AbbVie –After having paid $100 million to license a first patent from plaintiffs to market its Humira anti-inflammatory, AbbVie was sued for infringement of a second patent. That second patent was found invalid for double patenting since the narrow species of the newer patent were not patentably distinct from the genus claimed in the first patent.
mFormation – A JMOL of noninfringement is affirmed because there was no legally sufficient evidentiary basis on which a reasonable jury could have found that BlackBerry infringes the asserted claims. In so holding, the Circuit rejects the arguments of mFormation that the district court altered claim construction after the verdict was rendered, that claim construction was incorrect in that it limited the steps to the order in which they were claimed, and that there was substantial evidence to support the verdict.
Ferring – In two separate rulings the Circuit finds that generic versions of Lysteda®, a popular treatment for heavy menstrual bleeding, to be non-infringing, either because the active ingredient released more slowly or too quickly to infringe the patents in suit.
AbbVie, Inc., et al. v. The Mathilda, et al., Fed. Cir. Case 2013-1545 (August 21, 2014)
The Mathilda and Terrance Kennedy Institute of Rheumatology Trust (Kennedy) owns the '442 and '766 patents directed to methods of treating rheumatoid arthritis. When the '442 patent application was filed, it claimed priority to the '766 patent. The specification of the '442 patent is identical to that of the '766 patent. Unlike the '766 patent, which is directed towards all "individuals in need" of rheumatoid arthritis treatment, the '442 patent claims treatment of a more specific patient group: individuals with "active disease." The claim language is also different in that the '442 patent references "adjunctively administering" the two drugs, whereas the '766 patent refers to "co- administering" the two drugs.
AbbVie sought and obtained a license to the '766 patent and AbbVie paid Kennedy over $100 million in royalties for AbbVie's sale of Humira in the U.S. Once the '442 patent issued, Kennedy demanded that AbbVie secure an additional license for that patent in order to continue sales of Humira. Unwilling to pay further royalties for the right to sell the same product, AbbVie filed this declaratory judgment action contending that claims of the '442 patent were invalid over the '766 patent for obviousness-type double patenting.
Despite the longstanding recognition of the prohibition against double patenting, Kennedy contends that the Uruguay Round Agreement Act (URAA) and its implementation of a 20-year period of patent protection that runs from a patent's earliest claimed priority date, eliminated the need for the obviousness-type double patenting doctrine. Kennedy views the purpose of this doctrine narrowly: Measuring the 20-year term from the date of filing was established to curb the practice known as submarine patenting. Now that the patent term is measured from the earliest claimed priority date as opposed to the date of issuance, Kennedy contends that the submarine patent problem no longer exists and that the URAA amendment vitiated the policy basis for the doctrine of obviousness-type double patenting.
According to the panel, this argument ignores another crucial purpose of the doctrine: It is designed to prevent an inventor from securing a second, later expiring patent for the same invention. That problem still exists. Patents claiming over-lapping subject matter that were filed at the same time still can have different patent terms due to examination delays and resulting patent term adjustments at the PTO. So too, where, as here, the applicant chooses to file separate applications for overlapping subject matter and to claim different priority dates for the applications, the separate patents will have different expiration dates since the patent term is measured from the claimed priority date. When such situations arise, the doctrine of obviousness-type double patenting ensures that a particular invention (and obvious variants thereof) does not receive an undue patent term extension.
The panel then turns to the question of whether the doctrine applies here. The obviousness-type double patenting analysis involves two steps: "First, the court ‘construes the claims in the earlier patent and the claims in the later patent and determines the differences.' Second, the court ‘determines whether those differences render the claims patentably distinct.'" "‘A later claim that is not patentably distinct from,' i.e., ‘is obvious over or anticipated by,' an earlier claim is invalid for obviousness-type double patenting."
