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PTAB Reverses Course, Institutes Review Of Herceptin Patent

The Patent Trial and Appeal Board, in a rare move, has reconsidered an earlier decision and agreed to institute America Invents Act review of a Genentech Inc. patent covering the mega-blockbuster breast cancer drug Herceptin in a challenge from Hospira Inc.

In a decision Thursday, the PTAB said Hospira, which is part of Pfizer Inc., had shown a reasonable likelihood it would succeed on arguments that each of the patent’s claims are invalid because they would have been obvious.

The decision is a reversal for the board, which in July denied Hospira’s request for inter partes review after finding the drugmaker wasn’t likely to be successful in its challenge. Seeking a rehearing, Hospira contended the board misinterpreted part of the patent.

“After reconsidering the current record, we find petitioner’s argument persuasive,” the PTAB wrote, finding Hospira “has offered sufficient evidence to institute an inter partes review.

Such reversals from the PTAB are uncommon; by most accounts the success rate on motions for reconsideration is in the low single digits. An attorney for Hospira declined comment and counsel for Genentech could not immediately be reached.

Herceptin, which treats breast and gastric cancers, is among the world’s best-selling drugs, earning $6.5 billion globally in 2015. Earlier this year, Mylan NV announced it secured a licensing deal that will allow it to sell a copycat version of the drug, known as a biosimilar.

Pfizer, which is also developing a biosimilar to Herceptin, has challenged several of the drug’s patents through its Hospira unit. In a series of decisions in July, the PTAB agreed to institute review of three of those patents, finding Hospira had shown claims in each were likely invalid.

The reconsideration decision dealt with a fourth patent that the board declined to review that month based on Hospira’s challenge. The PTAB did, however, later agree to institute review of the patent in a separate case that was brought by Celltrion Inc.

In the Hospira ruling, the PTAB said certain of the drugmaker’s arguments were previously considered by a patent examiner. Other arguments, it said, were not likely to succeed in showing the patent is invalid. The reconsideration decision focused on the latter arguments.

Hospira argued in its request for a rehearing that there were inconsistencies in Genentech’s interpretations of a key term. The version adopted by the PTAB, it said, imported a requirement that is contrary to the position Genentech took during prosecution of the patent.

“If the decision would lead to illogical and unfair consequences resonating well beyond the confines of this case, permitting patent owners to monopolize what was already indisputably known and practiced in the prior art, while relying on inconsistent interpretations of the claims to secure priority,” it wrote in an August filing.

The PTAB said it found Hospira’s argument regarding the term “persuasive.” And on second look, it said the drugmaker had provided sufficient evidence to institute trial.

A final decision on patentability has not been made. The board noted Genentech presented evidence on various secondary considerations, including the “enormous commercial success” of Herceptin, which it argues establishes the patent is not obvious.

The PTAB said Hospira has not yet had a chance to respond to those arguments so it would be best to let trial proceed before weighing that evidence.

The patent at issue is U.S. Patent Number 7,846,441.

Hospira is represented by Amanda Hollis, Ben Lasky, Stefan Miller, Karen Younkins and Mark McLennan of Kirkland & Ellis LLP.

Genentech is represented by David L. Cavanaugh, Owen K. Allen, Robert J. Gunther Jr., Lisa J. Pirozzolo, Kevin S. Prussia and Andrew Danford of WilmerHale and Adam R. Brausa and Daralyn J. Durie of Durie Tangri LLP.

The case is Hospira Inc. v. Genentech Inc., case number IPR2017-00731, at the Patent Trial and Appeal Board.