Abstract
The chapter summarizes the pertinent provisions of the Biologics Price Competition and Innovation Act (“the Act”) that relate to patent issues, including the so-called patent dance, the two waves of litigation, and due to its significance to biosimilar practice, inter partes review.
The chapter first examines the statutory framework of the Act that governs the contemplated exchange of confidential-information between the sponsor and biosimilar applicant resulting in the list of patents to be litigated—the infamous patent dance. It also discusses the two distinct waves of litigation that the Act envisioned, and the 180-day notice of commercialization that triggers the second wave. Also provided are suggestions for both sponsors and applicants on preparing for litigation under the Act. The chapter then reviews the leading cases that have addressed the workings of the Act including the information exchange process, the patent dance, discovery, and remedies. Significantly, the Supreme Court ruled that information exchange and patent dance provisions are optional, and the 180-day notice of commercialization can be given at any time after FDA filing. Certain ramifications of the decision are explored in the cases discussed. The chapter concludes with a discussion of Hatch-Waxman safe harbor, which is applicable to biologics/biosimilars and unchanged under the Act, and inter partes review, which will continue to play a significant role in biosimilars’ attempts to avoid district court litigation for their proposed products.
Brian Coggio is of Counsel and Ron Vogel and Tasha Francis are associates with Fish & Richardson P.C. The opinions expressed herein are those of the authors and do not necessarily reflect the views of the firm or its clients.
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Notes
- 1.
- 2.
For a comprehensive discussion of the background of the BPCIA, see Carver et al. (2010).
- 3.
“Considerations in Demonstrating Interchangeability with a Reference Product,” issued by CDER and CBER (January 2017).
- 4.
“Nonproprietary Naming of Biological Products,” issued by CDER and CBER (Aug. 2017).
- 5.
See Coggio and Vogel (2016).
- 6.
See Amgen Inc. v. Hospira, Inc., 866 F.3d 1355 (Fed. Cir. 2017).
- 7.
Amgen Inc. v. Apotex Inc., 2017 U.S. Dist. LEXIS 13919 (S.D. Fla. Jan. 31, 2017) aff'd, 712 Fed. Appx. 985 (Fed. Cir. 2017).
- 8.
See generally, Vogel and Coggio (2016).
- 9.
Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005).
- 10.
Momenta Pharmaceuticals Inc. v. Teva Pharmaceuticals, Inc., 809 F.3d 610 (Fed. Cir. 2015).
- 11.
Shire LLC v. Amneal Pharmaceuticals LLC, 802 F.3d 1301 (Fed. Cir. 2015).
- 12.
Amgen Inc. v. Hospira, Inc., 2018 WL 4080353 (D. Del. Aug. 27, 2018) ($70 million awarded for stockpiling.).
- 13.
See Coggio (2014).
- 14.
137 S. Ct. 1664 (2017).
- 15.
Id. at 1674.
- 16.
Amgen Inc. v. Sandoz Inc., 877 F.3d 1315 (Fed. Cir. 2017); see also Coggio and Vogel (2017).
- 17.
137 S.Ct. at 1675.
- 18.
Id. at 1678.
- 19.
Id. at 1675 n.2.
- 20.
2:16-CV-01118 (D.N.J. 2016).
- 21.
Amgen Inc. v. Hospira, Inc., 232 F. Supp. 3d 621 (D. Del. 2017).
- 22.
Janssen Biotech Inc. v. Celltrion Healthcare Co., 239 F. Supp. 3d 328 (D. Mass. 2017).
- 23.
Id. at 332.
- 24.
Amgen Inc. v. Hospira, Inc., 866 F.3d 1355 (Fed. Cir. 2017).
- 25.
Amgen, Inc. v. Hospira, Inc., No. 16-2179 (Fed. Cir. Aug. 12, 2016), ECF No. 16.
- 26.
866 F.3d at 1360.
- 27.
Id. at 1362.
- 28.
Id.
- 29.
Id.
- 30.
42 U.S.C. § 262(l)(2)(A).
- 31.
Id., § 262(l)(2)(B).
- 32.
See Amgen Inc. v. Sandoz Inc., No. 16–1276 (D.N.J. 2016).
- 33.
Immunex Corp. v. Sandoz Inc., No. 3:16-cv-01118 (D. N.J.).
- 34.
Sandoz, No. 3:16-cv-01118, D.I. 1 at ¶ 56.
- 35.
Id. at ¶ 57.
- 36.
Id. at ¶¶ 56–57.
- 37.
Janssen Biotech Inc. v. Celltrion Healthcare Co., 2015 WL 7078048 (D. Mass. Mar. 6, 2015).
- 38.
Id.
- 39.
Amgen Inc. v. Hospira, Inc., No. 15-839-RGA (D. Del. Aug. 5, 2016).
- 40.
Amgen, No. 15–839, D.I. 9.
- 41.
Amgen, No. 15–839, D.I. 1 at ¶¶ 51–53.
- 42.
Genentech, Inc. v. Amgen, Inc., No. 1:17-cv-00165 (D. Del. Mar. 3, 2017).
- 43.
Id., D.I. 1 at ¶ 6.
- 44.
Id.
- 45.
Id. at ¶7.
- 46.
Genentech, Inc., v. Amgen Inc., No. 1:17-cv-00165 (D. Del. Mar. 3, 2017), Doc. 16.
