Prior to 2022, all BPCIA litigation involved biosimilars of the same nine different reference products: Remicade®, Neulasta®, Neupogen®, Avastin®, Herceptin®, Rituxan®, Humira®, Enbrel®, and Epogen®. These reference products had been on the market a relatively long time, and many were long past the twelve years of marketing exclusivity afforded by the BPCIA—for example, Epogen® was first FDA-approved in 1989, Neupogen® was first FDA-approved in 1991, and Remicade®, Herceptin®, Rituxan®, and Enbrel® were all FDA-approved in the 1997–1998 timeframe.
In 2022, a new wave of lawsuits were filed for more recent reference products, including, Tysabri® (first FDA-approved in 2004), Stelara® (first FDA-approved in 2009), and Eylea® (first FDA-approved in 2011). As discussed below, these newer reference products have introduced new issues in BPCIA litigation. We now turn to these new cases and other recent litigation activity.
A. Ongoing BPCIA District Court Litigation
Four new BPCIA cases were filed in 2022. Those four new cases make up all of the ongoing BPCIA litigation, as all of the cases filed prior to 2022 have been resolved. The ongoing cases are identified in Table 3.
Table 3. BPCIA Cases Filed in 2022
We discuss each briefly below.
Genentech v. Tanvex (22-cv-00809 S.D. Cal.)
This case involves Tanvex’s proposed biosimilar of Genentech’s Herceptin® (trastuzumab) called TX05. Tanvex is the fifth trastuzumab biosimilar developer against which Genentech has brought BPCIA litigation, following litigation against Pfizer, Celltrion/Teva, Amgen, and Samsung Bioepis, all of which settled between 2018 and 2020. In 2017, Genentech also reached a settlement with Mylan in relation to Genentech’s patents for trastuzumab, in which Mylan agreed to withdraw two inter partes review challenges. Each of these companies has commercially launched its trastuzumab biosimilar in the U.S. (See Appendix A, below.)
On June 2, 2022, Genentech filed a complaint against Tanvex, asserting U.S. Patent Nos. 8,574,869 (“the ’869 patent”), 10,662,237 (“the ’237 patent”), and 10,808,037 (“the ’037 patent”). (Dkt. 1 at ¶ 63.) These patents are directed to methods of manufacturing. (Id. at ¶¶ 64–66.) Genentech previously asserted both the ’237 and ’869 patents against various biosimilar companies. (See Dkt. 20 (Notice of Related Cases).) The ’037 patent had not been previously asserted.
The parties engaged in the patent dance and agreed to litigate these three patents in the first wave of litigation. (Dkt. 1 at ¶ 3; see also id. at ¶¶ 53–62.)
The initial pleadings raised themes common in BPCIA cases. For example, Genentech alleged deficiencies at each step of the patent dance, such as Tanvex’s alleged failure to provide “other” manufacturing information as required under 42 U.S.C. § 262(l)(2)(A). (Id. at ¶¶ 54–56.) Genentech therefore claimed that Tanvex’s document productions “failed to fully describe Tanvex’s manufacturing process, such that Genentech was unable to evaluate many of Tanvex’s non-infringement arguments.” (Id. at ¶ 57.) Tanvex disputed that its productions under (2)(A) were deficient. (See, e.g., Dkt. 17 at ¶ 54.)
The parties also disputed whether Tanvex could raise invalidity theories in litigation that were not included in the patent dance statements, an issue that has been before the courts in several other cases. (E.g., Genentech v. Amgen, 17-cv-01407, 2020 WL 636439 (D. Del. Feb. 11, 2020); Genentech v. Samsung Bioepis (20-cv-00859 D. Del.);2 AbbVie v. Alvotech hf. (21-cv-02258 N.D. Ill.; 21-cv-02899 N.D. Ill.), discussed below.) Here, Genentech alleged that during the patent dance Tanvex “failed to provide any statements of invalidity … for any of the patents.” (Dkt. 1 at ¶ 58.) However, Tanvex’s counterclaims of invalidity, filed September 1, 2022, included exemplary invalidity theories and identified prior art. (See, e.g., Dkt. 17 at ¶¶ 33–34.) In answering the counterclaims, Genentech objected to Tanvex’s approach, claiming that “[w]here Tanvex could have, but did not, provide the required detailed statement on invalidity [during the patent dance], Tanvex has waived any invalidity arguments in future litigation or in an administrative proceeding based on information that was available when Tanvex served its contentions.” (Dkt. 32 at ¶ 31.)
Although a claim construction and tutorial hearing were scheduled for May 4, 2023 (Dkt. 41 at 3), the deadlines were vacated when the parties notified the court they had reached an agreement-in-principle to resolve their claims and expected to file a joint stipulation to dismiss sometime in January or early February 2023. (Dkt. 55; Dkt. 58.)
Regeneron v. Mylan (22-cv-00061 N.D. W. Va.)
