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Feb 15, 2009 (Vol. 29, No. 4)

Does Offshoring Put Patents in Jeopardy?

Piracy of Intellectual Property Remains Major Concern Especially in Gene Manufacturing

  • Intellectual Property Risk

    The single most prevalent and costly risk associated with offshoring to China is the risk posed to intellectual property. According to statistics out of Hollywood, 9 out of 10 DVDs that are sold in China are pirated. While there have been some efforts made by the Chinese government to better protect IP, estimates are that global piracy costs U.S. companies upwards of $60 billion a year. Closer to home for the life science industry, it is reported that 9 out 10 Western medications sold in China are pirated.

    The GAO reported before a House Judiciary Committee last year that, “High profits and technological advances have also increased the risk of IP infringements by making counterfeiting and piracy more attractive and easy to conduct. At the same time, deterrents such as penalties and other measures have failed to keep pace. The seriousness of these risks has been exacerbated by weak enforcement in some countries, particularly China.”

    What does the piracy of entertainment or software industry intellectual property have to do with life science? In the area of gene manufacture, the intellectual property is in the precise sequence of bases in the same way that the programming of bits that make up a software application is what is valuable. In either case, ripping additional copies of the physical original is incredibly cheap and easy to do.

    Intellectual property is the cornerstone of the life science industry. Certainly the sequences of DNA that are being utilized in drug discovery, biofuels research, and in furthering the understanding of biological and biochemical processes are some of the most fundamental elements of intellectual property for life science companies and research institutions.

    Scientists have naturally come to depend on an industry of gene suppliers in order to facilitate their research in a timely, cost-effective manner. Gene suppliers are able to apply their expertise and scalability to produce genes and sequences of DNA in a fraction of the time that it would take researchers to do on their own.

    Quite a number of gene manufacturers operate out of China, while many major gene suppliers have taken to offshoring the manufacture of genes to sites in the country. Genes manufactured in China can be attained at a cheaper price, but what are the risks in procuring genes made there?

    With no concerted effort by the Chinese government to enforce IP protection, companies and research organizations are playing Russian roulette with their patents and confidential intellectual property. While it might make sense to manufacture common sequences at whichever competent facility can provide the lowest price, why would a company risk its valuable IP by having patented sequences manufactured in a country notorious for the violation of intellectual property rights? 

    Start-ups, in particular, are in need of watertight protection for their intellectual property, as they don’t have the legal resources of the big pharma companies to engage in filing suits and otherwise protect IP.
    Several U.S.-based suppliers of genes offshore the manufacture of genes to China without any mention of the practice to their customers. This practice is dishonest, and it puts their customers’ intellectual property at risk without their knowledge. Certainly, reputable gene providers will make it clear to their customers where their orders are being made. However, organizations need to be responsible for protecting their critical intellectual property.

    Managers, company attorneys, investigators, and researchers themselves need to be vigilant in protecting their organization’s intellectual property. This means being cautious in deciding how and where to manufacture genes and finding out just where the gene manufacture takes place.

    With the economic downturn greatly affecting both life science companies and academic institutions, the importance of protecting intellectual property is more critical than ever. While outsourcing is certainly an important cost-saving measure to be utilized strategically, there is still too high a risk of exposing intellectual property associated with manufacturing genetic material in China. Although recent passage of stronger IP laws in China should offer better protection, academic institutions and companies must continue to be vigilant in protecting their highly confidential sequences.

Readers' Comments

Posted 03/13/2009 by Pride goes before the fall

If the software industry and Hollywood, with their vast resources and lawyers can't stop piracy, it would be sheer arrogance if biotech thinks it's immune.

Posted 02/19/2009 by information

With the current weak standing of sequence based patents (Science, Trend in Human Gene Patent Litigation, Holman, 2008, 322:198), and the inconsistent international protection, one can never be too cautious protecting ones biotech IP.

Posted 02/17/2009 by Dr

As long as there are regulatory hurdles (e.g., FDA) to overcome, bio-therapeutics are safe. Not relevant comparing DNA to DVDs.

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