Patent And Trademark Bulletin For The District Of Massachusetts: A Reporter On Recent Patent And Trademark Opinions From The United States District Court For The District Of Massachusetts - March 2011

PATENT

Fresenius Medical Care Holdings, Inc. v. Paddock Laboratories, Inc.; Fresenius Medical Care Holdings, Inc. v. Amneal Pharmaceuticals, LLC, C.A. Nos. 09-11130-RGS, 10-111429-RGS, 2010 U.S. Dist. LEXIS 107080 (D. Mass. Oct. 6, 2010) (Stearns, D.J.) [Claim Construction].

Plaintiff Fresenius Medical Care Holdings, Inc. ("Fresenius") filed suit separately against defendants Paddock Laboratories, Inc. ("Paddock") and Amneal Pharmaceuticals, LLC ("Amneal") alleging that both companies' proposed generic versions of Fresenius's PhosLo gelcaps infringe U.S. Patent Nos. 6,576,665 ("'665 patent") and 6,875,445 ("'445 patent"). The cases were consolidated and the District Court (Stearns, D.J.) recently issued an order on claim construction disputes.

The Fresenius PhosLo gelcaps at issue deliver a calcium acetate composition to patients suffering from hyperphosphatemia, which is an excess of phosphate in the bloodstream (the condition is often seen in patients with chronic renal failure). Calcium acetate is one of the most effective phosphate binders that can help clear phosphorous from the body before it enters the bloodstream. The '665 and '445 patents are directed to calcium acetate capsules that are smaller than those in the prior art and that better mask the unpalatable taste of the calcium acetate.

The Court construed four terms favoring Fresenius's arguments in each case. The first term considered was "caplet." Claim 1 of both the '665 and '445 patents refers to a "quantity of calcium acetate" formed into a "caplet." Fresenius argued that, because its caplets are placed inside an outer capsule, "caplet" should be construed to mean a "generally oblong cohesive mass for fitting into a capsule body so that, after the capsule top is fitted onto the capsule body, the volume of the resulting finished capsule is substantially completely filled." Paddock contended that a caplet must have sufficient integrity to be "an independent dosage form." After examining the specifications of both patents, their prosecution history, and various extrinsic sources, the Court agreed with Fresenius that forming a caplet is a step in the process of filling a capsule, and a caplet need not have sufficient integrity to be an independent dose. Accordingly, the Court construed "caplet" to mean "a capsule-shaped tablet with sufficient integrity to survive insertion into the capsule delivery vehicle."

The second term considered was "capsule," itself. Here, Paddock asserted that statements made during prosecution, along with the importance of size stressed by Fresenius, meant that "capsule" should be construed as meaning capsules smaller than size #00 (the largest size that can be swallowed by most patients). Paddock pointed to passages from the '665 patent disclosing that, contrary to the claimed invention, prior art manufacturing techniques were "unable to produce a calcium acetate capsule or tablet of the usual dosage amount that is less than #00 in size." Paddock also pointed to several instances in the prosecution history where Fresenius highlighted reduced pill size as a key benefit of the invention. Ultimately, the Court found that Fresenius had not clearly disclaimed the use of capsules of size #00 or greater, and construed the term to mean "a capsule within a size range consistent with what a human patient with chronic renal failure can manipulate and swallow." The Court noted that this may or may not include a size #00 capsule, an issue to be decided by a jury after hearing expert medical evidence.

The third term addressed was the word "about," which was used in describing bulk density ranges for the calcium acetate compositions. The Court summarily stated that nothing in the record suggested Fresenius meant to define "about" to mean anything other than "approximately."

The final term construed was the phrase "bulk density." Bulk densities of the calcium acetate compositions are important because Fresenius found that compositions having particular bulk density ranges could be compressed further to create a smaller caplet. The '665 patent defined "bulk density" as "the density, typically of a solid, as poured or passively filled into a measurement device." Paddock argued that the term was indefinite and incapable of construction, whereas Amneal argued that it must mean a quantity of material that has not been modified in any way. Fresenius, in response, asserted that bulk density simply referred to the density of the compositions "immediately before compression" into a caplet. Citing the specification of the '665 patent, the Court sided with Fresenius and construed "bulk density" to mean "the mass-to-volume ratio of the calcium acetate composition immediately prior to compression, as measured by one of two methods set forth in the patent specifications."

Haemonetics Corp. v. Fenwal, Inc., C.A. Nos. 05-12572-NMG, 09-12107-NMG, 2010 U.S. Dist. LEXIS 108985 (D. Mass. Oct. 13, 2010) (Gorton, D.J.) [Status Conference].