Through claim construction, Kennedy attempts to enlarge the scope of the '766 patent while narrowing that of the '442 patent. First, Kennedy urges that the district court erred in limiting the term "co-administering" in the '766 patent to three modes of administration. However, the panel holds that the '766 patent's specification confirms the correctness of the district court's claim construction.
Kennedy also contests the district court's construction of the term "active disease," as used in the '442 patent.
The panel assumes, without deciding, that Kennedy's proposed construction of "active disease" was correct. Thus, the panel indicated it must decide whether a patent that claims to treat a subset of patients with more severe rheumatoid arthritis (the '442 patent) is an obvious variant of a patent that claims treatment of rheumatoid arthritis patients generally (the '766 patent).
If the later expiring patent is "merely an obvious variation of an invention disclosed and claimed in the [reference] patent," the later expiring patent is invalid for obviousness-type double patenting. But "the nonclaim portion of the earlier patent ordinarily does not qualify as prior art against the patentee."
To be sure, obviousness is not demonstrated merely by showing that an earlier expiring patent dominates a later expiring patent. Nor does the panel think that the district court here relied on any such principle. It is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus.
But not every species of a patented genus is separately patentable. First, when a "genus is so limited that a person of ordinary skill in the art can ‘at once envisage each member of this limited class,' . . . a reference describing the genus anticipates every species within the genus." "The disclosure of a small genus may anticipate the species of that genus even if the species are not themselves recited."
Thus, 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. Here, the panel concludes that a reader of the '766 patent could have easily envisioned a species limited to sicker patients. Therefore, the district court was correct in concluding that the species of the '442 patent was not patentably distinct from the genus of the '766 patent.
mFormation Technologies, et al. v. Research in Motion Limited, et al., Fed. Cir. Case 2012-1679, 2013-1123 (August 22, 2014)
Mformation Software Technologies, Inc. ("MST") appeals the grant of JMOL that Defendants (BlackBerry) do not infringe the '917 patent. The panel affirms the decision because there was no legally sufficient evidentiary basis on which a reasonable jury could have found that BlackBerry infringes the asserted claims.
The '917 patent discloses the wireless activation and management of an electronic device without the need to have physical access to the device. Should someone lose a smartphone, the patent discloses a way to remotely delete the sensitive data. The '917 patent also discloses methods to remotely deploy software updates and troubleshoot, and it provides for the completion of these tasks without the need for a constant connection or an initial activation.
BlackBerry makes and sells BlackBerry handheld wireless devices. BlackBerry also markets its Blackberry Enterprise Server ("BES") software that allows its corporate customers to deliver e-mail and other data to their employees' BlackBerry devices. Additionally, the BES software allows companies to remotely manage their employees' devices. The BES software is installed on a company server and communicates with a BlackBerry device by sending data in packets over the cheapest available network. If the BlackBerry device is connected via Wi-Fi, the command is sent over that channel; otherwise, the command is sent (at a greater cost) over a cellular network. Regardless of which network is selected, all communications between the BES software on the server and a BlackBerry device are sent using an additional proprietary Gateway Message Envelope ("GME") protocol.
In the trial below, a jury found that there was infringement of all asserted claims and returned a verdict of $147.2 million. The court then issued an order requesting further briefing in support of the parties' post- trial motions. In its order, the court explained that the "establishing a connection" sub-step must be completed before the "transmitting the contents of the mailbox" sub-step can commence. In view of that statement, BlackBerry renewed its JMOL motion, arguing that there was no evidence that a connection is completely established before the start of the "transmitting" sub-step. The district court granted BlackBerry's motion, overturning the verdict, and granted BlackBerry's conditional motion for a new trial.
Plaintiff also moved for a new trial, alleging that the district court had changed the claim construction of the "establishing a connection" sub-step post-verdict to require an order-of-steps, i.e., that the connection be completely established before transmission, arguing that such a requirement is both missing from the claims and was not presented to the jury.
