Following a jury trial, Judge Richard G. Andrews recently entered judgment on the jury’s verdict, pursuant to Rule 58(b)(2), that Claims 15, 16, 17, 19, 20, 21, 50, 60, 63, 70, 73 and 80 of L-3’s U.S. Patent No. 5,541,654 are valid. L-3 Communications Corp. v. Sony Corp., et al., C.A. No. 10-734-RGA (D. Del. Apr. 21, 2014).
Judge Richard G. Andrews recently considered the parties summary judgment motions in Robocast, Inc. v. Apple, Inc., C.A. No. 11-235-RGA (Apr. 22, 2014). Judge Andrews’ decisions on the parties’ Daubert motions can be read here, here and here.
Apple moved for summary judgment of non-infringement and invalidity and on damages, injunctive relief and indirect infringment; whereas Robocast moved for summary judgment of no unenforceability. Judge Andrews denied Robocast’s motion and Apple’s motion on non-infringement and invalidity finding underlying factual disputes for the jury. Id. at 7-18. Judge Andrews granted in part Apple’s summary judgment motion on damages, injunctive relief and indirect infringement. Regarding damages, Apple argued that because the Court excluded Robocast’s damages expert, summary judgment of no damages was appropriate. Id. at 18. Judge Andrews disagreed. “While Apple envisions a scenario where Robocast cannot prove any damages, much can happen between now and trial. Perhaps this is an exceptional circumstance in which it would be appropriate to allow Robocast to read [Apple’s damages expert’s] deposition into the record [should Apple de-designate its expert].” Id. at 19. Judge Andrews granted Apple’s motion regarding “pre-suit” willful and indirect infringement, finding that Robocast did not make an adequate showing of pre-suit knowledge of the patent-in-suit. Id. at 21-22. Regarding injunctive relief, Judge Andrews denied Apple’s motion, determining that “whether a permanent injunction is an appropriate remedy is better decided after a trial[.]” Id. at 22-23.
There has been a recent flurry of activity surrounding injunctive relief in the Edwards LifeSciences AG v. CoreValve, Inc. case, which involves aortic heart valve replacement technology. Edwards filed suit in 2008, alleging that Defendants Corevalve and Medtronic infringe its patents. In 2010 a jury returned a judgment of infringement in favor of Edwards against Medtronic, awarding lost profits and reasonable royalty damages, and the Federal Circuit later affirmed. In late 2013, Edwards moved for a preliminary injunction to stop what it alleged would be Medtronic’s infringement once Medtronic obtained FDA approval for its new “CoreValve Generation 3” product. Chief Judge Sleet held an evidentiary hearing on the “public interest factor of the preliminary injunction motion” on April 11 and issued a written decision on April 15 explaining his oral order at the hearing granting in part and denying in part the preliminary injunction. Edwards Lifesciences AG, et al. v. CoreValve, Inc., et al., C.A. No. 08-91-GMS, Memo. at 1-2 (D. Del. Apr. 15, 2014).
Edwards and Medtronic both make transcatheter heart valves that allow implanting of prosthetic aortic valves using a catheter thereby avoiding open heart surgery. The two companies are each other’s only competitors in the United States. Each company manufactured an older, predecessor type of transcatheter heart valve, and each company sought FDA approval of a new type of transcatheter heart valve. Although the FDA had not yet approved the product, the 2010 jury verdict of infringement related to Medtronic’s newer product, the CoreValve Generation 3. Before FDA approval of Medtronic’s infringing product, Medtronic had been able to make it available to patients through a continued access clinical trial. In January, however, the FDA approved the sale of the Medtronic product, which ended the continued clinical trial. Accordingly, Medtronic sought to begin commercially selling its CoreValve Generation 3 product. Edwards expected to obtain FDA approval for its new competing product and begin selling it in the near future as well. Id. at 2-4.