On August 2, 2022, Regeneron filed a complaint against Mylan asserting infringement of 24 patents. (Dkt. 1.) The case relates to Mylan’s Eylea® (aflibercept) biosimilar called M710. This is the first BPCIA litigation filed in the Northern District of West Virginia, the first BPCIA litigation involving Regeneron, and the first BPCIA litigation involving a proposed biosimilar of Eylea® (aflibercept). Eylea® (first FDA-approved in 2011) is the newest biologic to be subject to BPCIA litigation, raising issues of first impression for the courts.
Regeneron’s complaint alleges that Mylan submitted its biosimilar BLA in October 2021, and the parties engaged in the patent dance from December 2021 through July 2022. (Dkt. 1 at ¶¶ 3–5; see also id. at ¶¶ 18–22.) During the dance, Regeneron proposed litigating “a targeted subset of the listed patents,” but Mylan maintained that all 25 of the relevant listed patents should be included. (Id. at ¶ 21.) Thus, at the end of the patent dance, Regeneron filed suit on the full portfolio of patents. (Id.) Regeneron no longer asserted one of the patents against Mylan, so its complaint included 24 patents. (Id. at ¶ 22 & n.3.)
On August 5, 2022, Regeneron filed a motion requesting an expedited status conference “under Rule 40 and 28 U.S.C. § 1567 to position this case for trial no later than June 2023, so that Regeneron may avail itself of the relief provided by 35 U.S.C. § 271(e)(4)(D).” (Dkt. 7 at 1.) The statutory provision of § 271(e)(4)(D) provides for an injunction when BPCIA exclusivities have not yet expired, a situation that did not arise in previous litigations involving older biologics. Specifically, § 271(e)(4)(D) states that for the artificial act of infringement of filing a biosimilar BLA:
the court shall order a permanent injunction prohibiting any infringement of the patent by the biological product involved in the infringement until a date which is not earlier than the date of the expiration of the patent that has been infringed under paragraph (2)(C), provided the patent is the subject of a final court decision, as defined in section 351(k)(6) of the Public Health Service Act, in an action for infringement of the patent under section 351(l)(6) of such Act, and the biological product has not yet been approved because of section 351(k)(7) of such Act.
(Emphasis added.) Regeneron explained that this statutory permanent injunction “requires resolving the parties’ disputes through final judgment and appeal before the date on which FDA may approve the biosimilar product for marketing.” (Dkt. 7 at 1 (bold emphasis added).) Regeneron alleged that its marketing exclusivity and additional pediatric exclusivity will run through May 2024. (Id. at 1, 5.) Regeneron therefore asked for trial in June 2023 (either on a subset of patents or all patents), so that any appeals could be exhausted by May 2024 and the statutory injunction could be available. (Id. at 5–6.) Regeneron also acknowledged the novel questions presented by this case, alleging that “[t]his is the first biosimilar patent case that will proceed while the innovator product’s regulatory exclusivity remains in place.” (Dkt. 41 at 5.) Mylan opposed the motion. (Dkt. 26.)
On October 25, 2022, at Regeneron’s request, the court entered a scheduling order proceeding on a subset of patents with a trial scheduled for June 2023. (Dkt. 87 at 1–2.) As required by the court, Regeneron identified six patents from three patent families for these initial proceedings. (Dkt. 88.) According to Regeneron, the six patents include: one patent covering the “drug product” (specifically “the actual solution in a vial that maintains the drug’s stability for months”), two patents directed to the use of aflibercept (specifically “how much and how often the drug should be administered to permit more time between doses than patients enjoyed with previous treatments while achieving therapeutic gains”), and three patents concerning “methods for making aflibercept.” (Dkt. 124 at 1.) Regeneron will need to narrow its patent selection down to no more than three patents and 25 claims before the June trial. (Dkt. 87 at 2.) Regeneron also stipulated that “it will not seek injunctive relief on the other 18 patents asserted in its Complaint (ECF 1) with respect to the United States marketing or sales of Mylan’s current aBLA Product (BLA No. 761274).” (Id. at 1 (emphasis omitted).)
On December 9, 2022, Mylan filed a motion for leave to amend its answer, defenses, and counterclaims to add a declaratory judgment counterclaim of no lost profits or injunctive relief with respect to the patents that Regeneron did not select to proceed in the first stage of litigation. (Dkt. 164 at 1–2.) Mylan alleged that Regeneron had “effectively dismisse[d] those [18 other] patents without prejudice from the (l)(6) suit” and was therefore limited to a “reasonable royalty” pursuant to 35 U.S.C. § 271(e)(6)(B). (Dkt. 163-1 at ¶¶ 216, 226.) The court has not yet ruled on the motion.
