Medical devices and diagnostic inventions in India: patentability requirements

Introduction
Patentability of medical devices
Medical device per se
Software involved in medical devices
Mere use of known process
Methods of treatment and diagnostics
System claims

Introduction

The Indian medical devices market is the fourth largest in Asia, after Japan, China and South Korea, and it is among the top 20 globally. As of 2020, the Indian medical devices market was estimated to be worth $12 billion, with an expected compound annual growth rate (CAGR) of 15% – two-and-a-half times the global growth rate. Between 2020 and 2025, the diagnostic imaging market is expected to expand at a CAGR of 13.5%.

IP laws – primarily those concerning patents – play a crucial role in promoting innovation relating to medical devices. This article, part of a series on medical devices in India, focuses on the patentability requirements for inventions relating to medical devices.

Patentability of medical devices

A "patent" is a right granted by a state to an inventor for a fixed period (20 years in India) in exchange for the disclosure of the invention. However, since several fields are involved in the development of medical devices – including biotechnology, computer science, mechanical engineering, electronics and pharmaceuticals – navigating the Indian patent landscape is challenging.

The fundamental patentability criteria are universal – namely: novelty, inventive step (non-obviousness) and industrial applicability. In particular, to qualify as a patentable invention, the invention:

• must not be in the public domain or have been published or used previously;
• must not be obvious and must involve a technical advancement; and
• must be capable of being implemented commercially.

Inventions must also not fall within the scope of non-patentable subject matter according to law. Non-patentable subject matter varies from country to country.

In India, the claims of a medical device invention broadly fall within the ambit of the following embodiments:

• a medical device per se;
• the software involved in the device;
• diagnostic kits;
• a method of diagnosis; or
• system claims.

Medical device per se

Section 3(f) of the Patent Act states that "the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way" is not patentable.

Therefore, a medical device that is not simply an arrangement or rearrangement of known devices, each of which functions independently of one another in a known manner, is patentable in India subject to its novelty and inventiveness.

A mobile hospital comprising a stretcher, an oxygen cylinder, a surgical table and a vehicle to house these components would not be patentable.

To avoid a medical device being rejected on the grounds of section 3(f), applicants should:

• describe in detail the essential elements and features of the medical device, along with the associated functions;
• define how different elements of a medical device interlink or interact with each other;
• describe how such interaction produces the desired functioning of the medical device; and
• if the elements are known, describe how combining the elements was difficult or had never been contemplated before. The applicant should also define the advantage of the combination.

Software involved in medical devices

At times, the novelty and inventiveness of a medical device are imparted by novel software embedded therein. In such a scenario, the Indian Patent Office (IPO) assesses patentability according to section 3(k) of the Act. This section prohibits the patentability of "a mathematical or business method or a computer programme per se or algorithms".

An "algorithm" can be understood as a process, a set of rules or procedures, or a sequence of steps or methods, expressed as a list of instructions, to solve a problem.

While algorithms as such are not patentable in India, if the claims in a patent application carry out a technical process or achieve a technical effect, they may be allowed. However, a technical effect by itself is not sufficient – the invention must also represent an improvement to existing technology and be novel.

In such a case, the claim should establish the technical effect caused by the interaction between the novel software and the hardware. Applicants should avoid using expressions such "algorithm", and "software" in medical device patent applications as they may attract objections under section 3(k).

The following case study elaborates on how claims can be reworded to obviate a section 3(k) objection.

Case study
The following claims were rejected on the grounds that they constituted a mental act/software and a method of treatment:

An apparatus (100) for quick pain suppression, comprising:

• a main module (104) comprising a data storage (110) and data processing means (112);
• a synthesizer module (106); and
• one or more channel modules (108);
• wherein said data storage (110) is adapted to store data comprising:
  • first parameters (Vi) identifying a set of primitive waveforms (S00-S15), each primitive waveform (Si) having a periodic and predetermined pattern over time; and
  • second parameters (T-packi, Freqi, T-sloti) associable to each of said primitive waveforms (Si),
  • and in that said data processing means (112) are adapted and configured to process a data set (Bi) identifying a sequence (S) consisting of one or more of said primitive waveforms (Si) in a time sequence, each of the primitive waveforms of the sequence (S) being processed on the basis of one or more of said second parameters (T-packi, Freqi, T-sloti);
• wherein the synthesizer module (106) comprising means for generating an electric output signal corresponding to said sequence (S); and
• wherein the one or more channel modules (Chk) (108) comprising means for applying said electric output signal to a patient's body.