The District Court (Gorton, D.J.) denied the motion of plaintiff Haemonetics Corp. ("Haemonetics") for a status conference at which Haemonetics sought to set a discovery schedule, culminating in a second Markman hearing with respect to its revised infringement theory in these consolidated cases. The Court instead ordered the parties to file summary judgment motions.

The '05 Case: In the '05 case, Haemonetics sued Fenwal Inc. and Baxter Healthcare Corp. (collectively "Fenwal") for infringement of U.S. Patent No. 6,705,983 (the "'983 patent"). Haemonetics and Fenwal both manufacture and sell centrifuge devices designed to separate red blood cells from human blood. The '983 patent describes a "centrifugal unit" comprising (1) a vessel in which blood components are separated in a separation chamber and (2) tubing through which blood flows in and out of the vessel. The District Court construed the disputed term "centrifugal unit" in claim 16 to mean the vessel of the blood separation device only and not any associated tubing. The jury then returned a verdict for Haemonetics, finding the '983 patent to be valid and infringed.

On appeal, the Federal Circuit reversed and vacated the jury verdict, finding that the District Court had erred in its construction of "centrifugal unit" to mean just the vessel because claim 16 specifically defines "centrifugal unit" as containing two structural components—both the vessel and its associated tubing: "[a] centrifugal unit comprising a centrifugal component and a plurality of tubes."

The '09 Case: During the pendency of the appeal in the '05 case, Fenwal redesigned its blood separation device, but Haemonetics sued Fenwal for infringement on this redesigned product as well.

After the Federal Circuit denied its petition for rehearing en banc in the '05 case, Haemonetics filed new infringement contentions in the District Court in which Haemonetics sought a new claim construction —this time involving the phrase "plurality of tubes"— to revive its infringement case. It also moved for a status conference to discuss case scheduling leading up to a second Markman hearing. The Court denied the motion for a status conference on the grounds that a second Markman hearing was unnecessary since Haemonetics was not entitled to a "second bite at the apple." The Court described Haemonetics' new proposed construction as "pure sophistry" and found that it was inconsistent with the meaning previously stipulated to by the parties at trial in the '05 case. The Court further held that Haemonetics was barred by the doctrine of judicial estoppel from advancing a new construction of "plurality of tubes." At Fenwal's urging, the District Court set a briefing schedule for summary judgment motions based on the Court's initial claim construction as modified by the Federal Circuit.

Palomar Medical Technologies, Inc. v. TRIA Beauty, Inc., C.A. No. 09-11081-RWZ, 2010 U.S. Dist. LEXIS 112200 (D. Mass. Oct. 13, 2010) (Zobel, D.J.) [Claim Construction].

Plaintiff Palomar Medical Technologies, Inc. ("Palomar") filed suit against Defendant TRIA Beauty, Inc. ("TRIA") alleging infringement of U.S. Patent No. 5,595,568, entitled "Permanent hair removal using optical pulses" (the "'568 patent"), and U.S. Patent No. 5,735,844, entitled "Hair removal using optical pulses" (the "'844 patent"). The District Court (Zobel, D.J.) resolved claim construction disputes regarding various terms within the asserted claims of the '568 and '844 patents.

The first claim construction dispute concerned the meaning of "transparent device" and "transparent apparatus" within the '568 patent. Palomar argued that the terms correspond to the "contact device" in the specification and should be construed to include the limitation "for converging optical radiation." The Court agreed with Palomar that the "transparent device" and "transparent apparatus" correspond to the "contact device," but found that the specification only provides that the contact device is preferably convex so as to converge radiation. Because "preferred embodiments do not define the scope of the patent claims" (citing Kara Tech, Inc. v. Stamps.com Inc., 582 F.3d 1341, 1348 (Fed. Cir. 2009)), the Court declined to adopt the limitation proposed by Palomar that the "transparent device" and "transparent apparatus" converge optical radiation.

The next claim construction issue concerned the phrase "a surface shaped to contact said skin region" within claim 14 of the '568 patent. TRIA argued that the term "shaped" means "not flat." The Court declined to accept TRIA's proposed construction, however, because the specification explicitly states that the contact surface "can be either convex or substantially flat."

The Court also noted that the doctrine of claim differentiation precluded TRIA's construction because a subsequent dependent claim limited the shape to a convex surface. The Court reasoned that if TRIA's proposed exclusion of a "flat" shape were accepted, the dependent...