- 47.
Sandoz, Inc. v. Amgen Inc., 773 F.3d 1274 (Fed. Cir. 2015).
- 48.
42 U.S.C. § 262 (l)(9)(A).
- 49.
Post grant review (PGR) is less applicable to biologic patents because it is limited to “first-to-file” patent within 9 months of issue. Although PGR allows challenges under almost any statutory ground for unpatentability, including § 112, it requires a higher threshold for institution than IPRs under the “more likely than not” standard. Moreover, because the estoppel effect of PGR is very broad (extending to all statutory bases for invalidity), petitioners who wish to preserve invalidity arguments for district court may not prefer the PGR route.
- 50.
35 U.S.C. § 311(b).
- 51.
A petitioner must also identify any “real party-in-interest.” 35 U.S.C. § 315(b). A real party in interest has been defined as “a party that funds and directs and controls an IPR or PGR petition or proceeding.” Trial Practice Guide (Rule), 77 Fed. Reg. 48759-60 (Aug. 14, 2012).
- 52.
35 U.S.C. § 315(b).
- 53.
35 U.S.C. § 313.
- 54.
35 U.S.C. § 316(a).
- 55.
Expert testimony is critical to both the petition and the Patent Owner’s response. The Patent Owner can provide expert testimony to rebut a petitioner’s expert evidence before the Board makes a decision on institution. IPR institution is, in fact, a preliminary determination on the claim construction and prior art. Engaging an expert early in the process is key.
- 56.
Discovery is very specific and is typically limited to issues surrounding privity/real party in interest, secondary considerations of non-obviousness, and facts relied upon by an expert that are not readily available.
- 57.
138 S. Ct. 1348, 1359–60 (2018). It is not clear whether SAS has retroactive effect on past decisions in which the PTAB instituted and tried cases on fewer than all challenged claims or on only a subset of the grounds requested.
- 58.
PTAB, Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).
- 59.
PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018).
- 60.
83 Fed. Reg. 21,221 at 21224 (May 9, 2018).
- 61.
37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to inter partes review proceedings).
- 62.
Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).
- 63.
83 Fed. Reg. 21221 at 21222 (May 9, 2018).
- 64.
35 U.S.C. § 315(e).
- 65.
Shaw Industries Group v. Automated Creel Systems, 817 F.3d 1293, 1296, (Fed. Cir. 2016).
- 66.
Great West Casualty Co. et al. v. Intellectual Ventures II, IPR2016-01534, Paper No. 13 (PTAB Feb. 15, 2017)
- 67.
Id. at 12-13.
- 68.
Ex Parte Kobelco Research Inst., Inc., Patent Owner & Appellant, 2010–009563, 2011 WL 3793611, at *2 (Aug. 24, 2011) (citing In re Yasuhito Tanaka, 640 F.3d 1246 (Fed. Cir. 2011)).
- 69.
See, e.g., Molenda and Praseuth (2017).
- 70.
A 2016 PTAB report showed that the Board had denied 112 out of 118 motions to amend.
- 71.
In Aqua Products, Inc. v. Matal, the Federal Circuit discarded the PTAB rule that Patent Owners seeking to amend their patents in IPRs have the burden of proving that the proposed new claims are patentable. 872 F.3d 1290 (Fed. Cir. 2017). The majority held that the Petitioner challenging the validity of the patent has the burden of showing that the new claims are unpatentable. See also Bosch Automotive Serv. Sols., LLC v. Matal, 878 F.3d 1027, 1040 (Fed. Cir. 2017), as amended on reh’g in part (Mar. 15, 2018) (“the petitioner bears the burden of proving that the proposed amended claims are unpatentable by a preponderance of the evidence”). The PTO issued guidance on motions to amend in view of Aqua Products stating that if a Patent Owner files a motion to amend that meets the requirements of 35 U.S.C. §~316(d) (i.e., proposes a reasonable number of substitute claims, and the substitute claims do not enlarge scope of the original claims of the patent or introduce new matter), the Board will proceed to determine whether the substitute claims are unpatentable by a preponderance of the evidence based on the entirety of the record, including any opposition made by the Petitioner. See, PTO (2017). Practitioners note that the impact of these changes is unclear because most proposed amended claims have been rejected because the Board has found they are not distinguished from the prior art, and it not clear that shifting the burden of persuasion on petitioners will change that (especially when the burden of coming forward with evidence remains with the Patent Owner).
References
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Coggio BD, Vogel R. Has Amgen already won its BPCIA dispute with Sandoz. IP Law360. 2017 Aug 2.
John Molenda, Richard Praseuth. Current trends in biologics-related inter partes reviews. IP Law360. 2017 July 20.
PTO. Guidance on motions to amend in view of aqua products. Alexandria, VA: USPTO; 2017.
Vogel R, Coggio BD. Safe harbor in the United States and Europe. Pharm Law Ind Rep. 2016;14(47).
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Coggio, B.D., Vogel, R., Francis, T. (2018). Litigation-Related Issues Under the Biologics Price Competition and Innovation Act. In: Gutka, H., Yang, H., Kakar, S. (eds) Biosimilars. AAPS Advances in the Pharmaceutical Sciences Series, vol 34. Springer, Cham. https://doi.org/10.1007/978-3-319-99680-6_4
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