On December 16, 2022, Regeneron filed a motion for judgment on the pleadings as to Mylan’s inequitable conduct defenses and counterclaims. (Dkt. 176 at 1.) Regeneron argued that (1) Mylan failed to plead any of its theories of inequitable conduct with particularity; (2) any non-disclosure of materials to the United States Patent and Trademark Office in earlier applications was cured because Regeneron later disclosed those materials when applying for the relevant patents-at-issue; and (3) the “purported misrepresentations [to USPTO] Mylan cites were not material assertions of fact but mere attorney argument, which cannot form the basis of an inequitable conduct claim or defense.” (Id. at 2–3.) Mylan filed a motion for extension of time to file its response until January 13, 2023 (Dkt. 189), which Regeneron did not oppose (Dkt. 196), and the court granted (Dkt. 198).
A Markman hearing is scheduled for January 24, 2023, and a trial is scheduled for June 12, 2023. (Dkt. 87 at 2; Dkt. 209.)
Biogen v. Sandoz and Polpharma (22-cv-01190 D. Del.)
Biogen filed a sealed complaint against Sandoz and Polpharma on September 9, 2022, related to the defendants’ Tysabri® (natalizumab) biosimilar PB006. (Dkt. 2, 10 (redacted version).) Biogen’s complaint asserted 28 patents relating to natalizumab and associated manufacturing and testing methods. (Dkt. 10 at ¶¶ 2, 4, 112–167.) This is the first BPCIA litigation involving Biogen as the reference product sponsor, the first BPCIA litigation involving Polpharma, and the first BPCIA litigation involving a proposed biosimilar of Tysabri® (natalizumab).
The heavily redacted filings suggest that the parties engaged in some steps of the patent dance, but did not complete the entire process. According to the complaint, Sandoz announced that FDA accepted the biosimilar BLA on July 25, 2022. (Id. at ¶ 27.) Sandoz provided some confidential information to Biogen, but refused Biogen’s requests for any additional information. (Id. at ¶¶ 103–104.) Biogen served a (3)(A) patent list, but Sandoz declined to participate in any other steps of the patent dance. (Id. at ¶¶ 105–107.) Biogen therefore was entitled to file a declaratory judgment complaint under 42 U.S.C. § 262(l)(9)(B). (Id. at ¶ 108.)
On October 5, 2022, Sandoz filed an answer, affirmative defenses, and counterclaims. (Dkt. 14, 19 (redacted version).) Sandoz counterclaimed for invalidity of each of the 28 asserted patents. (Dkt. 19 at Counterclaims.) On October 26, 2022, Biogen moved to dismiss Sandoz’s counterclaims of invalidity under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief can be granted. (Dkt. 29.) Biogen alleged that “Sandoz’s counterclaims of invalidity are merely threadbare legal conclusions devoid of any supporting factual allegations.” (Id. at 1.) The motion to dismiss was subsequently mooted because, on December 1, 2022, Biogen filed a first amended complaint, reducing the number of asserted patents from 28 to 17. (Dkt. 51, 56 (redacted version).) Sandoz answered the amended complaint on January 4, 2023. (Dkt. 63, 68 (redacted version).)
As of mid-November 2022, Biogen had not yet served Polpharma, a Polish company, with the original or amended complaint. On October 19, 2022, Biogen filed a motion for alternative service, seeking “entry of an order pursuant to Federal Rule Civil Procedure 4(f)(3), authorizing alternative service on Polpharma” by email to U.S. counsel. (Dkt. 30 at 1; see also Dkt. 24.) Sandoz opposed the motion. (Dkt. 34, 37 (redacted version).) The court has not yet ruled on Biogen’s motion for alternative service.
On October 14, 2022, Biogen and Sandoz filed a joint stipulation and scheduling order for expedited preliminary injunction proceedings. (Dkt. 20, 22 (redacted version).) According to a letter from Biogen’s counsel, Biogen “intend[s] to seek a preliminary injunction in advance of the launch of defendants’ biosimilar product.” (Dkt. 27; see also Dkt. 21.) The court entered a sealed order on October 20, 2022. (Dkt. 26.) According to publicly available information, Biogen needed to elect up to five patents and 10 claims for the preliminary injunction proceedings by November 2022. (Dkt. 22 at 2–3.) Briefing on Biogen’s motion for preliminary injunction is scheduled to be completed by April 2023, and a preliminary injunction hearing is to be scheduled thereafter. (Id. at 3.)
Janssen v. Amgen (22-cv-01549 D. Del.)
Janssen filed a complaint against Amgen on November 29, 2022, alleging infringement of U.S. Patent Nos. 6,902,734 (“the ’734 patent”) and 10,961,307 (“the ’307 patent”). (Dkt. 1 at ¶ 5.) The ’734 patent covers ustekinumab, and the ’307 patent covers methods of treating ulcerative colitis with ustekinumab. (Id.) This is the first BPCIA litigation involving a proposed biosimilar of Stelara® (ustekinumab).
