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.
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.
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.
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.
Last week, the Supreme Court heard oral arguments in Oil States Energy Services v. Greene’s Energy Group—a case that addresses whether inter partes review unconstitutionally usurps the federal courts’ authority to adjudicate the validity of patents. An examination of the Justices’ questions provides hints of how they are thinking and suggests that IPRs may survive constitutional review.
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