Data protection

Manufacturers spend many millions of dollars researching, developing, testing and marketing new products.

Companies are entitled to protect their new products from those who may quickly replicate and sell duplicate products.

Agcarm asks for a fair go through data protection and patent protection.

Data protection

The research required for a product to become registered is very detailed and demands investment of significant resources.

Regulatory data is the research and test results generated by crop protection and veterinary medicine companies to prove the safety and efficacy of a product.

The protection of regulatory data is essential for innovation and development of new products.

What is the data for?

Data is required by the Environmental Protection Authority and the Ministry for Primary Industries before they approve the sale of an agricultural compound. This information, often costs millions of dollars to obtain, can then be copied by other companies.

How much protection in NZ?

New Zealand offers:

  • 10 years protection for innovative products
  • five years for new uses
  • five years for reformulations/non-innovative
  • five years for reassessments

The ACVM (Data Protection) Amendment Bill, which included these increases to data protection, was passed into law on 8 November 2016.

See:

The recent data protection increase strikes that balance, between the rights of innovator companies to receive an acceptable return from their investment in innovative products, while working in a competitive market in which generic copies of their products keep prices down.

Data protection is not the same as patent period

Patents protect the invention, not the data required for pre-market approval. Patents and data protection should run concurrently meaning, in some cases, the data protection period will expire at the same time as the patent.

Patents

New Zealand’s patent law needs two major improvements.

The first focuses on allowing the term of a New Zealand patent to be extended.

In 1994, the term of a patent was extended from 16 years to 20 years, but at the same time a provision was repealed that would have allowed for a maximum term of up to 26 years in cases where regulatory delay had occurred.

Agcarm would like to see the law changed to allow for extensions to the current maximum term.

This would make sense, particularly in our industry where regulatory conditions and product registration processes are not always straight forward, but investment in research and development is significant and needs to be fully recouped.

Opposing ‘springboarding’

Springboarding was introduced in 2002 without public consultation to allow Pharmac to facilitate more easily the introduction of cheaper, generic pharmaceuticals on to the New Zealand market.

However, springboarding has serious intellectual property implications for our industry and does pose significant commercial risks.