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    US Perspectives
    After Mayo, Is Patent Law More Restrictive In US Than Europe?

    Published on 5 April 2012 @ 3:18 pm

    By for Intellectual Property Watch

    The United States is known for taking an unusually expansive approach towards patentable subject matter. Compared with Western Europe, for instance, the US has been far readier to grant patents on business methods, medical diagnostic processes, and human genes.

    America’s leniency, however, may be ending. In the last decade, the nation’s courts significantly cut back on the types of inventions that can be patented. And the US Supreme Court’s 20 March ruling in Mayo Collaborative Services v. Prometheus Labs., Inc. [pdf] restricts patentability still further. The decision could bar patents on many medical diagnostic methods, personalized medical treatments, and human genes. Depending on how the ruling is interpreted, America’s standard of patentability could become, in some important ways, even stricter than Europe’s.

    US law, like that of nations around the world, declares that natural phenomena and laws of nature are not patentable subject matter. No one can patent e=mc2, for instance.

    Inventions that apply natural laws or natural phenomena are, however, patentable. One can thus patent a process for turning uncured rubber into moulded rubber products, even though the process uses a law of nature to determine when to open the mould.

    But if an invention uses only “well-understood, routine, conventional” acts in order to apply a law of nature, that is basically an attempt to patent the underlying law of nature – and the invention is unpatentable subject matter, the US Supreme Court unanimously held in Mayo. The court applied this reasoning to strike down a patent on a process for using thiopurine in personalized medical treatments.

    Thiopurine is known to be an effective treatment for autoimmune diseases, but people vary significantly in their ability to metabolize it. The same dose of thiopurine affects different people differently. As a result, doctors have trouble predicting how much of the drug to administer any specific patient. They know that if the dose is too low, it will be ineffective, and if the dose is too high, the patient can suffer harmful side effects.

    The invention at issue in Mayo was a simple process for determining thiopurine dosage: administer thiopurine, then determine the level of thiopurine metabolites in the patient’s blood, and adjust the dosage if the metabolite level is too high or too low. The Supreme Court found that the relationship between the amount of thiopurine metabolites and the effect of thiopurine was simply a law of nature.

    The remaining parts of the invention – administering the drug and determining the level of drug metabolites in a blood sample – were just “well-understood, routine, conventional activity already engaged in by the scientific community,” and this was not “sufficient to transform unpatentable natural correlations into patentable applications,” the court held.

    Mayo’s ramifications could be far-reaching. The decision could be “a big step towards restricting the scope of patentable subject matter,” said Prof. Rebecca Eisenberg of the University of Michigan Law School.

    It could prohibit patents on many other personalized medical treatments. If so, this would bring the US more in line with Europe – which forbids patents on medical treatment.

    The ruling also “has the potential to invalidate a large number of diagnostic patents,” said Ned Israelsen, a partner in Knobbe Martens, Olson & Bear. That could put the US in the unusual position of denying legal protection to some inventions – in vitro diagnostic methods – that other countries are willing to patent. “In vitro diagnostics are generally patentable in Europe [and] Japan,” noted Michael Gollin, a partner in Venable.

    Mayo may also undermine gene patents. Less than a week after the Supreme Court issued its decision in Mayo, the court vacated a controversial ruling [pdf] that isolated human genes are patentable subject matter and remanded [pdf] the case “for further consideration in light of Mayo.”

    The gene patent case, Association for Molecular Pathology v. Myriad Genetics, now goes back to the Federal Circuit (often called the nation’s patent court”). Isolated DNA has been patentable for decades in the US, and many experts expect the Federal Circuit will reaffirm its prior ruling that isolated genes are patentable.

    Some experts, however, are not so sure. Prof. Dennis Crouch of the University of Missouri Law School noted on his blog that “Following Mayo, the court could logically find that the information in the DNA represents a law of nature, that the DNA itself is a natural phenomenon, that the isolation of the DNA simply employs an isolation process already well known and expected at the time of the invention, and ultimately that the isolated DNA is unpatentable because it effectively claims a law of nature or natural phenomenon.”

    If the US courts rule isolated genes are not patentable subject matter, America’s standard of patentability in this area will be stricter than Europe’s. The European Patent Organization, which has 38 member states, follows the EU’s Biotech Directive, which states that “biological material which is isolated from its natural environment” may be patentable “even if it previously occurred in nature.”

    Steven Seidenberg is a freelance reporter and attorney who has been covering intellectual property developments in the US for more than 15 years. He is based in the greater New York City area and may be reached at info@ip-watch.ch.

     

    Comments

    1. After A Tough 2012, IP Owners In US Face An Uncertain 2013 | Intellectual Property Watch says:

      [...] March, the Supreme Court narrowed the scope of patentable subject matter. The ruling in Mayo Collaborative Services v. Prometheus [...]


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    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

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