FRANK ROSCHANGAR^*1, PHILIP I. DATLOW^*2, WOLFGANG STOCK³, DAVID M. BOSTROM⁴, MICHAEL STEIGERWALD⁵
*Corresponding authors
1. Global CMC Regulatory Affairs, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany  
2. Legal, Boehringer Ingelheim USA Corporation, Ridgefield, USA  
3. Patents Biopharmaceuticals, Boehringer Ingelheim International GmbH, Biberach an der Riß, Germany  
4. IT Governance, Quality and Compliance IP & Security Americas, Boehringer Ingelheim USA Corporation, Ridgefield, USA  
5. Global Department Sourcing Direct, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany

Abstract

Intellectual property (IP) is one of the most valuable assets of a biopharmaceutical company, and its mindful protection is essential to the firm’s future prospect in delivering novel, efficacious and safe medicines to patients worldwide.  Presently, due to significant outsourcing of drug manufacturing activities and other related services across all phases of the drug’s lifecycle, biopharmaceutical companies must scrutinize how their intellectual property, including both patented and unpatented confidential and proprietary information within the IP “umbrella”, is protected and managed by their external partners, in particular in countries where IP laws are still evolving and where there may be an increased risk of IP loss or misappropriation.  Herein, we disclose a newly established process at Boehringer Ingelheim that evaluates IP risks when working with external partners.  A key success factor of the process is how we work with our external partners to mitigate identified IP risks collaboratively.  In this Part 1 of a two-part series, we provide an overview of the program and then describe the preparation phase of the IP risk assessment process, including the supplier selection procedure and the process for securing documentation from the supplier to support the IP risk assessment.

INTRODUCTION

Every innovative medicine contains a treasure, namely the knowledge of which raw materials and processes are required for its manufacture and which supportive technologies are involved.  The development of a new drug is time consuming and extremely expensive, and results in the creation of highly proprietary technical information and know-how related to the final drug candidate, e.g. its exact chemical structure and its method of manufacture.  Such highly proprietary Intellectual Property (IP) may provide a competitive advantage and therefore is of high value and must be protected against premature leakage or disclosure.  Therefore, biopharmaceutical companies have policies and procedures in place to protect their IP.  These firms regularly acquire raw materials and advanced drug precursors from external suppliers to develop new medicines.  In some cases, external suppliers are tasked with the development and execution of the ...