Customs and Border Protection (CBP) Order Overturned: Masimo Disputes Decision Permitting Apple to Reinstate Infringing Pulse Oximetry Capability

Customs and Border Protection (CBP) Order Overturned: Masimo Disputes Decision Permitting Apple to Reinstate Infringing Pulse Oximetry Capability

In an unexpected turn of events, Masimo Corporation, a leading medical technology company, has filed a complaint against the U.S. Customs and Border Protection (CBP) and several U.S. government officials. The complaint, filed on Wednesday, October 2023, questions the CBP's recent decision regarding Apple's smartwatches.

The controversy stems from a series of events that began with the U.S. International Trade Commission (USITC) determining, in October 2023, that Masimo had established a Section 337 violation through Apple's importation for sale of light-based physiological measurement devices infringing upon claims of two Masimo patents. As a result, the USITC issued a limited exclusion order (LEO) prohibiting Apple from importing wearable electronic devices with the LED pulse oximetry functionality.

However, the CBP ruled that these smartwatches could not be excluded under the LEO because Apple had disabled their pulse oximetry functionality. This ruling was issued in an ex parte proceeding, a type of proceeding conducted without the participation of all parties, which Masimo claims it was not informed about or given an opportunity to participate in.

The timing of the CBP's ex parte ruling is questionable, given its close proximity to a series of major U.S. investment announcements by Apple, including a $100 billion increase in its commitment to spend $500 billion in capital projects, announced on August 6.

The CBP's ex parte ruling concluded that Apple could overcome the LEO by shipping its smartwatches separately from iPhones. However, this ruling was not consistent with a 2009 USITC ruling, according to Masimo's complaint, which alleges that the CBP's conclusion is improperly supported by this earlier ruling.

Masimo seeks injunctive relief permanently enjoining the CBP and its agents from giving effect to the ex parte order and declaring that their actions are unlawful. The complaint challenges ex parte rulings that allow Apple to restore pulse oximetry functionality to several smartwatch models. The complaint also includes counts for arbitrary and capricious agency action, ultra vires action exceeding statutory authority, and violation of the Fifth Amendment's Due Process Clause.

In a response to Masimo's concerns, the CBP provided a redacted version of the ex parte ruling to Apple the day after Apple announced it could restore pulse oximetry functionality. Despite CBP's recognition that Apple's pulse oximetry functionality must remain disabled, Apple announced on August 14 that a recent U.S. Customs ruling enabled it to immediately restore this functionality through a software update.

Apple had previously requested a second Section 177 ruling based on similar redesigns, but the CBP denied Apple's second request. Masimo's complaint points out the CBP's consideration of indirect infringement issues as underscoring the agency's belief that it had exceeded its jurisdiction.

As the case unfolds, the court will determine whether the CBP's actions were lawful and whether Masimo's concerns about the ex parte proceedings are valid. This case could have significant implications for the tech industry and the role of U.S. Customs and Border Protection in enforcing intellectual property rights.

Read also:

• Catastrophe at a U.S. Steel facility in Pennsylvania results in the loss of two lives. crucial details unveiled
• Manipulating Sympathy: Exploiting Victimhood for Personal Gain
• Prices remain a concern for the Germans
• Auto Industry Updates: Geotab, C2A, Deloitte, NOVOSENSE, Soracom, and Panasonic in Focus