Biosimilars and The Biologics Price Competition and Innovation Act (BPCIA)

Posted on 02-21-2019


By: Michael Furrow, DLA Piper, and Whitney Meier, Venable LLP

The Biologics Price Competition and Innovation Act (BPCIA) provides an abbreviated pathway for companies to bring biologic drugs to market that are biosimilar to previously approved branded reference products by relying on clinical studies that were performed by the reference product sponsor (RPS).

THIS ARTICLE INTRODUCES BIOSIMILARS AND THE LITIGATION process set up by the BPCIA to facilitate resolution of patent disputes between RPSs and biosimilar manufacturers, and touches on related trends, such as the potential use of inter partes review proceedings by biosimilar manufacturers as an alternative to or in addition to litigation.


Four out of the five top-selling prescription drugs in 2017 were biologics. Conventional drugs, like Tylenol® (acetaminophen), Nexium® (esomeprazole magnesium), and Advair® (fluticasone propionate), generally have fully characterized chemical structures, and are assembled through a sequence of chemical reaction and purification steps. Biologics, in contrast, tend to be complex mixtures of much larger proteins, polysaccharides, or nucleic acids that may not be fully structurally characterized and are produced by biotechnology methods that can result in variation between lots. Examples include:

  • Antibodies (proteins that target (e.g., proteins expressed by cancer cells to trigger the body’s immune response)) such as Herceptin® (trastuzumab)
  • Growth factors (proteins that affect the growth of a cell) such as Regranex® (becaplermin)
  • Enzymes (proteins that speed up biochemical reactions) such as Fabrazyme® (agalsidase beta)
  • Immunomodulators (agents that affect immune response) such as Orencia® (abatacept)1

In 1984, Congress modified the Food, Drug, and Cosmetic Act and the Patent Act to permit generic manufacturers of conventional drugs to apply for marketing approval through an abbreviated process by relying on clinical studies performed by the sponsor of the reference brand name drug. It was not until March 2010 that the BPCIA created an abbreviated pathway for companies to bring biologic drugs to market that are biosimilar to previously approved branded reference products by relying on clinical studies that were performed by the RPS.

Approaching a decade later, there are now more than 10 FDAapproved biosimilars in the United States, and the Food and Drug Administration (FDA) is working to facilitate further biosimilar development and market access. The number of biosimilars is expected to increase in coming years as companies become more familiar with the legal framework and major biologics begin to lose patent protection and marketing exclusivity.

What Are Biosimilars?


Section 351(i) of the Public Health Service Act (PHS) defines a “biological product” as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.”2 Marketing of a new biologic product requires filing a biologics license application (BLA) pursuant to Section 351(a) of the PHS.3

Abbreviated Biologics License Applications: Demonstration of Biosimilarity and Interchangeability to the Reference Product

The BPCIA modified Section 351(k) of the PHS to allow for licensure of biosimilar products through an abbreviated BLA (aBLA).

A biosimilar is “highly similar to the reference product notwithstanding minor differences in clinically inactive components” and has “no clinically meaningful differences” from the reference product in terms of “safety, purity, and potency.”4 Biosimliarity is based on analytical studies; animal studies, including toxicity assessments; and a clinical study or studies, including assessments of immunogenicity and pharmacokinetics or pharmacodynamics.5 The biosimilar must have the same dosage form, strength, mechanism of action, and conditions of use as the approved reference product.6 An interchangeable is a biosimilar for which it has been further demonstrated that the proposed product is “expected to produce the same clinical result as the reference product in any given patient” and that the risk of alternating between the proposed interchangeable and the reference product “is not greater than the risk of using the reference product without such alteration or switch.”7 As the name suggests, the demonstration of interchangeability means that the FDA has concluded that it may be substituted for the reference product without consulting the prescriber.8 Whether a product may be automatically substituted, or consent must be sought from the patient or prescriber, is governed at the state level. As of mid-2018, 41 states and Puerto Rico had laws relating to substitution.9 In addition, the first interchangeable product, but not the first biosimilar, is entitled to up to one year of market exclusivity as against other interchangeable products.10

