**5. Look before leaping to patent**

Before filing a patent application, ensure that a thorough prior art search is done and in relation to that prior art, map out all possible obvious extensions to the art that are likely to occur to a person of ordinary skill in synthetic biology (*e.g.*, the average post-doc). If your invention goes beyond the obvious extensions, and fulfils the statutory requirements of novelty, nonobviousness and utility then expeditiously file a patent application for your invention ensuring that you fully describe the invention (including the best mode) therein. File a provisional application if necessary to claim priority over other inventors and follow it up in a timely manner with a non-provisional application. Scrupulously follow patent office protocols. Getting a patent is expensive, so a business analysis before filing is prudent.

#### **5.1. Prior art search**

Historically, pioneering technologies have created intense patentability debates [46, 47] that range from conceptual to political. For example, IPR opponents in the past had argued agriculture was not an industry, patents on pharmaceuticals would be unethical, biotechnol‐ ogy is about trying to play God, software and business methods are non-technical, etc. In the 1970s, concerns surfaced about recombinant DNA technology that innocuous microbes could be engineered into human pathogens resistant to then known antibiotics, or enable them to produce toxins, or transform them into cancer causing agents [47]. Fears have since abated. Recombinant DNA technology now dominates research in biology. In synthetic biology, the fears are more in terms of our ability to regulate research and industrial activities so that these

In societies that abhor monopoly rights and favour level playing fields of competition, even limited period monopoly creates social tension. Thomas Jefferson (1743–1826), the third President of the United States (1801–1809), the principal author of the Declaration of Inde‐ pendence (1776), a well-known scientist of his time, the initiator of the first U.S. patent system in 1790, and the author of the 1793 Patent Act, had this to say in 1813 in a letter to Isaac

Considering the exclusive right to invention as given not of natural right, but for the benefit of society, I know well the difficulty of drawing a line between the things which are worth to the public the embarrassment of an exclusive patent,

The demarcation debate between openness and limited period monopoly may never end. In synthetic biology this debate is complex because it involves the assimilation of a new technol‐ ogy by society and of inventions that were never anticipated to become part of the patent system. Indeed, some of these future inventions may well be bio-robots and bio-computers with the DNA serving as programmable memory. It would require tremendous legislative efforts to equitably deal with such live inventions. However, one expects that bio-weapons,

Before filing a patent application, ensure that a thorough prior art search is done and in relation to that prior art, map out all possible obvious extensions to the art that are likely to occur to a person of ordinary skill in synthetic biology (*e.g.*, the average post-doc). If your invention goes beyond the obvious extensions, and fulfils the statutory requirements of novelty, nonobviousness and utility then expeditiously file a patent application for your invention ensuring that you fully describe the invention (including the best mode) therein. File a provisional application if necessary to claim priority over other inventors and follow it up in a timely manner with a non-provisional application. Scrupulously follow patent office protocols.

Getting a patent is expensive, so a business analysis before filing is prudent.

activities are carried out safely [16] and the human species preserved.

like atomic weapons, would be kept outside the patent system.

**4.5. The IPR side of IP outputs**

and those which are not.

**5. Look before leaping to patent**

McPherson [48]:

210 Biotechnology

Prior art or state-of-the-art is all information, available in any form (including social media), in the public domain. It does not include secret information, *e.g.*, trade secrets or confidential communications. Patentability searches of prior art – to decide whether or not an invention is patentable – especially from the point of view of novelty and non-obviousness are routinely performed by patent examiners. Even then, it is usually prudent to pre-emptively carry out a similar search. *Inter alia*, such a search provides valuable information to the lawyer drafting the patent application. First, it helps him define the prior art and the background of the invention so that he can highlight patentable features of the invention. Second, he will be able to strike a balance between framing too broad or too narrow claims for the invention.

Learn the art of prior art search. Automated searches (*e.g.*, Google scholar) are valuable as a lead-in to conducting a specialized manual search or as a follow-up to locate patents or other prior art after a manual search. If affordable, get a professional search done. Note that no search can guarantee that it is complete or completely accurate. More importantly, only the absence, and not the existence, of novelty of your invention can be established.

#### **5.2. PHOSITA**

This legal fictional person (or a team) having ordinary skill in the art, called a PHOSITA who is neither a genius nor a layperson, is considered to possess average skills and knowledge in a particular technical field and hence unlikely to ever become an inventor. He thus serves as a reference for determining by comparison whether an invention is obvious or not. If a PHOSITA is deemed capable of coming up with the invention if required, assuming he/she would make the effort to study relevant prior art, then the particular invention is deemed unpatentable. Note that a "person of ordinary skill is also a person of ordinary creativity, not an automaton." [49]. Further, "in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." [49].

The skill profile of a PHOSITA is determined on a case-by-case basis, depending on the level and technological features of the invention. Factors used in profiling include the education level of the inventor, type of problems encountered in the art, known prior art solutions, rapidity with which innovations are made in the art, sophistication of the technology, and education level of active workers in the field. Clearly, a PHOSITA's profile changes with time as he continuously imbibes new advances in related technologies. A PHOSITA of today, may have been an expert yesterday! This is clearly true in synthetic biology where the PHOSITA will most likely be a researcher with a PhD.

#### **5.3. Novelty, non-obviousness, utility, written description, claims**

Only an invention that can be classified as machine, manufacture, process, or composition of matter and further if it is considered novel with respect to prior art, non-obvious to a PHOSITA, and useful to society at the time the patent application (provisional or non-provisional) is filed is eligible for consideration of a patent grant provided the invention is clearly and fully described. Patent prosecution is the process by which a non-provisional patent application is

defended before the patent office. Prosecution begins with the filing of the non-provisional patent application and ends with the final decision on the application by the patent office.

