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April 2019: Alvogen Pine Brook LLC v. Celgene Corp

April 2019

The firm recently secured Decisions Not to Institute Review against five petitions for Inter Partes Review (“IPR”) challenging patents covering methods of using Celgene’s blockbuster drug Revlimid®.

            Revlimid® is approved to treat certain patients having three different cancerous conditions – mantle cell lymphoma (“MCL”), myelodysplastic syndromes (“MDS”), and multiple myeloma (“MM”). Three generic pharmaceutical companies seeking to make generic copies of Revlimid® joined forces to attack patents protecting each of these indications.

            Quinn Emanuel quickly identified the weaknesses in each petition and worked to exploit them in Celgene’s Patent Owner Preliminary Responses. Since the challenged patents were also involved in co-pending litigations, Quinn Emanuel had to balance positions across both forums. To achieve successful results, the firm convinced the Patent Trial and Appeal Board (“PTAB”) to focus on discrete issues that were fatal to each petition. The PTAB agreed, liberally quoting from our briefs in its decisions not to institute.

            Celgene’s MCL patent faced a dual attack: obviousness and anticipation. For obviousness, we argued that the generic challenger’s argument was strikingly similar to the challenge the patent faced during prosecution. While the generic challenger used different references than those considered during prosecution, the firm argued that those references did not present any new information. The PTAB agreed, and invoked its discretion under 35 U.S.C. § 325(d) to deny institution. For anticipation, the firm argued that the petitioner had failed to prove that an asserted reference qualified as prior art. The PTAB agreed with our all-out attack, holding that the petitioner had presented no evidence of when, where, or to whom the asserted reference was available, or how it was allegedly accessible. The same strategy was successful for the petitions filed against the MDS patents.

            For the MM petition, Quinn Emanuel crafted a Preliminary Response that invited the PTAB to focus on 9 single claim element, which we argued was missing from the prior art. This strategy—focusing on a single claim element—was not without risk, but it was a complete success. The PTAB held that none of the asserted references disclosed the claim element, and that the generic challenger could not use conclusory expert opinion and hindsight to fill the gap in the prior art. The PTAB also relied heavily on affirmative evidence that Quinn Emanuel presented, which showed that an ordinarily skilled artisan would not have arrived at the claim element, let alone the claimed inventions as a whole.

            The firm’s subject-matter expertise and our deep familiarity with the PTAB’s approach to challenges in this space allowed us to stop each attack against Celgene’s Revlimid® patents at the institution phase, with the PTAB finding that none of the five petitions warranted a full trial.