Health Law Daily AbbVie did nothing unlawful in filing intertwining Humira® patents
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Wednesday, June 10, 2020

AbbVie did nothing unlawful in filing intertwining Humira® patents

By Jeffrey H. Brochin, J.D.

AbbVie exploited advantages conferred on it through lawful patent practices and thereby kept prices for Humira high, but nothing in existing antitrust doctrine prohibited their actions.

A federal district court in Illinois has dismissed the complaint filed by a group of indirect purchasers of the anti-inflammatory drug Humira, that alleged that AbbVie, Inc. (AbbVie) violated antitrust laws in the course of their complex scheme to keep competing biosimilar drugs out of the U.S. market. Although AbbVie’s arrangements with would-be competitors blocked competition, the legal and regulatory backdrop for patented biologic drugs, together with a well-resourced litigation strategy, gave AbbVie the ability to maintain control over Humira without violating the Sherman Act antitrust prohibitions (In Re: Humira (Adalimumab), June 8, 2020, Shah, M.).

Acquisition of Humira. Humira’s active ingredient is an antibody called "adalimumab." Abbott Laboratories bought the patent (the ‘382 patent) for adalimumab and used it to launch a new drug—Humira—in 2002. Abbott sold Humira throughout the world for 11 years before passing the patent off to its spin-off biologic and branded drug business, AbbVie, Inc. The patent expired in December 2016. However, in 2018 the global sales of Humira reached $20 billion, and between 2012-2018 U.S. sales alone amounted to $456 billion making it the best-selling drug in the country. The sales dollars come not from volume, but from price: a one-month prescription of Humira injections costs about $4,500.

A ‘thicket’ of IP protection. The suit alleged that in the months and years leading up to the expiration of the ’382 patent, AbbVie created a thicket of intellectual property protection so dense that it prevented would-be challengers from entering the market with cheaper biosimilar alternatives. It was further alleged that AbbVie Inc. and AbbVie Biotechnology Ltd. used that intellectual property as leverage during negotiations with other companies, forcing the drug makers to agree to delay their market entry in return for licensing agreements that cut through AbbVie’s patent thicket. AbbVie’s conduct was alleged to have violated both federal antitrust statutes as well as several state antitrust laws.

Reliance on continuation applications. In the process of building a patent portfolio for Humira, AbbVie relied heavily on continuation applications. For example, AbbVie used one application from 2002 to serve as the basis for twenty-two continuation applications, all of which would have been barred by prior art but-for their ability to relate back. AbbVie’s 100-plus Humira-related patents can be traced back to twenty root patents, forming 20 "patent trees." The plaintiffs claimed that by targeting the root patents that lie at the base of the patent trees, they could quickly identify whole swaths of AbbVie’s IP portfolio that should not have issued.

Misrepresentations to USPTO. The indirect purchasers claimed that AbbVie’s alleged wrongdoing was not limited to its continuation applications, and that AbbVie in fact withheld information from the United States Patent and Trademark Office (USPTO), such as when it had already been using a way to make and sell a certain product for several years when it told the USPTO that the method was not obvious. And, while prosecuting another patent, AbbVie filed a declaration affirming that a certain process was unexpected to be successful despite earlier disclosures that suggested the process was not only likely to be successful but was in fact the standard method for achieving that result.

The indirect purchasers argued that any formulation patent that described a variant of Humira, (i.e., one that did not describe Humira as it was approved by the FDA) should not be used to block biosimilars of Humira, and, that any manufacturing process that was not used to make Humira when it launched, must not be necessary to make Humira, meaning it should be no bar to making a biosimilar.

A new kind of antitrust claim. The court noted that this was a new kind of antitrust claim. The complaint brought together a disparate set of aggressive but mostly protected actions to allege a scheme to harm competition and maintain high prices. However, the allegations—even when considered broadly and together for their potential to restrain trade—fell short of alleging the kind of competitive harm remedied by antitrust law.

What the plaintiffs described was not an antitrust violation. AbbVie exploited advantages conferred on it through lawful practices, and to the extent this has kept prices high for Humira, existing antitrust doctrine did not prohibit it. Much of AbbVie’s petitioning was protected by the Noerr–Pennington doctrine, and indirect purchasers’ theory of antitrust injury was too speculative. Because the federal antitrust claims failed, the state antitrust claims also failed.

Based on the foregoing, the court granted AbbVie’s motion to dismiss, but without prejudice.

The case is No. 1:19-cv-01873.

Attorneys: Adam J. Pessin (Fine, Kaplan And Black, RPC) for UFCW Local 1500 Welfare Fund. David S. Scalia (Dugan Law Firm, APLC) for Louisiana Health Service & Indemnity Co. d/b/a Blue Cross Blue Shield of Louisiana. James F. Hurst (Kirkland And Ellis LLP) for AbbVie Inc. and AbbVie Biotechnology Ltd. Bruce Roger Braun (Sidley Austin LLP) for Amgen Inc. Brent M. Byars (Cravath, Swaine & Moore LLP) for Mylan Inc.

Companies: Louisiana Health Service & Indemnity Co. d/b/a Blue Cross Blue Shield of Louisiana; AbbVie Inc.; AbbVie Biotechnology Ltd.; Amgen Inc.; Mylan Inc.

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