| Abstract|| |
Dentistry in recent years has developed interest in the field of intellectual property rights (IPR) and Patents due to extensive research in the fraternity and existing competition. There have been various patent applications and grants in the field of dentistry abroad due to better understanding of IPR but India still has very few patent grants and applications on the subject matter. This review article in particular deals with the understanding of IPR and Patents as a whole, especially for dental professionals involved in research and development. Hence, this would also act as an asset for dental researchers to explore and expand their scope of activities, with special privileges empowered for their work.
Keywords: Development, intellectual property rights, patents, research, dentistry
|How to cite this article:|
Bijle MA. Patent law in dentistry: An overview. Indian J Dent Res 2011;22:574-9
Dental profession has for many years concerned itself with practical problems with patenting of processes for the production of substances and devices used in diagnosis, prevention, and treatment of diseases. Dentistry in recent years has developed interest in the field of intellectual property rights (IPR) and Patents due to extensive research in the fraternity and existing competition.
Thus, there is an era of understanding certain laws related to protection of properties developed by intellect. Even today, numerous inventions are being performed in the field of dentistry, but due to the lack of knowledge related to IPR and Patents, it is unable to obtain its substantial value in the society.
There have been various patent applications and grants in the field of dentistry abroad due to better understanding of IPR, but India still has very few patent grants and applications.  This implies that Indian scenario for Patents related to dentistry still has a long way to go and development is must for the progress of nation. To implement a strategy that promotes research and development in the field of dentistry and increases the number of invention, in turn increases the number of granted patents, is the need of an hour.
Thus, proper documentary evidence is required to introduce the understanding of IPR and Patents in the field of dentistry and its implementation. This paper in particular deals with the understanding of IPR and Patents as a whole, especially for dental professionals involved in research and development. Hence, this would also act as an asset for dental researchers to explore and expand their scope of activities, with special privileges empowered for their work.
| Patent Law and Its Understanding|| |
IPR is a legal right given to creator or innovator of an intellectual property; whereas, intellectual property is the results of human mind (intellect) creation which is sometimes intangible. One of the IPR protection forms is patent. A patent is an exclusive legal right granted to the owner of an invention in a specified territory for a period of 20 years. The law of patents is a legal framework that establishes a patent system which supports and encourages technological innovation and promotes economic development.
It is hoped that an increased understanding of the process of IPR and Patent will eliminate some of the misconceptions held by the dentists and, to a lesser degree, the academic and dental research community.
Some of the questions that always remain a matter of concern are as follows:
- What are some of the factors that control the grant or denial of a patent? What do the patent laws require for an invention to qualify for a patent?
- What kind of scrutiny does an application for a patent receive before a decision is made to grant or deny a patent?
- Who are the examiners who perform this scrutiny and make the decision to grant the patent or not? What is their level of expertise and experience?
- How are patent statutes and case law applied? When a patent is issued, how might the application of the statutes have affected the claims that are actually granted?What is the invention that is actually covered by the patent document? What are the rights that a patent confers on the inventor or the patent owner?
- In this article, we will try to answer these questions for better understanding of IPR and Patents as far as Dentistry and Medicine is concerned.
Statutory requirements for obtaining a patent
In order for an invention to be patented, it must fulfill certain criteria depending upon the territory into which the exclusive rights are applied for. In this paper, the requirements as per USA Patent Law and the Indian Patent Law are described.
USA Patent Law
The patent law of the United States is grounded in the U.S. Constitution, Article 1, section 8, which states: "The Congress shall have power to . . . promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries." The basic requirements for obtaining a patent are set forth in four sections of Title 35 of the U.S. Code: §§ 101, 102, 103, and 112.
