Log in
E-mail
Password
Show password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
  1. Homepage
  2. Equities
  3. United States
  4. Nyse
  5. AbbVie Inc.
  6. News
  7. Summary
    ABBV   US00287Y1091

ABBVIE INC.

(ABBV)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector newsMarketScreener Strategies

AbbVie : N.D. Ill. Finds That A Foreign Parent Corp. May Be Sued Under BPCIA Without The U.S. Subsidiary That Signed And Filed ABLA

09/22/2021 | 01:41am EDT

In what appears to be a case of first impression, on August 23, 2021 U.S. District Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant's motion to dismiss a patent infringement suit brought under the Biosimilar Price Competition and Innovation Act ("BPCIA") against a foreign parent corporation that did not file or sign the relevant abbreviated Biologics License Application ("aBLA"). AbbVie Inc. v. Alvotech hf., No. 21-cv-02258, (N.D. Ill.). In so doing, Judge Lee relied heavily on parallels between the Hatch-Waxman Act and the BPCIA.

Plaintiffs, AbbVie Inc. and AbbVie Biotechnology Ltd. (collectively, "AbbVie"), make the biologic, Humira® (adalimumab), which is used to treat a variety of autoimmune conditions including rheumatoid arthritis, psoriasis, and Crohn's disease. Defendant, Alvotech hf., is an Icelandic corporation in the business of developing, manufacturing, marketing, and selling biologic drugs. In May 2018, Alvotech hf. began clinical trials for a biosimilar of Humira® called AVT02. In January 2019, Alvotech hf. incorporated its "wholly-owned, regulatory affairs, governmental policy and legal subsidiary," Alvotech USA, in Virginia. And in fall of 2020, Alvotech USA signed and filed an aBLA seeking FDA approval for AVT02. Following the BPCIA's biosimilar litigation framework, the parties completed the "patent dance" information exchange and, on April 27, 2021, AbbVie sued Alvotech hf., but not Alvotech USA, for infringement of four patents under 35 U.S.C. § 271(e)(2)(C) in the Northern District of Illinois. (For some of Mintz's prior coverage of the BPCIA and its patent dance information exchange, see articles regarding the effect of factual statements made during the patent dance and regarding the seminal Supreme Court interpretation of BPCIA patent dance and notice of commercial marketing provisions.)

Alvotech hf. moved to dismiss the complaint for lack of subject matter jurisdiction, lack of personal jurisdiction, failure to state a claim, and failure to join an indispensable party, all largely premised on AbbVie's suing Alvotech hf. but not the U.S. subsidiary, Alvotech USA. The court first concluded that the primary issue was not one of subject matter jurisdiction under Rule 12(b)(1), but rather involved the merits under Rule 12(b)(6). In so ruling, the court relied on Federal Circuit precedent in the Hatch-Waxman context holding that § 271(e), which provides the infringement cause of action in both Hatch-Waxman and BPCIA infringement suits, is not a jurisdictional statute.

The court then turned to the central questions of whether Alvotech hf. "submitted" the aBLA, despite not signing or filing it, and whether Alvotech USA "submitted" the aBLA and was a necessary party to the suit. The court observed that the same word "submit" appears in the general section of § 271(e)(2) and should therefore be interpreted the same in both the Hatch-Waxman (§ 271(e)(2)(A)) and BPCIA (§ 271(e)(2)(C)) contexts. The court further noted that the additional BPCIA and patent dance provisions, including their references to one who "submits" an aBLA, did not compel departure from ANDA litigation jurisprudence.

As a result, the court applied the Federal Circuit's In re Rosuvastatin Calcium Patent Litigation, 703 F.3d 511 (Fed. Cir. 2012) holding that an ANDA "submitter" is a party "actively involved in preparing the ANDA," "includ[ing] marketing and distributing the approved generic drugs in the United States," and one "participating in the [drug's] manufacture [or] importation," "regardless of whether they are the named applicant, especially where the parties involved are in the same corporate family." Id. at 528; Adverio Pharma GmbH v. Alembic Pharms. Ltd., No. CV 18-73-LPS, 2019 WL 581618, at *4 (D. Del. Feb. 13, 2019). The court observed that according to the complaint, Alvotech hf. created and prepared the information in the aBLA, especially where at least one AVT02 clinical trial began before Alvotech USA existed, and Alvotech hf. will engage in the commercial manufacture and supply of AVT02 and financially benefit in significant manner from the approval of the AVT02 aBLA. The court thus concluded that Alvotech hf. was a "submitter" of the aBLA, and denied the Rule 12(b)(6) motion accordingly.

