BECAUSE A SKILLED ARTISAN WOULD HAVE RECOGNIZED THE LIMITATIONS OF ONE PRIOR-ART REFERENCE AND WOULD HAVE BEEN MOTIVATED TO SELECT THE TEACHINGS OF ANOTHER REFERENCE TO OVERCOME THEM, THE PATENTS-IN-SUIT WERE OBVIOUS.

Case Name: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., No. No. 16-7721 (BRM) (JAD), 2020 WL 3428078 (D.N.J. June 22, 2020) (Martinotti, J.)

Drug Product and Patent(s)-in-Suit: Narcan® (naloxone) nasal spray; U.S. Patents Nos. 9,468,747 (“the ’747 patent”), 9,561,177 (“the ’177 patent”), 9,629,965 (“the ’965 patent”), and 9,775,838 (“the ’838 patent”)

Nature of the Case and Issue(s) Presented: Naloxone, which has been used since the 1970s, can treat opioid overdoses, including from oxycodone, fentanyl, and heroin. Narcan® was the first and only FDA-approved naloxone nasal spray. The patents-in-suit claimed pharmaceutical compositions, delivery methods, and devices used with Narcan. The court held a two-week bench trial. The opinion constituted the court’s findings of fact and conclusions of law that the asserted claims of the patents-in-suit were invalid.

Why Teva Prevailed: Before the priority date of the patents-in-suit, to administer naloxone intranasally, individuals utilized a MAD kit, which consisted of a mucosal atomizer and a syringe of naloxone solution that had to be assembled prior to use. The MAD Kit had numerous drawbacks, including that it was an injectable dose that was converted for intranasal administration (i.e., not optimized for intranasal delivery), it delivered too much fluid to a patient’s nostrils, and it had to be assembled prior to use. In contrast, the prior-art Aptar UnitDose device was able to deliver the correct volume of drug and the off-the-shelve, commercially-available, device was pre-primed and required no assembly. As a result, a POSITA would have recognized the limitations of the MAD Kit and been motivated to select the Aptar UnitDose device when developing an improved intranasal naloxone product.

Further, it was known that naloxone was a relatively safe drug and that it had lower intranasal bioavailability by comparison to intramuscular or intravenous administration. Moreover, it was known that a layperson using a MAD Kit to administer a 2 mg dose of intranasal naloxone had to re-dose nearly half of the time. As a result, the court found that a POSITA would have been motivated to use a 4 mg intranasal dose.

Before the priority date, the naloxone MAD Kit was not optimized for nasal administration. As a result, the court explained that a POSITA developing a nasal naloxone formulation would have found it obvious to add sodium chloride, hydrochloric acid, BZK, and EDTA, which are typically used in nasal formulations.

The court next explained that Adapt failed to demonstrate that any secondary indicia of non-obviousness were sufficient to overcome the prima facie case of obviousness. As to unexpected results, the court disagreed that the bioavailability of the claimed formulation was significantly greater than that of the prior-art formulations. The court also rejected Adapt’s commercial-success argument, finding that the sales were attributable to features already in the prior art. Similarly, the court found that any industry praise was related to features already known in the prior art. The court also declined to afford any weight to Adapt’s alleged failure of others, which related solely to failure to obtain FDA approval. The court also found that any evidence of unmet need, copying, and skepticism were unpersuasive.