Patent law and genetic engineering in the US and Europe

Are living organisms patentable in the US? Are human genes patentable in Europe?

A patent is the exclusive intellectual property right to an invention of a technical product or process. To file a patent, an invention needs to meet three essential criteria: 1) Novelty, 2) Inventive step - The creation should not be an obvious improvement over an existing product or invention, and 3) Industry applicability. According to the 2018 annual report of the European patent office (EPO), pharmaceuticals and biotechnology patent applications together recorded 14,183 applications demonstrating strong growth among the technical fields. This article is to help molecular biologists get a sneak peek into the world of patenting and encourage them to patent the fruits of their hard work.

How did the first-ever patent on a living organism come into being?   It all began in 1972 when Geneticist Dr. Ananda Mohan Chakrabarty developed a technique to insert circular DNA (plasmids) from many different strains of bacteria into one bacterium to enable the clearing of oil spills in the ocean. This modified bacterial species was derived from Pseudomonas putida. When Dr. Chakrabarty applied for a patent on the technique and the newly developed species, the then patent law ‘Patent Act of 1952’ did not have provisions to patent living microorganisms under its subject matter.

One relevant subsection that would come handy and be interpreted to enable patenting life forms is 35 U.S.C. § 101 ‘Inventions patentable.’ It is mentioned in the subsection that ‘Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.’ Thus clarifying once and for all that, the four statutory subject matter that could be patented are process, machine, manufacture, and composition of matter. Also, the terms ‘invent or discover’ in the 35 USC. § 101 of the Patent Act of 1952 are to interpret that the patentee is the first creator of the subject matter and not the first person to stumble upon on something that is already existing in nature. Dr. Chakrabarty’s patent application claimed the genetically engineered bacterium itself and not the growth of the bacterium in the culture medium as a whole.

After years of litigation at various levels, the supreme court of the United States of America, held in June 1980, ruled that the newly created genetically engineered bacteria was indeed manufacture or composition of matter that is not preexisting and its capabilities are not processed by any naturally occurring bacteria. In this way, the first life form patent was granted for a bacterial plasmid DNA genetic engineering method back in December 1980, after the historic ruling by the Supreme Court of the United States of America in a case Diamond vs. Chakrabarty.   Are Human genes patentable?   Recent ruling in the case of the Association for Molecular Pathology v. Myriad Genetics, Inc., 569 US 576 (2013) has conclusively reinforced that human DNA cannot be patented in the US. The human genome has 23 paired of Chromosomes, which constitutes all genes and non-coding regions of the human genetic material. Back in 1990, scientist Dr. Mary Claire Kane revealed that her team has found that a section of DNA on the 17th chromosome has a gene that is related to breast cancer.

Enormous public resources were spent to find the gene. Alongside the original team, a large number of researchers joined the race. Soon, a group of researchers from the University of Utah found two genes BRCA1 and BRCA2. Female patients with a mutation in one of the two genes have a high risk of contracting breast cancer in their lifetimes. The most important commercial application of this discovery was that the mutation in these genes could be tested, and the risk of breast cancer could be detected by simple screening. Some researchers went ahead and patented the 21,328 nucleotides long sequence of the BRCA1. They formed a company ‘Myriad genetics Inc’ and thus retained exclusive rights to do anything with the gene, thereby establishing a monopoly on gene testing form breast cancer. This caused public outrage, and the American Civil Liberties Union (ACLU) brought Myriad genetics Inc to court.

The case lasted for a few years and finally came to the Supreme Court of the USA. The Supreme Court of the USA, in the case between the Association for Molecular Pathology v. Myriad Genetics, Inc., 569 US 576 (2013), ordered that human genes cannot be patented in the US. The argumentation was that nothing new was created while discovering a gene that is already existing in nature. In one strike, the supreme court’s decision nullified over four thousand human gene patents in the US. This ruling was based on the foundation that the genes could be more readily available for R&D and developing genetic testing for life-threatening diseases.

The US supreme court ruled that Isolated DNA is no longer patentable subject matter under restriction or exclusion criteria, thus making sure not only genes of human origin but also genes of prokaryotic or eukaryotic origin cannot be patented. Patenting of Complementary DNA or cDNA of microbial genes is still allowed as it is synthetic and not readily available in nature. Remarkably, genes of all origin are still patentable in Europe. The requirement of patent eligibility in Europe is different from that of the US in many ways. For example, in Europe detailed functionality of the gene or DNA fragment along with the polypeptides it encodes for, and its specific industry application need to be disclosed in great detail at the time of the patent application.

Can you patent your PhD/thesis in the Netherlands?

Yes. If you have an incredible invention, it is highly advisable to contact the legal division of the organization before presenting the work as a poster or publishing the findings in a conference to see if the invention is patentable. It is a widespread mistake to present intricate parts of the work in a conference and thereby losing the ability to apply for a patent as it would nullify the novelty criteria if the invention is made public before the date of application of the patent. A room full of people can be made prevy to the details after they sign a Non-disclosure agreement if necessary.