By Scott A. McKeown
| June 22, 2016

High Court Upholds BRI & Appeal Bar for AIA Trial Proceedings


In Cuozzo Speed Technologies, LLC v. Lee, the Supreme Court  unanimously upheld the use of the broadest reasonable interpretation (BRI) of patent claims in AIA trial proceedings, and, upheld (6-2)  the appeal bar for AIA trial institution decisions.  While many simply assumed that the High Court would not have granted certiorari absent an interest in reversing the Federal Circuit, my take all along was that this was just a "kick of the tires" on a BRI issue the Court had not had occasion to address previously.  As I, and the rest of the patent world, have beaten the BRI topic to death, let's move onto the second issue as this one is more than a bit murky going forward.  

To my eyes, the second issue was less predictable.  That is, did the appeal bar of 35 U.S.C. § 314(d) bar all appeals, or just interlocutory appeals of institution decisions? The High Court upheld the appeal bar, but in the process may have called into question the reviewability of a patent's CBM eligibility as held by the Federal Circuit in Versata Development Group v. SAP America, Inc.

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By Scott A. McKeown
| June 20, 2016

HUMIRA® Subject to Additional IPRs

Guest Post by Tia Fenton & Jeff McIntyre

As discussed previously, biosimilar applicants can gain significant strategic advantage by availing themselves of Patent Trial & Appeal Board (PTAB) patent challenge mechanisms. Last week, the Board agreed to consider two additional patentability disputes over AbbVie’s HUMIRA® drug (IPR2016-00188 and IPR2016-00189).
 
In the new ‘188 and ‘189 IPRs, Coherus challenged the patentability of AbbVie’s U.S. Patent Nos. 9,017,680 (“the ‘680 patent) and 9,073,987 (“the ‘987 patent”), respectively.  The ‘680 and ‘987 patents are two of a series of patents covering various aspects of AbbVie’s HUMIRA® drug.  HUMIRA®, one of the top selling drugs in the world, is used to treat numerous autoimmune diseases including rheumatoid arthritis. Coherus announced its plans to file an application to market a biosimilar version of HUMIRA® in the second half of 2016 and filing IPRs against HUMIRA® patents is part of Coherus’s strategy for entering the market.
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By Scott A. McKeown
| June 16, 2016

Instituted Grounds Can be Supported with New Evidence Not Present in Petition/Institution Decision


Within the past week, the Court of Appeals for the Federal Circuit (CAFC) has issued two significant opinions on AIA trial practice—both of which explain the critical import of the Administrative Procedure Act (APA). As discussed earlier this week, 5 U.S.C. § 554(b)(3) prevents the Patent Trial & Appeal Board (PTAB) from introducing new claim interpretation theories without notice, or opportunity to respond in SAS Institute Inc., v. ComplemenSoft LLC. On the heels of that decision comes perhaps an even more significant decision in Genzyme Therapeutic Products LP v. BioMarin Pharmaceutical Inc.

In Genzyme, the Court dispelled a widely held belief held by many practitioners and PTAB judges alike.  Namely, that an AIA trial petition must function as a storehouse for all possible evidence and arguments.  In a plainly worded opinion the Federal Circuit found that "[t]he purpose of the trial in an inter partes review proceeding is to give the parties an opportunity to build a record by introducing evidence—not simply to weigh evidence of which the Board is already aware." (emphasis added) (here)

Simply stated, this decision is an AIA trial practice game changer.
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By Scott A. McKeown
| June 14, 2016

Pre-Suit Opinion of Counsel/PTAB Challenge Critical to Avoiding Enhanced Damages


Section 284 of the Patent Act provides that, upon a finding of patent infringement, courts “may increase the damages up to three times the amount found or assessed.” Up until this past Monday, the Federal Circuit’s en banc decision in In re Seagate Technology, LLC controlled  this determination, requiring patentees to show that an accused infringer’s actions were both objectively and subjectively reckless—both by clear and convincing evidence.

Needless to say, patentees rarely met these exacting burdens of proof.  

In most cases, accused infringers would raise ex post infringement defenses that raised “a substantial question as to the validity or non-infringement of the patent” to negate a finding of objective recklessness. In other words, even if the infringer was unaware of the colorable defense when infringement began, Seagate’s-objective prong could provide a get-out-of-jail free card if a colorable defense was later developed during trial. The ability to wait for a lawsuit was an especially cost effective tool for in-house counsel that hoped to avoid costly, proactive strategies such as procuring an opinion of counsel, or openly challenging the patent on at the PTAB.  That is, pre-suit, smoking gun evidence of infringement was readily negated by a proficient trial defense. 

The game has now changed—significantly—with the Supreme Court’s decision this week in Halo Elecs. v. Pulse Elecs (here)
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By Scott A. McKeown
| June 13, 2016

APA Precludes New Theories Absent Requisite Notice § 554(b)(3)

The Patent Trial & Appeal Board (PTAB) will often change its construction of a disputed claim term over the course of an AIA patent trial proceeding. What was less clear, however, was whether or not the Board had the authority to advance an entirely new claim construction of its own—of  a term not in dispute—for the first time, at final decision. This practice, occurring with increasing frequency as of late, was addressed last Friday by the Federal Circuit.

This decision will have significant impact on both PTAB trial and appeal practice going forward.

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