After reviewing a manufacturing patent related to the antibiotic ertapenem, the US Court of Appeals for the Federal Circuit determined that the claimed manufacturing process was obvious because the prior art disclosed everything except for details that would have been routinely implemented by a person of skill in the art. Merck Sharp & Dohme Corp. v. Hospira Inc., Case No. 874 F.3d 724 (Fed. Cir., Oct. 26, 2017) (Lourie, J) (Newman, J, dissenting).
In May 2014, Hospira filed an abbreviated new drug application (ANDA) seeking approval to market a generic version of Merck's Invanz product—i.e., ertapenem. Merck sued Hospira for infringement of US Patent Nos. 5,952,323 and 6,486,150. Each patent claims a different method relevant to the production of a stable form of ertapenem. Merck created a stable form of ertapenem by forming a carbamate adduct by reacting ertapenem with a carbon dioxide source at a specific pH range of 6.0 to 9.0. The '323 patent describes and claims the carbamate adduct form of ertapenem. The '150 patent claims a process for making a formula with a generic chemical compound that encompasses the carbamate adduct of ertapenem using specific steps.
During a bench trial, the district court determined that (1) Hospira's generic product infringed both patents, (2) the '323 patent was not anticipated or obvious, and (3) the '150 patent was obvious in view of the disclosure in the '323 patent. Merck appealed the finding that the '150 patent was obvious in view of the '323 patent.
The Federal Circuit affirmed the district court's obviousness opinion. First, the Federal Circuit compared the prior art '323 patent to the claims of the '150 patent. The Federal Circuit acknowledged that the prior art did not disclose the specific order and detail of the manufacturing steps. However, the prior art taught the benefit and rationale for each of the manufacturing steps. For example, while the prior art did not teach the specifically claimed low temperature range, it did teach that low temperatures would decrease degradation of the carbamate adduct. In fact, the Federal Circuit found that the prior art disclosed all elements of the process except (1) the order of the steps, (2) the addition of a base at the same time as the ertapenem, (3) the specific temperature range and (4) the final moisture content of the product. These elements were experimental details that a person of skill in the art would have utilized via routine experimentation, however, and therefore the claimed process was obvious.
The Federal Circuit then evaluated secondary considerations and upheld the district court's determination that the evidence of secondary considerations could not overcome the "strong showing of obviousness."
Judge Newman dissented. She argued that the district court used the incorrect standard in evaluating obviousness, based primarily on the treatment of objective indicia of non-obviousness. Judge Newman criticized some of the Federal Circuit's obviousness opinions as looking to determine whether the prior art established a prima facie case of obviousness, and only subsequently turning to "secondary considerations" to rebut that case. Judge Newman insisted that an evaluation of objective indicia of non-obviousness is one of the four Graham factors and should be included in the initial obviousness determination. Thus, Judge Newman remanded the case for a correct evaluation of obviousness including objective indicia in the first instance.
Practice Note: Given Judge Newman's dissent in this case and Judge Reyna's dissent in Intercontinental Great Brands LLC v. Kellogg N. Am. Co., Case No. 869 F.3d 1336 (Fed. Cir. 2017), it is clear that several Federal Circuit judges favor including an evaluation of objective indicia of non-obviousness in the underlying obviousness determination rather than treating them as "secondary considerations."
Undisclosed Routine Details Insufficient to Distinguish Prior Art from Claimed Method
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