Jordan M. Engelhardt, Counsel

The fight over proposed Enbrel^® (etanercept) biosimilar Erelzi^® continues. Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (“Sandoz”) recently filed a petition for certiorari requesting review of the judgement of the Federal Circuit on whether:

The last two years saw the launch of several biosimilars.  Looking ahead to 2021, several others may be on the horizon.  In 2019-2020, the FDA approved thirteen biosimilars directed to seven reference products.  Eight of the approved biosimilars have launched, while five are either embroiled in litigation or awaiting agreed-upon launch dates. 

Last week, Mylan filed a brief in opposition to Valeant’s petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402. In November, a Federal Circuit panel held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”  Valeant contends that rehearing is necessary because the panel’s decision conflicts with precedent regarding “what the act of infringement is” and “where the act of infringement occurs” under Section 271(e)(2) of the Patent Act.  By contrast, Mylan contends that the petition for rehearing should be denied because the “panel correctly applied black-letter rules of statutory interpretation” in reaching its decision, and the precedents identified by Valeant are derived from “far-afield cases and ignore the governing venue precedents.” Dkt. 89 at 7-15.

Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s decision limiting venue in Hatch-Waxman cases conflicts with precedent regarding “what the act of infringement is” and “where the act of infringement occurs” under Section 271(e)(2) of the Patent Act.  Dkt. 75 at 15, 20.  In its panel decision, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated."

On November 5, 2020, in Valeant Pharms. N. Am. LLC  v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”  Slip op. at 3.  If the ruling stands, it will restrict venue available against domestic generic drug makers in ANDA cases, and may similarly impact venue in litigation under the Biologics Price Competition and Innovation Act (“BPCIA”).

On October 6, FDA issued updated guidance for industry concerning “Emergency Use Authorization for Vaccines to Prevent COVID-19,” updating the previous guidance issued in June.  The updated guidance, which is being “implemented immediately” and “without prior public comment,” is intended “to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA . . . for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency."

September 17, 2020 Update: The Trump administration is currently considering accelerating the approval of an experimental Covid-19 vaccine being developed by Oxford University and AstraZeneca.  In line with FDA’s June 2020 guidance on the development and licensure of Covid-19 vaccines, it appears that the administration is considering granting Emergency Use Authorization (EUA) for the vaccine.  However, Michael Caputo, a spokesperson for the U.S. Department of Health and Human Services, which includes FDA, has dismissed the idea that an EUA for the vaccine would issue before November 2020.  Phase 3 clinical trials for the vaccine were paused earlier this month after a participant became seriously ill, but have since resumed in the United Kingdom.  The vaccine is currently one of three in Phase 3 clinical trials.  See below for more information on EUA and FDA’s other tools for expediting the review and approval of promising Covid-19 biologic treatments or vaccines.

Earlier this month, in Immunex Corp. v. Sandoz Inc., the Federal Circuit upheld two patents covering Enbrel’s active protein and a process used to manufacture the drug, effectively blocking Sandoz’s Enbrel® biosimilar Erelzi from the U.S. market until 2029 and providing a major victory for Amgen.[1]  Enbrel is the brand name for the molecule etanercept, which is used to treat rheumatoid arthritis and several other inflammatory conditions.  A blockbuster drug, last year Enbrel generated over $5.2 billion in sales for Amgen, representing 22% of the company’s revenue.

At the end of 2017, inter partes review (IPR) proceedings for biosimilar products were on the rise.  This was followed by a dip in the number of new filings in FY 2018 and the first half of 2019.  Through Q1 2020, this downward trend has continued.  Specifically, there has been one new biosimilar IPR filing in the nine-month period from the beginning of Q3 2019 through the end of Q1 2020, leading to a total of 102 total biosimilar patent IPRs.  See Fresenius Kabi USA, LLC et al. v. Amgen, Inc. et al., IPR2020-00314 (December 20, 2019).

Last week, the U.S. Food and Drug Administration (“FDA”) issued a final rule to amend its regulation that defines the term “biological product” in line with the definition set by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), as amended by the Further Consolidated Appropriations Act, 2020, enacted on December 20, 2019 (“FCA Act”). 

Last week, Mylan and Biocon announced the U.S. launch of Ogivri™ (trasuzumab-dkst), a biosimilar to Herceptin® (trasuzumab).  Genentech’s Herceptin, which was first approved in 1998, is a monoclonal antibody used to treat breast cancer and metastatic stomach cancer.

Earlier this week, the Federal Circuit declined to further extend the patent term of an antibody patent held by the Mayo Foundation.  In Mayo Foundation v. Iancu, the court held that the time spent on a request for continued examination (“RCE”) following a declaration of interference did not count toward the three-year application pendency period for purposes of patent term extension.  As discussed below, the Mayo decision could have implications for the terms of biologics patents issued following a request for continued examination.

In Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, the Supreme Court suggested that whether inter partes reviews (“IPRs”) apply to pre-AIA patents is an open constitutional question.  But following the Federal Circuit’s recent decision in Celgene Corp. v. Peter, it appears that retroactive IPRs are here to stay, at least for now.