Regulatory Exclusivities

No 351(k) application for a biosimilar can be filed for four years after the date the reference product was first licensed for approval.11 Reference products also have 12 years of marketing exclusivity before approval of a biosimilar can be made effective.12 These periods of exclusivity can be extended an additional six months for pediatric exclusivity if the RPS completes FDA-requested pediatric studies within the allotted time frame, and the FDA completes its review and accepts the study report more than nine months before the original exclusivity would expire.13 Reference products may be separately entitled to a seven-year period of “orphan drug” exclusivity for an approved indication for treating a condition affecting fewer than 200,000 in the United States (or more but with no hope of recovering costs).14

Biosimilar vs. Generic Version of Conventional Drug

While biosimilars are sometimes described as generic versions of biologics, there are important differences between biosimilars and generic versions of conventional drugs. Because of the complexity and biosynthetic preparation, biosimilars are not exact copies of the reference active component and require additional testing to demonstrate similarity than for conventional generic drugs.15 As a result, biosimilars are significantly more expensive and time-consuming to develop than generic small molecule drugs.16 Marketing costs are also expected to be higher for biosimilar products, at least for those that are not granted the interchangeable stamp.

In addition, unlike for generic drugs, biosimilars have their own proprietary and non-proprietary names. The FDA has issued guidances requiring the non-proprietary name to be a combination of the core name of the reference product and a suffix of four lowercase letters that is devoid of meaning.17 In general, biologics are protected by larger patent portfolios than small molecules. These patent portfolios may include patents covering the active component itself, variations thereof, manufacturing processes, formulations, and methods of treatment. Unlike conventional drugs, for which the RPS has the opportunity to identify patents covering a product or an approved method of use by way of FDA Forms 3542/a,18 which the FDA then publishes in the FDA’s Orange Book,19 there is no equivalent listing mechanism for biologics. This can make it difficult to determine how many and what patents an RPS could potentially assert against a 351(k) applicant.

Biosimilar Litigation

The BPCIA contains a framework that contemplates various exchanges of information between the RPS and the 351(k) applicant and two rounds of patent litigation, often referred to as the patent dance. The U.S. Supreme Court confirmed that this patent dance is not required, and the 351(k) applicant can choose to opt out of the various exchanges.20 This gives the 351(k) applicant control over how and when litigation transpires.

Patent Dance: Phase I

Section 271(e)(1) of the Patent Act21 excludes from patent infringement liability certain actions taken in connection with seeking approval from the FDA to market a new drug or biologic. As discussed below, additional provisions of 35 U.S.C.S. § 271(e) set forth conditions of constructive patent infringement following submission of an aBLA. Prior to satisfaction of conditions set forth in Section 271(e), however, no case or controversy may exist supporting a declaratory judgment action.22

351(k) Applicant Provides aBLA

The first phase of litigation may be initiated when, within 20 days of the aBLA being accepted for review, the 351(k) applicant provides the aBLA to the RPS and “such other information that describes the process or processes used to manufacture” the proposed biosimilar or interchangeable.23 Disclosure of the aBLA is limited to designated outside counsel and one in-house attorney who do not engage in patent prosecution “relevant or related to the reference product.”24 If the aBLA is timely provided, neither the RPS nor the 351(k) applicant may file a declaratory judgment action until the 351(k) applicant provides notice of commercial marketing.25

RPS Provides Patent List

Within 60 days of receipt of the aBLA, the RPS provides to the 351(k) applicant a list of patents for which the RPS believes a claim of patent infringement could reasonably be asserted “if a person not licensed by the reference product sponsor engaged in the making, using, offering to sell, selling, or importing into the United States of the biological” product that is the subject of the 351(k) application as well as a list of such patents that the RPS “would be prepared to license.”26 Failure to timely list a patent by the RPS means the RPS cannot sue the 351(k) applicant on that patent under 35 U.S.C. S. § 271(e). Thus, the RPS may not be able to sue on that patent until the 351(k) applicant commercially markets.27 Given the relatively short notice, to the extent possible, the RPS should be prepared with its patent lists in advance of the four-year date on which an aBLA may be submitted. Likewise, the RPS should also include patents that could potentially be infringed; the U.S. Court of Appeals for the Federal Circuit found no Rule 11 (Fed. R. Civ. P. 11) problem listing patents for which additional discovery might be needed beyond the aBLA to determine potential infringement.28

