Latest 5 Cases This Week: Amgen Inc. v. Sanofi, Aventisub LLC (Fed. Cir.), Chudik v. Hirshfeld (Fed. Cir.), cxLoyalty, Inc. v. Maritz Holdings ...

Why the Biden Administration Was Right Earlier This Week to Change Course in the Obamacare Challenge Pending Before the Court

VIKRAM DAVID AMAR

Illinois Law Dean Vikram David Amar comments on an unusual move by the U.S. Solicitor General’s office, sending a letter to the U.S. Supreme Court amending the position of the federal government in a case currently pending before the Court challenging the Affordable Care Act. Dean Amar explains why the arrival of a new administration should generally not trigger such position reversals, but he argues that the unusual circumstances—specifically the “exceptional implausibility” of the government’s prior filings—may justify the government’s action in this instance.

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Amgen Inc. v. Sanofi, Aventisub LLC

Court: US Court of Appeals for the Federal Circuit

Docket: 20-1074

Opinion Date: February 11, 2021

Judge: Alan David Lourie

Areas of Law: Drugs & Biotech, Intellectual Property, Patents

Elevated LDL cholesterol is linked to heart disease. LDL receptors remove LDL cholesterol from the bloodstream; the PCSK9 enzyme regulates LDL receptor degradation. Amgen’s 165 and 741 patents describe antibodies that purportedly bind to the PCSK9 protein and lower LDL levels by blocking PCSK9 from binding to LDL receptors. Amgen sued Sanofi, alleging infringement of multiple patents, including the 165 and 741 patents. Amgen and Sanofi stipulated to infringement of selected claims and tried issues of validity to a jury. The court granted judgment as a matter of law (JMOL) of nonobviousness and of no willful infringement. Following remand, a jury again found that Sanofi failed to prove that the asserted claims were invalid for lack of written description and enablement. The district court granted Sanofi’s Motion for JMOL for lack of enablement and denied the motion for lack of written description. The Federal Circuit affirmed. Undue experimentation would be required to practice the full scope of these claims, which encompasses millions of candidates claimed with respect to multiple specific functions. It would be necessary to first generate and then screen each candidate antibody to determine whether it meets the double-function claim limitations.

Chudik v. Hirshfeld

Court: US Court of Appeals for the Federal Circuit

Docket: 20-1833

Opinion Date: February 8, 2021

Judge: Richard Gary Taranto

Areas of Law: Intellectual Property, Patents

Dr. Chudik applied to the Patent and Trademark Office (PTO) for a patent on his “Guide for Shoulder Surgery” in 2006. The PTO examiner issued a second rejection in 2010. Rather than taking an appeal to the Patent Trial and Appeal Board (35 U.S.C. 134(a)), Chudik requested continued examination (section 132(b)). In 2014, the examiner again rejected his claims. Chudik appealed to the Board. Instead of filing an answer, the examiner reopened prosecution and rejected the claims as unpatentable on a different ground; that process repeated in 2016. In 2017, while Chudik’s fourth notice of appeal from an examiner rejection was pending, the examiner issued another rejection, which led to a notice of allowance after Chudik altered his claims. Chudik’s patent issued in 2018. The PTO awarded Chudik a patent term adjustment of 2,066 days (35 U.S.C. 154(b)) but rejected Chudik’s claim for an additional 655 days of “C-delay,” for the time his four notices of appeal were pending in the PTO. C-delay covers appellate review by the Board or a federal court in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability. The PTO concluded that, in light of the reopening of prosecution, the Board’s jurisdiction never attached and there was no Board or reviewing court reversal. The district court and Federal Circuit affirmed. C-delay for “appellate review” requires a reversal by the Board or a court.

cxLoyalty, Inc. v. Maritz Holdings Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 20-1307

Opinion Date: February 8, 2021

Judge: Sharon Prost

Areas of Law: Intellectual Property, Patents

Customer loyalty programs issue points that customers can redeem for goods and services. Maritz’s patent relates to a system and method for permitting a customer to redeem loyalty points without human intervention. A graphical user interface provides allows the participant to communicate with a web-based vendor system, such as an airline reservation system. An application programming interface interfaces with the GUI and the vendor system to facilitate information transfer between them. cxLoyalty petitioned for a covered business method (CBM) review of claims 1–15 of the patent. The Patent Trial and Appeal Board concluded that original claims 1–15 are ineligible for patenting under 35 U.S.C. 101 but that proposed substitute claims 16–23 are patent-eligible. cxLoyalty appealed as to the substitute claims; Maritz cross-appealed both the determination that the patent is eligible for CBM review and the ruling as to the original claims. The Federal Circuit dismissed Maritz’s challenge to CBM eligibility and held that both the original and substitute claims are directed to patent-ineligible subject matter. The threshold determination that a patent qualifies for CBM review is non-appealable under 35 U.S.C. 324(e). Representative claim 1 is directed to transfers of information relating to a longstanding commercial practice and is directed to an abstract idea. The claims amount to nothing more than applying an abstract idea using techniques that are, individually or as an ordered combination, well-understood, routine, and conventional.

Infinity Computer Products, Inc. v. Oki Data Americas, Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 20-1189

Opinion Date: February 10, 2021

Judge: Sharon Prost

Areas of Law: Intellectual Property, Patents

The Infinity patents share a specification and involve using a fax machine as a printer or scanner for a personal computer. The indefiniteness issues revolve around the connection between the fax machine and the computer, termed a “passive link.” In a suit alleging that Oki infringed the patents, the district court found the patent claims indefinite. The Federal Circuit affirmed. Infinity has taken materially inconsistent positions regarding the extent of the claimed “passive link”— specifically, whether it ends at the I/O bus inside the computer or merely at the computer’s port; the endpoint of “passive link” is not reasonably certain and the term is indefinite. Because there is no reasonable certainty about where the “passive link” ends, there also cannot be reasonable certainty about where the “computer” begins.

Mojave Desert Holdings, LLC v. Crocs, Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 20-1167

Opinion Date: February 11, 2021

Judge: Timothy B. Dyk

Areas of Law: Bankruptcy, Government & Administrative Law, Intellectual Property, Patents

Crocs's Design Patent 789, titled “Footwear,” has a single claim for the “ornamental design for footwear.” Crocs sued Dawgs for infringement, Dawgs sought inter partes reexamination (IPE) under 35 U.S.C. 311. The district court stayed its proceedings. The examiner rejected the claim as anticipated, 35 U.S.C. 102(b). While an appeal to the Patent Trial and Appeal Board was pending, Dawgs filed for Chapter 11 bankruptcy. The bankruptcy court approved the sale of all of its assets to a new entity, Holdings, “not free and clear of any Claims Crocs . . . may hold for patent infringement occurring post-Closing Date by any person ... or any defenses Crocs may have in respect of any litigation claims that are sold.” The bankruptcy court authorized the distribution of the net sale proceeds and dismissed Dawgs’s bankruptcy case. Holdings assigned all rights, including explicitly the claims asserted by Dawgs in the infringement action and the IPE, to Mojave. Dawgs dissolved but continued to exist for limited purposes, including “prosecuting and defending suits" and "claims of any kind.” The Board declined to change the real-party-in-interest from the IPE requestor to Mojave, then reversed the examiner’s rejection of the patent’s claim. The Federal Circuit granted the motion to substitute. The assignments indicate that Mojave is Dawgs's successor-in-interest; as such, Mojave has standing. If the Board precludes substitution on the basis of a transfer in interest because of a late filing, it would defeat the important interest in having the proper party before the Board.