Section 101 provides that "whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore," if it meets the conditions and requirements of Title 35. This section governs two requirements that have become very important in the biotechnology/biomedical fields in recent years: The requirement that the claims be directed to subject matter that is eligible for patent protection (eligible subject matter) and the requirement that the invention be useful, that it have utility. Laws of nature, naturally occurring phenomena, and abstract ideas are not patent-eligible subject matter. However, products of nature are patent-eligible subject matter if they are claimed in a form that does not occur in nature, i.e., they have been altered in some way by the "hand of man." Thus, a pure strain of bacteria qualifies as patent-eligible subject matter where its existence as a pure strain requires that the hand of man select, clone, and expands a colony into a pure population. (Patent-eligible should not be equated with patentable-the purified strain must be novel, unobvious, adequately described and enabled, and useful to fully qualify for a patent.) Computer-implemented processes also qualify as patent-eligible subject matter as long as they produce a "useful, concrete and tangible result."
On the other hand, a compilation or mere arrangement of data stored in a computer-readable medium is considered nonfunctional descriptive material and is not patent-eligible subject matter.  With respect to the utility requirement, the claimed invention must have a specific, substantial, and credible utility. The requirement for specificity precludes a general utility that is not specifically related to the claimed subject matter (an often-used example of a general utility is the use of a transgenic mouse as snake food). A substantial utility is a real-world use that represents an end in and of itself, for example, a method of making a useful pharmaceutical compound, or a research tool, that can be used to accomplish a specific task. A protein or nucleic acid whose function is not known, and whose only use would be as a subject of further research, would not have a substantial utility. A credible utility is one that would be believable by a skilled artisan in the field of the invention based on the record or the nature of the invention. To ensure that the appropriate legal standards of patentability are met, examiners have been given extensive guidance in how to apply the § 101 utility requirement. 
Sections 102 and 103, respectively, set forth the requirements for novelty and non-obviousness over the prior art. An invention is novel if it is not "anticipated," that is, described in all its particulars (as claimed) by the prior art. Non-obviousness is determined by assessing the scope and content of the prior art, the differences between the claimed invention and the prior art, and the level of ordinary skill in the art, an analysis prescribed by the Supreme Court in Graham v. John Deere.  The question then is, in view of these factors, would the person of ordinary skill have been able and motivated to bridge the gap between the prior art and the claimed invention? In recent decisions related to nucleic acids, the Federal Circuit has concluded that structural obviousness is necessary to support a rejection under 35 U.S.C. § 103, and that the existence in the prior art of a method of obtaining a particular nucleic acid does not make the nucleic acid obvious. 
Among other requirements, section 112 spells out the duty of the inventor to provide a written description of the invention that is adequate to enable one of skill in the art to make and use the invention. This is a two-pronged requirement for a disclosure that first must describe the invention in sufficient detail that a person of skill in the art would recognize that the inventor had possession of the invention at the time the application was filed, and second, must provide sufficient detail about how the invention can be made and used to allow the skilled artisan to reproduce the invention. Section 112 also requires that the invention be defined in one or more claims "particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention." This is very important because the claims provide the legal definition of the invention, as discussed in more detail later.
The United States Patent & Trademark Office (USPTO) administers the patent statutes as interpreted by its reviewing courts. Decisions of the Supreme Court and the Federal Circuit provide substantial guidance to the USPTO regarding factors that should be considered in analyzing a patent application to determine whether or not it meets the statutory requirements for a patent. As pointed out above, Supreme Court decisions are responsible for expanding the subject matter that is eligible for patent protection into areas such as living organisms. Other decisions of the federal courts have been instrumental in explaining how one should analyze the evidence of record to determine whether an invention would have been obvious over the prior art, whether the patent application provides an enabling disclosure, whether or not there is adequate written description of the invention when it is a biological molecule, and whether an invention has utility. 
Indian Patent Law
Chapter II of the Indian Patent Act lays down a list of inventions that are patentable and not patentable. All inventions or discoveries listed under Section 3 of Chapter II are not inventions within the meaning of the Patent Act and are therefore not patentable. Thus, in a similar manner, Section 2 of Chapter II enlists various inventions that could be patented. Unlike USA patent law, an extra criteria to be "Patentable Subject Matter" is included apart from other criteria of novelty, non-obviousness, and industrial applicability.