The parties did not engage in the patent dance. According to the complaint, on November 7, 2022, “Amgen informed Janssen of its intention, pursuant to 42 U.S.C. § 262(l)(8)(A), to begin marketing its biosimilar version of STELARA® in 180 days (i.e., on May 6, 2023) or immediately upon receiving FDA approval thereafter.” (Id. at ¶ 4.) “Amgen further stated that it intends to market ABP 654 for all indications for which STELARA® is approved.” (Id.) On November 11, 2022, “counsel for Janssen asked Amgen’s counsel whether Amgen had filed its aBLA with FDA, whether and when FDA had accepted Amgen’s aBLA application, whether Amgen intends to participate in the BPCIA ‘patent dance,’ and whether Amgen would provide its aBLA to Janssen.” (Id. at ¶ 25.) According to the complaint, “Amgen refused to disclose when it filed its aBLA, whether the FDA has accepted it, whether Amgen intends to participate in the BPCIA ‘patent dance,’ or whether the BPCIA’s deadline by which Amgen must provide Janssen with a copy of its aBLA has passed.” (Id.) “Amgen also refused to provide Janssen with either a copy of its aBLA or any other requested information.” (Id.) As of the filing of the complaint, FDA had not yet approved Amgen’s proposed ABP 654 biosimilar product. (Id. at ¶ 23.)
On December 20, 2022, the parties filed a joint stipulation to extend the deadline for Amgen to move, answer, or otherwise respond to the complaint through and including January 23, 2023. (Dkt. 8.) On the same day, the court ordered the extension.
B. BPCIA Litigation Settled or Resolved in 2022
BPCIA cases settled or otherwise resolved in 2022 include:
- Amgen v. Hospira (20-cv-00201 D. Del.); Neulasta®/Nyvepria™
- Genentech v. Samsung Bioepis (20-cv-00859 D. Del.); Avastin®/SB8
- AbbVie v. Alvotech hf. (21-cv-02258 N.D. Ill.); Humira®/AVT02
- AbbVie v. Alvotech hf. (21-cv-02899 N.D. Ill.); Humira®/AVT02
We discuss each of these resolved cases briefly below.
Amgen v. Hospira (20-cv-00201 D. Del.)
This case involved Hospira’s biosimilar of Amgen’s Neulasta® (pegfilgrastim). Amgen filed a complaint against Hospira and Pfizer on February 11, 2020, asserting U.S. Patent No. 8,273,707 (“the ’707 patent”), which is directed to methods of protein purification requiring a certain combination of salts at certain concentrations. (Dkt. 1 at ¶¶ 8, 54, 61–62.) Amgen previously asserted this patent in BPCIA litigation against two other biosimilar developers, Coherus and Mylan, and both of those cases were resolved in 2019.
Before the case was dismissed, the court issued several orders. First, the court denied a motion to dismiss brought by Hospira and Pfizer. The defendants had argued that prosecution history disclaimer and estoppel precluded infringement for the same reasons as the Coherus decision. (Dkt. 19 at 1–4.) The court also construed a disputed term, leading Amgen to confirm it would only seek a finding of infringement under the doctrine of equivalents, not literal infringement. (Dkt. 75 at 1.)
Hospira and Pfizer had also filed a motion for summary judgment of non-infringement, arguing that there was no infringement under the doctrine of equivalents because the accused manufacturing process uses a “low” salt concentration below the claimed “intermediate” range. (Dkt. 84 at 7–8.) Amgen responded that genuine disputes of material fact precluded summary judgment. (Dkt. 91 at 2.) While fully briefed, the court did not rule on the motion.
On March 18, 2022, the parties filed a stipulation and order of dismissal with prejudice, stipulating and agreeing that all claims and counterclaims between the parties in this action be dismissed with prejudice, with each party to bear its own costs, expenses, and attorneys’ fees. (Dkt. 100.) On March 21, 2022, the court ordered the dismissal.
Genentech v. Samsung Bioepis (20-cv-00859 D. Del.)
This case involved Samsung Bioepis’s proposed biosimilar of Genentech’s Avastin® (bevacizumab). Genentech filed a complaint against Samsung Bioepis on June 28, 2020, alleging infringement of 14 patents covering methods of manufacturing bevacizumab and methods of treating patients with bevacizumab. (Dkt. 1.) Samsung Bioepis is the third bevacizumab biosimilar developer against which Genentech has initiated BPCIA litigation, following litigation against Pfizer and Amgen, which settled in 2019 and 2020, respectively.
Except for one discrete issue related to a protective order dispute, the case had been stayed since February 2021.
On September 7, 2022, the parties filed a joint stipulation of dismissal, stating that the parties had “entered into a Bevacizumab Settlement Agreement, and mutually agree[d] to voluntarily dismiss all claims and counterclaims asserted in [this] case with prejudice.” (Dkt. 72 at 1.) The parties stipulated that “[i]n the event Genentech files a patent infringement action based on the asserted patents of [this] case against Samsung [Bioepis], nothing in this Order shall prevent Samsung [Bioepis] from challenging the validity, noninfringement, or enforceability of any of the asserted patents in such action.” (Id. at 2.) On September 8, 2022, the court ordered the dismissal. (Dkt. 73.)
