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DCMA’s Cybersecurity Oversight Takes Shape: Revised CPSR Guidebook Outlines DFARS Safeguarding Clause Audit Standards

Client Alert | 1 min read | 03.06.19

Following guidance issued by Under Secretary of Defense Lord, the Defense Contract Management Agency (DCMA) has revised its Contractor Purchasing System Review (CPSR) Guidebook to incorporate new standards DCMA auditors will use to assess contractor supply chain management under the DFARS Safeguarding Clause 252.204-7012.  Notably, the new standards require contractors to “validate” that their subcontractors have information systems “that can receive and protect” Covered Defense Information (CDI) and to “determine” whether subcontractor systems are “acceptable.”  Other new standards require contractors to demonstrate:

  • How CDI is properly marked and securely transferred to subcontractors; and
  • How subcontractor notifications regarding requests to vary from the NIST requirements and the submission of cyber incident reports are managed and documented.

The revisions also emphasize that 252.204-7012 is not an indiscriminate flowdown and applies only where the subcontractor will be utilized for operationally critical support or performing duties that involve CDI.

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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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