By Mark J. Cohen
In Amgen Inc. v. Sandoz Inc., Appeal No. 2018-1551 (Fed. Cir. 2019), the Federal Circuit, in a decision decided May 8, 2019, by Judges Lourie, O’Malley and Reyna, made the following statement: “The doctrine of equivalents applies only in exceptional cases and is not ‘simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims…’” Taken out of context, this statement implies that the doctrine of equivalents is only viable only in extraordinary cases, thereby practically eviscerating the doctrine of equivalents. However, when taken in context of this case, it is apparent that this extreme interpretation is not what the Federal Circuit meant.
The standard for infringement under the doctrine of equivalents has often been articulated that infringement may be found if an accused device performs substantially the same function in substantially the same way to achieve substantially the same result. Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608, 70 S.Ct. 854, 856, 94 L.Ed. 1097, 85 USPQ 328, 330 (1950). It is an equitable doctrine which evolved from a “balancing of competing policies, each of which supports the Constitutional purpose of promoting the ‘useful arts’… London v. Carson Pirie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991).
As stated in London v. Carson Pirie Scott & Co.:
On the one hand, claims must be “particular” and “distinct,” as required by 35 U.S.C. §112, so that the public has fair notice of what the patentee and the Patent and Trademark Office have agreed constitute the metes and bounds of the claimed invention. Notice permits other parties to avoid actions which infringe the patent and to design around the patent. …
On the other hand, the patentee should not be deprived of the benefits of his patent by competitors who appropriate the essence of an invention while barely avoiding the literal language of the claims… Accordingly, the doctrine of equivalents emerged. Although designing or inventing around patents to make new inventions is encouraged, piracy is not. Thus, where an infringer, instead of inventing around a patent by making a substantial change, merely makes an insubstantial change, essentially misappropriating or even “stealing” the patented invention, infringement may lie under the doctrine of equivalents.
To understand the context of the statement of the Amgen Court, reference is made to the facts of Amgen. Amgen commercialized two related biologic products, filgrastim and pegfilgrastim, both of which are indicated to be useful for treating neutropenia, a deficiency of white blood cells which often results from exposure to certain chemotherapeutic regimens or radiation therapy during cancer treatment. In 2014, Sandoz submitted to the Food and Drug Administration (“FDA”) an abbreviated Biologics License application (“aBLA”) to market a biosimilar filgrastim product. In 2015, Sandoz received FDA approval for its biosimilar product, and began selling same. In addition, in 2015, Sandoz also submitted an aBLA to market a biosimilar pegfilgrastim product.
Amgen sued Sandoz for infringing, inter alia, Claim 7 of U.S. Patent No. 8,940,878 in the District Court for the Northern District of California. Claim 7 of the ‘878 patent recites a multi-step process for purifying a protein by expressing a protein in a non-mammalian cell, lysing the non-mammalian cell; solubilizing the expressed protein in a solubilization solution; forming a refold solution comprising the solubilization and a refold buffer; directly applying the refold solution to a separation matrix, such as an ion exchange matrix; washing the separation matrix and eluting the protein from the separation matrix. Sandoz argued that its process did not infringe Claim 7, alleging that Sandoz’s process only involves one step–applying the refold solution to the matrix, with no separate washing or eluting steps. In fact, according to the Amgen Court, it is undisputed that the Sandoz’s process involves only one step. The district court granted summary judgment, finding that Sandoz did not infringe Claim 7, either literally or under the doctrine of equivalents, and the Federal Circuit affirmed.
To determine whether Sandoz infringed Claim 7 of the ‘878 patent, the Amgen Court determined the scope and meaning of the claim based on the specification, the prosecution history and other evidence of record. The Amgen Court agreed with the interpretation of the district court that Claim 7 requires a sequence of steps that include the application of “refolding”, washing” and “eluting” solutions. Since these are separate steps which are part of the claim, the doctrine of equivalents cannot be applied to “read out” a claim limitation. Since Sandoz did not perform all of these steps, the Amgen Court held that Sandoz did not infringe Claim 7, either literally or under the doctrine of equivalents.
This rationale used by the Amgen Court is not novel. In its decision, the Court cited London v. Carson Pirie Scott & Co., 946 F.2d 1534 (Fed. Cir. 1991) and Duncan Parking Techs., Inc. v. IPS Grp., Inc. 914 F.3d 1347 (Fed. Cir. 2019). In both London v. Carson Pirie Scott & Co. and Duncan Parking Techs., Inc. v. IPS Grp., Inc., the alleged infringers did not meet all of the claim limitations of the patent asserted against them.
As the Federal Circuit stated in Duncan Parking Techs., Inc. v. IPS Grp., Inc.:
If the public comes to believe or fear that the language of patent claims can never be relied on, and that the doctrine of equivalents is simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims, then claims will cease to serve their intended purpose.
The ’310 patent claims fundamentally distinguish the housing from the device… Holding that the Liberty Meter infringes the ’310 patent claims under the doctrine of equivalents would essentially void the claim limitation of a “housing [with] a cover panel being movably attached to the intermediate panel set [and with] a plurality of buttons.” We have consistently held that the doctrine of equivalents does not extend so broadly… (“The doctrine of equivalents cannot be used to erase ‘meaningful structural and functional limitations of the claim on which the public is entitled to rely in avoiding infringement)…
Duncan Parking Techs., Inc. v. IPS Grp., Inc., 914 F.3d at 1362.
When the quote “[T]he doctrine of equivalents applies only in exceptional cases” is placed in context, it is clear that the Federal Circuit meant that the doctrine of equivalents is not always an viable option in infringement suits. As held in Amgen, the doctrine of equivalents is not applicable in situations when its application would erase limitations in a claim of an asserted patent. Thus, placed in context, the statement by the Federal Circuit is not as radical as it first appeared.
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