This appeal concerns Mformation's challenges to the district court's grant of JMOL of no infringement. First, Mformation argues that the district court improperly introduced a new post-verdict claim construction which added an order-of-steps claim requirement. Second, Mformation argues that even if the district court did not alter the claim construction post-verdict, its construction was incorrect. Third, Mformation argues that JMOL is improper even when relying on the district court's order- of-steps requirement in the claim construction.
Whether the District Court Altered the Claim Construction
Mformation argues that the district court impermissibly added an order-of-steps claim requirement post- verdict in its JMOL opinion—i.e., a requirement that a connection must be completely established beforethe transmitting step begins. However, according to Mformation, with respect to the "wherein the connection is established . . ." limitation, the district court only informed the jury that this limitation requires that the connection be initiated before transmitting. Thus, Mformation argues that the jury was told that transmitting could begin before the connection is fully established, as long as the connection is later completed. The record indicates that such a sequence is not only possible but also what indeed occurs with BES software.
The panel agrees with BlackBerry and concludes that the district court did not change its claim construction post-verdict. Rather, the district court at most clarified its previous construction that was already present in the jury instructions.
The Order-of-Steps Requirement in the Claim Construction
The panel then turns to the issue of whether claim 1 patent requires that a connection be completely established before transmission. As a general rule, "unless the steps of a method claim actually recite an order, the steps are not ordinarily construed to require one." However, a claim "requires an ordering of steps when the claim language, as a matter of logic or grammar, requires that the steps be performed in the order written, or the specification directly or implicitly requires" an order of steps. Below, the district court read an order-of-steps requirement into the claim, concluding that "before the server can ‘transmit' the command, it must first ‘establish a connection'" that is used for transmitting. The district court explained that, "in the context of a network communication, the ordinary meaning of the phrase ‘a connection' is ‘a means of communication or transport.'"
On appeal, Mformation challenges the district court's construction. It argues that the patentee's use of "ing" in "establishing a connection between the wireless device and the server" conveys that formation of the connection is in progress, rather than completed. And Mformation adds that the wherein clause does not specifically dictate when the connection must be established; it only requires that a connection eventually be established.
The panel agrees with the district court and BlackBerry that claim 1 requires that a connection be established before transmission, being persuaded by BlackBerry that the separate sub-step for establishing a connection would become "superfluous" if it concluded that a connection did not have to be established (completed) before transmission. Further, the panel notes that other sub-steps in claim 1 inherently require an order-of-steps. As a matter of logic, a mailbox must be established before the contents of said mailbox can be transmitted. And while it is true that "we have expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment," the panel notes that its conclusion is consistent with the sole embodiment in the specification.
The Grant of JMOL of No Infringement
Finally, Mformation argues that BlackBerry is not entitled to JMOL even if an order-of-steps requirement is read into the claims. Mformation argues that there is still substantial evidence of infringement because BlackBerry's BES software need not create the communication channel itself but, rather, could use an existing wireless communication channel. And Mformation claims to have presented ample evidence at trial that, before the start of the "transmitting" sub-step, the BES software selects an existing wireless communication channel that allows a server to communicate with a remote device. Consequently, Mformation claims that a reasonable juror could find that the accused products establish a connection between the BES software and the wireless device before commencement of the "transmitting" sub-step.
The panel disagrees. As the district court noted, Mformation's expert based his infringement opinion on his understanding that the claims do not require a connection to be established between the server and the wireless device before transmission. Based on his mistaken view, Mformation's expert testified that the "establishing a connection" sub-step is satisfied by: (1) the BES software "packaging the command in the GME protocol"; and (2) a component of the BES software determining whether to transmit that GME message via cellular or Wi-Fi. However, both of these actions occur entirely within the BES soft- ware installed on a company server. Neither preparing a GME message nor determining how to transmit that message results in establishing a connection between the BES software and a BlackBerry device, as the claim requires. In other words, selecting a path for a wireless connection is not the equivalent ofestablishing a wireless connection.