351(k) Applicant Provides Counter-List and Detailed Statement

Within 60 days of receiving the patent lists, the 351(k) applicant “may” provide to the RPS a list of patents that the 351(k) applicant believes could be reasonably asserted by the RPS pursuant to 42 U.S.C.S. § 262(l)(3)(A), and “shall” provide (1) for each of the patents identified by the RPS and the 351(k) applicant, a detailed statement on a claim-by-claim basis of the factual and legal bases for any assertion of invalidity, unenforceability, and noninfringement; and (2) a response regarding each patent identified by the RPS for potential licensing.29 Within 60 days of receiving these materials from the 351(k) applicant, the RPS provides a detailed statement on a claim-by-claim basis of the factual and legal bases for allegations of infringement and responses to the assertions of validity and unenforceability.30 Statements in these letters may be party admissions, and therefore great care should be taken in drafting.31

The Parties Negotiate

After the exchange of patent lists and detailed statements, the parties then negotiate which patents should be the subject of immediate infringement litigation.32 If the parties cannot reach an agreement within 15 days, the 351(k) applicant tells the RPS the number of patents that the applicant will provide, and the parties subsequently exchange respective lists with that number of patents for immediate litigation.33 This gives the 351(k) applicant significant control over the scope of phase I litigation. If the 351(k) applicant lists no patents, the RPS is still permitted to list a single patent.34 Given the relatively short time frame for negotiation, both parties should be prepared as early as practicable with strategies regarding which patents to litigate at this stage.

RPS Brings Suit

Within 30 days of agreeing to a list of patents for immediate resolution or within 30 days after the exchange of lists when no agreement can be reached, the RPS shall bring an action for patent infringement with respect to each implicated patent.35 Section 271(e)(2)(C)(i) of the Patent Act makes the filing of the 351(k) application an artificial act of infringement of these patents. Phase I litigation may result in injunctive relief or damages due to any commercial manufacture, use, offer for sale, or sale within the United States not protected by the safe harbor provision of 35 U.S.C.S. § 271(e)(1).36 For example, a jury in the District of Delaware recently awarded $70 million in damages for patent infringement even though the biosimilar had not yet been approved by the FDA because the jury found the manufacture of the product was not “solely for uses reasonably related to” seeking FDA approval.37 At the time of writing, motions for judgment as a matter of law were pending. 351(k) applicants that manufacture product or store product in the United States should be ready to demonstrate a nexus to FDA approval.

Injunctive relief is granted (“the court shall order a permanent injunction”) for any patents on which the RPS is successful during phase I litigation where the reference product has time remaining in the 12-year period of market exclusivity.38 Failure to file an infringement suit within the applicable 30-day window (see above) limits a successful RPS to a reasonable royalty; no injunctive relief will be available.39

For patents that issue or are exclusively licensed after the first exchange of lists, the RPS has 30 days to provide a supplemental list with these patents to the 351(k) applicant.40 These later issued patents will be included in second phase of litigation.41

Patent Dance: Phase II

The second phase of litigation is initiated when the 351(k) applicant provides notice of intended commercial marketing, which must occur at least 180 days before marketing first occurs.42 This notice can be provided even prior to FDA approval.43 After receiving that notice, the RPS “may seek a preliminary injunction prohibiting the subsection (k) applicant from engaging in the commercial manufacture or sale of such biological product until the court decides the issue of patent validity, enforcement, and infringement” of any patent included in the lists of patents provided by the RPS and 351(k) applicant in the previous exchanges that were not the subject of phase I litigation44. Because the 351(k) applicant is not statutorily required to notify the RPS of the actual launch date, the RPS has little choice but to make best use of the 180-day window post-notice to file any infringement action and seek injunctive relief.

