Adapt Pharma Operations Ltd. v. Teva Pharm. USA, Inc.

ADAPT PHARMA OPERATIONS LIMITED, et al., Plaintiffs, v. TEVA PHARMACEUTICALS USA, INC., et al., Defendants.

Case No. 2:16-cv-7721 (BRM) (JAD)

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY

June 5, 2020

NOT FOR PUBLICATION

OPINION FILED TEMPORARILY UNDER SEAL

[REDACTED]

MARTINOTTI, DISTRICT JUDGE

Before the Court¹ is an Amended Complaint for Patent Infringement brought by Plaintiffs Adapt Pharma Operations Limited; Adapt Pharma, Inc.; Adapt Pharma Limited (collectively "Adapt"); and Opiant Pharmaceuticals, Inc. ("Opiant") (together with Adapt, "Plaintiffs") against Defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries Ltd. (collectively, "Teva" or "Defendants"). (ECF No. 43.) This action relates to the validity of the following claims of the corresponding United States Patents held by Plaintiffs: (1) Claims 7 and 9 of United States Patent Number 9,468,747 (the "'747 Patent") (TX-0001)²; (2) Claim 4 of United States Patent Number 9,561,177 (the "'177 Patent") (TX-0002); (3) Claims 21, 24, and 25 of United States Patent Number 9,629,965 (the "'965 Patent") (TX-0003); and (4) Claims 2, 24, 33,and 38 of United States Patent Number 9,775,838 (the "'838 Patent) (TX-0004) (collectively, the "Patents-in-Suit"). The Patents-in-Suit cover the pharmaceutical formulations, methods of treatment, and devices encompassed within Plaintiffs' patented invention NARCAN® Nasal Spray ("Narcan"). (ECF No. 287.) Narcan is a branded nasal spray used to treat patients suffering from an opioid overdose. (Id.)

The Court held a two-week bench trial beginning on August 26, 2019, and concluding on September 6, 2019. Due to scheduling issues, testimony from the parties' experts on pharmaceutical economics was heard on October 17, 2019. The parties submitted opening post-trial briefs, and proposed findings of fact and conclusions of law on November 13, 2019. (ECF Nos. 284-87.) The parties submitted responsive post-trial briefing on December 6, 2019. (ECF Nos. 300, 302-04.) Closing arguments were held on February 26, 2020.

This Opinion constitutes the Court's findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a). The findings of fact are based on the Court's observations and credibility determinations of the witnesses who testified, and a thorough review of all the evidence admitted at trial. For the reasons set forth below, and for good cause shown, the Court finds that the asserted claims of the Patents-in-Suit are INVALID.

I. BACKGROUND

The Patents-in-Suit cover the pharmaceutical formulations, methods of treatment, and devices encompassed within Plaintiffs' patented invention Narcan, which was approved by the Food and Drug Administration ("FDA") on November 18, 2015. (ECF No. 287 ¶¶ 1-2.)³ Narcan is a branded nasal spray used to treat patients suffering from an opioid overdose. (Id. ¶ 2.) Teva filed an abbreviated new drug application ("ANDA") No. 209522 seeking FDA approval tocommercially manufacture and sell a generic version of Narcan 4mg spray. (ECF No. 241 ¶ 46.)⁴ "Teva included in its ANDA . . . a certification alleging, [inter alia], that the claims of the [P]atents-in-[S]uit are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of Teva's ANDA Product." (Id. ¶ 47.) Narcan is the reference listed drug ("RLD")⁵,⁶ for ANDA No. 209522. (ECF No. 287 ¶ 3.) Teva does not contest infringement of the asserted claims of the Patents-in-Suit and, therefore, the issue before the Court is whether or not the asserted claims of the Patents-in-Suit are invalid due to the legal principle of obviousness. (See ECF No. 241 ¶¶ 48-51; see TX-1018 at 2-8.)

A. Parties

Adapt is the current holder of New Drug Application ("NDA") No. 208411 under which the 4mg/spray dose of Narcan was approved. (ECF No. 241 ¶ 42.) Opiant was formerly named Lightlake Therapeutics, Inc. ("Lightlake"). (Id. ¶ 5.) Adapt and Opiant are the assignees of the Patents-in-Suit. (Id. ¶¶ 22, 28, 34, 41.) Teva is a manufacturer and distributor of generic drugs. (Id. ¶ 10.) As referenced above, Teva has sought FDA approval to manufacture and sell a generic 4mg/spray naloxone hydrochloride nasal spray prior to the expiration of the Patents-in-Suit. (Id. ¶ 46.)