Amgen Inc. v. Coherus Biosciences Inc., No. 2018-1993, Slip op. at 6 (Fed. Cir. July 29, 2019) stems from a Biologics Price Competition and Innovation Act action brought by Amgen against Coherus seeking FDA approval to market a biosimilar version of Amgen’s pegfilgrastim product Neulasta.

In Enzo Life Sciences v. Roche Molecular Systems, No. 2017-2498, 2017-2499, 2017-2545, 2017-2546, Slip op. (Fed. Cir. July 5, 2019), the Federal Circuit affirmed summary judgment of invalidity for lack of enablement of Enzo’s two patents relating to non-radioactive labeling of polynucleotides.  The decision highlights non-enablement issues that may arise with respect to broad functional claims in an unpredictable field.

On February 6, 2019, the Federal Circuit issued its latest opinion on patentable subject matter under 35 U.S.C. § 101 in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 2017-2508, slip. Op. (Fed. Cir. Feb. 6, 2019).  Judge Lourie wrote for the majority in this split decision, expressing some regret but affirming an order invalidating a diagnostic patent involving proteins.  Judge Newman dissented, voicing a concern that § 101 jurisprudence has become counterproductive to the goals of patent law.  Though unsurprising, the decision further narrows an already shrinking space for patents to diagnostic methods.  It is unclear from this decision what diagnostic methods, if any, are safe from future § 101 challenges.   

On January 7, 2019, the United States Patent and Trademark Office (USPTO) published new guidance for patent examiners intended to address concerns expressed by Federal Circuit judges, industry stakeholders, and others about the perceived lack of predictability and clarity in determining subject matter eligibility under 35 U.S.C. § 101.  See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019).  The guidance, which is intended for use by USPTO personnel in evaluating subject matter eligibility, “revises the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas).”  Id.  This new guidance represents an attempt by the USPTO to address “the legal uncertainty surrounding Section 101,” recognizing that “[m]any stakeholders, judges, inventors, and practitioners across the spectrum have argued that something needs to be done to increase clarity and consistency in how Section 101 is currently applied.”  Id.

Two cases decided by the Federal Circuit in 2018, Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, en banc rehearing denied, 890 F.3d 1354 and Berkheimer v. HP Inc., 881 F.3d 1360, en banc rehearing denied, 890 F.3d 1369, address what qualifies as patent-eligible subject matter under 35 U.S.C. § 101 and how courts should resolve that question.  These cases expose divisions within the court on § 101 issues, however, and leave uncertainty in their wake.  Many stakeholders, including judges, are therefore calling for guidance from the Supreme Court as to how to resolve such issues or seeking the aid of Congress.

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal a PTAB decision upholding the validity of BMS’s patent relating to a formulation of Orencia® (abatacept) in an IPR brought by Momenta before having filed a biosimilar marketing application.  The Federal Circuit is expected to decide whether a petitioner must have filed a marketing application in order to have Article III standing to appeal from an unfavorable PTAB decision.  As months have passed without a decision, Momenta and BMS have both used the time to further press their case. 

The Supreme Court of the US handed patent owners a significant victory in WesternGeco v ION  by overturning the Federal Circuit’s bright-line rule prohibiting recovery of lost profits accrued overseas as a result of domestic patent infringement under § 271(f)(2) of the Patent Act.§ 271(f)(2) prohibits supplying components of a patented invention from the US with the intent that they be combined abroad.

To continue reading Irena Royzman and Jordan Engelhardt's article from Intellectual Property Magazine, please click here.

Allergan’s attempt to shield its Restasis patents from inter partes review by assigning the patents to the Saint Regis Mohawk Tribe was rejected last week by a unanimous Federal Circuit panel.  The Federal Circuit affirmed the PTAB’s February 2018 decision holding that tribal sovereign immunity does not bar IPRs.

Analytical studies to demonstrate that a biosimilar is highly similar to its reference product are central to the biosimilar development and approval process.  For this reason, there have been calls from industry for more guidance from FDA on its expectations for evaluating and demonstrating analytical similarity.

Two recent Federal Circuit decisions address when a party has standing to challenge the validity of a patent. Though the cases arose in different contexts, they both center on the question of what it means for a party to be facing an imminent and cognizable injury. In Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., 17-1487, the Federal Circuit upheld a party’s standing to appeal from a post-grant review where it was at risk of an infringement suit. In AIDS Healthcare Foundation v. Gilead Sciences, Inc. et al., 16-2475,[1] however, the court reached the opposite conclusion and determined that the immediacy requirement to bring a declaratory judgment action was not met for a party that had an interest in purchasing generic drugs, but did not itself produce them.

Last week, the Supreme Court upheld the constitutionality of inter partes review (IPR), as expected by most observers.  However, it was the Court’s decision in a second IPR-related case that will have an immediate impact on patent practitioners.  In SAS Institute Inc. v. Iancu, the Supreme Court, in a 5-4 decision, held that the PTO’s practice of “partial review”—instituting an IPR on some but not all claims challenged in a petition for IPR—is inconsistent with the text of the AIA.  The decision will lead to immediate consequences, not the least of which is a major increase in the number of claims tried before the PTAB.