Section 3(i) states that any process for the medicinal, surgical, curative, prophylactic, or other treatment of human beings or any process for a similar treatment of animals or plants to render them free of disease or to increase their economic value or that of their products is not patentable.
This provision rules out the patentability of methods used for treatment of human beings, animals, and plants. In order to fall outside the scope of patentability, the method should be for medicinal, surgical, prophylactic, curative, or other treatment. By including the words "or other treatment" after prophylactic, this clause has been given a wide scope which means that any method for any sort of treatment shall be considered to be unpatentable under the Indian Law. Thus, India has a very strong exclusion clause for medical methods.
What kind of scrutiny does a patent application receive before it is allowed or denied?
Charged with administering the patent laws, the patent office is responsible for examining each patent application to determine whether the claimed invention, and the disclosure of the invention contained in the application as filed, meet the requirements specified in the sections of Title 35 of the USA patent law mentioned above, as interpreted by precedential court decisions. Detailed guidance in interpreting case law and applying the statutes is provided to patent examiners in the Manual of Patent Examining Procedure,  which also instructs the examiners in mandatory and recommended procedures to follow in the course of examining a patent application.
The patent office further provides examination guidelines that are designed to assist examiners in analyzing claimed subject matter for compliance with substantive law. Examination guidelines and training materials are available to the public.  Prior to focusing on specific statutory requirements, the examiner must determine what, precisely, the applicant has invented and is seeking to patent, and how the claims relate to and define that invention. Claim construction, determining the meaning of the claim and what it actually encompasses, is an essential part of the examination process. Each claim must be analyzed separately and given its broadest reasonable interpretation in light of and consistent with the written description. Once the meaning of the claim(s) has been construed, the examiner searches the prior art. After obtaining the most relevant references, the examiner reviews them to determine whether they demonstrate or suggest that the invention was known or, following the analysis set forth in Graham v. Deere , whether the invention would have been obvious at the time the application was filed.
The patent examiner also analyzes the disclosure and claims to determine whether the claimed invention is eligible for patent protection, whether the claimed invention has a specific, substantial, and credible utility, whether the disclosure provides an adequate written description of the claimed invention, and whether the description provides sufficient direction to enable a person "of skill in the art" to make and use the claimed invention. The examiner also determines whether the claims clearly see forth the "metes and bounds" of the claimed invention, which serves to ensure that one skilled in the art is apprised of the scope of the claim.
If the examiner concludes that the invention does not meet one or more of the statutory requirements for a patent, he or she has an initial burden to establish a prima facie case of unpatentability, i.e., to show that it is more likely than not that applicant has not complied with the statutory requirements. For each statute under which the invention is deemed unpatentable, the rationale and evidence supporting the prima facie case is communicated to the applicant, who then has the opportunity to try to show why the prima facie case has not been made, to provide evidence that overcomes it, or to amend the claims in such a way that they comply with the statutory requirements. If, upon full consideration of the applicant's response, the examiner determines that the rejections have been overcome, the application will be allowed to issue. If the examiner deems that the response fails to overcome the rejections, he or she will maintain the rejections and make them "final" and will communicate the reasons that they have been maintained to the applicant. When a rejection has been made final, the applicant's opportunity to argue or enter new evidence is limited and the case is either made allowable by the applicant's next response, abandoned possibly in favor of a continuing application, or appealed to the Board of Patent Appeals and Interferences for appellate review.
Who are the examiners who scrutinize patent applications and make the decisions as to whether an invention is patentable or not?
Examiners must have at least a bachelor's degree in their field. PhD. and Master's Degree are much more preferable. Law degrees are not required for examiners; patent examiners undergo extensive training, mostly in the form of hands-on mentoring, during their early years in the USPTO and Indian Patent Office (IPO). Depending on their levels of education and experience when hired, they must work at least four years before they are given the authority to make final decisions as to the fate of a patent application. Such authority is granted only after a rigorous review process, which involves independent review of the examiner's work for a period of six months to determine that the examiner is routinely making correct decisions and taking correct actions in performing the examination process.
How does the examination process affect the patent application?