No Patent Dance

The 351(k) applicant is not required to provide the aBLA to the RPS, and the RPS cannot compel its production.45 If the aBLA is not provided, 35 U.S.C.S. § 271(e)(2)(c) makes the filing of the 351(k) application an artificial act of infringement “for a patent that could be identified” by the RPS in phase I of the patent dance, and 42 U.S.C.S. § 262(l)(9)(C) permits declaratory judgment claims “of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.”46 If the 351(k) applicant initiates phase I by providing the aBLA but then fails to take an action required in phase I of the patent dance or to provide notice of commercial marketing, the RPS but not the 351(k) applicant “may bring” an action for declaratory judgment “of infringement, validity, or enforceability of any patent” included on the RPS’s initial list of patents.47 Thus, if the 351(k) applicant fails to comply with the patent dance procedure, the RPS gains significant control over the scope and timing of litigation.

Biosimilars and Inter Partes Review

The America Invents Act (AIA) created the inter partes review (IPR) as a quicker and less expensive avenue for third parties to challenge the validity of patents on 35 U.S.C.S. §§ 102 or 103 grounds based on prior art patents or printed publications in a trial proceeding conducted before a panel of administrative patent law judges.48 The AIA also created procedurally similar post-grant review proceedings that allow third parties to challenge patents issuing under the new first-to-file system (effective priority date on or after March 16, 2013) within nine months of issuance, which can include additional grounds of invalidity not available in IPRs such as lack of written description or enablement.49 IPRs are generally completed within 18 months of initial petition, with a six-month period for the Patent Trial and Appeal Board (PTAB) to decide whether to institute a trial if the patent owner files a preliminary response to the petition and a one-year period to issue a final written decision.50

Patent challengers can only file an IPR if they have not already filed a declaratory judgment action challenging the validity of the patent.51 However, if the patent owner sues the patent challenger for patent infringement, there is a one-year window for the challenger to file an IPR.52 351(k) applicants should consider early whether it is preferable to file an IPR instead of seeking a declaration of invalidity.

In an IPR, the patent is not presumed valid, and accordingly, the challenger has the burden of proving unpatentability by a mere preponderance of the evidence, instead of the clear and convincing evidence standard of district court litigation.53 At the time of writing, in contrast to the Phillips claim construction standards that apply in district court litigation, the PTAB applies the broadest reasonable construction in light of the specification.54 The standards of construction, however, may become aligned.55

In further contrast to district court litigation, the patent owner in an IPR has an opportunity to amend the challenged claims by canceling them or proposing substitute claims.56 The U.S. Court of Appeals for the Federal Circuit sitting en banc recently held that under the current rules, the burden of proving patentability does not rest with the patent owner, upending a standard that had been relied on to deny claim amendments.57 It remains to be seen whether this burden shifting will result in more successful claim amendments.

It has been common for multiple IPRs to be filed against single patents covering biologics.58 The PTAB, however, has warned petitioners against filing serial or follow-on petitions challenging patents that have already been challenged in a previously unsuccessful IPR.59 Such petitions may be denied institution under 35 U.S.C.S. §§ 314(a), 325(d), and 37 C.F.R. § 42.108(a) to prevent petitioners from waiting to file the best challenges until they receive guidance from the PTAB and/or the patent owner’s preliminary response. It is therefore a risk to file a single IPR, wait to see if it is instituted, and then file a subsequent IPR on the same patent with different art without having an explanation as to why the subsequent IPR could not have been brought sooner.

Unlike Article III court litigation, there is no standing requirement to bring an IPR challenge.60 Accordingly, companies have used IPRs early in an attempt to knock-out patents before there would be declaratory judgment jurisdiction. While IPRs appear to be a convenient and easier way to invalidate a patent, there are risks for the petitioner. If unsuccessful at the final written decision stage, the petitioner is estopped from making further arguments in another IPR or district court proceeding that were already raised or could have been raised during the first IPR trial.61 An unsuccessful patent owner also faces estoppel from taking action inconsistent with an adverse judgment, including seeking a patent claim that is “not patentably distinct” from a finally refused or canceled claim.62

