Today, Judge Robinson denied the defendants' motion for reconsideration of the Court's May 20, 2011 grant of a temporary restraining order in In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, 09-MD-2118-SLR (D. Del. May 24, 2011). In denying the motion for reconsideration, Judge Robinson stated that in the context of a post-trial TRO, the "likelihood of success" factor is "simply . . . one of the four factors to be considered when granting or denying an injunction." Id. at 3. Thus, the plaintiffs were not required to show a likelihood of success on the merits in order to obtain a temporary restraining order. Id. Further, although it is true that the defendants "will suffer harm from the issuance of a TRO" because the defendants already launched their generic product, Judge Robinson found that the balance of harms still weighed in favor of the plaintiffs because "Mylan brought the harm on itself" by choosing to launch its generic before the plaintiffs exhausted their appeals. Id. at 4.
Judge Robinson recently granted the plaintiffs' motion for a temporary restraining order pending appeal in an ANDA case, enjoining the defendants "from manufacturing, using, offering to sell, or selling generic extended release cyclobenzaprine products" as long as "plaintiffs agree to seek an expedited appeal and remove their generic product from the market." In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, 09-MD-2118-SLR (D. Del. May 20, 2011).
First, Judge Robinson found that "plaintiffs' success on appeal is just as likely as not," and therefore the "[likelihood of success] factor marginally supports a temporary restraining order." Id. at 6. Second, the Court stated that "[i]n every ANDA case there is a likelihood of irreparable harm for the name brand manufacturer as the generics have a ready-made market to flood as soon as they receive approval to release their products[,]" and therefore the "[irreparable harm] factor favors plaintiffs." Id. Third, Judge Robinson found that "[t]he harm to the defendants from a temporary restraining order is minimal[,]" and therefore the "[harm to defendants] factor favors plaintiffs" despite the fact that the defendants "claim that they have already launched their products[.]" Id. at 6. "Defendants bore the risk of a restraining order both from this court and the Federal Circuit." Id. at 7. Fourth, the Court found that "[t]he public interest factor is neutral[,]" stating that "[t]he public has both an interest in strong patent protection that encourages innovation as well as the ability to purchase inexpensive drugs." Id. at 7. Thus, Judge Robinson granted the temporary restraining order pending appeal as long as the plaintiffs agreed "to seek an expedited appeal and remove their generic product from the market." Id.
In The Medicines Co. v. Teva Parenteral Medicines Inc., C.A. No. 09-750-ER (D. Del. May 4, 2011), Special Master Poppiti recently denied defendant Hospira, Inc.'s motion for a protective order. The dispute centered on the question of whether the plaintiff was entitled to discovery of documents and testimony "relating to [defendant] Hospira's forecasts or business plans for its ANDA products[.]" Id. at 1. Specifically, Hospira argued that the discovery sought by the plaintiff was irrelevant because the plaintiff failed to "plead jurisdiction under the Declaratory Judgment statutes." Id. at 4. Special Master Poppiti rejected this argument, finding that the plaintiff was entitled to this discovery because (1) "[j]urisdiction must be based on diversity of citizenship or on a federal question[,]" not on the Declaratory Judgment Act, and (2) "[plaintiff] MedCo's failure to reference the Declaratory Judgment Act in its prayers for relief is not fatal to its pleading." Id. at 5.
Plaintiff Callaway Golf Company, argues that it was error for the Court "to remove from its final jury instructions language regarding a patent's presumption of validity." Callaway Golf Company v. Acushnet Company, C.A. No. 06-091-SLR, Memo. Op., at 15 (D. Del. April 21, 2011). Specifically, in this case, defendant's counsel argued during closing statements that the examiner spent minimal time on the large amount of references checked as reviewed during examination. Id. at 15-16. This argument was contrary to the Court's previous ruling that plaintiff could not "improper[ly] bolster[ ] the validity of the Sullivan patents by referring to the number of examiner considering those applications" or "speculate as to the extent to which such prior art was actually considered by the examiners..." Id. at 16 (internal citations omitted). The Court found that it did not commit legal error in excluding the instruction. Id. (Note: plaintiff did not object during the closing or address the statements made by defendant's counsel in its rebuttal argument.)
