Decision: Sanofi-Aventis U.S., LLC et al. v. Immunex Corp., IPR2017-01884 and IPR2017-01879 (P.T.A.B. Feb. 14, 2019) (HULSE, Moore, Obermann); see also denial of institution in Sanofi-Aventis U.S., LLC et al. v. Immunex Corp., IPR2017-01129 (P.T.A.B. October 14, 2017) (HULSE, Moore, Obermann)

Background: Sanofi and Immunex are currently involved in district court litigation on U.S. Pat. No. 8,679,487 in the Central District of California (2-17-cv-02613, complaint filed April 5, 2017). In March 2017, Sanofi filed an IPR petition to the same patent in IPR2017-01129. In July 2017, Sanofi filed two additional IPR petitions against the ’487 patent, IPR2017-01884 and IPR2017-01879. The first petition was denied in October 2017 because the asserted reference was held not to qualify as prior art against the ’487 patent.

Independent Claim 1 of the ’487 patent reads: An isolated human antibody that competes with a reference antibody for binding to human IL-4 interleukin-4 (IL-4) receptor, wherein the light chain of said reference antibody comprises the amino acid sequence of SEQ ID NO:10 and the heavy chain of said reference antibody comprises the amino acid sequence of SEQ ID NO:12.

In IPR2017-01129, Sanofi alleged that claim 1 was anticipated by a U.S. patent publication (“the Pub”), supported by two expert declarations. The parties disputed whether the Pub was prior art under 35 U.S.C. § 102(e). That question turned on whether, under 35 U.S.C. §120, the ’487 patent was entitled to a priority date earlier than the Pub’s publication date. The PTAB held that Sanofi did not establish a reasonable likelihood of showing lack of entitlement to the relevant priority date. Notably, the Office had concluded during prosecution of the ’487 patent that the claims were entitled to the challenged priority date. The PTAB found the Petition deficient because of (1) its failure to even address the Office’s prior determination of priority, (2) it presented an ambiguous position as to whether 35 U.S.C. § 112(6) applied to the construction of “antibody”, and (3) the Petitioner’s expert failed to consider the full scope of the disclosure regarding the issues of written description and enablement. Hence, PTAB denied the Petition.

IPR2017-01879 was instituted on one anticipation ground. Sanofi asserted that the ’487 patent was anticipated by US 2002/0002132 (the ’132 publication) under 35 U.S.C. §102(e).

The PTAB held that Petitioner failed to establish anticipation by a preponderance of the evidence. The ’132 publication was not “by another,” and therefore did not qualify as a prior art reference against the ’487 patent. Significantly, even though the ’132 publication listed a different inventive entity from that of the ’487 patent, the “portions of the ’132 Publication relied upon for anticipation represent[ed] the work of the ’487 patent inventors.”

The PTAB agreed with the patent owner that the Petitioner solely relied on mAb6-2 for anticipation ─a point also admitted by Petitioner’s counsel during the oral hearing. The ’132 publication disclosure of how to make, screen, and test the antibody in question, mAb 6-2, was the work of named inventors of the ’487 patent.

Petitioner’s allegation was based on the activity of another person not named on the ’487 patent. But, PTAB concluded he was “a technician for carrying out [] instructions, and not a joint inventor.”

The Patent Owner submitted a declaration of the named inventor in the ’132 publication, asserting that the Petitioner’s asserted person was NOT the inventor of mAb 6-2. As corroborating evidence, the Patent Owner additionally submitted declarations of two persons as well as minutes of meetings.

In a decision dealing with fascinating issues of burden of proof and burden of production, the PTAB concluded that Patent Owner had satisfied its burden of production to show that the ’132 publication was not §102(e) prior art. It was then the turn of Petitioner to carry its burden of rebutting the Patent Owner and showing that the ’132 publication was §102(e) prior art.

Petitioner unsuccessfully argued that the Patent Owner’s declarations were conclusory and lacked corroboration. Petitioner also unsuccessfully argued that the Patent Owner’s declarants contradicted each other and their sworn declarations.