AbbVie v. Alvotech hf. (21-cv-02258 N.D. Ill.; 21-cv-02899 N.D. Ill.)
These cases involved Alvotech’s AVT02, a proposed biosimilar of AbbVie’s high-concentration (100 mg/mL) Humira® (adalimumab). On April 27, 2021, AbbVie filed a complaint against Alvotech hf., alleging infringement of the four patents that resulted from the patent dance. (‑2258 Dkt. 1 at ¶¶ 61–62.) This was the first BPCIA litigation filed in the Northern District of Illinois, but the fourth BPCIA litigation brought by AbbVie against an adalimumab biosimilar manufacturer following litigation against Amgen, Sandoz, and Boehringer Ingelheim, which settled in 2017, 2018, and 2019, respectively.
On May 28, 2021, AbbVie filed another suit (the ‑2899 case) against Alvotech hf. In its complaint, AbbVie stated that Alvotech USA’s Notice of Commercial Marketing triggered AbbVie’s ability to file suit on all patents identified in AbbVie’s (3)(A) list during the patent dance. (‑2899 Dkt. 1 at ¶ 17.) AbbVie initially asserted 58 additional patents, but subsequently amended its complaint twice to add newly issued patents. (‑2899 Dkt. 77, 130.)
On September 20, 2021, the court ordered a trial on 10 patents (three from the ‑2258 case and seven from the ‑2899 case) starting on August 1, 2022 (about 16 months after the initial -2258 complaint was filed). (‑2258 Dkt. 63; see also ‑2258 Dkt. 54.) The court stated it planned to issue a trial decision by the end of October 2022, and, “[i]n light of that, [Alvotech] agreed not to launch AVT02 in the United States prior to the issuance of the Court’s decision.” (‑2258 Dkt. 63 at 4.) The 10 patents spanned technologies including autoinjector devices, methods of treatment, antibody purification, and pharmaceutical formulations.
Before the cases were dismissed, the court denied two motions to dismiss brought by Alvotech hf.:
- On June 2, 2021, Alvotech hf. filed a motion to dismiss the ‑2258 case, arguing, inter alia, that: (1) the court lacked subject matter jurisdiction and the complaint did not state a claim under the BPCIA because AbbVie failed to sue Alvotech USA, the subsection (k) applicant for the AVT02 biosimilar at issue (and instead sued Alvotech USA’s Icelandic parent company, Alvotech hf.); (2) AbbVie’s complaint failed to name a necessary party, Alvotech USA; and (3) AbbVie’s complaint should be dismissed for lack of personal jurisdiction over Alvotech hf. (‑2258 Dkt. 27.) In opposition, AbbVie argued that (1) Alvotech hf. was a proper defendant because it was the “submitter” of the AVT02 BLA; (2) Alvotech USA was not a necessary party to the litigation; and (3) the court had personal jurisdiction over Alvotech hf. (‑2258 Dkt. 31.) On August 23, 2021, the court denied Alvotech hf.’s motion to dismiss, finding that (1) “Abbvie’s complaint adequately alleges that Alvotech hf. is a ‘submit[ter]’ of the aBLA within the meaning of 35 U.S.C. § 271(e)(2)(C)”; (2) “Alvotech hf. [] failed to meet its burden of establishing that this case must be dismissed for failing to join Alvotech USA”; and (3) the court has specific jurisdiction “because the aBLA submission indicates Alvotech hf.’s intent to market and distribute its biosimilar drug in Illinois.” AbbVie Inc. v. Alvotech hf., 21-cv-02258, 2021 WL 3737733, at *9–12 (N.D. Ill. Aug. 23, 2021).
- On July 29, 2021, Alvotech hf. filed a motion to dismiss the ‑2899 case pursuant to Federal Rules of Civil Procedure 12(b)(1)–(2) and (6)–(7). (‑2289 Dkt. 29.) Alvotech hf. renewed its motion on December 3 and 29, 2021. (‑2289 Dkt. 91, 138.) Alvotech hf. argued, inter alia, that the BPCIA does not provide for “1) simultaneously filing claims under both 35 U.S.C. § 271(e)(2) and the Declaratory Judgment Act in a ‘second phase’ case; and 2) asserting ‘second phase’ claims against a party that neither provided a notice of commercial marketing under the BPCIA nor applied for approval for the contested biosimilar drug.” (‑2289 Dkt. 29 at 1.) Alvotech hf. argued that “the BPCIA provides no basis for claims under § 271(e)(2)(C) in this second phase,” and instead “requires the second phase suit to be one for declaratory judgment to determine potential future infringement.” ( at 1, 4.) In opposition, AbbVie argued, inter alia, that the BPCIA does not limit phase two to declaratory judgment actions. (‑2289 Dkt. 43 at 3–4.) The parties debated whether allowing 271(e) causes of action for second phase litigation would disrupt the structure of the BPCIA in future cases. (See, e.g., ‑2289 Dkt. 45 at 2 (alleging that AbbVie’s approach would “vitiate the clear two-phase structure that Congress created in the BPCIA”); ‑2289 Dkt. 43 at 5 (AbbVie responding that “Alvotech’s ‘doomsday’ scenario is … specious.”).) On January 26, 2022, the court denied Alvotech hf.’s motion to dismiss, finding that AbbVie could bring infringement claims under § 271(e)(2)(C)(i) during the second phase of litigation. AbbVie Inc. v. Alvotech hf., 582 F. Supp. 3d 584 (N.D. Ill. 2022). The court also rejected Alvotech hf.’s reading of the BPCIA that would “preclude the RPS from seeking injunctive relief pursuant to § 271(e)(4) during the second phase and limit[] second phase relief to a declaratory judgment and preliminary injunctive relief.” (Id. at 591.)
