As we discussed in May, PTAB decisions are a primary source for guidance regarding what constitutes a “printed publication” under § 102, because the PTAB faces the issue so frequently. Since that post, the PTAB has continued to define the scope of what is or is not a printed publication. In most instances, where the issue was contested, the PTAB found the petitioner failed to prove a document was a printed publication.
Topics: Printed Publications
Last week, the U.S. Supreme Court heard oral arguments in two patent cases concerning IPRs. The first case (Oil States Energy Services v. Greene’s Energy Group) has garnered much of the attention because it concerns the constitutionality of IPRs, but the second case (SAS Institute Inc. v. Matal) may actually have a bigger impact on how IPRs work. In SAS, the Supreme Court considered the PTAB’s practice of selecting which challenged claims it reviews, rather than, once it institutes a trial, issuing a final decision on the patentability of all claims challenged in the petition. The oral arguments suggest how the Justices are approaching the case.
IPR is a common way to challenge patents covering pharmaceutical compounds, often on grounds of obviousness. As illustrated in the recent decision in in Mylan Pharmaceuticals Inc. v. AstraZeneca (IPR2015-01340), such IPRs may rely on a “lead compound analysis” involving a two-prong inquiry that asks: (i) whether a structurally similar prior art compound would have been selected as a “lead compound” and (ii) whether there was motivation to modify that compound to arrive at the claimed compound.
When challenging a patent through IPR, petitioners may be tempted to offer an improved version of an argument that had been offered by the examiner during prosecution, using similar prior art but shoring up potential shortcomings of what came before. However, three decisions that the Board recently designated as “informative” illustrate that a petitioner that isn’t careful when reusing arguments may not be successful.
Topics: Prior Art
A Native American tribe’s recent deal to obtain several pharmaceutical patents and seek dismissal of pending IPRs on the basis of sovereign immunity has piqued the public’s interest in sovereign immunity to IPR. The same tribe also recently asserted several other patents against Microsoft and Amazon, and may assert sovereign immunity from IPR there too. Prompted by the tribe’s actions, a subcommittee of the House Judiciary Committee held a hearing on what Congress can and should do about it. Although much of the hearing focused on what many perceive as the problem of tribal sovereign immunity in IPR—not the use of sovereign immunity to IPR by state universities—many of the proposed reforms would also target state universities. Whether any of these reforms will be enacted remains to be seen, but there are reasons to doubt their constitutionality.
Topics: Sovereign immunity
It is not uncommon in the biotechnology and pharmaceutical fields to file new patent applications based on results of a clinical trial or discovery of a newly appreciated feature of a compound. However, results-based claim language, such as pharmacokinetic or drug release profiles, may not confer patentable weight, as shown in a recent IPR decision.
No matter whether you are the patent owner or petitioner in an IPR, expert witness testimony is an important aspect of building your case. The Board relies on expert witnesses to provide insight into the often highly technical aspects of a given case, and will inevitably choose to give more weight to the testimony of one side’s witness over the other. This can be especially true when the testimony of the opposing experts is in direct conflict. So how does the Board choose which expert testimony to give more weight? Sometimes it’s a question of timing, as in the recent decision in Mylan Pharmaceuticals Inc. v. AstraZeneca (IPR2015-01340).
To many patent owners in IPR, the prospect of a patent-saving claim amendment is all but illusory. The Board grants few motions to amend, which is one reason that few patent owners even request amendment. That may change with the Federal Circuit’s en banc decision in Aqua Products, Inc. v. Matal, which eased the patent owner’s burden of justifying an amendment, and increased the petitioner’s burden of opposing an amendment. This change affects not only the procedure of IPRs, which must now take into account the shifted burden, but also the strategy of IPRs.
Topics: Patent Owners
Parties accused of patent infringement often turn to IPRs to invalidate the asserted patents, and winning in an IPR can mean relief from whatever remedy would be imposed as a consequence of a finding of infringement. That strategy came under examination in a recent decision from the International Trade Commission (ITC), which declined to get rid of an exclusion order (i.e., an injunction) even after the PTAB found the infringed claims unpatentable. That does not mean, however, that the party found to infringe is without options.
Attorneys handling an IPR should never be neglectful, of course, but the director of the US Patent and Trademark Office (USPTO) recognizes that neglect in some circumstances is excusable. In a recent IPR, the USPTO determined that the patent owner’s late filed appeal was “excusable neglect”—i.e., not good, but not so bad that the patent owner should lose the right to appeal. Rather than inviting anyone to disregard deadlines, this case is a reminder for attorneys to avoid problems by communicating clearly with clients and co-counsel.
Topics: Patent Owners