The following is a summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit for the week ending August 22, 2014. Chris McArdle and Ross Barton prepared this edition.
Claim Interpretation: Generally
Infringement: Literal Infringement
Mformation Technologies, Inc., et al. v. Research in Motion Ltd., et al., Nos. 12-1679, 13-1123 (Fed. Cir. (N.D. Cal.) Aug. 22, 2014). Opinion by Prost, joined by Schall and Hughes.
Affirming the U.S. District Court for the Northern District of California’s determination of non-infringement, the Federal Circuit agreed that no reasonable juror could find that the accused system infringed the asserted claims. In so ruling, the Federal Circuit also determined that the district court did not improperly modify the claim construction after the jury’s verdict.
Mformation Technologies, Inc. and mFormation Software Technologies, Inc. (collectively “MST”) sued the maker of BlackBerry mobile devices, Research in Motion Limited and Research in Motion Corporation (collectively “RIM”) alleging infringement of U.S. Patent No. 6,970,917 (“the ’917 patent”). The ’917 patent relates to the wireless activation and management of an electronic device without the need to have physical access to the device. Certain asserted claims of the ’917 patent require that a command be delivered from the mailbox at a server to a wireless device “by establishing a connection between the wireless device and the server . . . wherein the connection is established based on a threshold connection.”
RIM makes and sells BlackBerry handheld wireless devices as well as the BlackBerry Enterprise Server software that allows corporate customers to deliver e-mail and other data to their employees’ devices. At trial, a jury found that RIM’s system infringed all asserted claims of the ’917 patent and awarded MST $147.2 million in damages. After the trial, the district court issued an order requesting further briefing in support of the parties’ post-trial motions and clarifying that the patent’s “establishing a connection” step must be completed before information is transmitted. Thereafter, RIM renewed its motion for judgment as a matter of law of noninfringement, which the district court granted.
On appeal, MST argued that the district court impermissibly added an order-of-steps claim requirement post-verdict in its JMOL opinion – i.e., a requirement that the connection is established before transmission occurs. The Federal Circuit noted, however, that at most the district court clarified its previous construction. Further, the Federal Circuit agreed with the district court that, as properly construed, the connection step must occur before the transmission step. The Federal Circuit based this conclusion on (i) the claim language, which would have been superfluous if the connection could be established at any time and (ii) the specification, which describes only one embodiment, one that is consistent with the Federal Circuit’s construction. As a result, the Federal Circuit affirmed the district court’s grant of RIM’s motion for JMOL of noninfringement, holding that no reasonable juror could find that the BlackBerry system establishes a connection between the BlackBerry Enterprise Server and a BlackBerry device.
Patentable Invention: Obviousness: Scope and Content of Prior Art
Infringement: Hatch-Waxman Act
Ferring B.V. v. Watson Laboratories, Inc. – Florida, et al., No. 14-1416 (Fed. Cir. (D. Nev.) Aug. 22, 2014). Opinion by Lourie, joined by Dyk and Reyna.
The Federal Circuit affirmed the U.S. District Court for the District of Nevada’s holding that the patents-in-suit were not invalid as obvious, but reversed the district court’s holding that Watson’s Abbreviated New Drug Application (“ANDA”) infringed the asserted claims. In reversing the district court, the Federal Circuit noted that, when an ANDA is silent on the potentially infringing aspect of a pharmaceutical compound, a party’s reliance on anomalous results of sample testing are not enough to show infringement.
Ferring B.V. (“Ferring”) sued Watson Laboratories, Inc. – Florida (“Watson”) and Apotex Corporation alleging infringement of U.S. Patent Nos. 7,947,739; 8,022,106; and 8,273,759, which relate to the treatment of menorrhagia in women and cover Ferring’s drug Lysteda. The patents-in-suit include limitations regarding the dissolution rates of a salt of the active pharmaceutical ingredient (i.e., the rate at which the salt dissolves in water) and a “modified release material,” which changes the release of an active pharmaceutical ingredient in water. Specifically, the patents-in-suit all contain a limitation that the pharmaceutical tablet contain a “modified release material” in a specified percentage and a limitation that less than “about 70% by weight” of the salt contained in that tablet has dissolved after 45 minutes.
