PTAB Finds DNA Sequencing Patent Claims to be Invalid

As we have previously reported, Inter Partes Review (IPR) was introduced on September 11, 2012, under provisions of the America Invents Act (AIA) as one of new several tools for challenging the validity of granted patents in the U.S. Patent & Trademark Office (USPTO). With an anticipated pendency of 18 to 24 months to final written decision upon filing of an IPR request, the USPTO’s Patent Trial and Appeal Board (PTAB) is presently proceeding to issue its first IPR decisions. Although a majority of IPR requests filed to date have been directed to patents in the electrical and computer arts, decisions are also being rendered for patents in other technology domains including the biological arts.

As recent examples relating to the biological arts, the PTAB on March 6, 2014, issued final written decisions in IPRs initiated by Illumina, Inc. to challenge three Columbia University patents:

U.S. 7,713,698 (Case IPR2012-00006, Paper 128)
U.S. 7,790,869 (Case IPR2012-00007, Paper 130)
U.S. 8,088,575 (Case IPR-2013-00011, Paper 130)

These three patents (together with two others for which IPRs were not requested) were earlier named in a corresponding patent infringement complaint brought by Columbia University against Illumina in the U.S. District Court for the District of Delaware (DED) on March 26, 2012. In its complaint, plaintiff Columbia describes the five patents (“the Ju patents”) as:

[Covering] next-generation sequencing (“NGS”) technologies that allow the rapid and precise sequencing of DNA. In particular, the Ju patents claim a type of NGS technology called “sequencing by synthesis … used in a variety of medical and research applications, including identifying genes an polymorphisms associated with disease and with individual variability on drug response …

After Illumina filed the petitions requesting IPRs for U.S. Patent Nos. 7,713,698, 7,790,869 and 8,088,575, the parties to the corresponding DED litigation stipulated on March 25, 2013, to an order by the Court “staying” further action in the litigation pending the IPRs. As stipulated, litigation was completely stayed, except for: 1) up to 80 hours of depositions per side, 2) documents responsive to existing requests for production and 3) additional interrogatories and requests for admission subject to the limits set by the Court’s scheduling order.

In each of the IPR petitions filed by Illumina, Illumina challenged fewer than the entire set of claims. We suspect that they may have chosen only those claims presenting a significant risk with respect to Columbia’s infringement claims in the DED litigation, and/or only those claims for which a strong invalidity position could be established in view of the prior art. While the PTAB instituted the IPRs on fewer than all grounds raised by Illumina, the instituted grounds proved to be sufficient for the PTAB to invalidate all claims asserted by Illumina as being obvious in accordance with 35 U.S.C. § 103(a).

In reaching its decisions, the PTAB considered evidence presented on the so called “secondary considerations of nonobviousness” as required under the test provided by Graham v. John Deere Co. of Kansas, 383 U.S. 1, 17 (1966). Patentee Columbia University proffered primarily documentary evidence and experts testimony regarding nonobviousness to show that the claimed inventions yielded: 1) unexpectedly improved properties of the claimed invention not present in the prior art, 2) praise and awards received by the claimed invention, 3) commercial success exhibited by the claimed invention, 4) evidence of copying by Illumina of claimed nucleotide analogues, 5) skepticism by others that the claimed nucleotides and methods would be successful, and 6) attempts by Illumina to license the claimed nucleotides and methods from Columbia. In each case, the PTAB found Columbia’s evidence in support of these considerations was of “insufficient weight and relevance” to be persuasive.

It will be interesting to see what transpires next. In accordance with 35 U.S.C. § 315(e), Columbia University is estopped from pursing infringement claims in the DED litigation based on any of the IPR-invalidated claims. It may therefore decide to pursue only those infringement claims that can be brought based on the remaining claims, and/or appeal the final written decisions to the U.S. Court of Appeals for the Federal Circuit in hopes of overturning the PTAB’s decisions (and the litigation estoppel and/or any binding precedent). Alternatively, the parties could move toward settlement.

We will continue to monitor and periodically report on items of significance relating to IPRs and other post-issuance procedures, with a focus on the interplay between these procedures and corresponding actions in the district courts and U.S. International Court of Trade.

Thomas J. Bean is a Director in the Gibbons Intellectual Property Department.