Product Labeling as Evidence of Patent Infringement

Published May 3, 2017

Medical device and pharmaceutical manufacturers should consider the content of product labeling carefully from a patent perspective. This includes device manuals, instructions for use, physician information, and marketing materials in order to avoid creating evidence of patent infringement.

The divided acts of multiple parties may combine to directly infringe a patented method claim, provided there is a relationship between the parties that urges one party to act. Under current law, established by a series of cases (referred to in the patent world as the Akamai cases), the acts of a first party may be attributed to a second party if the second party directs or controls the acts of the first party. Direction or control occurs when the second party: (1) conditions participation in an activity or receipt of a benefit upon the first party’s performance of one or more steps of a patented method, and (2) establishes the manner or timing of that performance.

Eli Lilly v. Teva Pharmaceuticals

In Eli Lilly v. Teva Pharmaceuticals, divided direct infringement of a patented method claim for administering a drug treatment was found where a patient self-administered a dose of a medication (step “a” of the claim) as a prerequisite to a doctor administering doses of two other medications (steps “b” and “c” of the claim). In view of product labeling (in the form of Physician Prescribing Information) provided to doctors – which explained the importance of step “a” and directed doctors to then explain the importance to patients – a doctor was found to control the act of a patient performing step “a”; and to be a direct infringer of the claimed method. Teva, the manufacturer of a generic version of one of the medications and the source of the Physician Prescribing Information, was ultimately liable for patent infringement for inducing direct patent infringement by the doctor.

The risk of creating evidence of patent infringement in the form of product labeling like that in the Teva case may be mitigated by a comprehensive patent clearance investigation that considers – not only the product itself – but also all labeling that will accompany the product.

About the author:

David Sarisky is a registered patent attorney with Loza & Loza LLP specializing in medical device technologies. He advises clients on intellectual property matters with an emphasis on patent law, including both domestic and foreign patent application preparation and prosecution, patent portfolio development and management as well as patent infringement, validity, freedom to operate, and due diligence investigations.

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