Next, the court addressed defendant's motion to dismiss under Rule 12(b)(7) for failure to join Alvotech USA as a necessary and indispensable party. Alvotech hf. argued, and AbbVie did not dispute, that if Alvotech USA were a necessary party to the litigation, it could not be joined to the current suit in the Northern District of Illinois because venue would be improper over the Virginia corporation. (See Mintz's prior coverage here of the Federal Circuit's restriction of venue in Hatch-Waxman litigation to districts in which acts related to the ANDA submission occurred, rather than districts where the ANDA product may be distributed once approved.) Nonetheless, the court concluded that the suit could proceed without naming the U.S. subsidiary because, under 7th Circuit law, it is unlikely that a "100 percent subsidiary could ever be an indispensable party," see Extra Equipamentos E Exportaçăo Ltda. v. Case Corp., 361 F.3d 359, 364 (7th Cir. 2004) (emphasis in original), and a parent corporation is presumed to adequately represent the interests of its wholly-owned subsidiary in the patent context. Where AbbVie sued Alvotech hf. for its own conduct as aBLA "submitter," the court found Alvotech hf. had not met its burden to show that the case must be dismissed under Rule 12(b)(7) for failure to join Alvotech USA.

Finally, the court concluded that specific personal jurisdiction was appropriate over Alvotech hf. in the Northern District of Illinois, again relying on Federal Circuit holdings in the Hatch-Waxman context. Specifically, in Acorda Therapeutics v. Mylan Pharmaceuticals, the Federal Circuit held that the submission of an ANDA is a "suit-related" and "substantial connection" where the defendant plans to market its proposed drug in the forum state. 817 F.3d 755, 762-63 (Fed. Cir. 2016). Likewise, in the case at hand, AbbVie alleged that Alvotech hf. will engage in commercial manufacture and supply of the aBLA product in the Northern District of Illinois, and defendant submitted no evidence to the contrary. Because Alvotech hf.'s "submission" of the aBLA indicates intent to market and distribute the biosimilar in Illinois, the court ruled, specific jurisdiction exists over it in the district.

Stay tuned for further coverage as this and other BPCIA issues make their way through the courts in this rapidly evolving area of law.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Mr Thomas Wintner
Mintz
One Financial Center
Boston
MA 02111
UNITED STATES
Tel: 6175426000
Fax: 6175422241
E-mail: www.mintz.com
URL: www.mintz.com

© Mondaq Ltd, 2021 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com, source Business Briefing

All news about ABBVIE INC.
10/21ASTRAZENECA : Puts Cancer Drug Trial On Hold Due To Safety Concerns
MT
10/18ABBVIE : Receives CHMP Positive Opinion for Risankizumab (SKYRIZI) for the Treatment of Ad..
AQ
10/18OYSTER POINT PHARMA : drug becomes first FDA-approved nasal spray to treat dry eyes
RE
10/15REVANCE THERAPEUTICS : U.S. FDA declines to approve Revance's frown-line treatment
RE
10/15ABBVIE : Says its Psoriatic Arthritis Drug Risankizumab Recommended by CHMP for Treatment ..
MT
10/15AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI®) for the Treatment of ..
CI
10/15AbbVie Gets CHMP Positive Opinion for Risankizumab in Psoriatic Arthritis
DJ
10/14PRESS RELEASE : Roche's Gazyvaro shorter 90-minute infusion time approved in Europe for pe..
DJ
10/14ABBVIE INC. : Ex-dividend day for
FA
10/12ABBVIE : Allergan Aesthetics Launches Series of Initiatives to Support Breast Cancer Aware..
AQ
More news
Analyst Recommendations on ABBVIE INC.
More recommendations
Financials (USD)
Sales 2021 56 197 M - -
Net income 2021 12 472 M - -
Net Debt 2021 66 426 M - -
P/E ratio 2021 14,9x
Yield 2021 4,76%
Capitalization 193 B 193 B -
EV / Sales 2021 4,61x
EV / Sales 2022 4,14x
Nbr of Employees 48 000
Free-Float 98,0%
Chart ABBVIE INC.
Duration : Period :
AbbVie Inc. Technical Analysis Chart | ABBV | US00287Y1091 | MarketScreener
Technical analysis trends ABBVIE INC.
Short TermMid-TermLong Term
TrendsNeutralBearishNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 22
Last Close Price 109,14 $
Average target price 125,48 $
Spread / Average Target 15,0%
EPS Revisions
Managers and Directors
Richard A. Gonzalez Chairman & Chief Executive Officer
Michael E. Severino Vice Chairman-Management Board & President
Robert A. Michael Chief Financial Officer & Executive Vice President
Thomas J. Hudson Chief Scientific Officer, Senior VP-R&D
Azita Saleki-Gerhardt Executive Vice President-Operations
Sector and Competitors
1st jan.Capi. (M$)
ABBVIE INC.1.86%192 870
JOHNSON & JOHNSON4.03%430 990
ROCHE HOLDING AG15.15%337 974
NOVO NORDISK A/S58.77%242 392
PFIZER, INC.16.44%241 985
ELI LILLY AND COMPANY44.37%220 979