Numerous other issues had been briefed, but remained undecided when the litigations were dismissed. For example, on February 18, 2022, AbbVie filed a motion to strike Alvotech hf.’s final invalidity and unenforceability contentions in both cases, arguing that the court should strike, inter alia, contentions that were not included in Alvotech hf.’s patent dance disclosures, initial contentions, or “unenforceability claims and defenses pleaded in [its] two answers.” (‑2258 Dkt. 256 at 1–2; ‑2899 Dkt. 242 at 1–2.) In opposition, Alvotech hf. argued, inter alia, that it was “permitted to raise additional prior art and arguments from those contained in the initial contentions and patent dance.” (‑2258 Dkt. 262 at 3–4; ‑2899 Dkt. 250 at 3–4.) In support, Alvotech hf. cited Genentech v. Amgen, 17-cv-01407, 2020 WL 636439 (D. Del. Feb. 11, 2020), where the court found that a biosimilar applicant is not precluded from raising a defense not disclosed during the patent dance. (‑2258 Dkt. 262 at 4; ‑2899 Dkt. 250 at 4.)
On March 9, 2022, the parties filed a joint stipulation of dismissal, dismissing all claims, affirmative defenses, and counterclaims in both actions without prejudice, with each party to bear its own attorneys’ fees and costs. (‑2258 Dkt. 276; ‑2899 Dkt. 262.) The court entered the dismissal on the same day. (‑2258 Dkt. 278; ‑2899 Dkt. 264.) AbbVie announced that it “resolved all U.S. HUMIRA (adalimumab) litigation with Alvotech,” and “[u]nder the terms of the resolution, AbbVie will grant Alvotech a non-exclusive license to its HUMIRA-related patents in the United States, which will begin on July 1, 2023.”
C. Section 112 Issues at the Supreme Court
This year, the Supreme Court granted a petition for writ of certiorari to consider the standard for enablement under 35 U.S.C. § 112 in a dispute related to antibodies. Although not a BPCIA decision, this case may have implications in the biosimilars context.
The Supreme Court will be reviewing the Federal Circuit’s decision in Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021), addressing the § 112 enablement requirement. The case involves Amgen’s Repatha® (evolocumab), an antibody product for treating high cholesterol. The Federal Circuit held that functionally defined claims covering a genus of antibodies were not enabled because undue experimentation would be required to practice the full scope of the claims. Id. at 1088. The relevant claims defined the claimed antibodies by their function: “binding to a combinations of sites (residues) on the PCSK9 protein, in a range from one residue to all of them; and blocking the PCSK9/LDLR interaction.” Id. at 1083. The court explained that functional limitations “pose high hurdles in fulfilling the enablement requirement for claims with broad functional language.” Id. at 1087. The court also concluded that the functional limitations here were “broad,” “the disclosed examples and guidance [were] narrow,” the invention was “in an unpredictable field of science with respect to satisfying the full scope of the functional limitations,” and “no reasonable jury could conclude under these facts that anything but ‘substantial time and effort’ would be required to reach the full scope of claimed embodiments.” Id. at 1087–88.
On June 21, 2021, the court denied Amgen’s petition for panel rehearing or rehearing en banc. Amgen Inc. v. Sanofi, Aventisub LLC, 850 F. App’x 794 (Mem) (Fed. Cir. 2021). Judge Lourie, joined by Judges Prost and Hughes, authored a separate opinion on the denial of the petition for panel rehearing to reject Amgen’s argument that the court created a new test for enablement. Id.
On November 18, 2021, Amgen filed a petition for a writ of certiorari, presenting the following questions:
- Whether enablement is “a question of fact to be determined by the jury,” Wood v. Underhill,46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or “a question of law that [the court] review[s] without deference,” Pet. App. 6a, as the Federal Circuit holds.
- Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scopeof claimed embodiments” without undue experimentation-i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort,”’ Pet. App. 14a (emphasis added).
Amgen Inc. v. Sanofi, Aventisub LLC, No. 21-757, 2021 WL 5506421 (U.S. Nov. 18, 2021).
