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Pharmaceutical Patents

Patents & Lifecyle Maximisation

Originator pharmaceutical companies practise what are euphemistically known as “total product strategies” or “lifecycle maximisation” by seeking to obtain as many patents as possible ...*

Ever increasing patent protection

Patent protection for pharmaceutical products has increased substantially since the 1980s. In fact, the EU currently boasts the highest level of market protection for pharmaceuticals in the world. Patents have been available for biotechnology products since 1998. The old 15-year patent regimes were replaced with modern 20-year product patents in the early 1990s. This 20-year protection can now be increased by up to 5 more years through a Supplementary Protection Certificate (SPC). SPCs were introduced in 1992 to compensate originator companies for the time and cost of developing registration data.

In addition to this 25-year protection, further patents for varying periods are regularly granted to pharmaceutical companies for new uses, indications, dosages and changes in formulation, colour or markings. These patents provide additional years of market monopoly for often insignificant changes, providing little or no added therapeutic value to patients.

Strategic Patenting

Pharmaceutical originators practise “total product strategies” or “lifecycle maximisation” by seeking to obtain as many patents as possible during the development and marketing cycle, and to extend them for new uses of established products, or to add on to the time-lag between patent grant and public health approval.

Originators erect “picket fences” or families of dozens of patents around a single product covering numerous aspects of the product such as:

• basic composition, including new or alternative compounds;
• method of treatment, including new use of known compounds, different
  dosing, and therapies in combination with other drugs;
• synthetic production;
• formulation and drug delivery;
• prodrugs releasing active ingredient;
• substances resulting from metabolism in body;
• different crystalline or hydrated structures;
• gene-markers showing response to drug therapy;
• even devices such as patches for administering the drug.

Risk of Infringement

The complex science and the extent of coverage of pharmaceutical patents therefore introduces considerable risk of infringement into product development, making professional legal and scientific advice essential. There are many genuine disputes over patent validity in comparing inventions, requiring specialist court interpretation.

The business risk of infringement therefore arises in any drug or medical device development. For generics, it arises particularly because a generic medicine is defined as being identical to a branded drug in terms of active principle, and having the same pharmaceutical form, safety level, and therapeutic effect.

Further Protection

Originator pharmaceutical companies in the EU also enjoy, in addition to patent protection, a separate period of regulatory data exclusivity during which the regulatory authorities are not allowed to refer to the data on file for an originator drug in order to process an application for marketing authorisation for a generic medicine. The European Union recognised the importance of allowing drug originators time to recoup R&D investment by harmonising this protection period in the new pharmaceutical legislation which resulted from the Pharma Review.

* From a text prepared by Veronica Lowe, EGA Board Member (Mayne Pharma)