B. Naloxone and Narcan

Naloxone is used to treat opioid overdoses, including overdoses from illegal drugs such as heroin or from prescription painkillers such as oxycodone or fentanyl. Naloxone works as an "opioid antagonist," in that it quite literally reverses the effects of opioids. Naloxone, however, is not new and has been around since 1971. (Smyth Tr. 326:14-18, ECF No. 292; Illum Tr. 576:19-23, ECF No. 293; TX-3195.02.) The drug was typically administered either intravenously or intramuscularly by trained medical providers. Injection-based administration of naloxone is limited to certified medical professionals, precluding many first responders such as police officers, firefighters, and even some EMTs from providing naloxone to overdose victims in that manner. As a workaround, many first responders combined a naloxone injection device with another device called a disposable Mucosal Atomization Device ("MAD"), which converted the injection-based naloxone delivery method into an improvised nasal spray. The MAD kits had several disadvantages in that they required assembly prior to use (Smyth Tr. 329:22-330:6) and that they delivered too much fluid into the nostrils (Illum Tr. 830:2-15).

In 2012, amidst the rise of opioid overdoses, the FDA held a public meeting to discuss naloxone's role in in preventing opioid-related deaths (the "2012 FDA Meeting"). The FDA specifically mentioned that it was curious about the bioavailability of an intranasal naloxone product as compared to the existing intravenous or intramuscular products. Narcan has since been critical in preventing overdose deaths, and now possesses more than 90% of the retail naloxone market.

Narcan is the first and only FDA-approved naloxone nasal spray. Narcan is used primarily by those without medical training, such as police officers or friends and family of opioid users, when those individuals encounter someone overdosing on an opioid. Narcan has simplified thedelivery of naloxone for non-medical professionals. Narcan's naloxone formula is housed in a ready-to-use, single-use, pre-primed device that is specifically designed for nasal delivery. (Smyth Tr. 333:2-23.) The device Adapt chose, pictured below, is the Aptar UnitDose device—a well-known off-the-shelf device used for nasal delivery.

Image materials not available for display.

(TX-3170.07⁷; ECF No. 285 ¶ 48.)

It has been well documented that the country is in the grips of an opioid epidemic. Over two million Americans struggle with opioid addiction,⁸ with approximately 130 Americans dying from opioid overdoses every day.⁹ At the time of this Opinion, the country is facing the uncertainty of the coronavirus pandemic. Those who suffer from opioid addiction are particularly vulnerableto infection and are likely to have a more severe case of the disease should they be infected.¹⁰ Individuals are also finding that addiction services have been disrupted amid fears of community spread.¹¹ As more and more individuals are isolated in their homes, "[c]ounty coroners, law enforcement and emergency responders around the country are reporting spikes in overdose calls and deaths."¹² There are even reports that at least one police department has suspended administering naloxone due to concerns that officers would contract the virus.¹³ While much is uncertain, it is clear that the coronavirus pandemic has exacerbated the opioid crisis.¹⁴

C. The Patents-in-Suit

The asserted claims in the Patents-in-Suit relate generally to the pharmaceutical compounds, delivery methods, and devices used with Narcan. The compound consists of about 4.4mg of naloxone hydrochloride dihydrate, between about 0.005mg and about 0.015mg of benzalkonium chloride ("BZK"), between about 0.1mg and about 0.5mg of disodium edetate ("EDTA"), between about 0.2mg and about 1.2mg of sodium chloride, and an amount of acidsufficient to sustain a pH balance of 3.5-5.5 in about 100 microliters of solution. That solution is delivered into a single nostril of a patient by the Aptar UnitDose device. The specific patent claims are described in more detail below.

1. United States Patent No. 9,211,253 (the "'253 Patent")

The '253 Patent, which is not at issue in this action, was issued on December 15, 2015. (ECF No. 241 ¶ 11.) The '253 Patent was issued pursuant to a patent application filed on March 16, 2015.¹⁵ (Id. ¶ 12.) The inventors of the '253 Patent are Roger Crystal and Michael Brenner Weiss. (Id. ¶ 14.) Lightlake, now Opiant, is the assignee of the '253 Patent. (Id. ¶ 15.) The '253 Patent expires on March 16, 2035. (Id. ¶ 13.)

2. The '747 Patent¹⁶

The '747 Patent was issued on October 18, 2016, and is entitled "Nasal Drug Products and Methods of Their Use." (ECF No. 241 ¶ 16.) The inventors of the '747 Patent are Roger Crystal and Michael Brenner Weiss. (Id. ¶ 21.) The '747 Patent was issued pursuant to an application that was a continuation-in-part of the application filed for the '253 Patent. (Id. ¶ 18.) Plaintiffs are asserting Claims 7 and 9 of the '747 Patent against Teva. (ECF No. 287 ¶ 4.) "Claim 9 of the '747 Patent is representative of the other asserted claims." (Id. ¶ 7.) Claims 7 and 9 depend from Claims 1, 2, and 3, which read:

[Claim 1] A method of treatment of opioid overdose or a symptom thereof, comprising nasally administering to a patient in need thereof a dose of naloxone hydrochloride using a single-use, pre-primed device adapted for nasal delivery of a pharmaceutical formulation to a patient by one actuation of said device into one nostril of said patient, having a single reservoir comprising apharmaceutical composition which is an aqueous solution of about 100 µL¹⁷ comprising:

about 4 mg naloxone hydrochloride or a hydrate thereof;

between

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