Will Genetically Modified Humans Be Patented In Near Future?

Will Genetically Modified Humans Be Patented In Near Future?

inquirerAugust 23, 2020

If genetically modified humans are created through vaccination will they be patented?

There is actually a historical precedent to this idea of patenting lab-made life-forms that most people probably don’t know about. Just a few decades ago legal scholars and the like probably would have found this idea of patenting life forms to be sci-fi fantasy. General public still believe this to be the case. But it is our current legislative reality now.

In order to understand that we have to go back through some of the historical presidents that has led us here. In and important 980 supreme court Decision, the court ruled in favor of Ananda Chakrabarty, holding that: A live, human-made micro-organism is patentable subject matter under 35 U.S.C. Respondent’s micro-organism constitutes a “manufacture” or “composition of matter” within that statute.

Genetically modified life can be Patented

The decision known as Diamond v Chakrabarty centered on a genetic engineer working for general electric who created a bacterium that could break down crude oil which could be used in the cleanup of oil spills. In his decision supreme court chief justice Warren Berger ruled that a live human-made microorganism is patentable subject matter under Section 101 of Title 35 U.S.C.

With this ruling the ability to patent living organisms so long as they had been genetically altered in some novel way was established in legal precedent. The implications of such a monumental ruling are understandably wide reaching, touching on all sorts of issues that have the potential to change the world around us.

It didn’t take long at all for the decision’s effect to make itself felt in one of the most important parts of the biosphere. Our food supply in the years following the diamond v chakrabarty decision. An entire industry rose up around the idea that these new patent protections could foster the economic incentive for major corporations to develop a new class of genetically engineered foods.

To help increase crop yields and reduce world hunger the first commercially available genetically modified food, Calgene Inc’s FLAVR SAVR tomato, was approved for human consumption by the food and drug administration in the u.s in 1992 and was on the market in 1994. Since then adoption of genetically modified foods has proceeded swiftly especially in the U.S where the vast majority of soybeans, corn and cotton have been genetically altered.

Demand for the FLAVR SAVR tomato was high and remained high, but the product was never profitable.

By 1997 the problems inherent in the patenting of these GM crops had already begun to surface in Saskatchewan, Canada. It was in the sleepy town of Bruno that a canola farmer Percy Schmeiser found that a variety of GM canola known as “roundup ready” had infected his fields mixing with his non-gm crop. Amazingly Monsanto the agrochemical company that owned the roundup ready patent sued Schmeiser for infringing their patent.

In 1997, Percy Schmeiser found Monsanto’s genetically modified “Roundup Ready Canola” plants growing near his farm.

After a years-long legal battle against the multinational that threatened to bankrupt his small farming operation, Schmeiser finally won an out-of-court settlement with Monsanto that saw the company agree to pay for the cleanup costs associated with the contamination of his field.

GM Genocide. The Sad Story of genetically modified seeds that killed farmers

In India tens of thousands of farmers per year have committed suicide in an epidemic labeled the gm genocide, a story of magic seeds that would produce immense yields. Farmers around the country were driven into ruinous debt by a combination of high-priced seeds, high-priced pesticides and crop failure.

Worst of all the gm seeds had been engineered with so-called terminator technology. Meaning that seeds from one harvest could not be replanted the following year. Instead farmers were forced to buy seeds at the same exorbitant prices from the biotech giants every year ensuring a death spiral that was impossible to escape. As a result hundreds of thousands of farmers have committed suicide in the Indian countryside since the introduction of gm crops in 1997.

Yes! It didn’t take very long at all before that tiny little wedge of the idea of patenting a genetically engineered bacterium became the gigantic flood of essentially the entire biotechnology industry as we now know it and of course the Monsanto monstrosity and the patenting of crops that killed thousands of farmers in India.

