FTC Announces New HSR and Section 8 Thresholds
Client Alert | 1 min read | 01.20.17
On January 19, the Federal Trade Commission announced that it will increase the jurisdictional thresholds applicable to both the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the HSR Act) and Section 8 of the Clayton Act. These dollar thresholds are indexed annually based on changes in the U.S. gross national product.
The HSR Act requires that certain large transactions be notified prior to their consummation. This year, the minimum "size-of-transaction" threshold for reporting mergers and acquisitions will increase from $78.2 million to $80.8 million. In addition, the "size-of-person" and filing fee thresholds will also increase. These revisions will become effective thirty days after their publication in the Federal Register.
The Commission also issued revised thresholds relating to the prohibition of certain interlocking directorates under Section 8 of the Clayton Act. These revisions will take effect immediately upon their publication in the Federal Register.
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Client Alert | 4 min read | 04.10.25
Hikma and Amici Curiae Ask Supreme Court to Revisit Induced Infringement by Generic “Skinny Labels”
In Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., C.A. No. 20-1630 (D. Del.), brand manufacturer Amarin brought an induced infringement claim against Hikma’s generic icosapent ethyl product, which lists Amarin’s Vascepa® as the reference listed drug. Vascepa was originally approved by the U.S. Food and Drug Administration (“FDA”) to treat severe hypertriglyceridemia, and later, Amarin obtained patents and approval for Vascepa as a treatment to reduce cardiovascular risk in certain patient populations. Hikma’s Abbreviated New Drug Application (“ANDA”) for generic icosapent ethyl included a Section viii statement that Hikma was not seeking approval for the patented cardiovascular indication along with a “skinny label” that included only the indication for severe hypertriglyceridemia.
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