Chief Judge Sleet ultimately granted the motion for preliminary injunction in part. In doing so, he faced several legal and practical issues. With regard to the likelihood of success on the merits, Judge Sleet faced a question regarding enforceability, given that the patent-in-suit had expired in the years since the jury verdict. The FDA, however, had granted an interim extension of patent rights under 35 U.S.C. § 156. Medtronic argued that Edwards’ extension was limited to copies of its old product, not to copies of its new product like Medtronic’s CoreValve Generation 3. Therefore, Medtronic argued, even though its Generation 3 product might infringe the patent-in-suit, it is different from the Edwards product on which the term extension of that patent was based. Judge Sleet did not accept this argument, finding that Section 156(b) addressed approved uses, not approved products. Thus, because the accused Generation 3 product had the same use as the original Edwards approved product, the patent term extension covers it. Thus, having prevailed on infringement and had its patent term extended, Edwards had shown a likelihood of success on the merits. Id. at 5-6.
Judge Sleet also concluded that Edwards had shown irreparable harm through potential price erosion and loss of sales, market share, and revenue. Id. at 6-13. The major argument from Medtronic against irreparable harm was that there exists a “countervailing consideration sufficient to trump the mandate that patent rights be enforced.” This public interest consideration is the possibility that enjoining Medtronic would “leave patients so at risk of inferior care or no care at all that the public interest requires Medtronic be allowed to sell the CoreValve Generation 3.” Id. at 13-14. Medtronic essentially argued that its product was a safer, superior alternative to Edwards’ products and that it should be permitted to continue selling its product to a class of patients regarded as “extreme risk” because in some cases those patients could not be helped by Edwards’ existing product or in other cases could not be helped by either Edwards’ existing product or its product being approved by the FDA. Judge Sleet rejected the first extreme risk patient argument because Edwards’ new product should be approved by the FDA in the near future. But Judge Sleet accepted the second argument, finding that “the public interest requires making some accommodation that would grant patients [who can only be treated by Medtronic’s devices] access to the CoreValve Generation 3.” Thus, Judge Sleet granted the motion for preliminary injunction in part, concluding that the injunction must be tailored because “the public interest weighs in favor of granting Edwards a preliminary injunction, subject to an accommodation for Medtronic to sell its devices to those patients who cannot be helped by Edwards’ devices.” Id. at 14-21.
Judge Sleet also granted Medtronic’s request for “a stay of seven business days to ‘seek emergency relief in the Federal Circuit’ and ‘give hospitals some notice of what ha[d] happened.’” Id. at 2 n.4. Medtronic then filed an emergency motion with the Federal Circuit asking the court to stay the injunction. Medtronic urged the same arguments in the Federal Circuit as it had in the District of Delaware: public interest weighs in favor of denying injunctive relief and the patent is not enforceable because it has expired. The Federal Circuit agreed on April 15 to expedite the appeal and issued a decision on Monday, April 21 staying enforcement of the preliminary injunction. The Federal Circuit panel granted Medtronic’s motion to stay “pending further notice by this court” in a 2-1 order that did not further explain its rationale. Circuit Judges Rader, Prost, and Newman sat on the panel, with Judge Newman dissenting. The Federal Circuit will now review the preliminary injunction on the merits.
It is rarely in doubt that a drug-maker has the right to bar generic entry into an exclusive market when the drug-maker’s patent is found valid and infringed by a generic applicant, or when such a finding is deemed reasonably likely by the court.
For this reason, it is somewhat surprising that Chief Judge Roberts denied drug-maker Teva’s request to reinstate an injunction against generic entry against its Copaxone® drug product to treat multiple-sclerosis. Notably, all of Teva’s patents-at-issue will expire at least by September 2015. While the length of remaining patent term could have been a factor in the denial of the request, it is difficult to know. The ruling itself is less than 200 words.
The Chief Justice acknowledged that Teva has shown “a fair prospect of success on the merits,” the prong of the analysis that often trips a patentee’s application for injunctive relief. Instead, this relief was denied because the alleged availability of money damages for past patent infringement was found adequate. Thus, the Chief Justice explained, “the extraordinary relief that Teva seeks is unwarranted.”
While it is very rare for the Supreme Court to reinstitute (rather than continue) a commercial injunction pre-hearing, this decision may spur a certiorari challenge to the long-standing view that drug-makers are typically entitled to injunctive relief against generic entry through patents found valid and infringed, or likely so.
