Dear Dr. Feng Tian,

Invention is differing from discovery. An invention has 3 characteristics:

1. Novelty

2. Inventive Step

3. Industrially applicable

Genes and their derivatives are products of nature and manipulation of them is not an invention. An Invention can be patented (and not a discovery). For example, electricity is a discovery; can you patent it? Therefore a second code hiding within DNA and even synthetic complementary DNA (cDNA) cannot be patented.

human gene itself is not patentable as its a natural product but its cDNA sequence can

Dear Dr. Feng Tian,

Invention is differing from discovery. An invention has 3 characteristics:

1. Novelty

2. Inventive Step

3. Industrially applicable

Genes and their derivatives are products of nature and manipulation of them is not an invention. An Invention can be patented (and not a discovery). For example, electricity is a discovery; can you patent it? Therefore a second code hiding within DNA and even synthetic complementary DNA (cDNA) cannot be patented.

One counter argument for the claim that genes are not patentable because it is a natural product :

I agree that the human genome is a natural product. However, is there a complete human gene floating around freely within a human body, separated from the genome? In other words, when a gene is activated or deactivated in a human, is the gene still part of the intact genome or an independent chemical entity different from the genome? If it is the former, then an isolated DNA fragment is not a product of nature because there is no such chemical entity before someone tells you where to cut.

As to the difference between a discovery and an invention, I believe a discovery of a natural phenomenon, natural product or natural law is not patentable, but a discovery of a man-made chemical entity is patentable.

There are still confusion related to biotechnology and patent. As you are telling fragment of DNA which is generated from specific cutting of DNA, Here you are adding your intellectual to get that fragment, and it is not commonly found in nature too. but fragment should have application too.

Patent rights are different in different countries.

I have a question. If you use PCR on an isolated gene, and then put it in a vector for expression, would this be non patentable, or be covered if a particular cDNA is covered?

Also, if the gene is non patentable, then the mRNAs, and proteins should not be covered as they also exist in nature. Any comments on this?

If then, one is making a cDNA from a non patentable source, and making a cDNA is obvious in the art, why would the cDNA be patentable?

Marcia Moss.....I agree with you. Also, patent shouldn't get to mRNAs, proteins, cDNA as there will be motivation and teaching in prior knowledge to synthetically derived these moieties or natural derived from human body in concern to very obvious prior art in gene related aspects.

Patent subject matter eligibility is a policy-driven judgment. Cultural norms and public policy considerations do play a critical role when countries deal with issues of patent subject matter eligibility. The different fates of the “Harvard Mouse” patent applications in the U.S. and in Canada nudged the interplay between patentability and national policy at the center stage.

In the U.S. where the advances in biotechnology are perceived to benefit public health and wellness, the court encourages innovative discoveries in this field by defining a broad patent eligible space and adding a man-made life form thereto. In Canada, the court is more concerned about the social impact of allowing higher life as a patentable subject matter. Accordingly, the Canadian court defines the allowed invention scope narrowly, rejects the transgenic mouse application, and suggests that a clear direction from Canadian Parliament is needed to deem the transgenic animal patentable. As shown in the Diamond v. Chakrabarty case, morality is not one of the benchmark on which the USPTO relies to issue patents. The U.S. court decision in the “Harvard Mouse” patent comports with the same approach. In contrast, the Canadian court is more conscious of its role as a regulator of societal impact of technologies beyond the four corners of the Patent Act. In both cases, national public policies won.

The influence of public policy in patentability issues is amply borne out in Association for Molecular Pathology v. Myriad Genetics, Inc. in 2013. The U.S. Supreme Court says that genomic DNA molecules are not patent eligible because they contain naturally-occurring sequences. However, in the U.S. naturally occurring chemical entities can be patented if they are sufficiently "isolated" from their naturally occurring states. Such patents include adrenaline, insulin, vitamin B12, and Botulinum toxin or Botox, the last of which is a poison! Further, naturally occurring peptides, in either its intact form or truncated forms, have been constantly patented in the U.S. Thus, banning genes based on their origin in Nature seems at odds with prior decisions and practice in U.S. patent law. It may best be explained from a public policy perspective as the Court’s attempt to rein in a wild horse, Myriad Genetics in this case, in the race of finding better biotech medicines: You may discover new things in Nature. But you cannot prevent others from reaping the benefits of the same natural product.

I think though Feng, that the non patent ability of genes as ruled by the Supreme Court opens the doors for other naturally occurring things to be non patentable, and there will be lots more law suits. The use of such things should still be covered, but if anyone decides to fight the patents or use naturally occurring entities, they may likely win now in the courts because of the Supreme Court decision.

As Marcia notes, *any*thing can be patented, all that s required is the force of law, which reflects the power of interests, which is a function, largely, of existing wealth patterns. Another question is: ought such things as genes be patentable? Is and ought are rather different kettles of fish.

For some time (150 years plus) the US Supreme Court has been skating around the question of whether what would be obvious over the natural (but previously unknown) would be patentable. For the time being, the answer is yes. But in the meantime, AMP v Myriad makes it clear that just cutting the useful out of its natural background is not enough for patentability of the substance per se in the US. It is in Europe, and any patent attorney with more than two neurons will find a patent claim format that you can get by with in Crystal City. J

THE ETHICAL DEBATE AND THE FUTURE OF HEALTH CARE

Patenting human genetic material is highly controversial and fuels substantial ethical debate within the research and biotechnology  communities since some rights are granted to the exclusion of others. Patent law has long provided the means to reward an inventor for toiling in research through economic gain and acknowledgment within the scientific community

http://digitalcommons.tourolaw.edu/cgi/viewcontent.cgi?article=1035&context=lawreview

The patent itself implies ownership and the concept of ownership when it comes to human beings is very controversial. Now, not all the DNA sequences from humans or their parts can be seen as "beings"; the human being is a person having biological, psychological and social traits which make a differentiation between humans and non-humans. Nowadays people cannot be owned, no financial interests can be legal if possesing human being, slavery is abandoned and there are strict regulations against that form of abuse of humankind. In agreement to Mr. Tafreshi that discovering any human trait cannot be patented; discovering itself means that something which already naturally existed is now known, but as itself it does not represent novelty and invention. The question that may remain open is whether inventions done by using humans genes can be patented; I would argue for "NOT" side from the perspective of bioethics, putting the law above the biological sciences in the interest of preservation of values of humankind; with developments in science, these issues would get more attention and perhaps other answers offered. But at the end, being it US Supreme Court decision, a part of international law or individual case law, the final decision would depend on societal values more than on possibilities in scientific progress.