Federal Circuit Says: Mind the “Plainly Obvious” Gap

Posted by Ed Walsh on Mar 27, 2018

Ed Walsh

In DSS Technology Management v. Apple, the Federal Circuit reversed a holding of unpatentability of claims that the PTAB considered plainly obvious in an IPR. The Federal Circuit found that merely stating that the claims were obvious did not fill a gap in the case of obviousness, such that the PTAB had failed to provide a sufficient explanation for its conclusion. The Federal Circuit then reversed the finding of obviousness (rather than remanding for the PTAB to elaborate), reasoning that there was insufficient evidence in the record to enable the PTAB to offer an adequate explanation—leaving the claims intact.

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Is Live Testimony a Dead Issue at the PTAB?

Posted by Austin Steelman on Mar 19, 2018

Austin Steelman

A recent PTAB decision highlights the difficulty of persuading the Board to allow live testimony from an expert during post-grant proceedings. In IPR2017-00433, the PTAB denied patent owner Polaris Industries Inc.’s motion for the live testimony of an expert, even as it acknowledged that his credibility was at issue.

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Topics: Experts

In IPR Petitions, Paste Makes Waste

Posted by Tom Chlebeck on Feb 26, 2018

Tom Chlebeck

The PTAB recently signaled a warning to petitioners about the dangers of third party submissions made during patent prosecution—even during prosecution of a separate but related patent. For patent holders, this warning serves as an opportunity to protect their patents in similar situations. In PGR2017-00038, Live Nation Entertainment, Inc. filed a petition to institute post-grant review of U.S. Patent No. 9,466,035. Live Nation’s arguments were that the claims were patent ineligible under 35 U.S.C. 101 and would have been obvious under 35 U.S.C. 103.

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Topics: Patent Owners, Petitioners

Discretionary Denial: Even the “Best” Prosecution Prior Art May Not Be Right for an IPR

Posted by Josh Miller on Feb 7, 2018

A pair of recent PTAB institution decisions highlights that petitioners should be cautious when relying on prior art that was cited during the prosecution of the challenged patent. Pursuant to 35 U.S.C. § 325(d), the PTAB has the discretion to deny institution if the petition relies on prior art or arguments that the examiner already addressed during patent prosecution. In two recent decisions that issued just one day apart and reached opposite conclusions, the PTAB provided some insight into circumstances that may lead to (or away from) a discretionary denial.

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PTAB Left to Mitigate the Damage from Collateral Estoppel

Posted by Nathan Speed on Jan 30, 2018

Nathan Speed

Collateral estoppel, or issue preclusion, is the legal doctrine that bars a litigant from re-litigating in subsequent litigations an issue that it lost in an earlier litigation. The doctrine had been applied in the administrative context previously, and in Maxlinear, Inc. v. CF Crespe, the Federal Circuit confirmed that it applies in IPR proceedings. In doing so, however, the court left the Board to resolve an interesting practical question as to how exactly collateral estoppel should apply on remand. Depending on how the Board resolves this practical issue, Maxlinear may provide petitioners a significant windfall as they will be able to challenge claims on the basis of prior art that they never cited to the Board. 

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Topics: IPR Estoppel

For PTAB Declarations, Better to Fly Solo

Posted by John Strand on Jan 22, 2018

John Strand

Many things in life are better done with someone else: board games, dinner parties, road trips, riding tandem bicycles. However, according to the PTAB, there’s one particular area where it’s best to fly solo: two people should not provide one declaration in an IPR. In CSL Behring GMBH v. Shire Viropharma Inc. (IPR2017-01512), the PTAB denied institution in large part because the petitioner submitted a joint declaration to support that one of its references was a printed publication.

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Topics: Printed Publications

Proving Them Wrong: FDA Skepticism Helps Save Patent Claims

Posted by Phil Hamzik on Jan 17, 2018

Phil Hamzik

Evidence of skepticism of others in an IPR can be used to support the patentability of claims in response to obviousness challenges—skepticism is a standard “objective indicia” or secondary consideration of nonobviousness. In a recent series of IPRs filed by several generic drug makers against Eli Lilly & Co. (IPR2016-00318, IPR2016-00237 and IPR2016-00240), Eli Lilly bolstered its case for nonobviousness by pointing to the skepticism of the U.S. Food & Drug Administration (FDA) concerning its patented method. The PTAB’s decision illustrates that while skepticism by some may be helpful to patent owners, skepticism by the right people may be critical.

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Topics: BioPharma, Obviousness

One Missing Link Can Break an Obviousness Argument

Posted by Jillian Parker on Jan 15, 2018

Jillian Parker

IPRs are often filed to challenge important patents – the same patents likely to be tested in litigation. In such circumstances, parties should pay careful attention when asserting arguments in the IPR that were addressed in the litigation. Several generic drug makers faced this circumstance in relation to obviousness arguments made in a series of IPRs against Eli Lilly & Co. (IPR2016-00318, IPR2016-00237 and IPR2016-00240), in which similar arguments made in a co-pending appeal before the Federal Circuit were found to be lacking. While the PTAB is not required to agree with courts on all issues, particularly in view of the fact that the standards of review between the two venues are different, these IPRs illustrate that petitioners and patent owners would be wise to carefully address what courts have said about the arguments at issue.

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Topics: BioPharma, Obviousness

Tipping the Scales in IPR with Effective Expert Testimony

Posted by William Zhang on Jan 10, 2018

William Zhang

Expert testimony is a feature of most IPRs, and effective expert testimony can make or break a party’s position. When evaluating expert testimony, the PTAB may consider several issues. First, are the expert’s qualifications sufficient? Second, even if the expert does not technically qualify as a “person of ordinary skill in the art,” should the expert’s testimony be given weight? The PTAB’s decision in Lupin Ltd. v. Horizon Therapeutics, Inc. (IPR2016-00829) addresses these questions and illustrates several ways to effectively use expert testimony.

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Topics: BioPharma, Experts

PTAB Says Yes to (Pro)Drugs

Posted by Jessica Chao on Dec 18, 2017

Jessica Chao

Prodrugs are inactive compounds designed to be converted into pharmaceutically active metabolites following delivery to a patient. Prodrugs have important pharmacokinetic advantages over traditional compounds, and a recent PTAB decision, Lupin Limited v. Vertex Pharmaceuticals Inc. (IPR2016-00558), illustrates how prodrugs can possess patent advantages as well. In its analysis of obviousness, the PTAB focuses on unpredictable results and whether a person of ordinary skill in the art has a reasonable expectation of success in view of the available art, as outlined in Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009), frequently applied in pharmaceutical cases.

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Topics: BioPharma, Obviousness

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This blog is intended to promote thought and debate on developing areas of the law. The opinions, commentary and characterizations of cases provided on this blog are not legal advice and do not represent the opinions of Wolf Greenfield or its clients.