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Aptalis Pharmatech v. Apotex

decided on January 4, 2018 by the Court of Appeals for the Federal Circuit

review by J. Matt Buchanan | published February 12, 2018 | updated February 19, 2018

tags: Hatch Waxman, claim construction, standard of review, limitation from specification, dictionary, prosecution history, disavowal

In Aptalis Pharmatech v. Apotex, the Court of Appeals for the Federal Circuit rejected a claim construction offered by the district court. Conducting its de novo, Phillips-guided claim construction, the Court adopted a narrower construction that reflects a dictionary definition of the term 'surrounding' and that is supported by the specification and prosecution history. The Court claims that this case "tiptoes" the fine line between reading a claim in light of the specification and reading a limitation into the claim from the specification, but seems to jump over that line with both feet. Pointing to a dictionary definition of "surround," portions of the specification, and the prosecution history, the Court ultimately construed the terms "coating" and "surrounding" in a way that requires a limitation — "continuous" — that doesn't appear in the asserted patents.

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claim construction | standard of review

Claim construction based solely on intrinsic evidence is a legal determination reviewed de novo

The Court explained that, when reviewing a district court claim construction that relies only on intrinsic evidence, "...the construction is a legal determination reviewed de novo." (citing Ruckus Wireless, Inc. v. Innovative Wireless Sols., LLC, 824 F.3d 999, 1002 (Fed. Cir. 2016) (additional citation omitted)). The key for this standard to be applicable is the complete reliance on intrinsic evidence by the district court.

claim construction | limitation from specification

Every embodiment, and contrast between background and chosen claim language, offered as support for narrow claim construction

The Court noted the "fine line between reading a claim in light of the specification[] and reading a limitation into the claim from the specification" (citing Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998)), and acknowledged that "[t]his case tiptoes that line." Even though the patent specification doesn't provide a definition for the term 'coating,' and the prosecution history "contains no clear and unmistakeable disavowal of claim scope," the Court was willing the adopt a narrower claim construction than that applied by the district court because "the intrinsic evidence would have taught an ordinarily skilled artisan that a[]...coating is limited to a continuous outer firm."

The court pointed to the specification as support for its narrow construction, noting that every embodiment describes a polymer coating that is external to the active core. According to the Court, "[t]hese disclosures would have taught a person of ordinary skill that the extended release coating is an outer coating of polymer relative to the active-containing core."

The Court also explained that the specification includes "frequent references to applying the extended release coating 'onto' the active containing core" and that this "comports with our understanding of the spatial orientation required by the claims."

The Court also pointed to the background section of the patent, noting that it demonstrated that the inventors had the "ability to describe a non-continuous coating when they so desired." The Court used a difference between language in the background section that discusses a prior art reference having a coating with apertures, i.e., a non-continuous coating, and the claim language that required a coating that surrounds a core to support its conclusion that the claim required a continuous coating, i.e., one that does not include apertures or other gaps.

claim construction | dictionary

No attention given to proper role of dictionary in claim construction despite adopting a construction based on the dictionary meaning of a term

It's interesting to note that, even though the district court "recognized" a dictionary definition of one of the claim terms at issue ('surrounding') and the Federal Circuit applied the same meaning in its de novo review, the Court made no mention of the proper use of dictionaries in a Phillips-guided claim construction. The Court's ultimate construction of the term ‘surrounding’ was based on the dictionary definition of the term, but the Court was careful to stress several points of intrinsic evidence that supported that meaning.

Compare this to the Federal Circuit’s 2008 decision in Mangosoft, Inc. v. Oracle Corp.. There, the Court explicitly rejected an argument that the district court had improperly relied on a dictionary in making its claim construction, noting that Phillips doesn't preclude the use of a dictionary as long as the ultimate construction is grounded in the intrinsic evidence. The Court gave the issue of dictionary use vis-a-vis intrinsic evidence significant attention in that case, and none here.

claim construction | drafting

Claim language decision can inform a person of ordinary skill in the art on the requirements of the claims

In noting that the inventors had the ability to describe a structure that resembles the Appellant's product, as evidenced by language in the background section of the patent, the Court explained that the claim language reflected a decision made by the inventors to define the claims in a way that did not include those structures.

"The inventors' decision to claim a coating that surrounds the core instead of claiming a coating with a certain percentage of exposed core surface would have informed a person of ordinary skill in the art that the claims require a continuous coating."

Every word in a claim has meaning. Every word in a claim reflects a decision made by the inventor, or, more likely, the attorney. And every decision has consequences.

claim construction | prosecution history | disavowal

A disavowal of claim scope is not a required threshold for using a prosecution history in claim construction

The Court rejected an argument that the prosecution history of the patent is irrelevant to the claim construction issue because it does not include a clear an unmistakeable disavowal of claim scope. A disavowal of claim scope, the Court explained, is not a required threshold that must be met before prosecution history becomes relevant to claim construction.

"[E]ven in the absence of a clear and unmistakeable disavowal, we conclude that the prosecution history can be evaluated to determine how a person of ordinary skill would understand a claim term."