Federal Government proposes to eliminate copyright uncertainty for pharmaceutical companies

On 24 February, the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 was introduced in the House of Representatives.  This Bill proposes to introduce a specific exemption into the Copyright Act for “Product Information” documents.  A copy of the Bill, together with the Explanatory Memorandum, can be found here.

Backdrop for the amendments

“Product Information” documents, or PIs, are lodged by pharmaceutical companies as part of the application process to register a medicine under the Therapeutic Goods Act.  The PI contains technical information about the medicine and is designed to assist doctors, pharmacists and other health professionals when prescribing and dispensing medicines.

To ensure pharmacists and doctors receive the same information, the Therapeutic Goods Act requires that the PI for generic medicines must be in substantially the same form as the PI for the “original” medicine.  Recently however, this has led some pharmaceutical companies who have PIs approved for original medicines to take, or threaten to take, legal proceedings against generic pharmaceutical companies for infringement of their (alleged) copyright in the approved PI.  Concerned that this may disrupt the provision of accurate and consistent information, the Federal Government has proposed a specific amendment to the Copyright Act to allow generic companies to prepare and lodge PIs that are substantially the same as PIs for an originator medicine.

What are the amendments?

If passed, a new section 44BA will be inserted into the Copyright Act to provide that:

  1. copyright in a PI approved under section 25AA of the Therapeutic Goods Act is not infringed by persons who submit a separate PI for approval by the TGA; and
  2. supplying, reproducing, publishing, communicating or adapting an approved PI will not infringe the copyright in that PI, provided that this supply, reproduction, publication, communication or adoption is for a purpose related to the safe and effective use of the relevant medicine.

The exemption will only apply to acts done after the commencement of the amendments.

The Bill also provides that, if the amendments would result in the acquisition of property from a person otherwise than on just terms, the Commonwealth must compensate that person.  This is a precautionary measure to ensure the Constitutional validity of the amendments.

We will keep you updated on the progress of the Bill.

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About the Author

James EllsmoreJames is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.View all posts by James Ellsmore

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