Teva’s “fair prospect of success on the merits” is perhaps more interesting because it suggests the Supreme Court agrees with the original premise of Teva’s petition for certiorari, and will reverse the Federal Circuit’s de novo review standard for at least some matters of claim construction.
The case is Teva Pharmaceuticals USA Inc. et al. v. Sandoz Inc. et al., case number 13-854, in the U.S. Supreme Court.
Click HERE to see the order denying the injunction.
Judge Richard Andrews recently granted motions to dismiss claims of willful infringement in two cases brought by Steelhead Licensing LLC. Judge Andrews explained that there was apparently no reason for use of the word “willful” in the complaints because the plaintiff seemed to have no facts in support of an allegation of willfulness. Judge Andrews therefore granted the motions to dismiss willfulness, stating that “Plaintiff, who I would expect might have an interest in moving this case along, puts itself at the mercy of the Defendants, who can stall by making a motion to dismiss, and the Court, whose default decisional standard is LILO.” Steelhead Licensing LLC v. Charter Commc’ns Inc., et al., C.A. No. 13-2075-RGA, 13-2076-RGA, Order at 1-2 (D. Del. Apr. 10, 2014).
In Intellectual Ventures I LLC, et al. v. Canon Inc., et al., C.A. No. 11-792-SLR (D. Del. Apr. 10, 2014), Judge Sue L. Robinson first resolved several summary judgment motions regarding the six patents asserted by plaintiffs (“IV”) that remained at issue: U.S. Patent Nos. 5,754,348 (“the ‘348 patent”), 6,121,960 (“the ‘960 patent”), 6,221,686 (“the ‘686 patent”), 6,023,081 (“the ‘081 patent”), 6,979,587 (“the ‘587 patent”), 7,365,298 (“the ‘298 patent”).
With respect to the ‘348 Patent, Judge Robinson found a genuine issue of material fact regarding whether the “zoom features” of the accused products satisfied the limitation of “selecting for magnification a selected region of an original image in the graphical user interface,” and therefore defendant’s (“Canon”) motion for summary of non-infringement. Turning to Cannon’s motion for summary judgment of invalidity of the ‘348 patent, Judge Robinson was first required to determine whether the term “digital image magnification in a graphical user interface” from the preamble of claim 1 was limiting. Both parties cited to Catalina Mktg. Int’l Inc. v. Cool savings.com, Inc., 289 F.3d 801 (Fed. Cir. 2002) as support for their positions, and Judge Robinson ultimately determined that the preamble was limiting. As Judge Robinson explained, the applicant “emphasized both ‘digital image magnification’ and ‘in the graphical user interface’ in distinguishing the invention from the prior art.” Judge Robinson found, however, that the experts’ disagreement with respect to the anticipatory references at issue was sufficient to create a genuine issue of material fact and denied Canon’s motion for summary judgment of invalidity. Id. at 9-13.
Judge Robinson also denied Canon’s motion for summary judgment of non-infringement as to the ‘960 patent, explaining that “[a]ttorney argument and conclusory expert opinions are insufficient to meet Canon’s burden of showing that there is no genuine issue of material fact.” As to invalidity of the ‘960 patent, Judge Robinson explained that in the Court’s prior claim construction order, claims 1 and 26 were found indefinite in view of the limitations “computing device for providing a main image” and “means for computing, the means for computing providing a main image,” respectively. In this regard, Canon’s motion for summary judgment was granted. However, the remainder of Canon’s motion on invalidity was denied in light of conflicting expert testimony. Id. at 16-20.
As to the ‘686 patent, Judge Robinson denied Canon’s motion for summary judgment of invalidity for claims 14 and 16. Judge Robinson further explained that Canon argued only that claims 14 and 16 cannot be infringed because they are invalid in light of the prior art, and did not provide any other opinion as to non-infringement of these claims. Judge Robinson therefore granted IV’s motion for partial summary judgment as to infringement of those claims. As to claim 15 of the ‘686 patent, Judge Robinson granted Canon’s motion for summary judgment of non-infringement under the doctrine of equivalents. Id. at 21-24.