Genetically Modified Human Genes

Intellectual Property pervaded and permeated itself into our existence including even to into our own bodies and our genetic code itself. The idea of patenting human genes is not new. The US patent office granted thousands and thousands and thousands of patents for human genes to various companies which was not a benign thing as anyone who was working with for example brca1 or brca2 genes associated with breast and ovarian cancer found out for example.

There were a number of laboratories using diagnostics that were meant to help women detect breast cancer that were based on the brca1 and brca2 genes and myriad genetics Inc was granted the patent to those genes. They actually sent cease and desist letters to various laboratories that were attempting to use those genes for its their diagnostics.

As you can imagine there was a bit of an outcry about this and the American Civil Liberties Union and the public patent foundation stepped up to the bat and filed a lawsuit back in 2009. The issue itself revolved around us code Title 35 USC § 101: Inventions Patentable: 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

Therefore Subject to the conditions and requirements of this title myriad’s brca1 and brcta2 patents were invalidated. Naturally occurring genes are no longer patentable. The major takeaway is that human genes as they exist in cells are unpatentable. But synthetic DNA is still fair game. The court tried to strike a balance in its ruling by banning some types of gene patents but not others.

The Fine line of synthetic vs. natural DNA

While companies can no longer patent genes with the same sequences found in natural human cells, the decision allows edited forms of genes not found in nature known as complementary DNA or cDNA to be patented. cDNA is not useful for diagnostic tests but it is crucial for producing protein-based drugs explained Robert cook Deegan, a professor of genome ethics law and policy at duke university’s institute for genome sciences and policy.

Those are the billion dollar molecule patents. Cook Deegan said biotech companies care a great deal bout cDNA patents and it should be reassuring to them that those patents are still fine. Court ruled that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.

cDNA is patent eligible under section 101as it is not a product of nature. cDNA does not present the same obstacles to patentability as naturally occurring isolated DNA segments. It’s creation results in an exons only molecule which is not naturally occurring. Its order of the exons may be dictated by nature but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.

There is a lot of microbiology involved and it’s a fascinating process but complementary DNA or cDNA is synthetic in nature. It is created and thus it is patentable and so how does that impact our daily lives at this point? Well, there are various uses for cDNA. For example, an European patent EP1375512B1 filed in 2002 granted (in 2009) infectious cDNA of an improved vaccine strain of measles virus, use for immunogenic compositions.

Patented vaccines that dictate human body’s immunity

Immunizations and other things can rely on cDNA. It presents an interesting premise of argument. The Business spent a lot of time and money developing the processes and techniques and of course refining the specific things that they want to introduce to your body to activate the immune system. So they need to protect that information in some way that will allow them to get paid for their effort. While they need these types of patents, it does present some interesting questions. Especially when we start moving into the realm of DNA and mRNA vaccines.

These vaccine technologies seek to inject DNA or RNA strands directly into our cells to hijack our cell’s own protein production process essentially to create certain proteins that can then be used as the antigens in an immunological response. Similar to vaccination but instead of giving you some sort of attenuated virus or something along those lines they’re going to inject DNA and RNA material directly into your cells. And the cells will start producing the proteins which will then be picked up by your immune system to cause the immune reaction to develop your immune response to various viruses like sarskov2.

We all know know this is coming and there are many different aspects of this that we will have to cover in much greater detail as things continue to progress. One part of this story is the however the patent story like Axios that claims joint ownership of Moderna‘s coronavirus vaccine and signed a contract this past December that stated mRNA coronavirus vaccine candidates are developed and jointly owned by the two parties.

The contract was not specific to the novel coronavirus and it was signed before the new virus had been sequenced. So basically they’re saying anything you develop is going to be partly owned by them and in fact are selling non-exclusive licenses to companies like Moderna and others who want to license these stabilized coronavirus spike proteins or whatever else the NIAID scientists claim.

