Medical Patent Law – The Challenges of Medical Treatment

Medical Patent Law – The Challenges of Medical Treatment

Eddy D. Ventose

This book provides a detailed and comparative examination of medical patent law and the issues at the heart of the medical treatment exclusion for therapeutic treatments, surgical treatments and diagnostic methods.

Chapter 10: United States of America

Eddy D. Ventose

Subjects: law - academic, biotechnology and pharmaceutical law, health law, intellectual property law

Extract

A INTRODUCTION The courts and the US Patent and Trademark Office (USPTO) oscillated on the issue of patent protection for methods of medical treatment. Medical procedures were initially excluded from patent protection, but in 1954 the Patent Office Board of Appeal (US) (POBA) in ex parte Scherer decided affirmatively that they were not outside the scope of patent protection. The patenting of medical treatments continued unhindered, without posing any serious threat to the medical profession and health care, after the decision in ex parte Scherer. The issues only climaxed in the aftermath of the Pallin v Singer1 litigation where one physician sought to enforce a patent for a method of medical treatment against another physician. The publicity given to this case in the media alerted the public to the possibility of patents negatively impacting health care. The legislators were quick to respond to what was perceived to be an upsurge in patents for methods of medical treatment. The Medical Procedures and Affordability Act 1996 (MPAA) was the resulting compromise that provided immunity to physicians and related health care entities against suits for patent infringement. The legislation, the drafters thought, achieved a proper balance between on the one hand, the public health considerations and, on the other hand, the economic incentives of the patent system. Recently, however, there has been an upsurge in decisions relating to methods of medical treatment reaching the Federal Circuit, and indeed one missed opportunity in Laboratory Corporation v Metabolite Labs for the United...

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