As to the ’081 patent, Judge Robinson denied Canon’s motion for summary judgment of invalidity, and denied Canon’s motion for summary judgment of non-infringement, in part. Turning to the ’587 patent, Judge Robinson granted Canon’s motion for summary judgment of non-infringement, noting that “[a]s explained in the court’s claim construction order, the applicant differentiated the claimed field stop layer from two layers found in the prior art, one of which was formed after the field area.” In this regard, Judge Robinson found the prosecution history to foreclose IV’s infringement argument. Judge Robinson, however, denied Canon’s motion for summary judgment of invalidity for the ’587 patent. Id. at 25-31.
Canon’s motion for summary judgment of non-infringement of the ‘298 patent was granted. Judge Robinson granted this motion in view of the fact that the Court’s claim construction required a “specific relationship to be present,” and IV’s expert could not “point to the two layers meeting” the limitation at issue. Canon’s motion for summary judgment of invalidity of the ‘298 patent, however, was denied. Id. at 31-35.
Lastly, Judge Robinson considered the parties motions to exclude certain testimony and evidence. Canon moved to exclude the testimony of IV’s technical experts “on secondary considerations regarding invalidity, particularly long-felt need and commercial success.” Canon argued that IV’s experts “have no training, education, experience, or specialized knowledge in the areas of economics, IP licensing, or any similar area that would qualify them to opine regarding the commercial aspects of the commercial success inquiry.” IV’s technical experts have PhDs in electrical engineering and/or computer science, and each have over 20 years of experience in their respective fields. While Judge Robinson found these qualifications to meet the “liberal standard for ‘specialized knowledge’ under Federal Rule of Evidence 702,” Judge Robinson also noted that “[a]s to the commercial success testimony, neither expert has a specific background in economics or the like.” Judge Robinson nevertheless denied Canon’s motion to exclude the testimony of IV’s experts, as “[n]either party . . . made clear to the court the specific testimony IV intends to present at trial, or the basis for that testimony.” Judge Robinson noted that IV would be required to make a proffer at trial before such testimony would be permitted. Id. at 35-36.
IV moved to exclude Canon’s experts on obviousness, arguing that the experts “used the asserted claims of the patents-in-suit as guides to find missing elements in the prior art.” Judge Robinson denied Canon’s motion to exclude, finding that “after identifying the prior art, Canon’s experts applied an obviousness analysis to reach their opinions regarding obviousness of the patents-in-suit” and that “IV is free to challenge Canon’s experts on cross-examination as to why a person of ordinary skill in the art would be motivated to combine the selected references.” Id. at 36-37.
In Andrulis Pharmaceuticals Corp. v. Celgene Corporation, C.A. No. 13-1644-RGA (D. Del. Apr. 10, 2014), Judge Richard G. Andrews considered defendant’s motion to dismiss plaintiff’s direct and induced infringement claims for failure to state a claim. As to direct infringement, plaintiff alleged both “undivided” direct infringement and joint infringement. Id. at 1.
Judge Andrews dismissed plaintiff’s undivided direct infringement claim, which alleged that plaintiff itself directly “administers the patented method.” Id. at 1-2. Plaintiff argued that dismissal was inappropriate because the pleading “complies with Form 18.” Judge Andrews explained, however, that compliance with Form 18 is “not limited to whether the form was simply parroted.” Id. Rather, Judge Andrews found that “notice and facial plausibility,” were required, which were both found to be lacking with respect to the undivided direct infringement claim. Id. Additionally, in response to plaintiff’s argument that “dismissal would require construing the claims, which is inappropriate at the pleadings phase,” Judge Andrews acknowledged in a footnote that “I am always hesitant to engage in claim construction without a Markman hearing.” Id. at 2 n.1. In this case, however, Judge Andrews found occasion to note that “the claim at issue is a method claim that cannot possibly be read to make direct infringers out of anyone other than the medical personnel who treat patients.” Id.