On November 4, 2022, the Supreme Court granted the petition for a writ of certiorari limited to Question 2. Amgen Inc. v. Sanofi, 143 S. Ct. 399 (Mem) (2022). Amgen’s brief on the merits was filed December 27, 2022. Amgen argued that (1) “the Federal Circuit’s reach-the-full-scope standard defies text, precedent, history, and policy”; (2) “the statutory ‘make and use’ standard should govern”; and (3) Amgen’s patents are enabled. (Brief at iii–iv.) On January 3, 2023, 14 amicus briefs were filed, and the Chemistry and the Law Division of the American Chemical Society moved for leave to participate in oral argument in support of Amgen. Amgen opposes the motion. Sanofi’s brief on the merits is due February 3, 2023.
While the Supreme Court has taken up the issue of enablement, the Court has declined invitations to review § 112 written description this term. In August 2021, the Federal Circuit issued a decision in Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330 (Fed. Cir. 2021), addressing written description. The case involves chimeric antigen receptor (CAR) T-cell therapies. The Federal Circuit reversed a jury award of over $1.2 billion because the jury’s written description verdict was not supported by substantial evidence. Id. at 1332. The claims at issue were genus claims that used functional language (binding function of single-chain antibody variable fragments (scFvs), a part of the CAR that determines what target molecule or antigen the CAR can recognize and bind to). Id. at 1333–34, 1335. The Federal Circuit pointed out that the specification identified only two exemplary scFvs for two different targets, which “[did] not provide information sufficient to establish that a skilled artisan would understand how to identify the species of scFvs capable of binding to the limitless number of targets as the claims require.” Id. at 1337. Further, “[e]ven accepting that scFvs were known and that they were known to bind, the specification provides no means of distinguishing which scFvs will bind to which targets.” Id. at 1338. The court also found that the specification “[did] not disclose structural features common to the members of the genus to support that the inventors possessed the claimed invention,” for example those structural features that distinguish between scFvs that bind and those at do not. Id. at 1338–39, 1342. On January 14, 2022, the court denied Juno’s petition for panel rehearing or rehearing en banc (No. 2020-1758). On November 7, 2022, the Supreme Court denied Juno’s petition for a writ of certiorari. Juno Therapeutics, Inc. v. Kite Pharma, Inc., 143 S. Ct. 402 (Mem) (2022). On November 23, 2022, Juno filed a petition for rehearing at the Supreme Court, arguing:
These two cases [Juno v. Kite and Amgen v. Sanofi] involve the very same sentence of the very same statute, 35 U.S.C. § 112(a). Both ask whether the “make and use” language from the statute provides the proper statutory test, and both ask whether the Federal Circuit’s addition of a “full scope” requirement is an appropriate addition to Congress’s language choice. The issues presented are tightly related, and the outcome in Amgen is likely to at least affect, if not be outcome-determinative of, this case.
Motion at 2. Juno therefore requested that “the Court grant rehearing of its order denying the petition for certiorari, vacate that order, and hold this case in abeyance pending the resolution of Amgen Inc. v. Sanofi.” Id. at 8. The Supreme Court denied Juno’s motion on January 9, 2023. Juno Therapeutics, Inc. v. Kite Pharma, Inc., No. 21-1566, 2023 WL 124509 (Mem) (U.S. Jan. 9, 2023).
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III. Antitrust and Competition
Humira®: Patent Thickets and Pay-for-Delay Settlements
In 2022, the Seventh Circuit affirmed the dismissal of an antitrust case brought against AbbVie related its practices surrounding Humira® (adalimumab), one of the highest grossing biologics. The Seventh Circuit’s decision struck a blow to antitrust claims based on “patent thickets” and novel “pay-for-delay” theories. It also appeared to endorse—or at least not deter—a patent prosecution strategy based on obtaining large numbers of patents to deter competition.
In June 2020, U.S. District Judge Manish Shah dismissed a complaint brought by indirect purchasers of Humira® (adalimumab) against AbbVie alleging federal antitrust violations based on two theories: (1) that AbbVie had constructed an anticompetitive “thicket” of weak patents and (2) that AbbVie had entered into anticompetitive pay-for-delay agreements with adalimumab biosimilar manufacturers by allowing earlier entry in Europe in exchange for staying off the market in the United States until 2023. In re Humira (Adalimumab) Antitrust Litig., 465 F. Supp. 3d 811 (N.D. Ill. 2020).
On August 1, 2022, a Seventh Circuit panel affirmed the district court’s dismissal. Mayor and City Council of Baltimore v. AbbVie Inc., 42 F.4th 709 (7th Cir. 2022).
The Seventh Circuit rejected the plaintiffs’ patent “thicket” theory based on the sheer number of AbbVie’s patents:
But what’s wrong with having lots of patents? If AbbVie made 132 inventions, why can’t it hold 132 patents? The patent laws do not set a cap on the number of patents any one person can hold—in general, or pertaining to a single subject. Tech companies such as Cisco, Qualcomm, Intel, Microsoft, and Apple have much larger portfolios of patents. Thomas Edison alone held 1,093 U.S. patents.
