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European Pharmaceutical Contractor

Expiry Date

Over the years, we have seen many changes in the intellectual property (IP) strategies used by pharmaceutical companies. The industry is no longer thinking about IP in terms of just patents and trademarks, but is devising plans for the entire lifecycle of products, incorporating all elements of protection – including three-dimensional (3D) and packaging trademarks, and registered designs. Three well-known drugs – Viagra®, Revatio® and Nurofen® – provide examples of how effective use of IP rights, at different points in a product’s lifecycle, can ensure continued revenues.

Long-Term Monopoly

Sildenafil is a phosphodiesterase-type 5 (PDE5) inhibitor, more commonly known as Viagra. First developed by Pfizer, sildenafil was originally identified as a treatment for pulmonary arterial hypertension (PAH). However, during clinical trials, a certain side-effect was observed in male test subjects, giving Pfizer the opportunity to market the drug for a secondary use. The company filed a European patent application directed to the drug compound in 1991, which was granted in 1995. Since the term of protection for a patent is 20 years from the date of filing, this gave Pfizer a monopoly over the compound until 2011.

For many medicinal products, the lengthy time period required for drug development and studies can often lead to only a short window remaining on a granted patent, once the product reaches the market. As a result, proprietors of pharmaceutical patents frequently have a very limited amount of time while the patent remains in force to recoup the extensive R&D costs. To overcome this, proprietors can apply for a supplementary protection certificate (SPC) – an IP right that extends the duration of product protection for up to five years. Pfizer was issued an SPC for sildenafil, which extended protection until June 2013.

Second Medical Use

Other than those focused on the compound itself, developers can also apply for ‘second medical use’ patents, in which the use of the compound to treat a particular disorder or disease is protected. Applying for such a patent is a tactic often used by developers to extend the term of protection for their product. Pfizer followed this strategy in 1994 and filed an international patent application, aimed at the use of sildenafil for the treatment of erectile dysfunction (ED). Patents directed to the specific use of sildenafil were granted in Europe and the US – however, the European patent was later revoked in opposition proceedings. While the US method of treatment has been challenged in court, this was unsuccessful – so, at present, the patent remains valid until 2019.

Because no patent relating to sildenafil is now in force in Europe, but a method of treatment patent remains in the US, generic versions of Viagra have become available in the former, but not in the latter.

The two separate uses of sildenafil mean that the drug requires two separate names in order for each individual use to be recognised. Consequently, sildenafil is identified as Viagra for ED and Revatio for its original use – the treatment of PAH.

Registered trademarks on the name were secured for Revatio in the UK and Europe – in 2000 and 2004, respectively – and EMA marketing authorisation was granted in 2005 – a classic IP strategy.

However, the IP tactics employed by Pfizer for Viagra were very different to its counterpart; partially due to the loss of the second medical use patent in Europe. Pfizer has in excess of 25 European Community Trade Marks (CTMs) covering words, acronyms and 3D shape marks relating to Viagra, which can last indefinitely. They also secured 3D CTMs depicting a blue rhomboid tablet with embossed ‘VIAGRA’ and ‘VGR’ characters. In addition, the company holds a Registered Community Design, filed in 2003, which protects the appearance of the drug. This lasts until 2028 – well after expiry of the patent. Pfizer received EMA marketing authorisation for the drug in 1998.

Available Generics

It was suspected that there might be a dramatic increase in the availability of generic versions of Viagra as of June 2013, when the patent for sildenafil expired. Indeed, according to the EMA, four applications were received in 2009 for the authorisation of generic sildenafil for the treatment of ED. At present, however, the British National Formulary only lists two manufacturers’ products for ED treatment using sildenafil: Viagra and Nipatra®, made by Amdipharm Mercury Company Ltd.

While both are prescription-only medication (POM), only Nipatra is available on the NHS. The British National Formulary lists the price points for Viagra and Nipatra at £21.27 and £1.03, respectively, for a 50mg pack of four tablets (£5.32 and £0.26 per tablet). In comparison, Revatio (available on the NHS for treatment of PAH) is priced at £446.33 for a 20mg pack of 90 tablets (£4.95 per tablet).