Applying for a patent and examining the patent application are not check-the-box, yes-or-no processes. Together, they are a complex negotiation in which the applicant attempts to obtain the broadest possible coverage for his or her invention and the examiner attempts to ensure that all statutory requirements are met. One possible outcome of examination is a clear demonstration that an invention is not patentable: The examiner finds prior art that unambiguously discloses the invention in all its critical details, or prior art that demonstrates the obviousness of the entire scope of the invention, or the specification fails adequately to describe and enable the invention, or the utility of the invention is not specific, substantial, and credible. Far more commonly, the application as filed will support a patentable invention, and the examination process becomes a means of determining what the applicant is actually entitled to after all the appropriate statutes have been considered in relation to the facts and evidence of record in the specific application.
In the area of medicine, dentistry, and biotechnology, where extrapolating from the thing actually done to what that thing suggests might be done is very unpredictable and fraught with difficulties that require further experimentation to overcome, rejections on prior art and enablement grounds serve to rein in the scope of the invention that is eventually defined by the claims in that issue. The requirement that a patentable invention has a credible, substantial, and specific utility has largely prevented the issuance of claims. It must be pointed out, however, that the patent office has no discretion in deciding what subject matter can, and cannot, be patented. Inventors are entitled to patents when they have met the statutory requirements for novelty, non-obviousness, and usefulness, and their patent disclosure adequately describes the invention and clearly teaches others how to make and use the invention. The burden is on the examiner to establish a prima facie case of unpatentability. In some instances, when an invention represents a breakthrough that opens up whole new areas of endeavor, the evidence to establish a prima facie case of unpatentability simply does not exist, and claims that definition of the invention in very broad terms will be issued.
What is the scope of protection covered by the patent?
There is often confusion among individuals who are not patent attorneys as to what invention is actually protected by a patent. It is very important to understand that the patent holder has the right to exclude others from making, using, selling, offering for sale, or importing into the country only the subject matter as defined in the claims, which are published at the end of the patent document. It is the language of the claims that defines the legal boundaries of the invention.
| Drawback and Merits Attributed to Patenting System|| |
Putative advantages include incentives to finance an extensive research establishment in order to provide a pipeline of potentially patentable products, incentive to incur development costs for patented products, and encouragement of individual researchers to develop new and useful processes and products (provided there is a mechanism for the individual to reap the financial benefits).
There are two different approaches that one could take when attempting to evaluate the usefulness of patents in socioeconomic development. One approach is attempting to decide if the benefits of a patent or IPR outweigh the cost involved during application process and the second approach is attempting to determine if a patent is an appropriate reward for all of the intellectual labor that was put into the development of the product. When attempting to decide if the benefits outweigh the costs, we need to consider the possible benefits. Some of the possible benefits could be advancement of medical research, biotechnology, medical drugs, and many other forms of technology. The costs that could occur are mostly limited to a company or corporation having a monopoly on the product they developed for the duration of the patent, which is 20 years. Other negative issues that could be raised about the patent a company may hold is when that patent is about to expire and the patent holder will alter the product just enough so they can get a new patent that covers the new and old product, thus extending their previous patent another 20 years. This seems to be a loop hole that patent holders can use to their advantage that could possibly hold back further advances in technology, if another company was waiting to use or produce the product that the patent was expiring on.
When considering the second desert-based approach, we need to decide if a patent is an appropriate reward for all of the labor done throughout the development process of the invention. We could say that patents are appropriate because someone who puts enormous amounts of time, money, and brain into researching and developing a product should be rewarded so that other individuals cannot steal their idea or product and sell it for their own gain. That would serve to be a serious disadvantage to the creator or the product and a patent would alleviate the risk of such disadvantage.
