Patent Focus February 08

Leighton Howard is a patent information expert with extensive generics experience. He has worked within the professional patent information industry and major generic pharmaceutical firms and now provides consultancy services to the generics industry and government organisations via his company XIP Pty Ltd. He is also the founder of GenericsWeb and remains instrumental in maintaining the high quality and accuracy of data contained in Pipeline Patent Intelligence. Please email any comments or queries.

Patent Focus: when does the patent expire?

As someone who has worked in the IP area of generic pharmaceuticals for some time, a question that I have heard many, many times, is “ When does the patent expire on Drug X?”. The response that I reluctantly offer is “Which patent?”.

It would not take long before personnel new to the Generics Industry would discover that pharmaceutical products are not protected by only one patent, but by many. Perhaps the molecule is protected twice, once in a racemic form and once as an enantiomer, a specific salt may also be protected as well as a crystalline form (or lack of) for that salt. And this is all before we begin to consider formulation and dosing regimen patents.

Patents are, of course, one of the key elements of a marketed ‘Brand Product’ that determines when or if a company will develop a generic equivalent. Of most concern to executives in the Business Development departments of generic developers is when the product can legally be sold in a certain country or, to flip the question on its head, what products can be sold in which countries at a certain date in the future.

The need for the answers to these questions for Business Development executives to be concise, accurate and with limited technical complexity stems from a combination of their (mostly) non-technical background and their need to make important commercial decisions quickly and with confidence.

However, given the change in the patent landscape surrounding a Brand Product from one of relative simplicity to enormous complexity, how can such questions be answered in the most suitable manner? The following process should be used to ensure that business development executives ask the right questions of their database or IP team in regard to the right patents, and remove complexity from the answers they receive:

1) Identify Key Patent Families: These contain patents that you would probably infringe if you were to copy the innovator product in every way and launch it immediately. Such patents can be identified by databases such as the new GenericsWeb Pipeline Scope, or by using public patent registers such as the Orange Book for US patents (although this has severe limitations so should be used with caution). At most you will perhaps identify eight patent families, but on average you should identify approximately two or three.

2) Categorise the Patent Families by Importance: This will assist in determining which patents will impact on the date of launch of your product, and which can be avoided or ‘circumvented’. We consider the most effective way of doing this is by using the following categories: Brick Walls, Hurdles & Stumbling Blocks (Table 1).

Table 1 – Categorisation of Key patents

3) Check for Scope/Status/Expiry of patent in each desired country, including SPCs: At this stage one begins to look more closely at protection in an individual country. A patent family may fall into a different category in each country, based on the differences in claims granted at patent offices around the world (scope). Caution should therefore be exercised at this stage in making assumptions that all patents are the same around the world and/or in using categories listed in some databases where the category is not specific to the claims of the patent in the country of interest. For example the Atorvastatin enantiomer patent is restricted to a specific salt in the claims of patents in some countries, so becomes a ‘Hurdle’ in one country instead of a Brick Wall’ in another. Bear in mind that there may be two or more patents in a family that offer protection in one country, and each may fall into a different category. Once this has been checked, the legal status and expiry of the patent in each country should be noted along with the normal and extended expiry dates. It should be noted that each country may implement its laws on extensions differently (even within the EU) resulting in wildly differing expiry dates and allowability. Therefore the specific extension application/certificate should be checked for existence, scope and expiry in each country individually. This stage will result in a list of patents for each country, each with a corresponding category, status and expiry date.

4) Determine whether your product can/will circumvent a patent that remains in-force: For this part you may need some assistance from someone with a technical background and a basic knowledge of patents. If you do not have such a person within your organisation, the GenericsWeb Patent Academy is designed specifically to provide the skills necessary to conduct basic evaluation of patents. If you have completed parts 2 and 3 correctly, your proposed product will fall within the scope of the claims of each patent in the ‘Brick Wall’ Category. For each identified patent in the ‘Hurdle’ and ‘Stumbling Block’ category you must then determine whether your proposed product falls within its scope in each country.

5) Work out the earliest launch date for your product in each country: Now comes the crucial part; once you have your list of key patents and expiries in each country you need to first identify the latest expiring patent in the ‘Brick Wall’ category. This is the earliest date at which an unauthorised generic may enter the market (assuming no regulatory barriers exist). However, if your particular product does not circumvent the claims of the Hurdle and Stumbling Block patents, then the earliest launch date is the date of expiry of that patent or its corresponding extension.

Genericsweb Pipeline Scope is a new product that is intended to provide the higher-level patent expiry information required by business development executives working within generics companies worldwide, and contains key patent and SPC/extension data for 30+ countries. For more information please contact Leighton Howard by email: l.howard@genericsweb.com or phone +44 (0)870 879 0081.

For questions and comments about this article please contact the author at l.howard@genericsweb.com.

Leighton Howard
Managing Director
GenericsWeb
February 2008
l.howard@genericsweb.com