Source: https://www.biosimilardevelopment.com/doc/the-doctrine-of-equivalents-a-major-barrier-for-the-marketability-of-biosimilars-0001
Timestamp: 2019-04-21 14:38:48+00:00

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Biosimilars are especially vulnerable to an attack under what is known as the doctrine of equivalents (DOE). DOE basically allows someone to sue for infringing on the general spirit of the patent more so than on its actual claims. The criteria for DOE centers around whether the infringer’s product does substantially the same thing in a similar manner…almost the exact criteria the biosimilar must establish for FDA approval as “biosimilar.” This was one of Congress’ many tragic oversights when crafting the Biosimilars Price Competition & Innovation Act (BPCIA). However, although this may seem like the perfect means to combat biosimilar compounds, as it uses the biosimilars’ own evidence of safety and efficacy against them, it has been used with mixed results.
The doctrine of equivalents has become the primary weapon of choice for biosimilar lawsuits so far. Understanding this doctrine is critical, as it drives the decision to wait until the patents expire on a biologic before marketing a biosimilar. The doctrine became binding upon all courts in 1950 when the Supreme Court held in Graver Tank & Mfg. Co. v. Linde Air Prod. Co. that an infringer will be liable if the alleged infringer’s invention “performs substantially the same function in substantially the same way to obtain the same result.”6 Basically, this gets to the spirit of patent protection, where if an infringer is trying to design around a claim with minor changes to accomplish the same task, it’s still infringement.
Do Biologics/Biosimilars Face Different Standards In Patent Litigation?
The courts have generally rejected imposing a higher standard for biologics to meet the literal infringement or DOE threshold, such as creating additional criteria for an infringement claim or permitting only the use of case law related to biotechnology in litigation. For example, in Regents of Univ. of California v. Dako N. Am., Inc., the court held that imposing a different standard would undermine the policy behind protecting pioneering inventions.10 This is not favorable to the holder of a biosimilar application, as it welcomes use of any patent case law for infringement, rather than expecting biotech-related litigation to be more persuasive. This means a biosimilar manufacturer may have to defend against binding or highly persuasive precedents that may have predated the existence of its technology, such as Graver Tank & Mfg. Co. v. Linde Air Prod. Co., which is not favorable to the alleged infringer.6 However, the Supreme Court opened Pandora’s box regarding DOE in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., with this line roughly seven years prior to the passage of the BPCIA: “Congress can legislate the doctrine of equivalents out of existence any time it chooses.”11 This means Congress, through amendments to the BPCIA or new legislation, could choose to pass legislation that would shield biosimilars and prevent them from having to wait until the expiration of numerous patents before being able to be safely commercialized.
In Novartis Pharm. Corp. v. Abbott Labs., the court reached a decision that could be favorable for biosimilar owners seeking to defend themselves in litigation related to DOE.12 It held that substituting one feature for another in a way that places it outside of a claims scope could shield it from DOE infringement.12 In this case, it was using a different substance not listed in Novartis’ claims to accomplish something similar, while the other compound and quantity were not listed in the claims.12 Thus, the court felt DOE was not a sustainable cause of action because doing so would increase the patent claims scope, something strictly forbidden by the policy underlying the public disclosure component of patents.12 A biosimilar by its very composition presents an issue for a sponsor biologic to challenge it under DOE, as it’s not likely to have the same molecular structure.13 Therefore, biosimilars are likely to have plenty of defenses to a DOE claim, especially given some of the more recent case law.
The doctrine of equivalents will not outright block biosimilars despite the numerous efforts of sponsor biologics to weaponize it. Further, courts have typically found case law surrounding generic drugs to be persuasive, as they see a parallel between them and biosimilars. This is critical because although there is very little case law addressing biosimilars, there is a great deal of case law on generic drugs. Allowing biosimilar manufacturers to draw from precedents in generic drug disputes produces a critical asset to ensuring biosimilar success. Further, courts tend to be very deferential to biosimilars because of their potential to increase patient access to affordable healthcare.
Epstein, Eckstrom's Licensing in Foreign & Domestic Operations, November 2017 Updated ed., (2017).
Larami Corp., v. Amron, No. CIV. A. 91-6145, 1995 WL 128022, at *1 (E.D. Pa. Mar. 23, 1995), aff'd, 91 F.3d 166 (Fed. Cir. 1996).
Sanofi-Aventis Deutschland GmbH v. Genentech, Inc., 473 F. App'x 885, 890 (Fed. Cir. 2012).
Tate Access Floors, Inc. v. Interface Architectural Res., Inc., 279 F.3d 1357, 1360 (Fed. Cir. 2002).
Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1345 (Fed. Cir. 2003).
Graver Tank & Mfg. Co. v. Linde Air Prod. Co., 339 U.S. 605 (1950).
Michael P. Dougherty, The New Follow-on-Biologics Law: A Section by Section Analysis of the Patent Litigation Provisions in the Biologics Price Competition and Innovation Act of 2009, 65 Food & Drug L.J. 231, 234 (2010).
Arkells N. Why Biosimilar Companies Should Pay More Attention to U.S. State Governments. Life Science Connect: Biosimilar Development & Bioprocess. PA. 2018.
Arkells N, Chopra A, Chopra I. Biosimilar Regulatory Policies Issues and Implications: Where Are We Headed? 23rd Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research, Baltimore, MD, United States, 2018.
Regents of Univ. of California v. Dako N. Am., Inc., No. C 05-03955 MHP, 2009 WL 1083446, at *11 (N.D. Cal. Apr. 22, 2009).
Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 122 (S. Ct. 1831, 152 L. Ed. 2d 944 (2002)).
Novartis Pharm. Corp. v. Abbott Labs., 375 F.3d 1328, 1339 (Fed. Cir. 2004).
Martha Rumore & Randy Vogenberg, Biosimilars: Still not Quite Ready for Prime Time, Pharmacy & Therapeutics, June 2016, DOI: PMC4894513.
Joyce Lee, Janssen Drops U.S. Lawsuit against Samsung Bioepis' Remicade copy, Reuters: U.S. Legal News, (Nov. 14, 2017), http://www.reuters.com/article/us-johnson-johnson-samsung-bioepis-lawsu/janssen-drops-u-s-lawsuit-against-samsung-bioepis-remicade-copy-idUSKBN1DE10R.
Nicolas Arkells is the CEO at Manticore Consulting Group, a global health economics and outcomes consulting firm. He has over 15 years of leadership experience ensuring organizational commitment to statistical analysis and implementation. His law and science juris doctorate concentrated on intellectual property, which encouraged his research in biotechnology, market access, policy, and patent law. His MBA focused on the application of analytics to provide solutions to real-world problems in the healthcare industry. He is certified in medical devices and pharmaceuticals by the Regulatory Affairs Professionals Society, Lean Six Sigma black belt trained in the healthcare industry, agile certified as a PSM and PSPO, and certified in global human capital through Columbia University. He has been recognized for excellence in legal research, leadership, alternative dispute resolution and as a US biosimilar policy expert. You can reach him via email or connect with him on LinkedIn.

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