BIO and BIA Call for Review of US Court Decision on Fetal DNA Test Patent


September 10, 2015.

   The Biotech Industry Organization (BIO) has teamed with the UK BioIndustry Association (BIA) and other industry groups, corporations and academics to call for the re-hearing of a panel decision of the United States Court of Appeals for the Federal Circuit to the full court to overturn the recent ruling on Sequenom’s fetal DNA test patent.    The method for non-invasive prenatal genetic diagnostic testing on paternally inherited foetal nucleic acids derived from maternal plasma or serum was originally patented by Isis Innovation Limited, a company owned by the University of Oxford. Sequenom subsequently acquired the rights to this intellectual property and they planned to leverage it for additional applications of their technology in the future. This new procedure, which is already available to patients, eliminates the need for risky amniocentesis.   A panel of US appeals court judges decided that the test patent was invalid as the newly discovered method "begins and ends with a natural phenomenon," and it is directed at "matter that is naturally occurring". If left unchanged, BIA reports, "the panel’s decision could prevent any analytical or detection method that investigates something that is naturally occurring from being patent protected - de-incentivising the R&D investments needed to drive innovation".    The BIA has filed an Amicus, or friend of the court, Brief to support the petition for the case to be reheard by the full Court. In its Amicus Brief the BIA has highlighted the possible impact on the bioindustry:   • It could make it impossible to secure R&D funding: The majority of BIA’s members are small and medium size enterprises. For these enterprises, their ability to raise R&D funding or attract larger companies to collaborate, heavily depends on the strength of their intellectual property, primarily in the form of patents. Lack of patent protection severely hinders their ability to bring to life new and improved treatments and, in many cases, makes it impossible. • It could damage the US biotech economy: Many of BIA’s members operate, or plan to operate, directly or indirectly in the United States. Start-ups and fledging businesses rely on the US market projections for securing R&D funding, as the US accounts for 47% of the global biotechnology market.   According to the USPTO, approximately 50% of all US patent applications are filed by foreign entities. • The panel decision is at odds with accepted patent eligibility standards and frustrates long standing harmonisation efforts: The panel decision in this case appears at odds with the global IP systems developed and woven into the fabric of international relations and trade for over a century and appears fundamentally incompatible with recent major legislation in the US. • The patent has been approved and upheld on appeal in Europe and the UK.      

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