From Kit Kat’s to genes…should we ‘take a break’ from patenting?

I love listening to the radio on the way to and from work. I love having a cheeky sing along and playing my favourite instrument (the steering wheel!) Sometimes I skip the news though as it makes me a little depressed to hear about all the awful things going on in the world!

But then today must have been a slow news day, as one of the main headlines was regarding Nestlé’s battle against Cadburys to patent their four finger Kit Kat! Apparently this has been a long standing battle to trademark the four finger square shape as Nestlé argue it’s iconic and therefore, deserves protection [1].

Personally, I think it is a little bit silly to be spending a lot of money fighting over the shape of a chocolate bar. However, patenting does interest me when it comes to DNA and genes! Before I explain why, let’s talk about what genes, cell lines and patents are.

What is a patent?

Patents are a way to protect your intellectual property. If you came up with an idea, such as a new product, design or write something of interest, you can apply and pay for a patent. Patents usually last for around 10 years and during this time, anyone who wants to use your product/gene/whatever it is, has to pay or can be sued! It has to be a physical thing e.g. not just the idea for a book, but you can patent the writing in the book. [2] Maybe I’ll patent my blog..!

The criteria for patenting intellectual property is quite complicated, but simply speaking, you can patent something that can be made or used and is brand new; not just a modification to something that already exists. [2]

What is a gene?

A gene is a section of DNA that codes for a protein. Proteins are of vital importance. Enzymes are essential proteins e.g. DNA polymerase is an enzyme that copies DNA so that our cells can then divide as part of mitosis. This allows us to grow and repair!

What is a cell line?

A cell line is made from a cell that divides uncontrollably; basically a cancer cell. Normal cells have a limit on how many times they divide. As part of cancer, some cells override this limit and have the ability to keep on dividing and dividing and dividing! Inside the body, this is obviously very worrying. However, in the lab they are very useful as it means a scientist can have lots of identical cells produced. As they are genetically identical and are grown through cell culture, scientists can minimise the effect of variables, helping scientists come to more valid conclusions.

Genes and cell lines have both been patented in the past and some still are! I’m not entirely against this, but have some bio-ethical concerns. Let’s look at two case studies and you can help make up your own mind!

Association for Molecular Pathology v. Myriad Genetics

Myriad are a large molecular diagnostic company who develop tests for lots of diseases. Myriad were very clever and located the exact location and sequence of two gene mutations linked to breast and ovarian cancer which are called BRCA1 and BRCA2. These are two examples of tumour suppressor genes. Tumour suppressor genes normally produce proteins which stop cells dividing uncontrollably. They act like guardians of mitosis!

From their discovery of the mutated BRCA genes, they then worked out the normal BRCA gene codes and developed a genetic test to identify those at risk from developing breast and ovarian cancer. They invested a lot of time, money, and brain power into this, and felt that they deserved intellectual recognition and financial gain.

Myriad Genetics applied for patents for these genes which meant they had ownership over the right to isolate an individuals BRCA 1 and 2 genes and create BRCA 1/2 cDNA (a copy of DNA which just contains coding regions). They were granted patents for this purpose and for their genetic test. [3, 4, 5]

Can you see any issues with this? The Association for Molecular Pathology did, as did many other scientists and healthcare institutions. It meant that if scientists wanted to investigate how BRCA mutations occur, how these genes are linked to other diseases, or even how treatments could affect the genes, they had to pay Myriad Genetics. This includes paying them to test for mutations in high risk individuals. This would have increased costs for research on this gene, and in turn, could have reduced interest in researching breast cancer treatments linked to this gene. How scary!

On the other hand, should Myriad not get financial gain for their hard work? It would be nice to think that we are all altruistic and only research for the good of knowledge and treating diseases. However, research and drug development costs A LOT of money. What is the incentive to put all that money in if you can’t guarantee money back?

The other plus of patenting is that the intellectual property has to be published and is therefore openly available for others to learn from. Since the BRCA genes were discovered, our understanding of breast cancer, ovarian cancer, tumour suppressor genes and treatment have vastly increased. Scientists can learn from the methods applied to other genes to learn about their functions.

