AIPPI: Is there light at the end of the gene-patenting tunnel?

During its World Congress in Sydney last year, the International Association for the Protection of Intellectual Property (AIPPI) passed an important resolution on gene patenting, which addresses the lack of international harmonisation regarding the patent eligibility of genetic material.

With an overwhelming majority of about 90% of the votes, the AIPPI delegates adopted the resolution, urging governments and patent authorities to treat nucleic acids as they would other chemical compounds.

The resolution also urged governments to implement the necessary legislative measures to ensure that genetic materials, when isolated from nature or artificially synthesised, constitute patent-eligible subject matter.

From the earliest gene-cloning experiments of the 1970s, the nucleotide sequence and function of genes from many organisms, including humans, had already been discovered and, in an isolated form, those genes with industrial and medical applications became the subject of patents around the world and the starting point for a thriving biotech industry.

The patenting of genes when isolated from their natural environment has long been controversial. In Europe, after considerable debate, the practice gained acceptance with the introduction in July 1998 of EU directive 98/44/EC on the legal protection of biotechnological inventions.

The directive provides that biotechnological inventions shall be patentable if they concern biological material, including molecules which are human genes or partial genes, which have been isolated from their natural environment or produced by means of a technical process (articles 3[2] and 5[2]).

An important further provision of the directive is that the industrial application of a sequence or partial sequence of a gene must be disclosed in the patent application (article 5[3]).

The provisions of the directive have been introduced into the implementing regulations of the European Patent Convention (see rule 29 EPC) and into the national laws of each EU member state. The Boards of Appeal of the European Patent Office (EPO) have further established that the function of the gene must at least be made plausible in the application as filed (eg, T1329/04).

The implementation of the directive nationally was not, however, consistent across all member states. In some EU countries, for instance France, Germany and Italy, the respective national laws specify that a claim to isolated human DNA protects it only to the extent that it is used for the identified industrial application.

In decision C-428/08 of July 6, 2010 (Monsanto v Cefetra and others), the Court of Justice of the European Union (CJEU) held that national patent legislation is precluded from offering “absolute protection” to patented DNA as such, “regardless of whether it performs its function in the material containing it”.

Accordingly, although the EPO grants patents with (product) claims to isolated nucleic acids per se, the protection afforded by such claims may be considerably reduced in EU member states during infringement proceedings.

Far-reaching implications

Much of the historical discourse in Europe regarding gene patents has concerned the ethics of patenting human DNA in particular.

However, the more general proposition of whether products isolated from nature should be the subject of a patent claim was brought into sharp focus by the patents of Myriad Genetics, for the BRCA1 and 2 genes, known to increase a woman’s predisposition to breast cancer.

Following a challenge to Myriad’s patents in the US by the Association for Molecular Pathology, the US Supreme Court held that a DNA segment in a naturally occurring setting does not become patent-eligible merely by being “isolated” (Association for Molecular Pathology v Myriad Genetics).

This prohibition was held not to apply to cDNA or other “modified” forms of DNA not existing in nature. Nevertheless, the outcome has far-reaching implications for the patenting of many nucleic acid molecules of industrial, agricultural and medical utility.

A key Myriad patent was also challenged in Australia in 2015, when the Australian High Court overturned a unanimous 5:0 decision of the full Federal Court of Australia and ruled that claims directed to isolated nucleic acids encoding the BRCA1 mutant polypeptide were invalid on the basis that they did not define a “manner of manufacture” (D’Arcy v Myriad Genetics).