The panel therefore concludes that substantial evidence does not support a jury verdict of infringement under the proper claim construction of the "establishing" sub-step. Because the district court's grant of JMOL of no infringement is affirmed, it need not address its conditional grant of a new trial.
Ferring B.V. v. Watson Laboratories, Inc. and Apotex, Inc., Fed. Cir. Case 2014-1416 (August 22, 2014)
Ferring's patents are directed to modified release formulations of tranexamic acid, the active ingredient in the drug marketed as a treatment for heavy menstrual bleeding, or menorrhagia, under the brand name Lysteda®. The claims of those patents are drawn to oral dosage formulations and methods of treating menorrhagia and require three elements: (1) about 650 mg of tranexamic acid; (2) a so-called modified release material that comprises either about 10% to about 35% or about 5% to about 50% by weight of the formulation; and (3) a specified dissolution release rate of the tranexamic acid in water.
Almost a year before the first of Ferring's patents issued, Watson filed ANDA seeking FDA approval to market tranexamic acid tablets as generic versions of Lysteda®. Upon issuance of the '739, '106, and '795 patents, Ferring sued for patent infringement in a first action, and prevailed in the district court.
Watson appeals from the decisions in the first case: (i) holding that the subject matter of the claims of Ferring's patents would not have been obvious, (ii) finding that Watson's generic tranexamic acid product infringed those claims, consequently (iii) ordering the FDA to reset the approval date of Watson's ANDA, and (iv) permanently enjoining the manufacture, use, sale, or offer for sale of Watson's generic product.
Watson contends that each limitation of Ferring's claims was disclosed or suggested in the prior art. Watson relies on a July 27, 2000 report by the a European aAgency that evaluates the safety and efficacy of a 500 mg tranexamic acid product comprising the excipient hydroxypropylcellulose, which was indicated throughout Europe for the treatment of menorrhagia. According to Watson, it would have been obvious to increase the amount of tranexamic acid to 650 mg and to package the drug in a modified oral dosage form because a patent of Nakagami described tranexamic acid as one of many medicinal ingredients that could be used with proposed sustained release granular preparations containing binders such as hydroxypropylcellulose and hypromellose.
According to the panel, the cited prior art references neither set forth the limitations required by the neither asserted claims, nor provided any reason or motivation to combine those teachings to derive the claimed formulations with specific dissolution profiles. In view of the foregoing, the panel affirms the district court's holding that Watson failed to prove that the asserted claims of Ferring's patents are invalid as obvious
The panel next addresses the district court's holdings that Watson's ANDA submission and generic tranexamic acid product infringed the asserted claims. Watson argues that the court erred in finding infringement because the accused products do not meet the claimed in vitro dissolution release rate profile. Watson contends that its finished, commercial tablets with the pH-dependent coating dissolve far slower in water than the limitations set forth in the asserted claims. Watson asserts that the data showing dissolution rates of uncoated cores with different levels of hardness compression reported in document PTX 381 fall within the experimental use privilege afforded by 35 U.S.C. § 271(e)(1) for developmental work done to support an ANDA application. Watson further asserts that the accused products do not have the claimed amount of modified release material.
In response, Ferring maintains that both Watson's uncoated cores and coated tablets infringe the asserted claims because they both contain the requisite amount of a modified release material and because they both meet the claimed dissolution limitations. Ferring argues that Watson's ANDA specifies that a blend of polymers and other inactive ingredients, including hypromellose, makes up 32.87–34.83% of the accused tablets and asserts that the ANDA describes how Watson chose the type and amount of such inactive ingredients in its uncoated cores "such that they would release the tranexamic acid ‘neither too fast nor too slow.'"
