasizes the need for patent applications to demonstrate an inventive concept beyond natural phenomena and routine conventional steps to meet the subject matter eligibility criteria under § 101.

Cited Sources

1. Banner Witcoff, IP Alert: INO Therapeutics v. Praxair Distribution - Banner Witcoff, February 22, 2019.
2. Casetext, INO Therapeutics LLC v. Praxair Distribution Inc., August 27, 2019.
3. Supreme Court, APPENDIX to cert. petition, March 6, 2020.
4. Supreme Court, INO Therapeutics LLC v. Praxair Distribution Inc. - cert. extension application, January 28, 2020.
5. Knobbe Martens, District Court Finds Mallinckrodt Patents Claim Unpatentable Natural Phenomena.