Introduction
In the domain of pharmaceuticals, drug patent enable the protection of the innovation of different drugs. They not only motivate the pharma companies to try their hands in research and development but also provide security for the resultant investment. This article takes an in-depth hal into the patent filing process for therapeutic discoveries, from explaining the fundamental aspects to mastering the intricacies of patent prosecution and further.
Understanding the Patent Process
A patent is a government’s document that bestows the patent holder with the exclusive rights to their invention for a certain period of time. With regard to drug invention, patents act as a necessary way to protect new chemical components, formulations, and applications, and thus, the innovator has the unique right to manufacture, use, and sell the patented invention. In the pharmaceutical industry, many kinds of patents are used. Utility patents are the most dominant type, they protect the new and useful processes, the compositions of matter, and the methods of use. Being a patent for the design of a product which is less common, design patents, nevertheless, can be used for the protection of the ornamental design of drug delivery devices or packaging. The scope of patentable subject matter in the pharmaceutical industry consists of the new chemical entities, formulations, and uses or methods of treatment, among others.
Why are drug patents important
Drug patents are important as they protect pharmaceutical innovations, encouraging research and development by providing inventors with exclusive rights to their discoveries, and ensuring they can recoup investments and continue to innovate.
Patent drugs vs generic drugs
Patented medicines are the new drugs that are granted patents; thus, the company that invents the drug is the only one that has the rights over it. On the contrary, the generic medicines are the exact ones as the patented ones but they are sold under their chemical names after the patent expires.
Pharmaceutical patent types in India
The pharmaceutical industry views the drug patent system to be the most vital tool to protect its inventions. In India, there are different types of patents related to drugs, like conventional patents, phase-out patents, and supplementary patents. These are the drugs that have the chemical structure of a drug, formulation patents, and synergistic combination patents for new drug combinations that involve the chemical structure of a drug, formulation patents for specific technologies used in drug preparation, and patents for new drug combinations. Technology patents are patents that are granted for the protection of the techniques used to solve technology related problems, and polymorph patents are the ones that are granted for the protection of the improved crystal structures of the known compounds. Biotechnology patents are the ones that are used for the pharmaceutical products that are developed using living organisms or biological materials. Each type of patent is there to shield the various parts of the pharmaceutical innovations, hence, inventors can share the benefits of their discoveries while at the same time, other people won’t be allowed to use their inventions without their permission.
Conducting a Patent Search
Prior to the date of the submission of a drug patent application, one has to conduct a broad search to see if the invention is unique and distinct from the existing knowledge. A foremost examination of the existence of the prior drug patent and published drug patent applications aids in the process of finding out the factors that may be responsible for the patentability of the invention. There are numerous resources that are available for the research of the prior art, for example the USPTO (United States Patent and Trademark Office), EPO (European Patent Office), and WIPO (World Intellectual Property Organization) databases. Patent searching is a very effective form of research since it is done in a systematic way, which comprises keyword searching, classification searching, and citation searching.
Preparing a Patent Application
A drug patent application usually comes with a specification, a list of claims, and the drawings (if required). The specification is a thorough explanation of the invention, which comprises of its history, a detailed description and the sketches (if required). The painting should be done in a way that it describes the invention perfectly and completely, so that a person who is good at the art can bring the invention to life. The specification should additionally be the one that has the best mode that the inventor knows how to implement the invention. Comprehensive claims are a significant aspect of the writing process because they define the limits of the protection that the inventor wants to obtain. The categories of claims are independent claims that are independent and do not need anything else and dependent claims that follow the independent claims and limit them more.
Filing the Patent Application
The patent application systems provide for the provisional, non-provisional, PCT (Patent Cooperation Treaty) applications, while the PCT application can be filed in any PCT member country without the need to get a patent in an individual country first. A colloquially application serves the purpose to place a filing date and herewith the priority date without needing formal patent applications and a entirety of information. On the contrary, a provisional patent application requires a general specification and an informal document that describes claims. The filing of a PCT application enables patent applicants to enter the global territory with one single patent application that offers the opportunity to pursue patents in any other designing countries. The drug patent application process requires filing all the requisite application forms, paying the required filing fees, and registering the notifications, specifications, claims, drawing, and any other possible supporting documents. It is necessary to obey the rules of timing, the priority deadline and filing deadline, to prevent ones’ invention from being out in the public domain.
