GENERIC PHARMA IN NEW ZEALAND - TAKING ADVANTAGE

On the world stage New Zealand is not a huge player in the pharmaceutical industry, our population of 4 million comprising less than 1% of the world pharmaceutical market.

From a regulatory point of view, New Zealand benefits the generic pharmaceutical manufacturers (generic pharma companies) by only having a five year period of data exclusivity on all new chemical entities authorised in the country, and no data exclusivity period on new formulations or indications. Data exclusivity provides the innovator company with a period of protection over the data supplied by them to gain regulatory approval in a country. Once this period of data exclusivity ends, the generic manufacturer may then use this data to prove the safety of their own bioequivalent drug, without the expense of conducting their own clinical trials. New Zealand's five year exclusivity period is in contrast to the longer exclusivity given in the EU and countries such as Japan and the United States, where the term can be up to ten years from first approval of a drug.

Also in favour of the generic pharma companies is section 68B of the New Zealand Patents Act. Section 68B is a regulatory review exception (otherwise known as "springboarding" or a "Bolar" provision), which states;

"It is not an infringement of a patent for a person to make, use, exercise or vend the invention concerned solely for uses reasonably related to the development and submission of information required under New Zealand law or the law of any other country that regulates the manufacture, construction, use, or sale of any product."

Since the introduction of section 68B, generic companies have been able to safely prepare their equivalent products and gain regulatory approval in New Zealand from MedSafe (New Zealand's Medicines and Medical Devices Safety Authority), prior to the expiry of patents covering the innovator drug. This allows them to hit the ground running when the patent comes off protection - a favourable outcome for both the consumer and the company's bottom line.

When comparing the New Zealand springboarding provision to those of other countries in Asia, the scope is fairly broad. There is no limitation on the product on which testing will be undertaken as there is in, for example Japan or Malaysia, where the provisions are restricted to the use of a chemical compound or medicine and the use of a pharmaceutical patent respectively. The broad scope of the provision in New Zealand opens the door for testing of any product that requires regulation, including veterinarian products, chemicals, foodstuffs and agricultural products to name a few.

Secondly, the wording of section 68B allows for use of the invention when working towards gaining regulatory approval in any country, not just New Zealand. For countries such as China, Indonesia and the Philippines, where there are currently no springboarding provisions in place, New Zealand is a potential location for companies looking to prepare their product for launch on expiry of the relevant patents in their own countries.

Gaining expert intellectual property advice is invaluable for both generic pharma companies and other companies working with products that have associated patent protection. Whether companies are based in New Zealand, or just looking to take advantage of New Zealand's current regulatory legislation in preparation for entry into a foreign market, having a good knowledge of the local environment will keep them a step ahead of the competition.

By Jennifer de Vere, Intellectual Property Specialist, James & Wells Intellectual Property