IP Update, Vol. 16, No. 9, September 2013

Edited by Paul Devinsky and Rita Weeks

Patents/Preliminary Injunction

Preliminary Injunction Ordered Based on Appellate Claim Construction Aria Diagnostics, Inc. v. Sequenom, Inc. by Shane Smith

Addressing a preliminary injunction filed by a defendant in a declaratory judgment action, the U.S. Court of Appeals for the Federal Circuit vacated and remanded a lower court's denial of a preliminary injunction on claim construction grounds, stating that equitable factors needed to be addressed on remand. Aria Diagnostics, Inc. v. Sequenom, Inc., Case No. 12-1531 (Fed. Cir. Aug. 9, 2013) (Rader, C.J.)

Aria sought a declaration that its fetal DNA diagnostic test did not infringe any claim of Sequenom's exclusively licensed patent. Sequenom counter-claimed for infringement and sought a preliminary injunction to prevent Aria from making, using or selling its test. The asserted claim recited "[a] method for detecting a paternally inherited nucleic acid of fetal origin" in a pregnant woman's blood. The claimed method comprised the step of "amplifying" the paternally inherited nucleic acid. After construing these and other claim terms, the district court found a substantial question of non-infringement and denied Sequenom's motion for a preliminary injunction.

The Federal Circuit vacated the ruling, finding that the lower court read additional limitations into the claims without finding justification in the plain claim language or intrinsic evidence. These errors were so apparent, the Federal Circuit indicated, that it need not address "flexibility" in case law setting out the proper standard of review for claim construction in the context of a preliminary injunction. The Federal Circuit nonetheless acknowledged a difference in authority on the issue.

The Federal Circuit reasoned that the paternally inherited nucleic acid that forms the object of the patent's independent claims need not be "known in advance," as the district court had decided. The patentee could have so limited the claims by adding those words to the claim language, yet it did not. The Federal Circuit further explained that "it is 'not enough that the only embodiments, or all of the embodiments, contain a particular limitation to limit a claim term beyond its ordinary meaning.'"

The Federal Circuit also reasoned that "amplifying" a paternally inherited nucleic acid—as that term arose in the claims—required only that the amount of the paternally inherited DNA increase. The Federal Circuit found that the district court erred by defining "amplifying" to require an increase in the proportion of paternally inherited nucleic acid relative to other DNAs in a blood sample. The Federal Circuittook a strict view of the requisite claim terms, noting that those terms did not specifically state that "amplif[ication]" affected the relative quantity of other DNAs present in the sample. The Federal Circuit placed an emphasis on claim language primacy.

Finally, turning to the issues directly related to injunctive relief, the Federal Circuit took issue with the district court's analysis of the Winter v. Natural Resources Defense Council balancing test. That Supreme Court of the United States test considers whether, on balance, four factors weigh in favor of imposing a preliminary injunction: (i) the movant's likelihood of success on the merits, (ii) the likelihood that the movant will suffer irreparable harm, (iii) the balance of equities, and (iv) the public interest. Here the Federal Circuit dispensed the following remand instructions:

It rejected the lower court's assumption that damages could compensate Sequenom for any loss of market share or price erosion as lacking supporting factual findings. The Federal Circuit explained that,"[i]n the face of that kind of universal assumption, patents would lose their character as an exclusive right as articulated by the Constitution and become at best a judicially imposed and monitored compulsory license." On the relative importance of whether a preliminary injunction would put Aria Diagnostics out of business, the Federal Circuit demanded an equally sympathetic look at harms potentially visited on Sequenom: "this court has seen no comparison of difficulties or losses [Aria] might experience weighed against the harms Sequenom might suffer without protection of its legal exclusive rights." After taking judicial notice of a new fact tending to show that an injunction was not contrary to the public interest, the Federal Circuit instructed the district court on remand to consider "this and other evidence pertaining to the public interest anew." Patents/Jurisdiction

Keeping it Out of the Supreme Court University of Utah v. Max-Planck-Gesellschaft Zur Forderung Der Weissenschaften E.V., et al. by Melissa Nott Davis

Addressing issues of sovereign immunity and original jurisdiction, the U.S. Court of Appeals for the Federal Circuit upheld the determination that a case between one state university and employees of another state university was not a dispute between states subject to the Supreme Court of the United States' exclusive jurisdiction. University of Utah v. Max-Planck-Gesellschaft Zur Forderung Der Weissenschaften E.V., et al., Case Nos. 12-1540, -1541, -1661 (Fed. Cir. Aug. 19, 2013) (Reyna, J.) (Moore, J., dissenting).

