Complexities of Patents in Biotechnology

South San Francisco, CA  February 20, 2020  by Filip Kovacevic, Special Correspondent

Part of life for citizens in industrialized nations is never considering the ostensible infinitude of technical novelties and luxuries. Few realize the extent to which biotechnology has allowed marvels to take place e.g. insulin, autoimmune drugs, anti-cancer drugs, blood transfusions, etc.


What is Biotechnology?

The research behind biotechnology helps heal the world by harnessing what’s provided in nature. In a way, it is using resources found in nature to become healthier and more efficient while also ensuring that we don’t damage or take too much from those same resources.


Biotechnology supports so many of our global efforts: reducing use and reliance on petrochemicals; cutting greenhouse gas emissions; decreasing water usage and waste generation; lowering rates of infectious diseases; saving children’s lives; and helping develop crops with enhanced nutritional profiles.


These benefits are attributable to research and development of biotechnology patents. Patents allow the distribution of knowledge, enabling everyone to contribute to improve the standard of living across the globe. This generation learns from the last, so that they may make a better future. Thus, the cycle continues ad infinitum.


If you’d like to learn more about contemporary efforts in biotechnology, see here.


Understanding Patents

But what exactly are biotechnology patents, and how do they work? Well, biotechnology patents are technically categorized under utility patents.


Certainly this begs the question, then what are utility patents? Essentially, utility patents are available for processes, machines, forms of manufacture, and compositions of matter. To elaborate further:


  • Process: a set or series of acts that are in order or a sequence. Ultimately, through following these, one thing is transformed into another, be it a state of being, characteristic, or property.


  • Machine: these are the combination of subparts, and they carry out a process. If the process is a recipe, then the machine is an oven.


  • Manufacture: raw materials that are changed, or assembled, as regards their form or physical properties. You can think of a desk that has been pieced together by shaping and rearranging wood.


  • Composition of matter: this is the combining of one or more substances so that they form a chemical union, thus transforming them at the atomic level.


Furthermore, utility patents need to satisfy a few criteria. That is, they need to demonstrate to the United States Patent and Trademark Office (USPTO) these are inventions which are novel, useful in a practical way to a field, and nonobvious. It can’t be understated how important it is to emphasize the degree to which an invention improves something or solves a problem. Otherwise, they are considered too obvious or simply unuseful.



Complexities of Patenting Biotechnology

Perhaps now you consider it exceedingly obvious what needs to be done in order to secure a patent. However, frequently in life unexpected complexities arise. The same is found to be true in patenting biotechnology.



Expenses: as per usual, research and development (R&D) of any technology tends to be expensive. It shouldn’t come as a surprise then, companies sustain heavy losses throughout the R&D period. Their hope is to recover those losses once they begin to sell their invention – post breakthrough, of course.


Assuming the breakthrough does come, they are in luck. While R&D may be expensive, production and imitation are relatively cheap. Therefore, it is imperative the compound be patented. With a patent, the inventor secures 20 years of exclusive rights to make, use, and sell whatever it is they have patented.


The last thing an inventor, or company, wants to happen is for their compound to be reverse engineered and distributed earlier on the market.


Defining nature: can any compound be considered man-made rather than just a natural process hitherto unobserved? Because of this question, an inventor must demonstrate their compound, or invention, is the first in the world to do what it does.


But even so, does that mean you made it rather than just discovered it? Furthermore, just because it is what it is now doesn’t mean it will always remain that way. So if its properties change as time elapses, does that mean it is still within the patent owner’s rights? Or, on the other hand, does the benefit cease when the inventor is no longer intervening in its physical properties?


A lot to unpack at once, but to emphasize the main point: an inventor needs to be able to demonstrate where nature stopped working on its own and he or she applied something novel to the process.


International applications: medicine isn’t necessary or particular to a region, seeking healthcare is common to everyone. This means you’re going to want to make, use, and sell around the globe. But in order to do so, you have to file an international application.


The good news is that international applications, if filed within 12 months of the original non-provisional application, hold the same claims and benefits. From there, it needs to be approved by national examiners in the countries you wish to engage. There is an 18 month window between the international application and when you have to decide with which countries in particular you intend to enter the market.


Obviously, these complexities highlight nuanced legal, scientific, and philosophical questions about patents, chemicals, nature, and international business. But what it really highlights more than anything is the requirement of good legal counsel i.e. a patent attorney.



Importance of a Patent Attorney

As aforementioned, it’s increasingly simple to reverse engineer compounds on the market. If a company wants to enter the market as soon as possible to recover losses during R&D, then they’re going to want to expedite the patent application process.


Normally, patent applications can take up to three to four years in order to be approved. Of course, it can take longer, but, with good advice, it can also be shorter.


  1. D. Houvener, founder and CEO of Bold Patents Philadelphia Law Firm, stresses the significant advantage one has when getting a patent attorney for assistance: “a thorough application with specific yet widely applicable claims is going to get the inventor the most rights to make, use, and sell without encountering competition on the market. Therefore, it’s highly recommended to hire an attorney to exponentially reduce the risk of infringement and increase profits.”


In Conclusion

Biotechnology provides so much unappreciated luxury in everyday life. The work of inventors and scientists across the globe contribute to the continual improvement of the standard of living.


Interestingly, this is accomplished largely thanks to the legal sphere of intellectual property (IP), specifically patenting. Rather than keeping things under the radar of the general public like trade secrets, patenting enables everyone to access information and improve upon what is available.


Of course, there are also numerous complexities with patents, especially in the field of biotechnology. Therefore, it is imperative that one seek assistance from a patent attorney to protect themselves and their business via IP law.



Filip Kovacevic is an entrepreneur and accomplished freelance writer in computer science and tech. Prior to starting his career in freelance writing, he worked on developing stories for the screen, in regards to technology. He holds a degree in Economics and Film production from Arizona State University.



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