Novel Approach

Not only has the IP strategy for Viagra differed from the classic model, Pfizer has also applied a novel commercial approach. The medication is viewed by many as a lifestyle drug and, therefore, is often not covered by insurance or national health services. There has been a major educational programme from Pfizer in relation to ED over the past 16 years, encouraging the general public to seek advice about the condition from their doctors – a scheme known as ‘VIAGRA Talk’. In 1998, it was an unusual strategy to initiate contact with the end-user of a pharmaceutical, rather than with medical practitioners, but its success resulted in the general public recognising Viagra as ‘the little blue pill’.

Although difficult to compare like for like, the impact of patent and SPC expiration on Viagra sales, thus far, appears to have been less extreme than on those of Revatio. A precipitous drop in sales revenue was observed for the latter after worldwide patent expiration in 2012. This was not the case following the end of European SPC protection for Viagra, despite major European markets accounting for almost one quarter of worldwide revenues in 2012. It will be interesting to see the impact on sales revenue following patent expiration in the US in 2019.

Brand Expansion: Nurofen

Ibuprofen, a long-standing pharmaceutical, is a non-steroidal, antiinflammatory drug for the treatment of pain and inflammation. Originally created by Boots Pharmaceuticals, the corresponding UK composition patent application was filed in January 1962. In 1969, it was launched as a POM, under the name Brufen®. The corresponding trademark application was filed in December 1967.

After its UK patent expired in 1983, due to its excellent safety record, the drug was granted over-the-counter (OTC) medication status. In 1981, Boots also applied for the registered trademark Nurofen, which was subsequently used for the OTC drug.

Since then, the Nurofen brand has seen expansion with the release of different formulations, including for cold and flu, and delivery methods such as oral suspensions for children. Between 1994 and 2001, the company is understood to have achieved a threefold revenue growth around the product.

In 2007, Reckitt Benckiser Healthcare (UK) purchased Boots Health International and its trademarks were assigned to the new owner. The £1.879 billion sale included the purchase of key brands – Nurofen, Strepsil®, Clearasil®, E45® and Optrex®, for example – adding over £1 billion to the value of Reckitt’s portfolio. Reckitt currently owns in excess of 26 CTMs relating to the Nurofen brand, demonstrating the value it has given the firm. According to Reckitt, in 2009, Nurofen was a leading analgesic in Europe, and has since been described in the UK as “the nation’s favourite branded painkiller”.

The price point of Brufen (POM) is £3.92 per 100 pack of 200mg tablets (£0.039 per tablet). Generic tablets can cost £0.99 per pack of 24 200mg tablets (£0.041 RRP). Meanwhile, Nurofen costs £2.77 per pack of 16 200mg tablets (£0.173 RRP).

The financial accounts of Reckitt demonstrate consistent revenue for Nurofen products year-on-year. This track record means future revenue is taken into account when calculating brand value. As a result, the value attributed to the Nurofen brand is actually higher than the sales revenue per annum. Trademarks of the drug are intrinsic to this brand value.

Planning for Success

Successful marketing for pharmaceutical drugs requires increasingly long-term strategic planning. While patents on compounds and their medical uses are key to preventing generic equivalents from entering the market, their expiration after 20 years can potentially lead to precipitous declines in revenue. However, as the example of Viagra demonstrates, if drug producers can take advantage of the 20 years of exclusivity conferred by a patent to build up a strong brand – which is normally associated with name alone, but strengthened if associated with appearance – then longer lasting trademark and design rights, protecting these brand elements from copying, can stem falling revenues.

Not only can trademarks and designs be valuable to patented drugs due to go off-patent, but, as the story of Nurofen tells us, they can be hugely valuable to drug brands marketed after the original patent has expired.

Note
Viagra, Revatio and Pfizer are all registered trademarks of Pfizer Inc. Nurofen, Strepsil, Clearasil, E45 and Optrex are all registered trademarks of Reckitt Benckiser Healthcare (UK). Nipatra is a registered trademark of Amdipharm Mercury Company Ltd. Brufen is a registered trademark of Abbott GmbH & Co.



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Tina Rees-Pedlar is a UK and European Trade Mark Attorney. She deals with contentious and non-contentions matters, including clearance searches and advice; filing and prosecution of trademarks; transfer and licensing; opinion and advice on trademark infringement; and passing off issues. Tina also handles oppositions and invalidation proceedings before the UK and Community Trade Mark Offices.
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Tina Rees-Pedlar
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