Obviousness creates a 'patent-free' zone around the prior art related to the invention and prevents trivial advances from being patented. Under the doctrine of equivalents, straying into the patent-free zone of a valid patent amounts to infringing the patent. (See Section 6.2.)

The invention must have a useful effect or a purpose meaningful to society else the invention is not patentable. The invention's utility must be specific to the subject matter claimed, credible to a person skilled in the field, and should not require further research to discover it.

The written technical description of the invention should enable a person skilled in the art to reproduce and use the claimed invention without undue research or experimentation beyond those normally expected from such a person. Because the experimentation may be complex for a particular invention it will not become undue if a person of skill in the art typically engages in such complex experimentation. The inventor must point out how his invention differs from prior art. Finally, the non-provisional application must include one or more claims that distinctly spell out specific aspects of the invention which the inventor claims are his intellec‐ tual property in need of legal protection. Omitted aspects that could have been claimed are deemed to have been gifted to mankind. Likewise, disclosing the invention by putting it in public use, testing it in public, describing it in a speech in a technical conference, sale of the invention, disclosing the invention to people without a signed non-disclosure agreement with them, discussing it in the social media, etc. before filing a patent application may be construed as placing the invention in the public domain and hence ineligible for a patent.

It must be clear from the written description that the applicant was in possession of the claimed invention at the time of filing. There is no statutory requirement that the inventor disclose why the invention works or how it was developed. Inventors are expected to write their invention using the language and ideas that are accepted in the field of the invention, say, by a PHOSITA. In some countries, it is a statutory requirement that the inventor set forth the best mode contemplated by him of carrying out his invention.

While the written description must be followed by one or more claims through which the inventor points out and distinctly claims aspects of the invention he believes are his original non-obvious contributions, he should not pre-emptively claim ideas, laws of nature or natural phenomena. Each claim must be so drafted that patent examiners and potential infringers can understand what the claimed subject matter is. Writing claims is a specialized art, and should preferably be drafted by a patent attorney. Claims lie at the heart of infringement litigation and they form the most important part of a patent.

A patent is invalid if its claims, read in light of the invention's description and prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. However, when the invention is novel and non-obvious, words may not exist to describe it so the law allows words to be invented and defined to describe the invention to fill unintended idea gaps in a language.

#### **5.4. Business prudence**

defended before the patent office. Prosecution begins with the filing of the non-provisional patent application and ends with the final decision on the application by the patent office.

Obviousness creates a 'patent-free' zone around the prior art related to the invention and prevents trivial advances from being patented. Under the doctrine of equivalents, straying into the patent-free zone of a valid patent amounts to infringing the patent. (See Section 6.2.)

The invention must have a useful effect or a purpose meaningful to society else the invention is not patentable. The invention's utility must be specific to the subject matter claimed, credible

The written technical description of the invention should enable a person skilled in the art to reproduce and use the claimed invention without undue research or experimentation beyond those normally expected from such a person. Because the experimentation may be complex for a particular invention it will not become undue if a person of skill in the art typically engages in such complex experimentation. The inventor must point out how his invention differs from prior art. Finally, the non-provisional application must include one or more claims that distinctly spell out specific aspects of the invention which the inventor claims are his intellec‐ tual property in need of legal protection. Omitted aspects that could have been claimed are deemed to have been gifted to mankind. Likewise, disclosing the invention by putting it in public use, testing it in public, describing it in a speech in a technical conference, sale of the invention, disclosing the invention to people without a signed non-disclosure agreement with them, discussing it in the social media, etc. before filing a patent application may be construed

to a person skilled in the field, and should not require further research to discover it.

as placing the invention in the public domain and hence ineligible for a patent.

contemplated by him of carrying out his invention.

212 Biotechnology

and they form the most important part of a patent.

unintended idea gaps in a language.

It must be clear from the written description that the applicant was in possession of the claimed invention at the time of filing. There is no statutory requirement that the inventor disclose why the invention works or how it was developed. Inventors are expected to write their invention using the language and ideas that are accepted in the field of the invention, say, by a PHOSITA. In some countries, it is a statutory requirement that the inventor set forth the best mode

While the written description must be followed by one or more claims through which the inventor points out and distinctly claims aspects of the invention he believes are his original non-obvious contributions, he should not pre-emptively claim ideas, laws of nature or natural phenomena. Each claim must be so drafted that patent examiners and potential infringers can understand what the claimed subject matter is. Writing claims is a specialized art, and should preferably be drafted by a patent attorney. Claims lie at the heart of infringement litigation

A patent is invalid if its claims, read in light of the invention's description and prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. However, when the invention is novel and non-obvious, words may not exist to describe it so the law allows words to be invented and defined to describe the invention to fill Economic viability of a patent depends on the following:

*Detectability*. Once a patent is granted, the idea and implementation details become public. Hence, to enforce your patent, you must be able to detect infringement easily, otherwise keeping the invention a trade secret may be a better option.

*Non-avoidability*. If viable alternatives to your invention exist or can be developed within reasonable timeframes and costs, then seeking a patent may be unwarranted.

*Business value*. Acquiring a patent is both time-consuming and expensive. So weigh the potential benefits that may accrue from a patent against potential risks of not seeking a patent.

*Technology obsolescence*. Track emerging technologies and technology trends to determine if your invention will become obsolete in the near future.

Since biotechnology patents generally underpin business, it is imperative that patent applica‐ tions are prepared and prosecuted by experienced patent attorneys and that inventors work closely with them to minimize prosecution hurdles and future litigation possibilities.
