February 22, 2022
On February 10, in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed a district court’s holding that Adapt’s methods of treatment of opioid overdose is invalid as obvious. The patented methods at issue relate to intranasal administration of naloxone for reversing drug overdoses and are listed in the orange book as covering the Narcan® name. Adapt sued Teva for filing an Abbreviated New Drug Application (ANDA) seeking approval for a generic form of Narcan®.
Before Adapt’s priority date, it was known to administer naloxone by injection or intranasally. Yet, these prior methods had disadvantages. Injections required a trained professional and the prior intranasal administration required assembly of a special device which delivered excess fluid. In 2012, the FDA publicly encouraged the pharmaceutical industry to develop improved intranasal naloxone products. In 2015, Adapt filed a U.S. patent application establishing the priority date for the patents in suit.
After a two-week bench trial, the district court ruled that the claims were invalid as obvious over two separate combinations of prior art asserted by Teva. On appeal, Adapt argued that the lower court erred in its conclusions regarding the existence of motivation to combine, the lack of teaching away in the art, and deficiencies in proffered objective indicia of nonobviousness.
The issues before the Federal Circuit primarily related to drug formulation aspects of the method claims. The representative formulation included specific amounts of naloxone, sodium chloride (isotonicity agent), benzalkonium chloride (preservative), disodium edetate (stabilizer), and acid for pH modulation.
Judges Stoll and Prost opined for the majority and took note of the close nature of case. Nonetheless, the two judges found that the district court had not erred in its conclusions regarding motivation to combine. At the outset, the judges noted that the FDA had provided motivation to formulate an improved intranasal naloxone product by publicly identifying problems associated with the prior methods of administration. Both the prior art and Teva’s expert testimony were also found to provide ample reasons for the claimed drug formulation via selection and optimization of prior art components.
Adapt had supplied a reference as evidence of teaching away from use of benzalkonium chloride with naloxone. Yet, the majority discounted this as only teaching away from use of high concentrations of benzalkonium chloride with naloxone and agreed that the prior art as a whole did not teach away.
The majority also rejected Adapt’s argument that the district court erred by considering objective indicia of nonobviousness only after concluding the claims were prima facie obvious. The majority found that there was nothing inherently wrong with the district court’s opinion discussing the objective indicia after the prima facie analysis. In detail, the majority agreed that Adapt had not shown the drug performance evidence was “unexpected” and agreed that evidence of copying was irrelevant in the context of ANDA litigation. The majority similarly agreed with the district court’s weighing of evidence of skepticism, holding that the district court did not err by finding that evidence of industry sketpticism did not support nonobviousness. While the majority found that the district court improperly considered Adapt’s evidence of long-felt need, the judges found the error harmless in view of the strong case of obviousness.
In a pointed dissent, Judge Newman noted the marked superiority of Adapt’s method and product and criticized the majority and district court for finding obviousness in light the prior art’s inadequate teaching or suggestion for the claimed combination and amounts of components in the claimed drug formulation. She further criticized Teva’s expert for merely stating the prior art components were “available” and for failing to provide reasons to select and combine the claimed elements. Judge Newman repeatedly criticized the district court and the majority for employing improper hindsight bias.
The dissent further asserted that the district court’s analysis of the objective indicia of nonobviousness was contrary to existing law, which requires courts to consider objective indicia of obviousness as part of the determination of prima facie obviousness. Judge Newman also disagreed with the district court’s treatment of the evidence of superior results. Her dissent notes that others had tried and failed to develop products that improved on the prior art, and that none of the references cited disclosed the specific combination of attributes claimed along with its ease of administration. After further noting that other objective indicia of nonobviousness had not been given proper consideration, Judge Newman concluded by speculating that the majority’s opinion would discourage innovation in crowded pharmaceutical fields and those in which the FDA has mentioned need for improvement.
Analyzing obviousness is a fact-intensive exercise, and the results can depend on evidence beyond the features disclosed in the art. As exemplified in this case, even Federal Circuit judges disagree on how to weigh facts relating to objective considerations of non-obviousness.
For more information on this topic, please contact Fitch Even partner Giles N. Turner, author of this alert.
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