Last week, Judge Robinson issued on an opinion and judgment in In Re: Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, C.A. No. 09-2118-SLR (D. Del. May 12, 2011) (an ANDA case). The patents-in-suit covered an extended release version of a drug that was available in the prior art. Interestingly, the Court found the patents invalid as obvious in light of four prior art references which, even when combined, did not actually disclose all of the elements of the patent. According to the Court,
[N]ot every limitation of a claimed invention need be found in the prior art in order for said invention to be obvious. The Graham factors direct the court to look to the scope and content of the prior art, the differences between the invention and the prior art, and the level of skill of one of skill in the art. . . . . While it may be easier to prove obviousness if each limitation of the claimed invention is found in the prior art, the level of skill of one of ordinary skill in the art can, at times, fill in the gap when limitations of the claimed invention are not specifically found in the prior art.Id. at 26.
The obviousness section of the opinion included some other points of interest:
- The Court gave some weight to the fact that a person of ordinary skill would know that at least one of the elements could be "calculated by a computer program," based on Federal Circuit precedent that "'the discovery of an optimum value of a variable in a known process is usually obvious.'" Id. at 28 (citing Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 1368 (Fed. Cir. 2007)).
- In the Court's obviousness analysis, the fact that one of four references in an obviousness combination had not been considered by the patent office was sufficient to ease the difficulty of proving invalidity: "The court notes . . . that the '215 patent, which claims the extended release delivery system used in the patents-in-suit, was not before the PTO during examination of the '793 patent. Therefore, while defendants must still prove that the patent is obvious by clear and convincing evidence, they do not have the additional burden of overcoming the presumption that is due a qualified government agency presumed to have properly done its job. Tokai Corp. v. Easton Enters., Inc., Civ. No. 2010-1057, -F.3d -, 2011 WL 308370, at *6 (Fed. Cir. Jan. 31, 2011) (citations omitted)."
- The Court held that commercial success alone is insufficient to prove the presence of a long felt need. Id. at 31.
The Court also addressed a number of other issues, including claim construction, infringement, best mode, and inequitable conduct.
Judge Robinson: Result of Earlier Patent Infringement Case Relevant to Lost Profits and Reasonable Royalty Analysis
In Boston Scientific Corp. v. Cordis Corp., C.A. No. 10-315-SLR (D. Del. May 4, 2011), Judge Robinson recently stated that the result of an earlier patent infringement case involving the same parties, the same patent, and the same asserted claim "is relevant to both lost profits and a reasonable royalty analysis[.]" Id. at 1. However, Judge Robinson limited the introduction of evidence of the earlier case to a single statement, to be read at trial, that (1) the earlier case involved the same parties, patent, and asserted claim, (2) the jury found that the defendant's products infringed and that the claim was not invalid, and (3) that this finding was affirmed on appeal and therefore "the jury verdict and judicial determinations of infringement and validity are final." Id. at 1-2.
Judge Sue L. Robinson: Motion to Stay an ANDA case pending appeal of litigation involving the same patents GRANTED
In Cephalon, Inc. v. Sandoz Inc., C.A. No. 10-123-SLR (D. Del. May 5, 2011), an ANDA case, Cephalon filed a motion to stay pending its appeal of related litigation. In the related case, involving the same patents, the court found that the defendant did not infringe and that the patents were invalid. Id. at 2. Judge Robinson determined that a stay was appropriate because, among other things, Sandoz’s 30-month stay was set to expire in July 2012, which would likely occur after the Federal Circuit disposed of the appeal. Id. at 4. “If the Federal Circuit affirms the court’s invalidity holding, there is no reason for trial and the expenses related thereto.” Id. Judge Robinson found that Sandoz would not be prejudiced because, among other things, it could not enter the marketplace prior to July 2012. Id.
In Oracle Corp. v. Parallel Networks, LLC, C.A. No. 06-414-SLR (D. Del. Apr. 29, 2011), Judge Robinson recently issued an amended memorandum order denying both parties' motions for summary judgment. After finding that several genuine issues of material fact compelled the denial of Parallel's motion for partial summary judgment of literal infringement, the court found that "Parallel has proffered sufficient circumstantial and direct evidence [of direct infringement by Oracle customers] to withstand summary judgment as to . . . the issue of induced infringement." Id. at 28-29. This evidence included a presentation at an Oracle conference and a best practices document, both of which allegedly instructed Oracle customers "'how to use the Accused Oracle Products in an infringing manner'" and "'freely and openly strongly encourage[d] them to do so.'" Id. Judge Robinson further denied Oracle's motion as to contributory infringement, rejecting Oracle's argument that it had adequately demonstrated "that each of its accused products have significant noninfringing uses[.]" Id. In denying Oracle's motion, Judge Robinson stated that "[a] reasonable jury could find that the accused products do not meet the definition of a staple article of commerce." Id. at 29.