ImageCube LLC v. The Boeing Co., No. 2010-1265 (Fed. Cir. Jun. 20, 2011) (Judges Lourie, Linn, and Dyk) (nonprecedential)

ImageCube’s patent covers a manufacturing process for airplane parts that that involves applying a thin layer of a mixture of “components A and B” on a piston and exposing it to radiation “such that components A and B homogenize” to form a solid, three-dimensional part. Slip op. at 3. The trial court construed “components” to exclude metallurgical phases of single alloy, and the “homogenize” portion of the claims were read to require “the intimate mixing of at least two components.” Id. at 4. Aeromet’s process involves only a single alloy, and thus a single component, so the trial court granted summary judgment of noninfringement in favor of Aeromet.

ImageCube asserted that the trial court’s construction of “components” should include metallurgical phases of a single alloy, but their argument didn’t fly at the Federal Circuit. The court noted that ImageCube’s construction is inconsistent with the specification, which requires that the homogenization process form an alloy with different physical or chemical properties from the original components. The Federal Circuit held that the district court’s construction of “components” is correct.

Read the original opinion here.

 

Smith & Nephew, Inc. v. Arthrex, Inc., No. 2010-1427 (Fed. Cir. Jun. 20, 2011) (Chief Judge Rader, Circuit Judges Plager and Moore) (nonprecedential)

Smith & Nephew sued Arthrex, claiming that Arthex’s RetroButton®, a bone-grafting device used in ACL surgery, infringed its patent. Although the trial court ruled that the there was no literal infringement, a jury found that the RetroButton® infringed under the doctrine of equivalents. The trial court denied Arthrex’s JMOL motions, but noted that the infringement issues were “particularly close.” Slip op. at 5.

On appeal, the Federal Circuit analyzed the trial court’s construction the term “graft connection element,” which required that the graft connection element include “a sling member [which is] a loop of material that supports the graft.” Slip op. at 3. Arthrex’s product contains only three strands of material at the bottom of the sling, and these strands do not attach to the body of the device (as Smith & Nephew’s patent also requires). The Federal Circuit concluded that Smith & Nephew had not offered sufficient evidence to prove infringement and reversed the denial of JMOL.

Read the original opinion here.

 

Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., No. 2010-1513 (Fed. Cir. Jun. 22, 2011) (Judges Newman, Bryson, and Gajarsa)

Tyco owns a patent covering a 7.5 mg dosage of temazepam, the active ingredient in the sleeping pill Restoril®. Although  Restoril® has been used to treat insomnia in the United States since 1981, the 7.5 mg dosage was not patented until 1993. Mutual filed an ANDA in November 2006 to request FDA approval to manufacture and sell a generic version of 7.5 mg temazepam capsules. Tyco responded by suing Mutual for patent infringement in March 2007. (Note: the timing of this suit is unusual, they are usually filed within 45 days of notice of the ANDA filing, assuming it is a Paragraph IV filing.) Mutual moved for summary judgment of noninfringement and invalidity, and the District of New Jersey court granted Mutual’s invalidity motion, concluding that Tyco’s patent was obvious in light of the prior art.  Tyco appealed.

The Federal Circuit affirmed. In its analysis, the court focused primarily on Tyco’s arguments concerning a 1983 edition of the British National Formulary (BNF), a medical reference book.  The BNF disclosed a dosage of 5 mg to 15 mg to treat insomnia in elderly patients, which created a presumption of obviousness. To rebut this presumption, Tyco relied on its expert’s testimony to show that a person of ordinary skill in the art would not have read BNF as recommending a 7.5 mg dose of temazepam. Tyco’s expert concluded that it neither states nor offers clinical or statistical evidence that a 5-15 mg dose would be effective in treating insomnia.

The court responded that discussions of efficacy are not relevant to the question of obviousness, remarking that the patent claims are not tied to the effectiveness of the drug. Regardless of the effectiveness of the 7.5 mg dosage in a treatment regimen, the claims recite only the dosage, and that dosage was disclosed in the BNF. The court rejected Tyco’s assertion at oral argument that “5-15 mg” should not be assumed to disclose all dosages between 5 and 15, calling that argument “silly.” Slip op. at 7 n.3. The court also rejected Tyco’s arguments concerning prior art references that teach away from the invention, pointing out various mischaracterizations of the prior art references. Finally, the court concluded that Tyco’s arguments with respect to secondary considerations were not sufficient to overcome Mutual’s clear and convincing showing of obviousness.

Read the original opinion here.

 

Creative Compounds, LLC v. Starmark Laboratories, No. 2010-1445 (Fed. Cir. Jun. 24, 2011) (Chief Judge Rader, Circuit Judges Clevenger and Linn)

This case is interesting because the Federal Circuit clarified that a clear and convincing evidence standard should be applied to the question of the priority date of a claimed invention in the invalidity context.

Starmark, formerly SAN, owns a patent with a priority date of December 2002 that issued in September 2006. Creative filed a patent application in April 2003 that issued in October 2006. Both patents cover creatine formulations, but Starmark’s patent is broader and also covers a genus of creatine salts. Creative sought a declaratory judgment that Starmark’s patent is invalid and not infringed. Starmark counterclaimed that Creative’s patent infringed its own and Creative’s patent is invalid.  Starmark later moved for summary judgment on all counts. Creative then moved to dismiss Starmark’s declaratory judgment action for lack of subject matter jurisdiction. The U.S. District Court for the Southern District of Florida granted Starmark’s motion and denied Creative’s motion. Creative appealed.

On appeal, Creative argued that the district court had applied an incorrect standard of proof to establish that Starmark’s patent was invalid. Creative relied on two Federal Circuit decisions that, similarly, had involved co-pending interfering patents to argue that a preponderance of the evidence should apply here.  Starmark distinguished those cases because they involved a § 291 action or “a judicial delineation of conflicting subject matter.” Slip op. at 8. Starmark asserted that a clear and convincing evidence standard should apply.

The Federal Circuit agreed with Starmark. The court took the opportunity here to clarify when the narrow exception of a lower standard of proof would apply—only when the parties identify common claimed subject matter and seek an adjudication of priority. The court noted that interference actions at the PTO and § 291 proceedings both require identification of common claimed subject matter. The court held that “an accused infringer cannot obtain the benefit of the lower burden of proof simply by alleging, as a defense to infringement, that the asserted patent is based upon a co-pending patent.” Slip op. at 11. Because Creative failed to identify interfering subject matter, did not file a § 291 action, and did not seek an adjudication of priority, the district court correctly applied the clear and convincing standard of proof.

The Federal Circuit also affirmed the district court’s grant of summary judgment on the merits. However, the court reversed and vacated the district court’s denial of Creative’s motion to dismiss Starmark’s declaratory judgment action for lack of subject matter jurisdiction. The court stated that declaratory judgment jurisdiction must stem from an underlying legal cause of action, not merely an adverse economic interest. Noting that Creative had not accused Starmark of infringement, the court concluded that Starmark’s interest in determining its rights was “at most . . . economic” and was insufficient to establish jurisdiction over Creative’s patent claim.

Read the original opinion here.

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