While in at least some circumstances, the Federal Circuit has held that estoppel does not apply to grounds that were not instituted, district courts have split on how narrow the estoppel provision is, and the scope of estoppel has not been clearly established.63 Further, to seek review of a PTAB decision upholding a patent claim on appeal to the Federal Circuit, Article III standing must be demonstrated.64 In a pending case before the Federal Circuit (No. 17-1694), Momenta Pharmaceuticals is seeking to establish standing in its appeal of a final written decision finding challenged claims patentable where no aBLA has been filed because Momenta had spent money developing a biosimilar to Orencia®. However, there is a risk that an unsuccessful early petition will leave the challenger unable to seek relief from the Federal Circuit and estopped from making similar arguments in later litigation. IPRs against patents covering biologics have increased significantly since 2016, but still represent a relatively small percentage of IPRs on biopharmaceutical patents.65 As of March 31, 2018, the institution rate for biologic drug IPRs was 53%, which is slightly less than the 60% institution rate for IPRs against Orange Booklisted patents and the 62% institution rate for IPRs against biopharmaceutical patents reported by the U.S. Patent and Trademark Office.66 Of those IPRs against biologic drug patents that have gone to a final written decision, more than 70% have found at least some claims unpatentable.67 Thus, when instituted, IPR challenges to patents covering biologics have been successful to date.

Michael Furrow is a partner at DLA Piper. His experience with and understanding of the challenges innate to discovery in the pharmaceutical and biotechnology fields fuels his passion to enforce and defend life sciences patents. He has represented innovators across these industries in high-stakes patent disputes both in federal court and before the U.S. Patent and Trademark Office, concerning drugs or biologics. Michael’s experience covers all aspects of life sciences innovation, including new chemical entities, salt forms, solid state forms, dosage forms, combination products, methods of use, biologics, and laboratory tools. In addition to his work in contested matters, he also has experience providing opinions on infringement and validity issues and conducting due diligence in connection with patent-related business transactions. Whitney Meier is an associate at Venable LLP. Her practice focuses on complex patent litigation and contested proceedings before the U.S. Patent and Trademark Office with an emphasis in pharmaceuticals and biotechnology. Her litigation and counseling experience cover a range of technologies, including chemotherapies, bisphosphonates, antipsychotics, small molecule formulation, genetically modified mice, and antibody manufacturing. Whitney’s practice also includes many aspects of trademark law, including clearing and prosecuting U.S. and foreign trademarks.

To find this article in Lexis Practice Advisor, follow this research path: RESEARCH PATH: Intellectual Property & Technology > Patents > Patent Litigation > Practice Notes

