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Fed. Circ. Backs Sanofi, Regeneron PTAB Win Over Amgen

Reported by Ryan Davis on Law360

The Federal Circuit agreed with the Patent Trial and Appeal Board and concluded that “human antibodies” is construed broadly to include both completely and partially human antibodies. Immunex, a subsidiary of Amgen, originally sued Sanofi and Regeneron in 2017 alleging that Dupixent, a biologic drug used to treat inflammatory conditions like atopic dermatitis, infringes on one of Immunex’s patents. The patent at issue is directed to antibodies that treat inflammatory disorders and specifically describes an “isolated human antibody.” Defendants challenged the validity of Immunex’s patent in an inter partes review. The Federal Circuit agreed with the board’s finding that Immunex’s patent claims were all obvious in view of the prior art, which refers to “humanized” antibodies that are partially human and partially derived from mice. Thus, Immunex’s patent was determined to be invalid. Ryan Davis summarizes the court’s analysis.

The Federal Circuit’s opinion explained that early therapeutic antibody development used antibodies generated by mice, but they caused harmful immune reactions in humans. Antibodies were therefore developed that were either fully human or “humanized,” mostly human with some nonhuman components.

Using a canine analogy, the court concluded that the use of the words “human antibodies” in the written description of Immunex’s patent is a “broad category encompassing both partially and completely human antibodies.”

‘[B]rown dogs’ plainly include ‘partially brown’ dogs, such as a mostly brown dog with a white spot.

Patent Reviews in ‘Limbo’ As Supreme Court Takes Case on Judges

Reported by Ian Lopez on BloombergLaw.com

While the U.S. Supreme Court reviews the Federal Circuit’s decision in Arthrex, Inc. v. Smith & Nephew, Inc., hundreds of cases lie in limbo. The decision made administrative patent judges (APJ’s) inferior officers under the U.S. Appointments Clause, in order to avoid the problem that the APJ’s had been unconstitutionally appointed. The Federal Circuit vacated a PTAB decision and sent it back for a redo with new, “now constitutionally appointed judges.” In fact, the court has remanded over a hundred PTAB cases. Ian Lopez explains the importance of Supreme Court review.

If the Supreme Court agrees with the Federal Circuit, dozens of patent cases will have to be reheard by the PTAB. But if the justices believe severance didn’t fix the problem, then much more of the patent office’s work could be cast into doubt, potentially placing the ball in Congress’ court to fix the tribunal.

Professors and scholars have also expressed their views, with many of them calling on lawmakers to make a clear statement.

A congressional fix could be “as easy as a line” in the America Invents Act, which created the PTAB, “saying the director should have unilateral discretion to review all PTAB decisions,” Duke law professor Arti Rai said.

Lopez points out that the legal implications of the Supreme Court’s decision will reach beyond the patent sector. The distinction between principal and inferior officers is important in many areas of the law and the Supreme Court has often expressed its interest in realizing the practical effects of such a distinction.

For more on this case, see our coverage.

Fed. Circ. Denies Appeal Of Order Backing Card IP Under Alice

Reported by Britain Eakin on Law360

Without elaborating on its reasons why, the Federal Circuit on Wednesday issued a two-page order rejecting an interlocutory appeal in the case AlexSam, Inc. v. HealthEquity, Inc. AlexSam, Inc. initially brought a suit against HealthEquity in June 2019 in a Utah federal court. AlexSam alleged that HealthEquity’s debit card, health account debit card and reimbursement account card products infringe on its patent. HealthEquity moved to dismiss the case, arguing that AlexSam’s patent was invalid under Alice. Although the district court judge expressed that this was a close case, he ultimately held that AlexSam’s patent on a card that can be used as a debit card, a loyalty card, and a gift card all at once was not directed to an abstract idea. Britain Eakin illustrates the nature of case:

Judge Nielson noted in his opinion that the case involved difficult and close questions. While he determined the claims were directed to the abstract idea of “accessing databases to facilitate various kinds of transactions,” he said they “could also be fairly characterized as being directed to ‘improving the process for accessing databases to facilitate various kinds of transactions.'”