About once a month we provide an update on activity in patent 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. There we also highlight non-patent cases that attract amicus briefs, but only once those cases have been scheduled for oral argument. Today, with respect to these cases we highlight three dispositions, four recent oral arguments, and one upcoming oral argument.
This past month the Federal Circuit issued three opinions in cases that attracted amicus briefs: two in patent cases and one in a trade case.
As we previously explained, this case addressed the issue of “what, if any, deference should be afforded to decisions of a Patent Trial and Appeal Board Precedential Opinion Panel (‘POP’).” The case also addressed whether the joinder and consolidation provisions of the America Invents Act (35 U.S.C § 315(c) & (d)) allowed for so-called same party joinder.
Addressing the latter question first, the panel “conclude[d] that the clear and unambiguous language of § 315(c) does not authorize same-party joinder, and also does not authorize joinder of new issues, including issues that would otherwise be time-barred.” In this respect, the panel reversed the Board, which had “permitted [Facebook] to join its otherwise time-barred IPR proceedings to instituted IPR proceedings where it was already a party.”
In reaching its holding, the Federal Circuit panel also considered what deference they should afford to the Board’s holding. Ultimately, the panel concluded that the PTO’s interpretation of § 315(c) would not receive Chevron deference because “the clear and unambiguous language of § 315(c) does not authorize same-party joinder or joinder of new issues.”
Notably, in a concurring opinion, all three judges on the panel (Prost, Plager, and O’Malley) highlighted that, “[b]ecause the opinion concludes that § 315(c) is unambiguous, the majority [opinion] does not address the question of what, if any, deference is owed to the PTO’s interpretation of § 315(c) by the Board’s Precedential Opinion Panel.” The judges wrote separately to “address what our alternative holding would be if § 315(c) were deemed ambiguous.” They concluded that, “were the statute ambiguous, [they] would alternatively resolve this matter in the same way.” In particular, they “would find that no deference is due to the POP opinion in Proppant and that the most reasonable reading of § 315(c) is the one [they] adopt in [their] majority opinion.”
In this case the panel affirmed the lower court’s holding via Federal Circuit Rule 36. The lower court held that the claims at issue were unpatentable subject matter under 35 U.S.C. § 101. Check out the case page to see all of our coverage of this case, including our argument preview and argument recap.
In this case the Federal Circuit held that the Trump administration’s tariffs on imported steel did not violate the nondelegation doctrine. Check out the case page to see all of our coverage of this case, including an argument preview and argument recap.
Since our last update, we highlight two new patent cases that have attracted amicus briefs.
In their opening brief, Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. (collectively, “Amgen”) challenge “[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.” Amgen argues that its “patents provide [persons of ordinary skill] a wealth of enabling information.” Further, Amgen contends that the enabling disclosure, when compared with the disclosure at issue in another case, is clearly sufficient.
Bristol-Myers Squibb Company and Merck Sharp & Dohme Corp. filed an amicus brief in support of Amgen. They similarly argue that “[t]he decision below, if allowed to stand, would make it far too difficult for pioneers of therapeutic antibodies to obtain sufficiently robust and reliable patent protection for their inventions.” Further, they argue that the correct inquiry for enablement is whether it would “require undue experimentation to obtain antibodies needed to practice the claimed invention.” They contend that the district court’s enablement standard, which questions whether iterative trial and error is necessary, goes too far and would require inventors “to reduc[e] to practice and describ[e] every single possible member of the claimed genus.”
In this case, Takeda Pharmaceuticals U.S.A. appeals the district court’s denial of its motion for a preliminary injunction. The district court held that Mylan Pharmaceuticals was entitled to launch its generic version of Takeda’s FDA-approved colchicine tablet product. The district court reached its holding in part by interpreting a license agreement between Mylan and Takeda.
