Life Sciences

While the majority of our matters are too sensitive to disclose, the following case studies are examples of the kinds of matters that we handle:

Case Study: Novel Neural Drug Delivery System

Our client developed a novel system for the highly accurate delivery of medicinal products and cells to parts of the patient’s brain. The system can be used to deliver therapies and diagnostics for a variety of brain tumours, various neural conditions, including Parkinson’s Disease and Alzheimer’s Disease. The drug delivery system is designed to be implanted using a stereotactic surgical robot and sophisticated software planning tools.

In some jurisdictions, the product is regulated as a series of drug device combination products. In other jurisdictions, the drug delivery system will be regulated as a standalone medical device.

As our client will provide its platform technology to a variety of partners developing conventional medicines and advanced therapy medicinal products, the contracts with each partner had to be very carefully constructed, particularly as regards regulatory requirements, access to data, IP and restrictive covenants.

Clinical studies in fields such as this tend to be simultaneously clinical investigations of investigational medical devices and clinical trials of investigational medicinal products. This tends to challenge most third parties who will be involved in the approval process: regulators and research ethics committees (and IRBs) assessing clinical study applications and protocols; healthcare institutions reviewing clinical study agreements; insurers; regulators considering the import of investigational medical devices; Notified Bodies and Regulators reviewing vigilance plans; and payers. Such third parties can be reluctant to approve the development of the system and the therapy.

Neurosurgeons regularly request the right to use such experimental devices for compassionate cases on an exceptional basis. Such requests have ramifications for the approval of the system and must be closely managed and documented. We have advised our client through each of these stages of the development and commercialisation of the system, including negotiations with multiple large pharmaceutical partners.

Case Study: Borderline Product

Our client developed a novel fusion protein for use in the treatment of stalled wounds. The product has two distinct modes of action: the dominant mode of action is physical and the ancillary mode of action is pharmacological. The Notified Body and the MHRA initially classified this product as a Class III medical device.

As the product is biological, the “usefulness” of the ancillary medicinal ingredient needed to be confirmed by the EMA. The EMA initially refused to conduct the assessment on the usefulness of the ancillary medicinal ingredient as it did not accept the classification of the product as a medical device. The EMA had no legal basis for either the refusal to conduct the assessment or its attempt to classify the product.

Working with the client, we compelled the EMA to conduct the assessment of the product. This involved freedom of information applications (or equivalent) in multiple jurisdictions, correspondence with the European Commission, the EMA, the MHRA and the Notified Body, assisting the client with its submissions to the CHMP (including attending the meeting of the CHMP).

What others say

Denoon and Hitchcock are highly recommended for pharmaceuticals regulation, medical devices and advanced therapy medicinal products, as well as commercialisation of IP.

The Legal 500 UK 2017

Expertise

  • Ranked within The Legal 500 UK
  • Alexander Denoon
    Recommended lawyer TMT (technology, media and telecoms) – Pharmaceuticals and biotechnology
    The Legal 500 UK 2017
  • Julian Hitchcock
    Recommended lawyer TMT (technology, media and telecoms) – Pharmaceuticals and biotechnology
    The Legal 500 UK 2017