A patent is a type of IP (Intellectual Property) that grants exclusive rights to the original inventor or researcher.
We shot a podcast with Dr. Gaurav Shimali, who holds 10 patents in life science. He revealed interesting information about patents, particularly. He further explained which things can be patented and which can’t.
This is a summary of his explanation and valuable information on life science patents.
“We can take a patent of a process, we can take a patent of any product, we can take a patent of any combination of products, we can take a patent of an industrial design also.” -Dr. Gaurav Shrimali.
Key Topics:
What Can Be Patented:
In biological sciences, including biotechnology, microbiology, and genetics, patentable inventions fall into the three major categories: products, processes, and designs.
All these patentable inventions must have ‘some’ practical and industrial applicability, and that should be demonstrated as new. Here is the list of things that we can patent and why!
Modified Biological Products
Any biological product that is artificially created, altered, or engineered can be patented.
For example, we can patent new bacterial strains that can produce enzymes, antibiotics, bioplastics, or biofuels that are not naturally produced. Basically, we can patent genetically modified microorganisms.
We can also patent other biological products such as plasmids, vectors, and fusion genes, which are human-made combinations of natural sequences.
In short, for patents, modification is the key. Once nature’s materials are intentionally engineered to gain new functions or compositions, they cross the boundary from discovery to invention and can be patented.
Novel Biological Processes:
Sometimes the biological material itself is not new, but the method or process you developed is new and unique, so you can also patent that process or method.
For example, you patent new techniques for the production of bioplastic, biofuel, biomolecules; unique extraction, purification, and synthesis methods; and improved culturing and transformation procedures.
Furthermore, your DNA extraction method with some unique modifications and better outcomes (either high yield or purity) can also be patented. Meaning, DNA itself can not be patented, but the process, protocol or SOP for extracting or purifying it can be patented.
Combinations and Formulations:
Dr. Gaurav Shrimali also explained that the known material can also be patented only if it is combined or formulated in a newer way. Meaning, a new combination, media or composition can be protected by IP.
For instance, a researcher developing a new enzyme mixture for biopolymer degradation can be patented but not the native enzyme. Similarly, media formulation that can enhance bacterial growth, efficiency and drug composition can also be patented.
The reason we asked, he further explained, “because the final combination or formulation did not exist before.” Meaning, these are the results of a scientist’s own biological knowledge.
Designs or Modifications Can Be Exclusively Patented:
While these are not biological in the strict sense, but rather are any device or part of any device or instrument that uses biological principles. So if these designs have some novel features, then that can be patented.
For example, a researcher designs a bioreactor or cell culture device that has higher sensitivity and accuracy; he or she can patent it. This also applies not only to life sciences but also to all fields.
Dr. Gaurval Shrimali told us, “Design patents are easy to file and get.”
What Cannot Be Patented:
Now here comes a crucial question: which things in life science can not be patented? The simplest answer is,
“Naturally occurring and unmodified biological material, you can’t patent.”
Any organisms, biological materials, samples, biomolecules, etc, are not considered as unique IPs. These are not innovations, but are discoveries that can not be patented.
These include several things, some of which I have discussed below:
Discovery of Organisms:
“A plant is not patentable, an animal or bacteria is not patentable.” -Dr. Gaurav.
Living organisms such as animals, plants, fungi, and bacteria cannot be patented simply because they are discovered and naturally occurring.
For example, a scientist isolated an E. coli strain that already exists – can’t be patented; rather, it can only be considered a discovery. The same thing applies to all the other organisms.
Contrary, in another case, if a scientist genetically modifies a new E. coli strain by gene insertion or something, and it can express a novel protein, in this case, the ‘modified’ strain can be patented.
So in conclusion, biological material – can’t be patented; modifications- can be.
Genes, DNA, and RNA Sequences:
DNA, genes, RNA and chromosomes are our daily research partners in life sciences and can not be patented.
“A gene can’t be patented but discovered.” Dr. Tushar Chauhan shared his knowledge during the conversation with Dr. Gaurav Shrimali.
Identification of a novel gene related to certain diseases can be considered as a novel gene discovery; the original contributor can not claim ownership of that gene.
Dr. Gaurav Shimali described that DNA and RNA sequences preexist in organisms without human intervention and therefore cannot be patented.
However, if a researcher engineers a recombinant variant, such as a synthetic gene construct or cDNA, then that can be patented because they are made artificially.
Primers Can Not Be Patented Directly:
The biggest misconception in the life sciences community is regarding the DNA/RNA primer patenting. Even though primers are ‘humanly-designed’, they can not be patented.
But here is an interesting catch!
In the case of primers, researchers can patent a primer cocktail- a mixture of many primers. For instance, a primer set for multiplex PCR. IPR’s authority considers a primer cocktail application as unique and thus patentable.
Be alert!
Genetic aspirant, here is an opportunity! Formulate a unique primer cocktail against a disease or condition, prepare the standard protocol, sell it or rent it at a high price and earn millions!
And lastly, the theories, concepts, and natural laws that make up the foundation of science cannot be patented. Patents can only be used to protect the practical applications of these fundamental principles.
Let’s simplify it all together. Before going for the patent, you should ask yourself one question:
- Have I created something new, or have I just found something that was already there?
- If it’s new, it can likely be patented; if it’s already there?
- Can I modify it for a better outcome?
- Can my modification be patented?
Wrapping up:
In conclusion, biological material, living organisms and preexisting material can not be patented, Dr. Gaurav Shrimali said; but unique modifications, formulations, designs, or altered products or materials can be patented.
Share this article with those you think can patent something and subscribe to Genetic Education.