There are already patent issues surrounding these new vaccines. This starts to question the whole genetic modification and what that term even means. When you start to look at DNR DNA and RNA vaccines and how they function and what they are actually doing by hijacking your own cell’s natural protein production process in order to create these immunogens the question gets blurred. What does it mean to hijack your cell to start producing something foreign, a protein, which itself is patented and is held by the government.

Non-exclusive licenses are issued to these big pharma players. What does that mean? Your body is producing something which is patented by a corporation. Does that mean that the company or the government has some sort of property stake in your body? Because that’s intellectual property that your cells are producing.

Caproate owned human genes !

The idea of corporations owning human genes and cells may sound ridiculous. But it would have sounded equally ridiculous a few decades ago to to say “You know? In the future they’re going to start to genetically modify crops and if one of the seeds from one of those genetically modified crops blows onto your farm and starts growing in your field then that company who owns the patent to that seed is going charge you with having illegally grown their proprietary intellectual property on your farm without their permission.”

A couple of US senators have already pushed for a controversial U.S. bill that would lift Supreme Court ban on patenting human genes. Many expressed concerns of how this will directly affect COVID-19 testing among other things.

A 2013 case on human gene patenting drew demonstrators to the Supreme Court in Washington, D.C. | MLADEN ANTONOV/AFP/GETTY IMAGES

Can companies get into a position where they can patent certain key parts of the the human genome or virus’s genome that can then be used as a monopoly club to wheel over anyone who wants to develop, for example, a COVID-19 diagnostic for whatever those things are worth?

So, yes ! Your body, antibodies, immune system and your cells may be hijacked to start producing certain proteins as part of an immune response as a vaccine. As more and more of these genetically modified components become part of your body through vaccinations and other intrusive molecular and cellular procedures we are eventually becoming genetically modified humans !

It depends who you ask. If you ask the reuters fact checkers, the answer is no. But would you trust the reuters fact checkers to do your thinking for you? Even if you were to conclude that the legal ramifications of this won’t be so broad at current time what about tomorrow ? What about genetically modified humans themselves?

Genetically Modified Humans just one policy away !

When Chinese researchers first edited the genes of a human embryo in a lab dish in 2015, it sparked global outcry and pleas from scientists not to make a baby using the technology, at least for the present.

It was the invention of a powerful gene-editing tool, CRISPR, which is cheap and easy to deploy, that made the birth of humans genetically modified in an in vitro fertilization (IVF) center a theoretical possibility.

After He Jiankui, a chinese scientist, announced the birth of twin girls with edited genomes, the questions facing the scientific community have grown knottier.

By engineering mutations into human embryos, which were then used to produce babies, He leapt capriciously into an era in which science could rewrite the gene pool of future generations by altering the human germ line. He also flouted established norms for safety and human protections along the way.

Before the world could comprehend the idea and come up with their next question he’s thrown in jail and never heard from again. The story kind of goes under the rug and no details given and no follow-up and we’ll never know. Apparently there are gene edited babies already walking around out there. At some point will there be gene edited humans that companies may have property right stakes in?

We don’t know if a company would ever come along and say they own this human being because it has their proper proprietary genetic modifications. At any rate we can certainly imagine where they have a some sort of stake in the proprietary information in your body. What does that mean again? We can’t answer this because we can’t point to us codes section 73 paragraph 14b because it doesn’t exist yet.

Obviously these types of things will come before the courts at some point and there will be case law that will be set to become the law of the land. But we haven’t seen it yet. And these are things that even just a few months ago would have seemed radical, amazing and incredible. Try to explain the year 2020 o December 2019. People start to call you crazy and that it will never happen. Well it’s already happened and one can only imagine what’s going to play out in the course of this decade.

Gene edited babies and genetically altered humans of various sorts revolve around the idea of ownership and what it means for companies to start claiming ownership of synthetic life forms, human genes and eventually genetically altered human embryos and humans. These are extremely important points regarding what they really mean for the future of humanity. There is no definitive answer yet

This article is based on the thoughts expressed in below video ins response to an intriguing and important question from one of the audience.

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