In Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., Appeals 2020-2073, -2142 (Fed. Cir. Nov. 24, 2021), the Federal Circuit affirmed a Patent Trial and Appeal Board’s final decision canceling claims in Indivior’s patent claiming a polymer matrix-containing film. Certain claims in the patent recited an amount of polymer matrix inadequately disclosed, according to the Board, in a predecessor application to which the patent claimed priority. As a result, the claims’ effective filing date was so late that prior art published between the patent’s actual filing date and its earliest claimed priority date rendered the claims unpatentable. Here the prior art was none other than the Patent Office’s publication of one of the claimed priority applications.
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Estoppel Remains Malleable
A few months ago, in BTG International Ltd. v. Amneal Pharmaceuticals LLC, the Federal Circuit invited the Patent Office’s views on the scope of the petitioner estoppel under 35 U.S.C. § 315(e)(2). We noted then that this is an estoppel a district court may apply, but the Patent Office may not. In response to the court’s invitation, the Patent Office said that a court may apply this statutory estoppel not only to petitioners who lose an IPR, but also to those who prevail. The Office conceded that estopping prevailing IPR petitioners “leads to the counterintuitive result that a district court would not be able to consider invalidity arguments that the Board found persuasive.” But the Office said that this will have no practical effect in most cases.
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When is There Standing to Appeal a PGR Final Written Decision?
In Altaire Pharm., Inc. v. Paragon Biotek, Inc., Case No. 2017-1487 (Fed. Cir. May 2, 2018), the Federal Circuit reversed in part a PGR final written decision that upheld the patentability of challenged claims, and determined that a risk of a future lawsuit for patent infringement may be sufficient to establish Article III standing for the appeal.
Under Supreme Court precedent, Article III standing requires: (1) a concrete and particularized injury, (2) caused by the challenged conduct, (3) which can be redressed by a judicial decision. Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (2016). Ironically, a party that has not been charged with infringement may have sufficient standing to file a petition with the PTAB, but lack standing to appeal the PTAB’s final decision to an Article III court.
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PTAB Grants Hospira Petition to Institute IPR of Genentech Antibody Purification Patent
IPRs are an attractive option for biosimilar applicants to clear the patent landscape before delving into litigation under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which is still in its infancy. Roche’s Herceptin® (trastuzumab) is a prime target for biosimilar makers, accounting for sales of over $6.5 billion in 2015. Mylan, Celltrion, and Pfizer, all with competing biosimilar candidates, have filed IPR petitions challenging patents reportedly covering trastuzumab. Recently, the PTAB granted a petition filed by Hospira (subsidiary of Pfizer) to institute IPR of U.S. Patent No 7,807,799 (“the ’799 patent”), directed to protein A affinity chromatography. Hospira, Inc. v. Genentech, Inc., IPR2016-01837, Paper No. 19 (April 7, 2017).
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Pending Bill Would Deliver More Judicial Scrutiny to USPTO and FDA Rules
The House of Representatives recently sent to the Senate its bill (H.R.5) that combines six previous regulatory reform bills, including, as Title II of the bill, the “Separation of Powers Restoration Act.” Section 202 of the bill effectively removes the option for courts to apply Chevron deference to agency rulemaking and interpretations. Thus, rather than deciding whether a regulation is permissible as reasonably related to the purposes of the enabling legislation, by amending 5 U.S.C. § 706, the bill will require a reviewing court to “decide de novo all relevant questions of law, including the interpretation of constitutional and statutory provisions, and rules made by agencies.” To eliminate any doubt about its intent, the amendment specifically states that the court shall not interpret any gap or ambiguity in a statue or regulatory provision as an implicit delegation of legislative rulemaking authority to an agency, and the court shall not defer to an agency’s interpretation on a question of law. As a result, rather than simply deciding whether an agency’s construction of silent or ambiguous statutory provisions are permissible as a matter of statutory interpretation, the reviewing court must make its own, independent interpretation. The change in the statute would mean that prior court approvals of agency rules, applying Chevron deference, will not dictate the outcome of future challenges under the doctrine of stare decisis.
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Another VIMOVO® Patent Survives Challenge by Coalition for Affordable Drugs – Updating the CFAD Scorecard
In the spirit of “if at first you don’t succeed, try, try again,” the Coalition for Affordable Drugs (CFAD) challenged a fourth Orange Book-listed patent relating to VIVOMO®, Horizon Pharma’s naproxen/ esomeprazole product. While denying CFAD’s previous three petitions, the PTAB instituted inter partes review for U.S. Patent No. 8,945,621. Despite CFAD’s success at the institute phase, the PTAB ultimately determined in its Final Written Decision that the Petitioner did not meet its burden in proving the unpatentability of the challenged claims.
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Purdue Not Estopped From Raising Invalidity Contentions at Trial That Were Submitted But Not Instituted During IPR
Recently, the Federal District Court for the District of New Jersey allowed Purdue Pharma to assert invalidity arguments in the litigation that were previously submitted in an IPR petition, but upon which IPR review was not instituted. See Depomed Inc. v Purdue Pharma LP, Civil Action 13-571, Order (D.N.J. Nov. 4, 2016). The Court rejected the patent owner’s arguments that Section 315(e) of Title 35 estopped Purdue from raising these argument.
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PTAB Cancels Gattax® Patent Claims in Coalition for Affordable Drugs IPRs
In two final written decisions (IPR2015-01093 and IPR2015-00990), the PTAB found that challenged claims in Shire’s U.S. Patent No. 7,056,886 (the ’886 patent) were invalid as obvious. The decisions highlight potential issues related to patents directed to pharmaceutical formulations that petitioners and patent owners alike may want to consider if confronted with an IPR related to such subject matter.
The Coalition for Affordable Drugs filed two petitions for IPR, one challenging claims 1−45 of U.S. Patent No. 7,056,886 (IPR2015-01093) and one challenging claims 46−52 and 61−75 of the ’886 patent (IPR2015-00990).
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Petitioner Avoids One-Year Time Bar by Acquiring ANDAs after Filing IPR Petition
A PTAB decision denying a patent owner’s motion for discovery concerning privity illustrates what may be a carefully-structured business transaction that permitted a petitioner to avoid the effect of the one-year time-bar for filing a petition under 35 U.S.C. § 315(b).
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“Providing . . . information” Step Given No Patentable Weight
The PTAB recently addressed the limits on strategies to patent drug labeling, canceling claims directed to a method of supplying a pharmaceutical product where the method includes a step of providing certain “information” to the medical provider. According to the PTAB, the claimed step of providing the information is entitled to no patentable weight under the “printed matter” doctrine where it is not functionally related to other elements of the claimed method. Specifically, even if the claim says that the information is “sufficient to” cause some effect (e.g., for a medical provider to avoid treating a patient) there is no functional relationship with the claim if the claim doesn’t recite that effect. Praxair Distribution Inc. v. Mallinckrodt Hospital Prods. IP Ltd., IPR2015-00529.
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