How long does a patent last for drugs
The initial duration for most drug patents is 20 years through filing the specific document of the patent. For instance, the patent for a new pharmaceutical product grants the developer an exclusive privilege to manufacture and sell that drug for 20 years (20 year; exclusive privilege of a pharmaceutical company to manufacture and sell a new drug for 20 years). Less market competition or lack of new rivalry makes it possible to cover the expenses of R&D and to get income from sales without expenses for advertising and promotion of brand. With the patent elapsed, competitors can then manufacture generic drugs, which in turn often result into more consumers payaring less due to competition.
Prosecution and Issuance
After filing, the drug patent application experiences examination at the patent office that contains a review of the patent application to meet the requirements of patent laws and regulations The patent office may send office actions, which are notifications that state the phase of the application process including rejections or objections. To manufacture a rejection or objections, actions of the office may include undertaking necessary modifications in the patent application as well as provide the legal arguments to prove the patentability of the invention. If, after review, the patent examiner finds that the invention meets all patentability standards, a drug patent will be allowed and issued.
Post-Grant Considerations
Patent holders must consider various post-grant issues, including patent term and term extensions, maintenance fees and annuities, and patent enforcement and litigation. The patent term is the period during which the patent holder has exclusive rights to the invention. Term extensions may be granted due to delays in the regulatory approval process. Patent maintenance fees must be paid periodically to keep the patent in force. Patent holders may enforce their patents through litigation if they believe their rights are being infringed upon.
Case Studies
Bayer Corporation v. Union of India & Ors.
The case is related to the topic of compulsory license. Section 84 of the act states that after 3 years from the date of grant, a person can apply for a compulsory license. For getting a compulsory license, three conditions should be fulfilled: the reasonable requirements of the public have not been satisfied; the patented invention is not available to the public at a reasonable price, and the invention is not manufactured in India. The court held that medicine has to be made available to every patient at a reasonable cost, and the petitioner was required to pay a royalty to the patent holder under a compulsory license.
Dimminaco A.G. v. Controller of Patents Design
In the case of Dimminaco A.G. v. Controller of Patents Design, a vaccine was invented after examination under Section 12 of the Indian Patent Act, 1970. It was reported that the vaccine was not an invention under 2 (j). The court held that the process for the preparation of the vaccine was new, novel, and included inventive steps. If the end product is a new article, it is patentable.
Novartis Ag & Anr. v Natco Pharma Limited
On the contrary, the judgement given to Novartis Ag & Anr. This means that as far even the post-grant opposition was decided by the Intellectual Property Appellate Board (IPAB), what the court said was that the rights of a patentee do not cease once the opposition is decided, rather during the pendency of the post-grant opposition, the right of the patentee remain viable. So, it follows that Patents Acts Section 48, when a post-grant opposition is ongoing, provides protections that can be relied on in favour of a patentee.
Drug patent
In a nutshell, the process of patenting for drug innovation entails a continuous interaction with the patent policy as well as the patent legal procedure, and this requires strong knowledge of both the law and the procedure. Patents are a vital factor in supporting drug innovation since they award researchers and inventors the required protection and enticements in order to invest their time and resources on them. With the development of pharmaceutical industry still in the making, the degrees of drug patenting will be more relevant for organizations as it provides a safety blanket to their investment and innovation.
Our team of advanced patent attorneys assists clients with patent searches, drafting patent applications, and patent (intellectual property) agreements, including licensing and non-disclosure agreements.
Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.
Quoted in and contributed to 50+ national & international publications (Bloomberg, FirstPost, SwissInfo, Outlook Money, Yahoo News, Times of India, Economic Times, Business Standard, Quartz, Global Legal Post, International Bar Association, LawAsia, BioSpectrum Asia, Digital News Asia, e27, Leaders Speak, Entrepreneur India, VCCircle, AutoTech).
Regularly invited to speak at international & national platforms (conferences, TV channels, seminars, corporate trainings, government workshops) on technology, patents, business strategy, legal developments, leadership & management.
Working closely with patent attorneys along with international law firms with significant experience with lawyers in Asia Pacific providing services to clients in US and Europe. Flagship services include international patent and trademark filings, patent services in India and global patent consulting services.
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