Dressed for International Success

Preparing (and Protecting) Drug and Device Patents for International Markets

The pharmaceutical industry is highly competitive and global growth continues. Although North America and Western Europe account for 56% of the global market, Asia Pacific has overtaken Western Europe as the second largest region. Some developing countries, including India, have seen enormous growth both from foreign investment and increased domestic R&D.

With some high-demand drugs losing patent protection and fewer drugs entering the market than before, pharmaceutical companies are racing to obtain patent protection in order to recoup their research and development expenditure. This competition extends far beyond domestic markets, as most pharmaceutical companies seek a patent in each country where they hope to market the drug.

It’s not hard to understand why competition in the patent arena is so high: approximately 80% of any given pharmaceutical company’s revenue is derived directly or indirectly from the patents it holds. Together the top 10 pharmaceutical companies account for 30% of global sales, making the market moderately fragmented. Those factors combine to create an environment that requires a streamlined approach to filing patents across dozens of countries to protect a drug or device in the markets a company plans to enter.

The drug development process involves high costs, high levels of risk and long lead times, with just one in 5,000 newly discovered chemicals actually becoming a medicine. Moreover, the process for developing a new drug is lengthy and costly, and the same can be said for the process of obtaining patent protection internationally. This process is hampered by the fact that most countries require pharmaceutical companies to file patents in that country’s native language. To patent a drug in the world’s key pharmaceutical markets, it will be necessary to accurately translate the patent into multiple different languages.

Source: “The Life cycle of Pharmaceutical Products”

Why Accurate Translation Is Important

It’s one thing to review a patent application in your native language with a fine-toothed comb. The process is exponentially complicated when you need to avoid errors in a variety of languages that are foreign to you and your legal department. A single translation error can have an enormous impact on the fate of your patent application in a given country.

The specifics of patent law vary from country to country, but there are three broad criteria that make drugs and devices patentable:

• The invention must be novel
• The invention must be non-obvious (inventive step requirement)
• The invention must be useful

Even if your drug or device meets these requirements, a translation error that materially alters the language of your application could increase the risk of invalidation, opposition, and weaken the patent’s position during infringement  litigation.

Streamlining the Translation and Filing Process

The cost of patent translation is an investment. Most in the patent industry are generally aware that pharmaceutical and biotechnology applications tend to be the longest. There is a huge amount of money at stake and even minor errors can have enormous consequences. Given that, and given the expenses faced by those organizations, it is extremely important to be proactively engaged in managing the translation component of your international portfolio strategy.

By developing a long-term relationship with a language service provider with expertise in the legal and patent sector, you will put yourself in the strongest position possible when entering new international markets and, in the end, lower your risks.

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You may also be interested in reading “Translation and the Growing Trend of Patent Filings in Latin America”.