Judge Andrews next considered plaintiff’s joint direct infringement claim, which alleged that “physicians administer the patented method under [defendant’s] direction and control.” Id. at 2. Finding these claims to survive the motion to dismiss, Judge Andrews explained that plaintiff “has pled more than enough factual allegations describing the relationship between prescribing doctors and Celgene” that would plausibly support the inference that defendant “direct or controls” the “doctors’ performance of the claimed method.” Id. at 3.
Judge Andrews also found plaintiff’s induced infringement claim to survive the motion to dismiss. Id. at 3-4. Defendant argued that “disseminating publications about an unapproved use of a product does not serve as evidence of intent that the product be used for that unapproved use because the FDA guidelines allow for dissemination of these materials.” Id. Judge Andrews found, however, that “[j]ust because the FDA labels materials as ‘non-promotional’ does not mean that doctors do not view these materials as promoting off-label uses.” Id. at 4. Accordingly, as Judge Andrews explained, “[t]he fact that [defendant] was aware of the patent and disseminated materials which it knew might be viewed as promoting that use is sufficient at this stage.” Id.
Judge Leonard P. Stark recently transferred a case to the Northern District of California based in part on the plaintiff’s actions and representations made to the Judicial Panel on Multidistrict Litigation. Genetic Technologies Ltd. v. Natera, Inc., C.A. No. 12-1737-LPS (D. Del. Apr. 15, 2014). Specifically, the Court noted that “[b]efore the [JPML], [the plaintiff] contended the Northern District was preferable to Delaware as a venue for centralizing pre-trial litigation.” Id. at 3. The JPML declined consolidating the cases into an MDL, leaving the plaintiff litigating in Delaware, North Carolina, New Jersey, and the Northern District of California. Although Judge Stark found that the plaintiff had rational reasons for wanting to litigate this action in Delaware, the Court found that the plaintiff’s representation to the JPML, as well as several other Jumara factors (including, notably, the convenience to the parties of litigating in Northern California, where the defendant’s principle place of business is located and which is some 2,500 miles closer to the plaintiff’s Australian headquarters than Delaware), weighed in favor of transferring the case. Id. at 2-4.
Chief Judge Gregory M. Sleet recently issued a memorandum and order resolving a post-trial dispute regarding the appropriate royalty rate to apply to post-verdict infringement. Telcordia Technologies, Inc. v. Cisco Systems, Inc., C.A. No. 04-876-GMS (D. Del. Apr. 14, 2014). The Court previously had found that a permanent injunction was not warranted, and ordered the parties to negotiate the terms of a reasonable royalty rate for post-verdict infringement. Id. at 1. The parties were unable to reach agreement, however, and ultimately submitted competing proposals that amounted to a difference of roughly $8.9 million. Id. at 4.
Chief Judge Sleet noted that royalty rates applied to post-verdict ongoing infringement frequently exceed royalty rates found at trial because of the parties’ changed legal status following a verdict, but that market circumstances also need to be considered in the analysis. Id. at 7. The Court found that the plaintiff was in a stronger bargaining position after prevailing at trial, and on appeal, but was not in a strong enough position to warrant the 3.5% “market rate” the plaintiff proposed with respect to its ‘763 and ‘633 patents (through the expiration of the ‘763 patent, after which the plaintiff proposed a 2% market rate through the expiration of the ‘633 patent). Id. at 8. The defendant proposed an “effective rate” of 0.64% on the two patents. The Court ultimately found that a 1.25% royalty rate on the ‘763 patent, and a 1% royalty rate on the ‘633 patent, were appropriate under the circumstances. Id. at 9.
Judge Richard G. Andrews construed the following claim terms of U.S. Patents Nos. 6,335,031 and 6,316,023 at issue in the Novartis Pharmaceuticals Corp., et al. v. Alvogen Pine Brook, Inc., et al., C.A. No. 13-52-RGA (consol.) (D. Del. Apr. 7, 2014) litigation:
“about 0.01 to about 0.5 percent by about 0.01 to about 0.5 percent by
“diluent or carrier”
“an amount of antioxidant effective to stabilize Compound A from degradation”