Takeda argues that Section 1.2(d) of the agreement, which would allow Mylan to launch the generic version of the drug, applies only when there is “a final decision holding that all of the unexpired claims of the Patents-in-Suit that were asserted and adjudicated are either (i) ‘not infringed’ or (ii) ‘any combination of non-infringed and invalid or unenforceable.” Further, Takeda contends that the district court’s determination that previous litigation invoked Section 1.2(d) is incorrect because “not all the claims that were asserted in that case were held to be not infringed or a combination of not infringed, invalid, or unenforceable by a Final Court Decision.”
Hikma Pharmaceuticals USA, Inc. and Hikma Pharmaceuticals International Limited filed an amicus brief supporting Takeda’s position. They say the issue in this case is “whether all of the patent claims that were ‘asserted and adjudicated’ in the [previous] West-Ward Litigation were held to be not infringed, invalid, or unenforceable.” They argue that “only three out of the eight total patents ‘asserted’ were ‘adjudicated’ to be not infringed on summary judgment.” They argue that the West-Ward litigation resulted in a “Stipulation and Order to Dismiss,” which “adjudicated the dispute between Takeda and Hikma regarding the five asserted . . . patents, without reaching any holding that the asserted claims in those patents were infringed, invalid, or unenforceable.”
Mylan Pharmaceuticals, in its response brief, argues that “[t]he District Court correctly applied Delaware principles of contract interpretation in construing the License Agreement.” Mylan argues that “Takeda’s concession that the five voluntarily dismissed patents were not ‘adjudicated’ under Section 1.2(d) is both binding and dispositive.”
In its reply brief, Takeda argues that Mylan’s alleged admission in its reply “only confirms that the district court abused its discretion in denying a preliminary injunction.” Takeda contends that Section 1.2(d) should not be invoked because “Mylan does not dispute that for these five patents, which were asserted in the West-Ward Litigation, there was no ‘holding’ on the issues of noninfringement, invalidity, or unenforceability.”
This case has not yet been set for oral argument.
Since our last report, the Federal Circuit has heard oral arguments in four cases that attracted amicus briefs.
- In Biogen MA Inc. v. EMD Serono, Inc., the court heard invalidity and infringement arguments related to IFN-β-related polypeptides, which can be used to treat multiple sclerosis. See our argument recap for more detail.
- In Immunex Corp. v. Sandoz Inc., the court heard arguments addressing the issue of obviousness-type double patenting. See our argument recap for more detail.
- In Caquelin v. United States, the court heard arguments to determine whether a notice of interim trail use (NITU) “amounted to a government-authorized physical occupation of the underlying property for purposes of [a] takings analysis.” Again, see our argument recap for more detail.
- In Voip-Pal.com, Inc. v. Twitter, Inc., the court heard arguments concerning patent eligibility under §101 for claims directed to “automatically routing telephone calls and other communications in a multi-network environment using a physical controller.” See our argument recap for more.
Upcoming Oral Arguments
Next week only one case that attracted an amicus brief will be argued.
In this case, 10X Genomics presents the following issues:
- “Is Bio-Rad barred as a matter of law from asserting infringement under the doctrine of equivalents where it amended its claims to exclude the very terrain it now accuses, and were the equivalent (consisting of a fluorinated material) vitiates a claim limitation (requiring a ‘non-fluorinated’ one)?”
- “Did Bio-Rad fail to prove literal infringement as a matter of law, where another limitation of the same patent requires an ‘interface’ between two surfaces and Bio-Rad concedes those two surfaces never touch in 10x’s products?”
- “Did the district court err in construing a preamble as non-limiting, where the body of the claim references and the preamble as an antecedent, the specification repeatedly recites the limitation emphasized by the preamble, and the examiner added the language in question to the preamble?”
- “Where a damages expert relies on licenses that are not comparable to the hypothetical negotiation and fails to apportion damages to the value of the patented technology, must the damages award be vacated?”
- “Where Bio-Rad never claimed that its products competed with four of 10x’s five product lines, and its products do not meaningfully compete on the fifth, did the district court abuse its discretion in enjoining all five lines?”
Earlier this week we posted our argument preview for this case.