If your biotech company is developing genetic products or methods, then you need to know that the laws of gene patentability could change in the United States and potentially elsewhere. 

To future-proof your R&D investments and innovation, we recommend that your patent applications relating to isolated molecules from humans or other animals are drafted to retain clear exemplification for both the functionality of the molecule and potential commercial uses, with appropriate claims to suit. This is the approach we take when drafting patent specifications for our biotech clients.

In this way, if isolated DNA (or other matter isolated from a body) is found to be unpatentable, patent protection for the specific uses and methods of use may still be gained.

We recommend that you speak to a biotech patent attorney to develop a strategy to match your company's goals and specific circumstances.

It is also important to keep track of ongoing developments as we have outlined below together with our interpretation and opinions on the matter.

Background

In March 2010, a New York District Court (a lower Court) ruled that Myriad's patent claims relating to breast cancer genes BRCA1 and BRCA2 are invalid.  The decision emphasised that isolated genes were, in essence, just DNA sequences which occur naturally in the human genome, and therefore are not patentable.

The District Court also concluded that Myriad's claims relating to methods of testing for mutation(s) in these genes for breast cancer diagnosis are not patentable. This was because it was found that it was merely an "abstract mental process" and a comparison, which is not patentable subject matter. 

This decision is by no means final. The District Court's ruling is just the start of an investigation of gene patentability. Myriad has appealed the decision to the Federal Circuit. 

Recent Developments

In October 2010, many opinions (termed "amicus briefs") were filed at the Federal Circuit by parties who are not directly involved in the case.  An important amicus brief is that of the Department of Justice (DOJ) - whilst the Federal Circuit may take the DOJ's stance on the matter into consideration when making their ruling, Myriad will still have the option appealing to the Supreme Court if the Federal Circuit's legal opinion is not favourable.

In summary, the DOJ brief:

- states that isolated matter from the human/animal body, without further manipulation or alteration, is not considered patentable subject matter as it is not considered to be a "human-made" invention.  It was argued that simply isolating a naturally occurring structure does not make the DNA patentable;

- considers the following molecules containing DNA are patentable as each requires human manipulation or alteration of a naturally occurring structure (DNA):

  •  cDNAs
  • vectors
  • recombinant plasmids
  • chimeric proteins
  • industrial products such as vaccines and genetically modified crops.

Interpretation

We consider there is still concern over what constitutes a "human manipulation or alteration". 

Indeed, an isolated version of a DNA molecule requires human manipulation for it to exist outside the body, and therefore should be patentable as outlined by the DOJ's amicus brief.

We consider it likely that the Federal Circuit will concur with the DOJ's amicus brief, drawing the line at isolated DNA in itself as being unpatentable, yet anything involving further manipulation beyond isolated matter will be considered patentable. 

In a worst-case scenario, the Federal Circuit may take a broader interpretation of isolated matter such that not only DNA, but also components such as proteins and antibody isolates will not be patentable.

Furthermore, any method of genetic testing/diagnosis will likely be considered patentable if it satisfies the general test for determining patentability of method claims (termed the "machine or transformation test" as outlined in Bilski).  Of course, the claims will also need to ensure it satisfies the standard novelty and inventiveness tests as well.

Our Opinion

We are of the opinion that the final decision on gene patenting should reflect a balance of convenience for both the general public and the biotechnology industry. 

The decision should allow companies to protect the valuable outcomes of their R&D investments where real innovation prevails.  Indeed, a specific isolated DNA molecule of interest can represent a valuable tool for applications not only for therapeutics, but also in a laboratory setting (e.g. PCR probes).

Without this level of protection, biotech innovation will suffer. This may ultimately affect the development of new therapeutics, treatment methods and diagnostics available to us all.

Also, if patents are not available for such isolated genes for example, many new genetic innovations may be kept as trade secrets, and not become public information for use after the patent term expiry.

Isolated DNA, protein, antibodies and other molecules should be patentable subject matter only if the Applicant can illustrate clear commercial value of the isolated matter through research.

In Myriad's case, we consider that the BRCA1 and BRCA1 isolated genes in their isolated form should be patentable.  This is due to the extensive research needed to identify the genes' importance and mutations therein which are linked to breast cancer.  Such a discovery leads to clear commercial opportunities when the discovery can be utilised by manipulating (e.g. isolating) the gene.  

Also, methods of testing or diagnosis, such as comparing an isolated DNA test sequence against marker sequences should also be patentable.  However, any such method claims must still satisfy the "machine or transformation test" defined in Bilski and general novelty and inventiveness requirements set out according to patent law.

If, however, isolated genes are found to be unpatentable subject matter, Myriad's claims relating to the isolated BRCA1 and BRCA2 genes could be amended, for example, to a novel composition for use as a gene therapy.  Similarly, the method of diagnosis claims could be amended to specify the use of a DNA sequencing device to satisfy the machine or transformation test. 

Clearly, the biotech industry is tentatively awaiting the decision of the Federal Circuit.

Keep up to date with our ongoing publications on this topic as the case develops both in the United States and other jurisdictions. 

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

James and Wells is the 2009 New Zealand Law Awards winner of the Intellectual Property Law Award for excellence in client service.