The panel first notes that under the Hatch-Waxman framework, the filing of an ANDA constitutes an "artificial" act of infringement for purposes of creating case or controversy jurisdiction. 35 U.S.C. § 271(e)(2)(A). The district court here thus erred to the extent that it read § 271(e) to mean that Watson's act of filing an ANDA, by itself, established infringement sufficient to preclude consideration of the ANDA specification and any amendments before the FDA. The filing only constituted a technical act of infringement for jurisdictional purposes. Once jurisdiction is established, the ultimate infringement inquiry provoked by such filing is focused on a comparison of the asserted patent claims against the product that is likely to be sold following ANDA approval and determined by traditional patent law principles."
Watson's ANDA specification does not itself resolve the question of infringement. There is no specification that calls for measuring the dissolution of its finished, coated commercial product in water; but silence does not answer the question of infringement. The focus that both Ferring and the district court thus gave to infringement by the uncoated cores of Watson's generic product is misplaced. The infringement evaluation is concerned only with the final, coated commercial tranexamic acid tablets for which Watson sought and was granted FDA approval to market as a generic version of a treatment of menorrhagia. Watson cannot sell the uncoated cores alone because it would not comply with its ANDA specification; to do so would be to sell both an unapproved and adulterated drug in violation of the law.
The independent claims of the '106 and '795 patents require "not less than about 50% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 90 minutes." The independent claim of the '739 patent requires "about 100% by weight tranexamic acid or a pharmaceutically acceptable salt thereof released by about 120 minutes." The dissolution data collected by both parties during discovery showed that, in an overwhelming majority of the samples tested by the claimed USP method, only about 27% to 44% of the tranexamic acid was released from the individual coated tablets at 90 minutes and only about 33% to 52% was released at 120 minutes, consistent with the biobatch data reported in Watson's ANDA itself. These data show the samples to be outside the scope of the asserted claims. Of the hundreds of coated commercial products tested, only about four individual tablets released more than 50% of their tranexamic acid at 90 minutes, and none of those released more than about 79% by 120 minutes.
The asserted independent claims also require that the accused product contain a certain amount of "modified release material," ranging from about 5% to about 50% by weight of the formulation in the '795 patent and about 10% to about 35% by weight of the formulation in the '106 and '739 patents. The district court construed the term "modified release material" to mean "a material that modifies the release of the active pharmaceutical ingredient." But under that construction, which the panel does not disturb, just because a certain material can modify release of the active pharmaceutical ingredient tranexamic acid, does not necessarily mean that it actually does. Experts for both parties agreed that testing is required to measure whether a particular excipient actually functions to modify the release of tranexamic acid in a given formulation and therefore qualify as a modified release material. Here, however, Ferring did not conduct any such testing and thus provided no basis from which to draw any reliable inferences regarding whether any of the inactive ingredients in Watson's ANDA product would modify the release of the tranexamic acid, regardless of the amount present.
Moreover, although it is not readily discernable from the record that the district court applied its stated construction in its infringement analysis, the only way for the court to have found that Watson's finished, coated commercial tablets infringed the asserted claims would have been for the court to have determined, as it suggested during trial, that a modified release material was any material that causes tranexamic acid to behave differently in some way than in water alone. That alone would constitute reversible error as it would not follow its own claim construction.
The panel thus concludes that the district court erred in finding that Ferring proved that Watson's finished, coated commercial tranexamic acid ANDA product infringed the asserted claims. Therefore, there is no basis for the court's order resetting the FDA approval date of Watson's ANDA or the court's grant of a permanent injunction as to Watson's generic tranexamic acid product, so the panel vacates both.