The main issue with the patents here are that these mutations are naturally occurring. Up until 2013, 4300 genes were patented! Imagine the impact on research! [5]

In 2013, as a result of the Myriad versus association for molecular pathology trial, the Supreme Court of the United States ruled that human genes cannot be patented in the U.S. This was on the grounds that DNA is a product of nature [4]. This ruling also meant that the other 4300 patents on genes became invalid [5]. Myriad still kept the patent to produce cDNA from the BRCA genes as this is something that is not naturally occurring in nature.

Imagine if the human genome project tried to patent the whole human genome! Imagine if the scientists who sequenced the Spanish flu genome patented it and allowed select groups of individuals to use it to their advantage. I personally am pleased most gene patents have been revoked.

John Moore versus the Regents of the University of California

John Moore was a patient at UCLA Medical Centre in the 1970’s, being treated by Dr Golde for hairy cell leukaemia. Investigations were completed and it was recommended that his spleen was removed. At the time, it was common knowledge that cell lines and other useful blood products could be obtained from patients with certain types of cancers and there was a lot of money to be made![6]  Moore was made aware that after removal, his spleen would be examined but he was not made aware for what purpose… Moore was told to keep coming back to see Dr Golde, driving all the way from Seattle to LA, to have more blood taken but this could ONLY be done by Dr Golde.

It turns out, that after examining Moore’s spleen, Golde was able to create a cell line using Moore’s cells from his spleen. He patented this, identifying himself as the inventor and licensed it for other companies to use, making over $450,000 and setting up contracts, making him potentially millions of dollars. [6] Moore did not make a penny and did not know that his cells had been used to create a cell line. When he eventually found out, he sued Moore and the hospital, the main bases being that the cell line was made from his blood and tissues and they were his personal property; therefore he was entitled to a share of the money. 

Moore lost his case as the judge ruled that Moore had no property rights over his cells but he could claim money back for travelling etc.

What do you think about this? Here are questions that this posed to me:

• Do we own our own DNA? We are 99.9% genetically identical each other [7]. Is that 0.01% enough to give us ownership of our DNA? Can someone take my DNA and use it to produce a clone of me or store my DNA without my consent?
• Do we own our tissues?
• Do we own our tissues/fluids/DNA once removed from our bodies? Say for example, I chop off my arm, is it still MY arm if it is not connected to me?
• Should doctors be able to be involved in research at the same time as treating patients as this can present a conflict of interest?
• Can you every truly have informed consent for procedure? Golde found useable cell lines from Moore’s spleen and Moore agreed to have his spleen removed. Did Golde know he would find the cells?
• Do we own our bodies before the age of 18? Prior to this, children can consent to have a surgery etc but cannot refuse consent if their parents want them to have a treatment and the hospital can over-rule parents, via a court order, if they decide not to consent for a treatment e.g. a blood transfusion.

Cell lines are extremely valuable tools and the cell line created by Moore’s cells has gone on to be used in valuable research. Another cell line that caused controversy was the HeLa cell line, as this was another cell line created without the patient’s consent (I will do a book review linked to this soon!). This was never patented though. Does this make a difference?

In conclusion, there are pro’s and con’s to patenting genes and cells. They offer financial incentives fir further research. At what cost to individuals though?

What do you think? I would love to hear any comments or questions you have! Please get in touch!

Beth x

N.B. The opinions in the blog are totally my own and the sources for my research are listed below in case you would like to do any further reading.

Research Sources

[1] http://www.insider.co.uk/news/cadbury-v-nestl-kitkat-trademark-10440567

[2] https://www.gov.uk/patent-your-invention

[3] https://www.genome.gov/19016590/

[4]https://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf

[5]https://ghr.nlm.nih.gov/primer/testing/genepatents

[6] http://law.justia.com/cases/california/supreme-court/3d/51/120.html

[7]http://www.genomenewsnetwork.org/resources/whats_a_genome/Chp4_1.shtml