Evergreening through Patent Strategies

One form of evergreening occurs when the originator manufacturer “stockpiles” patent protection by obtaining separate 20-year patents on multiple attributes of a single product. But many other evergreening strategies exist ...

Evergreening, in one common form, occurs when the brand-name manufacturer literally “stockpiles” patent protection by obtaining separate 20-year patents on multiple attributes of a single product. These patents can cover everything from aspects of the manufacturing process to tablet colour, or even a chemical produced by the body when the drug is ingested and metabolised by the patient.
In the 1980s the list of a drug’s properties eligible for patenting was relatively limited. They included:
·          Primary uses
·          Processes and intermediates
·          Bulk forms
·          Simple formulations
·          Composition of matter

During the 1990s the catalogue(1) grew to 18, nearly four times the amount of a decade earlier, to include patents on such additional aspects as:
·          Expansive numbers of uses
·          Methods of treatment
·          Mechanism of action
·          Packaging
·          Delivery profiles
·          Dosing regimen
·          Dosing range
·          Dosing route
·          Combinations
·          Screening Methods
·          Chemistry Methods
·          Biological Target
·          Field of use

Evergreening & Pharma Research Costs
When evergreening through patent strategies, the originator manufacturer simply keeps adding patents to the product (whether legitimate or not), essentially forcing the generic manufacturer to choose between waiting for all the patents to expire and applying for marketing authorisation anyway, running the risks of litigation and the associated costs and delays.
In fact, the practice has grown to such proportions that even the originator industry, caught in the trap they themselves created, have begun to complain about the costs involved in litigating disputes over multiple pharmaceutical patents involving their own research (2).

“Life-cycle management” & Evergreening
Indeed, originator laboratories no longer wait until the end of a product’s patent life to begin the evergreening process. In order to maximise revenues from their products, pharmaceuticals executives begin preparing strategies to extend patents and stifle generic competition at the outset of product life-cycles.
To evergreen their products, the originator company will develop what are euphemistically called “life-cycle management plans“ composed not only of patent strategies, but an entire range of practices aimed at limiting or delaying the entry of a generic product onto the market.

Questionable practices - higher prices for patients
While most of these strategies are, in the strictest sense of the word, legal, most represent a misuse of pharmaceuticals patents and the regulations governing authorisation. Evergreening is clearly anti-competitive, results in higher expenditure for Europe’s financially burdened healthcare systems, and drives up patient co-payments.

In the words of Greg Perry, Director General of EGA:

• Valuing Pharmaceutical Innovation (14/10/2008)
• Chugai Pharmaceutical Co. Ltd (07/10/2008)
• Contract Manufacturing Strategies (10/06/2008)

• Sanofi vs. Lupin (22/07/2006)
• Relpax (24/05/2006)
• Patent Expiry Dates (01/03/2006)

• IP case - Atorvastain (02/01/2006)
• IP Case - Sildenafil (22/12/2005)

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