Before Ferring’s patents issued, Watson submitted its ANDA seeking FDA approval to market a generic version of Lysteda. Watson’s ANDA product included a “core” of the active pharmaceutical agent and a binder. That “core” was surrounded by a film coating designed to resist degradation in the mouth and esophagus, but to dissolve immediately in the stomach. Data contained in Watson’s ANDA specified that only 16% of the active pharmaceutical salt was released at 45 minutes. At trial, the district court held that the claims of the patents-in-suit were not invalid as obvious because none of the prior art taught using such a high dosage of the active pharmaceutical ingredient. Additionally, the district court held that Watson infringed the asserted claims because (i) Watson filed an ANDA, (ii) Watson’s uncoated tablets met the claim limitations, and (iii) Watson’s coated tablets met the claim limitations. The district court entered a final judgment against Watson and enjoined them from further marketing the ANDA product.
On appeal, the Federal Circuit first affirmed the district court’s holding with respect to invalidity, explaining that Watson had not met its burden of proving invalidity. Specifically, as the district court found, none of the prior art Watson presented at trial used the same high dosage as claimed in the patents-in-suit. Moreover, Watson’s prior art did not disclose the claimed amounts of modified release polymers nor did Watson’s prior art disclose the dissolution limitations.
Next, the Federal Circuit reversed the district court’s infringement holdings. First, the Federal Circuit concluded that the district court’s holding that Watson infringed the patents-in-suit by merely filing its ANDA was legal error. Second, the Federal Circuit observed that it was improper for the district court to analyze the uncoated tablets because they could not be marketed under Watson’s ANDA. Third, the Federal Circuit determined that the dissolution rates of Watson’s ANDA product were far slower than what was stated in the claim and were thus outside the claim scope. The court rejected Ferring’s arguments to the contrary that were based on four aberrational tablets that dissolved much more rapidly. The court stated that it did “not agree with Ferring or the district court that reliance on such anomalies proves infringement by a preponderance of the evidence.” Accordingly, the Federal Circuit vacated the district court’s permanent injunction.
Claim Interpretation: Intrinsic Evidence: Generally
Infringement: Hatch-Waxman Act
Ferring B.V. v. Watson Laboratories, Inc. – Florida, et al., No. 14-1377 (Fed. Cir. (D. Nev.) Aug. 22, 2014). Opinion by Lourie, joined by Dyk and Reyna.
Affirming the U.S. District Court for the District of Nevada’s decision to dismiss as moot Ferring’s claims that Apotex’s amended Abbreviated New Drug Application (“ANDA”) infringed certain asserted patent claims, the Federal Circuit concluded that under the properly construed claims, Apotex’s ANDA product would not infringe. In so holding, the Federal Circuit also determined that the district court’s decision to consider the ANDA, amended after an infringement finding, was proper.
Ferring Corporation (“Ferring”) sued Apotex Corporation (“Apotex”) and Watson Laboratories, Inc – Florida alleging infringement of U.S. Patent Nos. 7,947,739; 8,022,106; and 8,273,759, which relate to the treatment of menorrhagia in women and cover Ferring’s drug, Lysteda. The patents-in-suit include a limitation regarding the dissolution rates of a salt of the active pharmaceutical ingredient (i.e., the rate at which the salt dissolves in water). Specifically, all of the patents-in-suit contain a limitation that less than “about 70% by weight” of the salt has dissolved after 45 minutes.
In 2010 Apotex submitted its ANDA seeking FDA approval to market a generic version of Lysteda. The 2010 ANDA had only one dissolution specification: that at least 80% by weight of the salt would dissolve in 80 minutes. The district court construed the term “about” to mean “approximately,” but did not adopt any numerical range for the term. At trial, the district court held that because Apotex’s 2010 ANDA was silent with respect to the weight percentage of the active pharmaceutical salt released at the times specified in the patents-in-suit, the 2010 ANDA permitted Apotex to sell an infringing product and “violate the patent.” The district court did, however, allow Apotex to amend its ANDA to include a restriction that not less than 75% by weight of the active pharmaceutical ingredient was released at 45 minutes. Additionally, the district court held that such a dissolution rate would be outside the scope of the patents-in-suit and further held that Apotex’s amended 2014 ANDA did not infringe the patents-in-suit. Accordingly, the district court dismissed the case.
