21 February 2020 by

The following article comes from a student of IP law at Georgetown University in Washington DC. Although somewhat outside the range of subjects usually covered by UKHRB I feel it is sufficiently important to keep up to date with this difficult and fast moving area, as law tries to keep pace with technological developments in this field. So here we have John Butcher’s survey of the field.

Inventors come from many different disciplines and fields of study. Arguably one of the most important are biotechnicians whose inventions dramatically help to improve our standards of living. From healing the body of diseases to restoring the environment, biotechnology pervades all aspects of life. 

While that sounds really nice, you might be wondering what exactly falls under biotechnology?

What is Biotechnology?

Biotechnology in the United Kingdom is the industry of organisms that manufacture commercial products. Interestingly, it can be quite controversial at times i.e. stem cells and gene cloning. Despite this, biotechnology is integral to advancements in the healthcare and pharmaceutical industry. 

Currently, most industrial biotechnological expenditure in the UK is in the field of healthcare. Consequently, the UK is the leader in Europe in the development of biopharmaceuticals – by quite a lead.

By using nature’s own toolbox i.e. genes, elements, microbes, etc., biotechnology seeks to improve the lives of everyone around the globe. Essentially, it’s harnessing nature and shaping it in order to improve our way of life. 

But biotechnology isn’t only about using resources until they’re all gone, instead we’ve found ways to assist nature’s processes e.g. insecticides, water and air purifiers, as well as crops capable of denser propagation. 

For more information on how the UK is great for biotechnology, see here.

Why is it Important?

Now, obviously nature doesn’t care if we do these things to help it – so why do we? 

  • Biotechnology reduces rates of infectious diseases;
  • saves children’s lives;
  • cuts greenhouse gas emissions;
  • produces food free of allergens; and
  • improves the content of food for increased cardiovascular health. 

In short, biotechnology heals the world. And it does so because it works off the progress people before have supplied.

A recent example within the UK is at OMass Therapeutics, a private biotech company in Oxford, whose irresistible moniker is “biology in flight”. The company is designing small molecule drugs to treat immunological and genetic disorders. OMass is utilizing a technique called “native mass spectrometry,” which is an advancement from regular mass spectrometry. It essentially allows them to identify key proteins and how they behave in the body. This information allows the biotechnicians at OMass to observe how the drug reacts with them much more closely, thereby determining, if necessary, what changes to make.

In this instance, OMass is utilizing the knowledge and techniques of those before them. They’re doing this in order to continue the work of treating health problems with prevalence today.

It’s evident, if you invent a new compound or means of solving a problem, it is imperative to choose to get a patent. Because patents, as opposed to trade secrets, allow for others to view and improve upon your ideas. In an altruistic sense, they allow for the continual improvement of technology and life.

For more info on contemporary efforts in biotechnology, see here.

Biotechnology Patents

But what exactly are biotechnology patents, how do they work, and how do you get one? 

One huge obstacle for obtaining patent protection for, say, a stretch of coding DNA such as the BRCA mutated gene for Breast cancer “discovered” by the US company Myriad. There have been a number of ferocious attacks on the US Patent Office’s decision to grant the company patent protection, because on of the first rules militating against such a grant is that what is found in nature, does not contain an “inventive step”. The literature on the Myriad litigation is myriad and there is no scope to go into it here but it is a landmark case because the US court considered the isolation of the “exons” – the stretches of genes that actually code for proteins – away from the “introns” – the “silent genes” ,which we are no longer permitted to describe with the perjorative terminology “junk DNA”, was a sufficiently inventive step to allow them their patent protection.

Technically, biotechnology patents are considered utility patents. This type of patent – a utility patent – is available for processes, machines, forms of manufacture, and compositions of matter. To elaborate further:

  • Process: these are 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: the combination of subparts which carry out a process. An easy way to think about this is if the process is a recipe, then the machine is an oven.
  • Manufacture: when you take raw materials and change, or assemble, them with regard to their form or physical properties. An example would be a chair that has been pieced together by shaping wood.
  • Composition of matter: the combination 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 UK’s Intellectual Property Office (IPO) that these inventions are novel, useful in a practical way to a field, and non-obvious. It can’t be understated how important it is to emphasise the degree to which an invention improves something or solves a problem. Otherwise, they are considered too obvious or simply unuseful. 

For more information on patents in the UK, see here.

Importance of Patenting

Patents provide inventors twenty years of exclusive rights to make, use, and sell their inventions. Some of the most favorable aspects include:

  • Creating barriers for similar products in the marketplace.
  • Enhances a company’s value.
  • Opportunities of generating licensing revenue.

Research and development (R&D) of any technology is usually an expensive endeavor. It’s no surprise then, companies sustain heavy losses throughout the R&D period. Their hope is to eventually recover those losses when they begin selling their invention.

Fortunately, while R&D may be expensive, production and imitation are relatively cheap. Hence, it is imperative the compound be patented less anyone wants their compound reverse engineered and distributed earlier.

Not only is there the financial aspect of having a monopoly on a product in the market, but there is also the more altruistic component of sharing knowledge with other inventors with which to create even better ideas.

One compound that’s shared leads to another. Medication that heals a disease with potentially risky side effects can be improved and the risks reduced. Surgical procedures dependent on harmful doses of medication can be substituted for something much less potent while maintaining the same inoculating component. This is the nature of advancements in science and technology.

To summarize, patenting makes life better for everyone.

Importance of a Patent Attorney

Patents are indisputably important for any inventor to obtain. Unfortunately, many don’t appreciate the complexities of how to get a patent. Many people attempt do-it-yourself type patent applications that usually get rejected, or worse, pass with extremely narrow claims that allow competitors to profit off their idea. Hence the importance of getting a patent attorney. 

The following paragraphs describe the process of instructing a patent attorney in the United States, but they are not dissimilar to the requirements in the United Kingdom.

J.D. Houvener, founder and CEO of Bold Patents Philadelphia Law Firm, stresses “the assistance of a patent attorney is imperative for an inventor to obtain the benefits of widely applicable claims that will prevent competitors from entering anything similar in the marketplace.”

Not only for protection, but for expediency, a patent attorney’s help is essential. They have the most experience to earn fast rates of approval for applications that can at times take up to four years. 

Obviously, this amount of time can be devastating to anyone’s business. Invest in your business today to prevent unnecessary amounts of stress and loss of profits in the future.

In Conclusion

Biotechnology does a great deal of good for the world. As such, we owe it to the inventors to allow them to profit off their ideas as well as we have. Thus, the importance of patenting: twenty years of exclusive rights to make, use, and sell their inventions in the marketplace.

Without patenting in biotechnology, compounds would be considered something more along the lines of trade secrets – no one except the owner would know how something is made or done. Entertaining this perspective doesn’t allow for advancements in technology, therefore, no substantive improvements in life. When we work together and share information, we can accomplish much more.

However, patents can be very tricky to navigate. Even if someone is successfully granted one on their own, competitors of larger businesses often find means to circumvent infringement laws and use another’s idea for their personal gain.

Hence, the importance of getting an experienced patent attorney’s help. These are professionals who spend years studying legalese and know the ins-and-outs of the IPO. So the best choice for yourself and your business is being thorough from the start. It’s the route that’s going to make you the most profits… and save you a lot of headaches.