| Patentability of Dental Treatment|| |
Patentability of dental treatment is one of the questions that are generally asked about. This could be better explained by one of the illustrations given below:
The IP High Court
Case H19 (Gyoke) No. 10369 decided June 24, 2008
The plaintiff, Shade Analyzing Technologies Inc. (US) filed a Patent Cooperation Treaty (PCT) Application (PCT/US99/22857) which entered into the Japanese National Phase as Application No. 2000-579144, addressing "Interactive Dental Restorative Network." The application was rejected on January 21, 2005 and the plaintiff (applicant) filed an appeal against the decision of rejection with the Board of Appeals (Appeal No. 2005-7446). In the appeal, the plaintiff tried to amend the claims on May 26, 2005, but the Board of Appeals did not accept the amendments for failing to satisfy the requirements of amendment. Thus, the rejection made final. The plaintiff appealed the decision to the Tokyo Appellate Court (currently called "the IP High Court"). The issues in the appeal were (1) whether the rejection of the claim amendments was appropriate and (2) whether the claimed invention satisfies the eligibility of an invention prescribed in Art.29 (1), main paragraph of Japan Patent law. As to issue (1), the IP High Court affirmed the rejection of the claim amendments. However, as to issue (2), the Court negated the Board Decision on the ground that the claimed invention satisfies the statutory eligibility of an invention.
The Board of Appeals states as follows: (1) The claim amendment is disapproved because it fails to satisfy any of the statutory requirements which provide that a substantive amendment shall be limited to (1) cancellation of claim(s), (2) restriction of claim(s), (3) correction of error(s), and (4) clarification of descriptive ambiguity; and (2) the claimed invention is not eligible for a patent, because it does not meet the statutory definition of an invention under Art.2(1) of the Japan Patent Law amended in 2003.
IP high court decision
(1) The Court held that the Board of Appeals had wrongly underestimated the meanings of "a means for identifying …" and "a means for designing …." The present invention is to provide a technical means for a dentist to rely on when he or she identifies and design a dental restoration need and a treatment plan therefore. (2) It is understood that the invention provides a method and system for assisting a dentist and a dental technician to make preliminary and final treatment plans to meet the identified dental restoration need, not by a mental act, but by aid of a computer which comprises a network server having a database; a communications network; one or more computers located at a dental office; and a device capable of image display and processing.
In conclusion, the claimed invention can be recognized to be eligible for a patent. Thus, the Court dismisses the Board's Decision.
| Conclusion|| |
The patent examination process is designed to apply a body of laws to achieve two primary purposes. One is to ensure that inventors receive the exclusivity rights of patent protection they are entitled to for the inventions they make or discover. The other is that the public is compensated for the cost of that protection by receiving a full and complete disclosure of the advancement made by the inventor. I hope that this article has provided some insight into how that process works, and will promote a better understanding of the scope and impact of a patent disclosure and the issued claims in the Field of Dentistry and Medicine.
| References|| |
|1.||An observation made as per the comparison of filed and granted patents in the field of dentistry. Available from: http://www.uspto.gov and http://www.patentoffice.nic.in [Last accessed on 2009 Dec 19]. |
|2.||Examination guidelines for computer-related inventions, Manual of Patent Examining Procedure (MPEP), § 2106 ^http://www.uspto.gov/web/offices/pac/mpep/documents/2100.htm. [Last accessed on 2002 June 15]. |
|3.||Utility Examination Guidelines, 66 FED. REG. 1092. Available from: http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf and, [Last accessed on 2002 June 15] and MPEP §§ 2107.01-2107.03. |
|4.||Graham V, Deere J. 383 U.S. 1, 148 USPQ 459 (1966). |
|5.||In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993); In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995). |
|6.||Graham V, Deere J. 383 U.S. 1, 148 USPQ 459 (1966); In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988); Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997); Brenner v. Manson, 383 U.S. 519, 148 USPQ 689 (1966). |
|7.||Available from: http://www.uspto.gov/web/offices/pac/mpep/index.html [Last accessed on 2009 Dec 20]. |
|8.||Available from: http://www.uspto.gov/web/offices/pac/dapp/mpepmain.html [Last accessed on 2009 Dec 20]. |
Mohammed Nadeem A Bijle
Department of Paedodontics and Preventive Dentistry, M. A. Rangoonwala College of Dental Sciences and Research Centre, Pune
Source of Support: None, Conflict of Interest: None