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1. See U.S. Food & Drug Administration, FDA 101: Regulating Biological Products ( 2. 42 U.S.C.S. § 262(i)(1). 3. 42 U.S.C.S. § 262(a). 4. 42 U.S.C.S. § 262(i)(2). 5. 42 U.S.C.S. § 262(k)(2)(A)(i)(I). 6. 42 U.S.C.S. § 262(k)(2)(A)(i)(II)–(IV). 7. 42 U.S.C.S. § 262(k)(4). 8. 42 U.S.C.S. § 262(i)(3). 9. See National Conference of State Legislatures, State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars (Oct. 22, 2018) ( 10. 42 U.S.C.S. § 262(k)(6). 11. 42 U.S.C.S. § 262(k)(7)(B). 12. 42 U.S.C.S. § 262(k) (7)(A). 13. 42 U.S.C.S. § 262(m). 14. 21 U.S.C.S. §§ 360bb, 360cc. 15. See U.S. Food & Drug Administration, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Apr. 2015) (; Considerations in Demonstrating Interchangeability With a Reference Product (Jan. 2017) ( 16. See Pfizer, Let’s See How Biosimilars Are Developed ( (estimated at $100 million over five to nine years for development of a biosimilar versus $1–2 million over two years for a conventional generic drug); Erwin A. Blackstone & P. Fuhr Joseph, The Economics of Biosimilars, 6(8) AMER. HEALTH & DRUG BENEFITS 469–78, 470–71 (2013) ( 17. See U.S. Food & Drug Administration, Nonproprietary Naming of Biological Products (Jan. 2017) ( 18. 19. 20. Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1669, 1673–74 (2017). 21. 35 U.S.C.S. § 271(e)(1). 22. See Sandoz Inc. v. Amgen Inc., 773 F.3d 1274, 1278–80 (Fed. Cir. 2014). 23. 42 U.S.C.S. § 262(l)(2). 24. 42 U.S.C.S. § 262(l)(1)(B). 25. 42 U.S.C.S. § 262(l)(9)(A). 26. 42 U.S.C.S. § 262(l)(3)(A). 27. 35 U.S.C.S. § 271(e)(6)(C). 28. Amgen Inc. v. Hospira, Inc., 866 F.3d 1355, 1362–63 (Fed. Cir. 2017). 29. 42 U.S.C.S. § 262(l)(3)(B). 30. 42 U.S.C.S. § 262(l)(3)(C). 31. See Amgen Inc. v. Apotex Inc., 2017 U.S. App. LEXIS 22638, at *9 (Fed. Cir. Nov. 13, 2017). 32. 42 U.S.C.S. § 262(l)(4). 33. 42 U.S.C.S. § 262(l)(5). 34. 42 U.S.C.S. § 262(l)(5)(B)(ii)(II). 35. 42 U.S.C.S. § 262(l)(6). 36. 35 U.S.C.S. § 271(e)(4). 37. Amgen Inc. v. Hospira, Inc., 232 F. Supp. 3d 621 (D. Del. 2017). 38. 35 U.S.C.S. § 271(e)(4)(D). 39. 35 U.S.C.S. § 271(e)(6)(B). 40. 42 U.S.C.S. § 262(l)(7). 41. Id. 42. 42 U.S.C.S. § 262(l)(8). 43. Sandoz Inc., 137 S. Ct. at 1677; Amgen Inc. v. Apotex Inc., 827 F.3d 1052, 1054–55 (Fed. Cir. 2016). 44. 42 U.S.C. § 262(l)(8)(B). 45. Sandoz Inc., 137 S. Ct. at 1674–77; Amgen Inc. v. Sandoz Inc., 877 F.3d 1315, 1327–30 (Fed. Cir. 2017). 46. 42 U.S.C.S. § 262(l)(9)(C). 47. 42 U.S.C.S. § 262(l)(9)(B). 48. 35 U.S.C.S. §§ 311–319. 49. 35 U.S.C.S. §§ 321–329. 50. 35 U.S.C.S. § 314(b); 42 37 C.F.R. § 42.100(c). 51. 35 U.S.C.S. § 315(a). 52. 35 U.S.C. S.§ 315(b). 53. 35 U.S.C.S. §§ 282(a), 316(e). 54. 37 C.F.R. § 42.100(b); Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 55. See 83 Fed. Reg. 21, 221 (May 9, 2018). 56. 35 U.S.C.S. § 316(d). 57. Aqua Products v. Matal, 872 F.3d 1290, 1296, 1327–28 (Fed. Cir. 2017). 58. See Venable LLP, Biologics HQ, Biologic Drug IPR Challenges (2018) ( 59. See, e.g., General Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 16–19 (P.T.A.B. Sept. 6, 2017) (precedential). 60. See, e.g., 35 U.S.C.S. § 311(a). 61. 35 U.S.C.S. § 315(e). 62. 37 C.F.R. § 42.73(d). 63. Compare Shaw Indus. Group, Inc. v. Automated Creel Sys., Inc., 817 F.3d 1293, 1300 (Fed. Cir. 2016) with HP Inc. v. MPHJ Tech. Investments, LLC, 817 F.3d 1339, 1347–48 (Fed. Cir. 2016); see also Biscotti Inc. v. Microsoft Corp., 2017 U.S. Dist. LEXIS 144164, at *15–21 (E.D. Tex. May 11, 2017) (recognizing differing interpretations by district courts). 64. Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1172–76 (Fed. Cir. 2017). 65. See Venable LLP, Biologics HQ, Bio/Pharma IPR Petitions Filed by Fiscal Year (2018) ( ), Venable LLP, Biologics HQ, IPRs Filed to Date (2018) ( ). 66. See Venable LLP, Biologics HQ, Institution Outcomes: Biologic and Orange Book Drug IPRs (2018) ( ); see also U.S. Patent and Trademark Office, Trial Statistics, IPR, PGR, CBM, slide 8 (Mar. 2018) ( ). 67. See Venable LLP, Biologics HQ, FWD Outcomes: Biologic and Orange Book Drug IPRs (2018) (https:// ).