The Complications Around Patenting Biotechnology

Many people around the world start their mornings by drinking a glass of orange juice. What these vitamin C drinkers might not know is that their ability to enjoy this tangy beverage stems from a victory within a complicated field of intellectual property law: the area of patenting biotechnology.

In 1873, microbiologist Louis Pasteur patented a new yeast-making method at the French Patent Office. Today, we know this process as pasteurization, and most commercial orange juice companies use his patented biotechnology to bring orange juice to the breakfast tables of hundreds of thousands of families.

Many modern luxuries that are often taken for granted — medicines, foods, beverages, and surgical procedures, among others — stem from advances in biotechnology that might not have been available for consumer use without patents. A few examples of patented products and procedures that save countless human lives are insulin, blood transfusions, anti-cancer drugs, autoimmune drugs — and pasteurization, of course.

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Patentability requirements

Biotechnology patents fall under the scope of utility patents. A utility patent is available for an invention or discovery of a new and useful machine, manufacturing process, composition of matter, or process. This type of patent is also available for improvements to a process that are considered new and useful.

Despite the critical role that biotechnology plays in saving, improving, and extending human life, there is an extremely complicated process behind the work of patenting these scientific ideas and advancements.

When an inventor applies for a patent, they must demonstrate that their creation meets certain eligibility requirements. For example, in the United States, the US Patent & Trademark Office set forth five elements for patentability. To qualify, an invention must fall under subject-matter eligibility, have utility, novelty, be non-obvious, and not have been previously disclosed.

biotechnology patents

Then, in Europe, the European Patent Office states that a patentable invention can be a product, a process or an apparatus. To be eligible for a patent, “it must be new, industrially applicable and involve an inventive step.”

When members of different EU member states apply for patents with the European Patent Office, their patent receives national validation in each state that is a party to the European Patent Convention. Article 2 of the convention states that “a European patent shall, in each of the contracting states for which it is granted, have the effect of and be subject to the same conditions as a national patent granted by that state, unless otherwise provided in the European Patent Convention.”

Patentability issues around biological materials

“An examiner is going to try to reject a biotechnology application by saying that the scientist’s invention is merely a creation of nature. They will argue that a scientist made an obvious variant of what organically occurs in nature. This is ineligible for a patent. This is especially a problem when it comes to genetically modified organisms, tissues and cells,” said J.D. Houvener, founder & CEO of Bold IP.

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In terms of novelty, the complication for a biotechnologist is demonstrating that their creation is a ‘new’ process rather than merely a natural one. The process also involves having an inventor demonstrate that their invention is the first in the world to do its specified action.

While any invention in the field of technology can feasibly be eligible for a patent, the patentability of biological materials is often a source of controversy.

Some argue that such biological materials are mere discoveries, and therefore not patentable.  Others argue that certain biological materials are man-made inventions, and are therefore patentable.

Another source of complexity regarding biotechnological inventions results from the fact that biological material is capable of reproducing itself. The potential for this shift invokes several complications, as one can imagine. For example, a biological material may be patented as it is one moment, but might change or morph the next moment. This would beg the question of whether the patent covers the shift or stops point blank at the invention pre-shift.

Case studies: CRISPR and Myriad

Technologies revolving around genetics are often the center of patentability controversy. One recent, well-known case centered upon the use of CRISPR gene editing, with a specific focus on whether certain educational institutions had the exclusive right to commercialize products developed with the CRISPR–Cas9 system, which makes targeted changes to the genomes of eukaryotes.

A lot of time, effort and money has been invested into resolving whether genes and gene editing are patentable. While these cases were more costly than many would have liked, some solid legal decisions have come out of them. In the case Association for Molecular Pathology v. Myriad Genetics, the US Supreme Court definitively and famously held that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”

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biotechnology patents DNA

In the same case, the court held that “manipulation of a gene to create something not found in nature — such as a strand of synthetically-produced complementary DNA (cDNA) — could still be eligible for patent protection.” This gave rise to the potential for CRISPR patentability.

However, the CRISPR patent battle has led to “a rather sad outcome,” says Houvener, “with $10M spent, and an over three-year long battle over the validity and infringement of CRISPR patents filed and owned by the Broad Institute.” In the US, the Broad Institute’s patents were upheld over those of the University of California, whereas the situation seems to be the inverse in Europe, where the Broad Institute’s patents have been revoked.

To complicate things even more, there is an earlier filed patent application by Virginijus Šikšnys, a Lithuanian scientist that did early work on CRISPR with the team of the University of California. The other parties didn’t know about this filing because of an 18-month secrecy period when applications are not published.

Why the obstacles are worth overcoming

Despite these obstacles, biotechnology companies continue to jump through the hurdles towards seeking out patents. The business models of most biotechnology companies often rely heavily on intellectual property rights. Patents are often the most important asset owned by biotech companies because the sector is extremely research-intensive.

They also minimize risk for investors. Investors often use patents as a litmus test in deciding whether to invest in a biotechnology company. Patents demonstrate whether the biotech company has freedom to commercialize its product without infringing on the intellectual property rights of other companies. Well-supported biotechnology patents also convince investors that a company has a tried and true intellectual property strategy with risks reduced to a minimum. 

Biotechnology is a field of fast innovation; by the time the law catches up, often there’s something new that needs to be taken into consideration. Knowing the complications and limitations of biotechnology patents is essential to make sure that technologies that can save lives and improve the world are properly protected.


Carly Klein is a law student at Loyola Law School in Los Angeles. A graduate from Boston University with a B.A. in Political Science & Philosophy, she previously served an Americorps term at the American Red Cross in Los Angeles on the Service to the Armed Forces & International Services Team.

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