AbbVie, Genentech Raise New Constitutional Challenge To Inter Partes Review

Firms contend that IPR should not apply to patents filed before America Invents Act was enacted, objecting to IPR decisions invalidating Humira, Avastin and Herceptin patents.

While the US Supreme Court ruled that the inter partes review (IPR) process is constitutional, AbbVie Inc. and Genentech Inc. contend that it left the door open to challenge the retroactive application of the proceeding. They are now trying to walk through that door.

Challenging decisions by the US Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) that invalidated their patents, they argue that it is unconstitutional to retroactively apply IPR to patents that were not filed before the America Invents Act of 2011, the statute that established the IPR proceeding, was enacted.

AbbVie is appealing five final written decisions that three Humira (adalimumab) patents are unpatentable for being obvious and Genentech is appealing decisions that its Avastin (bevacizumab) and Hercpetin (trastuzumab) patents are unpatentable.

The Supreme Court held in Oil States Energy Services v. Greene's Energy Group that inter partes review is constitutional, finding that it does not violate Article III or the Seventh Amendment of the Constitution. Oil States had argued that cases to invalidate patents must be tried before a jury in an Article III forum (the courts established under Article III of the Constitution), not an agency proceeding. (Also see "Inter Partes Patent Challenges Are Constitutional, US Supreme Court Rules" - Pink Sheet, 24 Apr, 2018.)

However, the high court said it was addressing "only the precise constitutional challenges" that Oil States raised.

"Oil States does not challenge the retroactive application of inter partes review, even though that procedure was not in place when its patent issued. Nor has Oil States raised a due process challenge," the court stated.

In a May 4 brief to the US Court of Appeals for the Federal Circuit in its appeal of Humira IPR decisions, AbbVie said the Supreme Court recognized that retroactive application of IPR to patents filed before the AIA raises distinct constitutional problems.

"It is one thing for an inventor who entered the patent system by disclosing an invention after the AIA to receive a patent subject to the known possibility that it could be challenged in IPR," AbbVie stated. "It is quite another thing for an inventor who entered the patent system before the AIA to have its patents subjected to a new form of invalidation."

"An inventor pays the price for patent protection when it discloses its invention. The public cannot subsequently change the terms of the bargain, at least not when it comes to something as fundamental as eliminating the traditional role of an Article III court or eroding the safeguards provided by the presumption of validity," AbbVie stated.

Government To Defend AIA Constitutionality

AbbVie also provided a separate notice to the Federal Circuit that it had raised a constitutional challenge to the application of the AIA. In an Oct. 31 order, the court stayed the IPR appeals, certified the notice to the Attorney General, and ordered the AG to inform the court whether the United States intends to intervene in the appeals.

In September, the AG filed motions to intervene in appeals in which Genentech raised the same constitutional challenge. The AG said it was doing so "to defend the constitutionality of the Act of Congress" that Genentech challenges.

The Federal Circuit granted the AG's motions in Sept. 26 and Oct. 3 orders. The government's brief in each case is due 40 days from the filing of the court's respective order.

William Jay, a partner at Goodwin Procter, said certification is a fairly normal occurrence when the constitutionality of a statute is challenged in a case between private parties and a federal agency is not already a party.

As for the chance AbbVie and Genentech will succeed, Jay said that until the issues are briefed it's hard to forecast who is likely to prevail.

IPR Challenges

The Humira cases involve appeals of five IPRs brought by Boehringer Ingelheim GMBH and Coherus BioSciences Inc. in which PTAB found three Humira patents to be unpatentable: No. 8,889,135; No. 9,017,680; and No. 9,073,987. The appeals of the decisions have been consolidated. The unconstitutionality of the IPR process is among several arguments AbbVie has raised in its appeals.

It is unclear what, if any, benefit BI and Coherus would gain if the Federal Circuit upholds PTAB's decisions. AbbVie has more than 100 patents covering Humira, which is one of the reasons that five biosimilar makers have inked settlement and licensing agreements with AbbVie: Amgen Inc., Samsung Bioepis Co. Ltd., Mylan NV, Sandoz Inc. and Fresenius Kabi AG. The deals provide for staggered launches, with Amgen able to launch its Humira biosimilar in the US on Jan. 31, 2023, Samsung five months later, Mylan one month after Samsung and Sandoz one month after Mylan. (Also see "AbbVie's Fourth Humira Patent Settlement Allows Sandoz Biosimilar US Entry Eight Months After Amgen" - Pink Sheet, 12 Oct, 2018.)

Fresenius, the most recent to obtain a licensing agreement, can launch at the same time as Sandoz, on Sept. 30, 2023.

Genentech is challenging PTAB decisions in two IPRs brought by Hospira Inc. In a March 6 decision, the Board found that patent No. 7,807,799, which claims methods of purifying certain proteins, particularly therapeutic antibodies, is unpatentable. 

Genentech says in its appeal brief that it has used this process to manufacture each of the humanized antibodies it has developed and marketed. It specifically notes the method was used to manufacture trastuzumab.

In the second IPR final written decision, issued on Jan. 18, the Board found patent No. 7,622,115, directed to a method of using bevacizumab, to be unpatentable as obvious.