Dr. Brenda Bass, a professor of biochemistry at the University of Utah (UUtah), focuses her research on RNA interference, a phenomenon in which RNA is involved in silencing expression of individual genes. Dr. Thomas Tuschl is a University of Massachusetts (UMass) researcher active in RNA interference research. Drs. Bass and Tuschl were familiar with each other's work, and each presented papers at professional conferences attended by the other. Dr. Tuschl was granted patents related to his work. He assigned these patents to UMass. UUtah, the potential assignee of Dr. Bass' rights, believed that the Tuschl patents "disclosed and claimed [her] conception," yet failed to name her as an inventor. UUtah asked defendants to cooperate in a petition to correct inventorship. Defendants refused. UUtah sued in district court, naming UMass as a defendant. UMass sought dismissal, arguing that the Supreme Court had exclusive original jurisdiction. UUtah responded by amending its complaint to replace UMass with four UMass officials. The UMass officials moved to dismiss, arguing that UMass (as the named defendant) was the real party in interest and the case was subject to the exclusive jurisdiction of the Supreme Court. The defendants also claimed sovereign immunity. The district court denied the motion, holding that the requested relief was prospective in nature and that moreover UUtah had elected to sue the officials, not the state itself. It also reasoned that the inventorship case was not a "core sovereign interest sufficient to make this a dispute between States." UUtah appealed.

On appeal, the Federal Circuit noted that the appropriateness of original (Supreme Court) jurisdiction depends upon "the seriousness and dignity of the claim," whether the "named parties" have another forum where relief may be had, and whether the case raises "serious and important federalism concerns." The Federal Circuit held that UUtah, in amending its complaint, decided to only bring a case against citizens of another state, not UMass. The Federal Circuit went on to find that UMass was not a real party in interest, because the district court could grant UUtah the relief it sought by simply directing the U.S. Patent and Trademark Office to correct the inventorship of the Tuschl patents. As such, there was no dispute between states and no exclusive jurisdiction. Because UMass is not a party in the case or the real party in interest, the court similarly rejected the argument that the individually named defendants were entitled to immunity under the 11th Amendment. Lastly, the Federal Circuit found that UMass' interests were adequately protected by the named defendants—which included all the other owners of the Tuschl patents—and ruled that UMass was not an indispensable party under FRCP 19. The Federal Circuit acknowledged that the Rule 19 inquiry is fact intensive and that it was possible that the facts may change on remand, making UMass indispensable; however, that was best resolved by the district court.

Patents/Claim Construction

Ambiguous Claim Terms May Soon Be Construed Against the Drafter 3M Innovative Properties Co. v. Tredegar Corp. by Mark Bentley

Addressing claim construction of a term with disputed grammar, the U.S. Court of Appeals for the Federal Circuit affirmed in part the district court's construction and remanded the case, explaining that grammatical rules give way to the written description when construing claims. 3M Innovative Properties Co. v. Tredegar Corp., Case No. 12-1241 (Fed. Cir., August 6, 2013) (Reyna, J.) (Plager, J. concurring) (O'Malley, J. concurring-in-part, dissenting-in-part).

3M sued Tredegar Corp. for infringement of patents directed to multi-layer elastomeric laminates. Such laminates may be found in the body-hugging areas of products such as the waistband or side tabs of disposable diapers. Tredegar is a supplier of breathable and nonwoven film laminates for personal care products.

Resolution of the infringement issue turned on the meaning of the claimed phrase "continuous microtextured skin layer over substantially the entire laminate." After the district court, agreeing with Tredegar, found that the claim required the microtexturing to be continuous over the entire skin layer, the parties stipulated to non-infringement. 3M appealed.

On appeal, the parties disagreed as to whether "continuous" applied to the microtexturing, the skin layer or both. 3M, citing The Chicago Manual of Style, argued that if the applicant intended that the microtexturing be "continuous," it would have used the adverb "continuously" instead of the adjective "continuous." Tredegar, also citing The Chicago Manual of...