The Second Opinion
At trial, Ferring conceded, and the district court found, that Apotex's actual product, based on its dissolution sample data, did not infringe the patents-in- suit under 35 U.S.C. § 271(a). However, the district court, analyzing Apotex's 2010 ANDA under Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals, Inc., 731 F.3d 1271 (Fed. Cir. 2013), concluded that because the 2010 ANDA was silent with respect to the weight percent of tranexamic acid released at the times specified in the patent-in-suit, the ANDA permitted Apotex to sell an infringing product and "permitted [Apotex] to violate the patent." At trial, Apotex agreed to amend its ANDA specification to include a restriction that not less than 75 percent by weight of the tranexamic acid was released at 45 minutes. The district court made a finding at trial that a tablet with such a dissolution rate by weight at 45 minutes would be outside the scope of the patents-in-suit, and therefore, Apotex's proposed amendment would be outside the scope (because the amount was in excess of "the about 70% by weight" permitted by the patent claims), and would not be enjoined.
After trial, Apotex amended its ANDA on February 10, 2014 (the "February 2014 amendment"), to specify that "not less than 75%" by weight tranexamic acid would be dissolved at 45 minutes" (the "2014 ANDA"). J.A. 3634. The FDA approved the change and concluded that the 2014 ANDA did not infringe the patents-in-suit. Apotex agreed to inform the FDA that both the district court and Ferring would be notified if Apotex ever attempted to change the dissolution specification in the future.
The district court dismissed the case and "found that Apotex's  ANDA No. 202286 infringed the patents-in-suit," but concluded that "Apotex having Stipulated to amend its ANDA No. 202286 [i.e., the 2014 ANDA] . . . moots Plaintiff's Complaint with regard to Apotex's proposed ANDA amendment." Ferring appealed.
The panel addresses whether either of Apotex's filed ANDAs— the original 2010 ANDA or the amended 2014 ANDA—infringed the patents-in-suit.
2010 ANDA Infringement
The district court concluded that under Sunovion, Apotex was infringing because Apotex could violate the patents-in-suit based on the 2010 ANDA, and Ferring makes the same argument on appeal. The panel disagrees, noting that Sunovion only applies when "an ANDA specification defines a compound such that it meets the limitations of an asserted claim." 731 F.3d at 1280. Here, the ANDA does not "clearly describe a product that meets the limitations of the asserted claims." Rather, the 2010 ANDA is silent with respect to the claim limitations of the patents-in-suit, which do not specify dissolved dissolution rate at 60 minutes.
Here, Apotex has provided bio-batch data that shows what Apotex is likely to sell. Ferring's expert testified that none of the tablets produced by Apotex in discovery was infringing. At trial, Ferring conceded that "there's [no] basis for the district court to find Apotex has violated 271(a)," i.e., that the product being sold by Apotex did not infringe the patents- in-suit. Therefore, the evidence shows that Apotex is not likely to sell an infringing product and that the district court erred in finding that the 2010 ANDA was infringing.
2014 ANDA Infringement
The panel also addresses whether the ANDA now in effect infringes the patents-in-suit. Apotex amended that ANDA in 2014 in an effort to preclude infringement. Apotex's 2014 ANDA—the 2010 ANDA with the February 2014 amendment—specified that "each unit dissolved NLT [ i.e., not less than] 75% [by weight tranexamic acid] in 45 minutes." The district court concluded that the 2014 ANDA would not infringe because the patents-in-suit required that less than about 70 percent by weight tranexamic acid be dissolved at 45 minutes, and therefore, the February 2014 amendment mooted Ferring's complaint. The district court construed the term "about" as "approximately," rejecting Ferring's proposed construction limiting the term to a particular numerical range. The panel agrees with the district court as to the construction since the reference in the specification that Ferring claims creates a tolerance does no such thing.
Under the circumstances, it fell to Ferring, the party with the burden of proof on infringement, to produce evidence that the 2014 ANDA infringed by proposing a 75 percent by weight dissolution rate, under the district court's claim construction. Ferring produced no such evidence and made no claim that the ANDA infringed under the district court's claim construction. The panel thus concludes that the 2014 ANDA specification speaks directly to the question of infringement and would not permit Apotex to market an infringing product.
The panel thus affirms the second opinion on the ground that Ferring has not established that either Apotex's 2010 or 2014 ANDA infringes the patents-in-suit.