Id. at 712 (internal citation omitted). The panel was also unconvinced by the argument that AbbVie’s patents were too weak to monopolize the sales of such an important drug, holding: “[w]eak patents are valid; to say they are weak is to say that their scope is limited, not that they are illegitimate.” Id. at 713.
Lastly, the panel held the challenged settlement agreements were lawful. AbbVie agreed in each agreement to biosimilar entry in each geographical region (Europe and the U.S.) before the last patents expired in that region. AbbVie also did not pay anyone to delay entry. The panel noted that the district judge saw this as “0 + 0 = 0” and concluded “[w]e see this the same way.” Id. at 715.
Outside of the courts, lawmakers and regulators have also continued to raise concerns about patent thickets. In a letter dated May 25, 2022, a bipartisan pair of Senators asked USPTO and FDA questions about how the agencies coordinate and review patent applications related to small-molecule drugs and biologics. The Senators’ letter was prompted by their belief that “[d]rug manufacturers are increasingly relying on patent thickets—dense webs of overlapping patents protecting a single drug—to evade competition.” On June 8, 2022, a different bipartisan group of Senators sent a second letter to USPTO Director Katherine Vidal, expressly urging USPTO to take action on patent thickets, defined as “large numbers of patents that cover a single product or minor variations on a single product.” The Senators quoted a statement from President Biden that patent thickets “have been misused to inhibit or delay—for years and even decades—competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” The letter requested that USPTO issue a notice of proposed rulemaking or public request for comments based on certain questions directed to issues concerning terminal disclaimers, obviousness-type double patenting, and examination requirements for continuation patent applications.
Remicade® and Praluent®/Repatha®: Anticompetitive Exclusionary Contracts
In 2022, Johnson & Johnson and Janssen reached a proposed settlement for $25 million in a class action lawsuit relating to Remicade® (infliximab) brought by consumers and third-party payors. The litigation, In re Remicade Antitrust Litigation, No. 2:17-cv-04326-KSM (E.D. Pa.), was brought over four years ago and alleged that Johnson & Johnson and Janssen violated federal and state antitrust and consumer-protection laws by engaging in anticompetitive devices, such as “a web of exclusionary contracts” (Dkt. 1 at 1), to block competition by lower-cost biosimilar competitors in the infliximab market. The Pennsylvania court has tentatively approved the proposed settlement and has scheduled a Fairness Hearing for February 27, 2023.
Anticompetitive exclusionary contracts related to biologics have cropped up in other contexts as well in 2022. For example, on May 27, 2022, Regeneron filed an antitrust lawsuit against Amgen in the U.S. District Court for the District of Delaware alleging that Amgen used an “unlawful, anticompetitive bundling scheme” and “substantial rebates on entirely unrelated medications in Amgen’s portfolios” to protect Amgen’s Repatha® (evolocumab) product and deprive patients of the benefits of Regeneron’s cholesterol-reducing medication Praluent® (alirocumab). (1:22-cv-00697 D. Del., Dkt. 1 at ¶¶ 1–4.) Amgen has moved to dismiss and stay the case. (Dkt. 17, 27.) While not a biosimilar case, this dispute could shed light on acceptable practices in the biologics and biosimilars space.
Relatedly, on June 16, 2022, the Federal Trade Commission issued a policy statement on “Rebates and Fees in Exchange for Excluding Lower-Cost Drug Products” to “explain its enforcement policy” with respect to these practices. FTC noted that “rebates and fees may shift costs and misalign incentives in a way that ultimately increases patients’ costs and stifles competition from lower-cost drugs, especially when generics and biosimilars are excluded or disfavored on formularies,” highlighting the example of insulin. FTC stated that it intends to closely scrutinize the impact of rebates and fees on patients and payers to determine whether the antitrust laws have been violated and monitor private litigation and file amicus briefs to aid courts in analyzing unlawful conduct that may raise drug prices.
Also in June 2022, FTC, citing “the urgent problems Americans have encountered in accessing and paying for insulin, among other drugs,” authorized, after a 5-0 vote, initiation of a study of the contracting practices of Pharmacy Benefit Managers “to evaluate whether and how PBMs contribute to competitive distortions in pharmaceutical markets.” FTC described PBMs as “unavoidable intermediaries in U.S. pharmaceutical markets” who “contract on behalf of payers—including employers and health insurance companies—with pharmacies and drug manufacturers.”
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IV. Post-Grant Challenges at the Patent Trial and Appeal Board
Biologic and biosimilar activity at the PTAB in 2022 stayed roughly in line compared to filings in 2021. 18 IPR petitions and five post-grant review petitions were filed in 2021.3 Similarly, in 2022, 15 IPR and two PGR biologic petitions were filed, returning PTAB filings to pre-pandemic levels.
Figure 3. Biologic IPR Petitions by Year