On appeal, the Federal Circuit vacated the district court’s finding regarding infringement of the 2010 ANDA. The Federal Circuit observed that the district court applied the wrong infringement standard and that under the correct standard, the evidence showed that Apotex would not sell an infringing product under its 2010 ANDA. Regarding the 2014 ANDA, the Federal Circuit affirmed the district court’s construction of the “about” term as “approximately” based on the claim’s reference to the U.S. Pharmacopeia and the plain meaning of the term, both of which were consistent with the court’s construction. On the issue of the 2014 ANDA’s infringement, the Federal Circuit first rejected Ferring’s argument that it was improper for the district court to even consider the 2014 ANDA. The Federal Circuit instead concluded that both 35 U.S.C. § 271 and 21 U.S.C. § 355(j) contemplate amendment of an ANDA, which can be done even after a finding of infringement.
Finally, the Federal Circuit determined that the 2014 ANDA spoke directly on the question of infringement and would not permit Apotex to market an infringing product. As such, it affirmed the district court’s non-infringement holding.
Patentable Invention: Double Patenting
AbbVie Inc., et al. v. The Mathilda and Terence Kennedy Institute of Rheumatology Trust, No. 13-1545 (Fed. Cir. (S.D.N.Y. Aug. 21, 2014). Opinion by Dyk, joined by Wallach and Chen.
Affirming the U.S. District Court for the Southern District of New York’s holding that the patent-in-suit was invalid under the doctrine of obviousness-type double patenting, the Federal Circuit made explicit that obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates.
The Mathilda and Terrance Kennedy Institute of Rheumatology Trust (“Kennedy”) owns U.S. Patent Nos. 6,270,766 (“the ’776 patent) and 7,846,442 (“the ’442 patent”), which relate to the treatment of rheumatoid arthritis using a combination of methotrexate and an antibody. In 2002 AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively “AbbVie”) obtained a license to the ’766 patent. Thereafter, AbbVie won FDA approval to sell its drug, Humira, an anti-TNFα antibody for use either alone or in combination with methotrexate for the treatment of rheumatoid arthritis. AbbVie paid Kennedy royalties under the ’766 patent license in connection with its sale of Humira. In 2010, the ’442 patent issued and Kennedy demanded AbbVie secure an additional license for that patent in order to continue sales of Humira. Unwilling to take a license to the ’442 patent, in 2011 AbbVie sought declaratory judgment that the claims of the ’442 patent were invalid over the ’766 patent for obviousness-type double patenting.
At a bench trial, the district court first construed the claims of the two patents, rejecting Kennedy’s proposed constructions of the terms “co-administering” in the ’766 patent and “active disease” in the ’442 patent, comparing the scope of the construed claims, and finding that the two patents covered the exact same invention. The district court thus invalidated all claims of the ’442 patent that were subject to the declaratory judgment action.
On appeal, the Federal Circuit first rejected Kennedy’s argument that the doctrine of obviousness-type double patenting had no place in the law after the Uruguay Round Agreement Act (“URAA”) implemented a 20 year patent term, which runs from the earliest claimed priority date. The Federal Circuit determined that despite the URAA, the doctrine still has applicability because related patents can have different terms due to PTO delays. Additionally, if applicants choose to file different applications, the separate patents could have different priority dates and different terms. Additionally, Federal Circuit precedent since the URAA enactment supported the continued existence of the doctrine.
Next, the Federal Circuit construed the terms at issue: “co-administering” in the ’766 patent and “active disease” in the ’442 patent. Regarding “co-administering,” the Federal Circuit rejected Kennedy’s position that the term included “patients who discontinued methotrexate” for treatment with the antibody alone and instead held that the specification only supported a construction of the term as administering methotrexate and the antibody “together.” For the sake of the obviousness analysis, the Federal Circuit assumed Kennedy’s construction of “active disease” (particularly sick patients) was correct.
Finally, the Federal Circuit analyzed whether the differences in the subject matter between the claims of the ’766 patent and the ’442 patent, namely the ’442 patent’s limitation to “patients with active disease,” rendered their claims “patentably distinct.” The Federal Circuit stated that the general rule is that species are unpatentable when prior art disclosures describe the genus containing those species such that a person of ordinary skill in the art would be able to envision every member of the class. Applying that rule, the court concluded that a reader of the ’766 patent could have easily envisioned a species limited to sicker patients. As such the claims of the ’442 patent were invalid over those of the ’766 patent.
Alston & Bird's Federal Circuit Patent Case Summaries are intended to be informational and do not constitute legal advice or opinions regarding any specific situation. The material may also be considered advertising under certain rules of professional conduct or other law. This publication may be reprinted without the express permission of Alston & Bird as long as it is reprinted in its entirety including the copyright notice, ©2014.