Roxane Laboratories, Inc. v. Camber Pharmaceuticals Inc. (Fed. Cir. 2016)

By Kevin E. Noonan --

The patent prosecutor's art requires exquisite foresight, if not prescience, in balancing the requirements for specificity needed to satisfy the disclosure requirements of § 112 while anticipating efforts to design around the claimed invention.  In a recent nonprecedential opinion, the Federal Circuit illustrated the consequences when these efforts prove inadequate, in Roxane Labs., Inc. v. Camber Pharm. Inc.

The case involved Roxane's U.S. Patent No. 8,563,032 ("the '032 patent"), which was directed to "a capsule formulation of calcium acetate granules, with each capsule containing a dose of 667 mg calcium acetate on an anhydrous basis."  The claimed formulations are used to treat end-stage kidney disease characterized by excess serum phosphorous levels, wherein the calcium acetate binds dietary phosphorus and prevents absorption by the gastrointestinal tract.  Claim 1 is representative:

A calcium acetate capsule formulation comprising flowable granules comprised of a pharmaceutically acceptable amount of calcium acetate along with other pharmaceutically acceptable adjuvants, wherein said granules are filled into and contained within a pharmaceutically acceptable capsule such that 667 mg of said calcium acetate on an anhydrous basis are present in said capsule that is size 00 or less.

It was undisputed that Camber's accused infringing article used capsules of size 00el, which had the same diameter but an elongate longitudinal profile.  The District Court construed the claims to be limited to "standard" size 00 capsules and that Camber's 00el capsules were outside the scope of the claims as the court construed them.  After claim construction Roxane sought and received a directed verdict, to pursue its appeal of the District Court's claim construction.

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges Mayer and O'Malley.  The panel found that the District Court properly relied on solely intrinsic evidence (and thus reviewed claim construction de novo), based on both the explicit disclosure in the specification and the prosecution history, specifically declaration evidence from one of the named inventors.

Regarding the disclosure, the Federal Circuit held that as used in the specification the term "size 00" was limited to standard length capsules and not the elongated 00el capsules used by Camber.  As the opinion characterizes the parties' differing positions, "[t]he main dispute in this appeal is whether 'size 00' in the '032 patent refers to a capsule of a specific diameter, length, and fill volume, or to a family of capsules with the same diameter but varying lengths and fill volumes."  The panel based its conclusion on the mere two instances in the specification of the term "size 00," which according to the opinion contained disclosure regarding the amount of calcium acetate the capsule can contain.  Because size 00el capsules should contain more calcium acetate than size 00 capsules (because while having the same diameter the capsules have different lengths and thus volumes that differ by πr² (l_ooel-l_oo)), Roxane's argument that the term "size 00" capsule should encompass size 00el capsules was inconsistent with statements in the specification regarding the content by weight of calcium acetate in the claimed formulation.

The prosecution history supported this conclusion.  As set forth in the opinion, the Examiner had rejected the claims based on prior art regarding size 0 capsules filled with compressed anhydrous calcium acetate and art that taught calcium acetate granules; also cited was a prior art table of capsule sizes (which did not list any elongated capsule sizes).  Roxane argued that statements by the Examiner that the amount of calcium acetate contained in size 00 capsules was 50% greater than in size 00 capsules encompassed size 00el capsules, because as it turns out size 00el capsules contain exactly 50% more calcium acetate than size 0 capsules.  The panel disagreed, finding that the evidence in the prosecution history showed the Examiner relied on the capsule size table only with regard to size 00 capsules and not the elongated variant.

This conclusion was supported, according to the Federal Circuit, by statements in the inventor's declaration provided during appeal of this obviousness rejection before the Patent Trial and Appeal Board.  In that appeal, the inventor stated that the prior art granules could not be filled in size 00 capsules in the amounts required by the claims.  The opinion interprets these statements as indicating that "size 00 capsules" had a specific and determined volume and that these statements were not consistent with the term comprising a family of capsules of constant diameter but differing lengths (and hence volumes).  In addition, in a Reply brief filed in the PTAB appeal Roxane had "emphasized that claim 1 does not cover capsules that are larger and have more fill capacity than 'size 00'" and that the volumes contained in the claimed capsules differed from what was possible in capsules that could be prepared according to the prior art.  These arguments were persuasive before the Board.  The Federal Circuit thus concluded that "size 00el capsules, which have a greater fill volume than the standard size 00 capsules tested by [the inventor], are outside the scope of the claims" and thus the District Court properly construed the claims to exclude the accused infringing article.

The appeal also contained a challenge by Roxane that the case should not have been transferred from a district court in the Sixth Circuit to a district court in the Third Circuit, but could not show any abuse of the court's broad discretion to transfer.

Assuming that size 00el capsules were known in the art (it seems evident that they were), Roxane's failure to preclude Camber from designing around their claims by changing the length of the claimed capsules suggests that these embodiments were not contemplated by the inventors or their counsel.  The outcome of this case shows how difficult it can be to envision all the ways a clever competitor can find embodiments of a claimed invention that falls outside the scope of the claims, and that as a result the protection assumed to be provided by the patent may ultimately fall short of what the patentee needs to protect its franchise.

Roxane Labs., Inc. v. Camber Pharm. Inc. (Fed. Cir. 2016)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Mayer, and O'Malley
Opinion by Circuit Judge Lourie

Comments

[Karl Weinrich]

𝝅r^2 is area not the volume of a cylinder which is 2𝝅rh. The overall closed length specification of a Coin-Snap capsule is 25.3 mm for the 00el and 23.3 mm for the 00. Thus, the extra 2 mm in length provides an increased volume of 51.39 mm^3 (using the external diameter of 8.18 mm or radius of 4.09 mm not exactly correct but a good approximation.)

[Karl Weinrich]

Flipping auto correct - it is Coni-Snap not Coin-Snap.

[Paul Cole]

Come to think of it, THREE litigators in the Federal Circuit for the patentee/plaintiff. Did NONE of them consider the prospects of success if the patent were seriously challenged e.g. for obviousness? Not a case that should EVER have got near a court!

[Kevin E. Noonan]

Thanks, Karl, but 𝝅r^2 was not the end of the formula - it was multiplied by (looel-loo), which was intended to be the difference in length between the size 00el and size 00 capsules. Sorry if that wasn't clear, and thanks for the extra calculations.

[Jim Demers]

This wasn't necessarily a case of failing to anticipate a design-around. A declaration that the limited volume of the 00 capsule is the basis for non-obviousness very clearly disclaims (and opens the door for non-infringing) larger-volume capsules. If the applicants decided that this was the only way to get allowance, it's a case of taking your chances with the scope of the claims.

[Mark Graham]

This what can happen when parties use "litigators" instead of "patent lawyer litigators." An able patent litigator with years of experience in the "prosecution trenches" wrestling with USPTO examiners over claims would probably have picked this up very early in the process.

When will pharma corporate learn?