The issue of corroboration was hotly contested. The PTAB credited the Patent Owner expert’s testimony supporting the argument that Petitioner’s asserted person was “a pair of hands for [the inventors’] thoughts.”

For all these reasons, PTAB found, in its Final Written Decision, no anticipation of the claims of the ’487 patent.

Thus, we see that in the first two IPRs, Petitioner failed on its unpatentability arguments. But the third time was the proverbial charm for Petitioner. In particular, IPR2017-01884 was instituted on two obviousness grounds: 1) Hart and Schering-Plough; and 2) Hart, Schering-Plough, and Hoogenboom.

Issue: In IPR2017-01884, were claims 1-17 of the ’487 patent unpatentable as obvious in light of 1) Hart and Schering-Plough; and 2) Hart, Schering-Plough, and Hoogenboom?

Outcome: PTAB issued a Final Written Decision Finding all claims Unpatentable under Ground 1.

The parties disputed the claim construction of the claim limitation, “human antibody.” Petitioner argued for a broad scope covering both partially human and fully human antibodies. Patent Owner argued that the term should be limited to only fully human antibodies. The PTAB, adopting the broader construction, concluded that the specification, “repeatedly teaches that the antibodies of the invention include both ‘partially human’ and ‘fully human’ monoclonal antibodies.” The prosecution history supported the broader construction. Noting that this construction was different than that adopted by the district court, PTAB justified its result because it “reach[ed] a different conclusion…based on the broader applicable case law here.”

In this case, the broader claim construction was key to the obviousness holding. It led the PTAB to reject the Patent Owner’s arguments against Petitioner’s expert testimony because those objections were based on the narrower claim construction.

The PTAB found that the asserted references contained all of the claim limitations. It then agreed with the Petitioner that the prior art provided a motivation to combine: a POSITA “would have had a reason to combine Hart and Schering-Plough because it was well known in the art that the ultimate goal of humanization is to decrease the immunogenicity of a non-human antibody while still maintaining its antigen binding specificity and affinity.” A POSITA would have been motivated to combine the references to “derive a less immunogenic version of MAb230 that could be used as a potential therapeutic.” Since humanization techniques were well known in the art, a POSITA would have had a reasonable expectation of success in combining the references.

The PTAB rejected Patent Owner’s arguments that the prior art did not provide a motivation to modify. The mere existence of alternative motivations does not “teach away.” “The law ‘does not require that the motivation be the best option, only that it be a suitable option from which the prior art did not teach away.’” (emphasis in original). Even some evidence of potential negative outcomes or side effects does not automatically mean a reference “teaches away.”

In this case, the PTAB found that the prior art taught the claim limitations, provided the motivation to modify and identified a small number of options (10). The method of preparation was within the skill of a POSITA, and there was a support for the conclusion that a POSITA would have had a reasonable expectation of success.

Interestingly, the Patent Owner submitted a declaration from one said to be “an expert on U.S. patent practice and procedure.” Whether the testimony was admissible or not, the PTAB gave it little weight as the testimony did not address portions of the specification and prosecution history relied on by the PTAB.

Prosecution Takeaways:

Any attack on a §102(e) rejection is to be addressed carefully. The goal is to ascertain what the Office is relying on in the rejection and whether those teachings are of another.

For “teaching away” in an obviousness analysis, there must be more than just multiple suggestions or even a suggestion of possible negative outcomes. Motivation does not have to be the best option; it must simply be a suitable option. So, in attacking motivation, the prosecutor should develop why the motivation expounded by the Examiner is not suitable.

In addition, we are reminded that the “expectation of success” required is only “reasonable;” it is not a standard of absolute certainty.

Patent Owners may want to consider a couple of things. First, if possible, separately argue the specific limitations of the dependent claims. This may be worth doing if later, broad claims fall, but narrower claims may be salvaged. Second, separately present any objective evidence of nonobviousness. Again, depending on the facts and circumstances, Patent Owners may want to submit such evidence to establish patentability, exercising care, of course, not to cherry pick data or otherwise mislead the USPTO.