Here is this month’s update on activity in cases pending before panels of the Federal Circuit where the cases involve at least one amicus brief. We keep track of these patent cases in the “Other Cases” section of our blog. Today, with respect to these cases we highlight one disposition, one new case, two recent oral arguments, and one upcoming oral argument.
This past month the Federal Circuit issued one opinion in a takings case that attracted amicus briefs.
As we explained in our opinion summary, this case addressed the issue of whether a taking occurred because a Notice of Interim Trail Use (NITU) amounted to a government-authorized physical occupation of the underlying property. The Federal Circuit affirmed the lower court’s decision that a taking had occurred, ruling in favor of Caquelin. Check out the case page to see all of our coverage of this case, including our argument preview and argument recap.
Since our last update, we highlight one new patent case that has attracted two amicus briefs.
In its opening brief, Amarin Pharma, Inc. appeals the district court’s judgment, arguing it “suffers from fundamental errors.” Amarin suggests that “the district court fell into the trap of hindsight—dismissing powerful objective evidence of non-obviousness because the court had already decided the claims were obvious.” Amarin further contends that the decision should be reversed because “the end result of the district court’s analysis was an obviousness judgment that effectively ruled that ordinary artisans had a reasonable expectation of producing that which had never been achieved before Amarin’s inventions.”
Aimed Alliance filed an amicus brief in support of Amarin. The brief argues that “[e]nsuring that patients are able to access safe and effective medicines is one of the cornerstones of federal drug patent law” and that “[b]y invalidating Amarin’s patents, the district court’s order threatens that access.” The brief argues that the lower court’s “decision will undermine the incentives that Congress created for companies to invest in developing innovative medications for patients in need.”
Biotechnology Innovation Organization (BIO) also filed an amicus brief. While it supports neither party, it argues that, “[s]ince the Supreme Court’s decision in Graham v. John Deere, [the Federal Circuit’s] obviousness analysis has evolved into two dueling frameworks for evaluating obviousness.” As a result, BIO says “there is a need for clarity in the law.”
There is activity to report in two patent cases.
This case concerns enablement regarding antibody claims in patent cases. In its opening brief, Amgen Inc. challenged “[w]hether the district court erred in holding that any reasonable juror was required to find that Sanofi-Regeneron established non-enablement by clear-and-convincing evidence.” An amicus brief was previously filed in support of Amgen by Bristol-Myers Squibb Company and Merck Sharp & Dohme Corp.
In its response brief, Sanofi argued that, “[a]s a matter of law, Amgen’s patents were not enabled . . . . [and that] [t]he undisputed evidence established that making and using the full scope of Amgen’s functional genus claims requires undue experimentation.” Sanofi goes on to further contend that Amgen’s “patents do not describe species representative of the claimed functional genus” and, thus, “lack adequate written descriptions as a matter of law.”
Pfizer, in its amicus brief, argues that Amgen’s claims have not met the enablement requirement. Pfizer goes on to point out that, “[i]f patentees are permitted to claim antibodies in a purely functional manner, as Amgen did in this case, such antibodies may nevertheless be captured by patents that fail to teach others how to arrive at such optimized antibodies.”
Eli Lilly argues in its amicus brief that Amgen’s claims lack “enablement and make clear that, until such time as this wholly unpredictable field becomes predictable, purely functional antibody claims, like Amgen’s, that preempt the use of biological targets in antibody research and development and thereby limit treatment options available to patients and the doctors who treat them.” Lilly contends that Amgen’s claims “violate the very tenets at the foundation of the U.S. Patent system.”
This case concerns the issue of personal jurisdiction in patent cases. Since we last reported on this case, Trimble has filed its reply brief. In it, Trimble argues that “if, as the district court assumed, Red Wing Shoe adopted a bright-line rule granting patent owners a constitutional privilege to threaten residents of other forums with patent infringement and a corresponding constitutional immunity from being sued where the recipients of those threats reside, then Red Wing Shoe was wrong and should now be overturned.” It goes on to argue that, “if, as PerDiemCo argues, Red Wing Shoe did not adopt such a bright-line rule, then the district court was wrong in applying such a bright-line rule.” “Either way,” it contends, “the dismissal of Appellants’ declaratory-judgment action should be reversed.”
New Supplemental Briefing
There is new supplemental briefing to report in the following cases:
- Sanford Health Plan v. United States: A joint supplemental brief for appellees was filed addressing the Supreme Court’s April 27, 2020 decision in Maine Community Health Options v. United States.
- Hardy v. United States: The government, defendant-appellees, filed a response to Hardy’s submission of supplemental authority that addressed the Federal Circuit’s May 29, 2020 decision in Caquelin v. United States.
Since our last report, the Federal Circuit has heard oral argument in two related cases that attracted amicus briefs.
In Takeda Pharmaceuticals U.S.A. v. Mylan Pharmaceuticals Inc. and Takeda Pharmaceuticals U.S.A. v. Alkem Laboratories Limited, the court heard arguments about breach of contract and patent infringement claims regarding the production of generic versions of Takeda’s patented product by two different alleged infringers, Mylan and Alkem. See our argument recap for more details.
Upcoming Oral Argument
Next month, one case that attracted an amicus brief will be argued.
In this case, Amgen Inc. presents the following issues:
- “Whether the Court should vacate the district court’s judgment of noninfringement by Watson and direct entry of the consent judgment necessary to effectuate the parties’ agreement to settle, because: a. It is ‘just under the circumstances,’ 28 U.S.C. § 2106, to vacate and remand when, during an at-risk generic launch and ongoing multi-party litigation, Watson admitted infringement, and both parties need vacatur and entry of a consent judgment to dispense with their claims and thus premised their agreement on that outcome; or b. the district court, in its denial of Amgen and Watson’s motion for an indicative ruling, committed several errors and applied the wrong legal standards for determining circumstances warranting vacatur.”
- “If the Court does not vacate in light of the parties’ agreement, whether the judgment of non-infringement should also be vacated because: a. the ruling on the doctrine of equivalents failed to apply the proper legal standard, and credited immaterial distinctions between Watson’s accused ANDA products and claimed elements, when the equivalents analysis ‘should not be the prisoner of a rigid formula,’ Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1579 (Fed. Cir. 1984); and b. Amgen’s trial presentation was belatedly upended by an erroneous construction of independent claim 1 that violates this Court’s Markush group and claim construction case law.”
We will provide our argument preview next week.