Myriad woes for US innovators
In April 2013 the US Supreme Court handed down its decision in Association for Molecular Pathology v Myriad Genetics, which concerned the validity of a series of patents directed to the breast cancer susceptibility genes BRCA1 and BRCA2. The case required the court to assess whether a naturally occurring ‘segment’ of DNA could be patent-eligible by virtue of its isolation from the rest of the human genome.
Despite the longstanding practice of the US Patent and Trademark Office (USPTO) to grant patents for ‘isolated’ DNA sequences, the court held that such sequences were not patentable and fell squarely within the ‘law of nature’ exception. Conversely, the court found that synthetically-created DNA, including complementary DNA (cDNA), was “not a product of nature” and therefore patentable.
USPTO guidance
In the wake of the Myriad decision, the USPTO issued preliminary guidance in June 2013, indicating that examiners should now reject product claims to naturally occurring nucleic acids, whether isolated or not, but that claims to non-naturally occurring nucleotides remained patent-eligible.
This preliminary guidance was therefore consistent with the Myriad decision, interpreting it narrowly to allow the grant of patent claims to inventions involving synthetically-created DNA and manmade variants of genetic sequences, thus minimising the likely impact of the decision on the US life sciences industry. More comprehensive guidance was promised.
Final guidance to examiners arrived in March 2014 and supersedes the preliminary guidance. It not only addresses the Myriad decision, but is said also to reflect the Supreme Court’s long-standing ‘rule against patents on naturally occurring things’ expressed in its earlier precedent decisions, including Diamond v Chakraborty and Mayo Collaborative Services v Prometheus Laboratories, Inc.
With potentially far-reaching implications for US innovative industry as a whole, the guidance extends the decision in Myriad beyond isolated nucleic acids to all claims concerning ‘judicial exceptions’ such as laws of nature and/or natural products.
The guidance includes a series of questions to determine whether subject matter is patentable:
Question 1: Is the claim directed to a process, machine, manufacture or composition of matter?
Question 2: If yes, does the claim concern one or more judicial exceptions, such as abstract ideas, laws of nature or natural products found in or derived from nature? This includes (without limitation):
o Chemicals derived from natural sources (egg, antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc);
o Foods (eg, fruits, grains, meats and vegetables);
o Metals and metallic compounds that exist in nature; minerals; natural materials (eg, rocks, sands, soils);
o Nucleic acids; organisms (eg, bacteria, plants and multicellular animals); and
o Proteins and peptides.
Question 3: If yes (or if there is any doubt), does a multifactorial assessment conclude that the claim as a whole recites something significantly different from the judicial exception? One factor that weighs against patent-eligibility is if something is ‘not markedly different’ in structure from a naturally occurring product; another is the inclusion of additional elements/steps that are well-understood/routine in the relevant field.
If the claimed product is a protein, the analysis must proceed to question 3, irrespective of whether it concerns, for example, an ‘isolated’, ‘recombinant’ or ‘synthetic’ product.
The guidance is likely to have a significant impact on the scope of claims relating to laws of nature and natural products that the USPTO is willing to grant. For example, claims to purified proteins and naturally-occurring antibiotics that were previously determined to be patentable subject matter are likely to be rejected. Additionally, ‘% identity’ sequence claims that correspond to nucleic acid or protein sequences found in nature will also not be patentable. Equally, vaccine claims that rely on a selected fragment that is identical to the natural protein will not be patentable unless they are ‘markedly different’ from the natural protein, which is likely to undermine the very purpose of the claim.
What ‘significantly’ or ‘markedly’ different means in anything other than extreme cases (or claims that fall squarely within the examples in the guidance) is likely to remain far from clear until the case law evolves, as will the relative weight to be attributed to each factor when assessing question 3.
The patent landscape in Europe
In Europe, the patentability of inventions in the field of biotechnology is governed by Directive 98/44/EC. In the 1980s, the backdrop for what finally resulted in this ‘Biotech Directive’ was a fear that European industry would lag behind its Japanese and US counterparts; in Japan and the US, patents were being granted for biological material of human, plant, animal and microbial origin. Although the European Patent Office (EPO) was adopting the same practice, there remained uncertainty as to how national courts would view the validity of such patents and concern about what impact this might have.
The Biotech Directive therefore aimed to establish harmonised, clear and improved standards within the framework of existing patent law. By the time it became law, the Biotech Directive reflected what had already become the established practice of the EPO in granting patents in this area.
Contrary to the current position in the USPTO guidelines, the Biotech Directive affirms that isolated biological material is patentable even if it has occurred previously in nature. Furthermore, an invention relating to gene sequences can be patented even if the sequence is identical to that occurring in nature, provided that the industrial application of the sequence is disclosed in the patent and all other patentability criteria are fulfilled.
Therefore, European patent protection is available for, for example, novel gene sequences, protein sequences, peptide vaccines and nucleic acid vaccines, even if such products correspond to those found in nature.
Uncertain times for US industry
Although the USPTO guidelines are not legally binding, until the courts interpret and clarify the impact of Myriad and the earlier decisions, US practitioners and US innovative industry face a period of uncertainty and many challenges ahead in crafting patent claims that distinguish inventions as much as possible from anything found in, or derived from, a natural product or law of nature. Additional guidance may also be forthcoming—on May 9 the USPTO hosted a public roundtable to solicit public feedback on the final guidance. However, for the moment, Europe offers a more predictable forum for achieving patent protection.
Whether this will provide a boost for the European life sciences industry remains to be seen. Either way, the USPTO’s guidance in its current form creates a stark divide between the scope of biotechnology patent protection that can be expected in Europe and what can be expected in the US.
Bethan Hopewell is an associate at Powell Gilbert LLP. She can be contacted at: bethan.hopewell@powellgilbert.com
Jennifer Antcliff is an associate at Powell Gilbert. She can be contacted at: jennifer.antcliff@powellgilbert.com