The following changes were made to the claims:

An apparatus (100) for quick pain suppression, comprising:

• a main module (104) comprising data storage (110) and data processoring means (112);
• a synthesizer module (106); and
• one or more channel modules (Chk) (108);
• wherein said data storage (110) is adapted to store data comprising:
  • first parameters (Vi) identifying a set of primitive waveforms (S00-S15), each primitive waveform (Si) having a periodic and predetermined pattern over time; and
  • second parameters (T-packi, Freqi, T-sloti) associable to each of said primitive waveforms (Si),
  • and in that said data processoring means (112) are adapted and configured to process a data set (Bi) identifying a sequence (S) consisting of one or more of said primitive waveforms (Si) in a time sequence, each of the primitive waveforms of the sequence (S) being processed on the basis of one or more of said second parameters (T-packi, Freqi, T-sloti);
• wherein the synthesizer module (106) comprising means for configured to generateing an electric output signal (C00-C15) corresponding to said sequence (S); and
• wherein the one or more channel modules (Chk) (108) comprising means for configured to applying said electric output signal to a patient's body.

The arguments raised included that:

• the as-filed claim was directed towards a method of treatment (relieving pain), which was amended to claim a process of applying an electric signal to a subject;
• the invention solved the technical problem of how to efficiently generate electrical signals as non-painful information. Generating the electrical signals using waveforms was not related to a method of treatment;
• the claims disclosed an apparatus, along with its hardware components and the mode of operating such apparatus for generating electrical signals; and
• the focus of the claims was on generating the electrical signals from the waveforms, and not on treatment.

The patent was granted following the amendments.

Mere use of known process

Section 3(d) of the Act prohibits, among other things, a "mere use of a known process". There have been instances where claims directed to in vitro diagnostic methods have been refused under the preclusion of this section.

For example, where the detection method and the biomarker are already known, and the claimed invention only recognises the "use" of such marker in the detection of a disease, the examiners may apply section 3(d). Understandably, where the method involves a novel biomarker and/or one or more novel process steps, such an objection, if raised, may be withdrawn.

Compared with article 53(b)(c) of the European Patent Convention, section 3(i) is more restrictive in that it does not provide any exception to methods practised outside the human or animal body. Thus, in vitro methods are also ostensibly drawn into the exclusion, so in vitro diagnostic or prophylactic methods cannot be patented.

Methods of treatment and diagnostics

A critical patentability exclusion can be found under section 3(i) of the Act, which provides that the following is not patentable:

Any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. (Emphasis added.)

In the context of section 3(i), the Manual of Patent Office Practice & Procedure 2011 and the Guidelines for Examination of Biotechnology Applications for Patent 2013 state that this provision excludes the following from patentability:

(a) Medicinal methods: As for example a process of administering medicines orally, or through injectables, or topically or through a dermal patch.

(b) Surgical methods: As for example a stitch-free incision for cataract removal.

(c) Curative methods: As for example a method of cleaning plaque from teeth.

(d) Prophylactic methods: As for example a method of vaccination.

(e) Diagnostic methods: Diagnosis is the identification of the nature of a medical illness, usually by investigating its history and symptoms and by applying tests. Determination of the general physical state of an individual (e.g. a fitness test) is considered to be diagnostic.

(f) Therapeutic methods: The term "therapy'' includes prevention as well as treatment or cure of disease. Therefore, the process relating to therapy may be considered as a method of treatment and as such not patentable.

(g) Any method of treatment of animal to render them free of disease or to increase their economic value or that of their products. As for example, a method of treating sheep for increasing wool yield or a method of artificially inducing the body mass of poultry.

(h) Further examples of subject matters excluded under this provision are: any operation on the body, which requires the skill and knowledge of a surgeon and includes treatments such as cosmetic treatment, the termination of pregnancy, castration, sterilization, artificial insemination, embryo transplants, treatments for experimental and research purposes and the removal of organs, skin or bone marrow from a living donor, any therapy or diagnosis practiced on the human or animal body and further includes methods of abortion, induction of labour, control of estrus or menstrual regulation.

(i) Application of substances to the body for purely cosmetic purposes is not therapy.

(j) Patent may however be obtained for surgical, therapeutic or diagnostic instrument or apparatus. Also the manufacture of prostheses or artificial limbs and taking measurements thereof on the human body are patentable.

Sometimes the claims are so drafted that a combination/composition of drugs in certain dosage forms is claimed, but the claimed subject-matter relates to application or administration of individual drugs in simultaneous, sequential or concomitant manner. In such cases, although the claims are directed to a combination/composition of drugs, but the claimed invention resides in the method of administration of individual drugs in the said manner and thus, it falls within the scope of section 3 (i) of the Act.(1)

However, in the past, certain diagnostic assay methods or testing methods that may not necessarily result in treatment have been allowed in some cases, based on the disclosure and scope of the invention.

In vitro screening methods have been allowed in some instances. However, it is unclear whether prognostic tests are covered by section 3(i). There are a few precedents pertaining to the grant of in vitro methods of screening and detection by the IPO. However, the examiners have recently been reluctant to allow such methods, owing to the lack of any explicit guidelines or precedents with respect to the exclusion of in vitro screening or detection methods from the purview of section 3(i).

System claims

An invention may also relate to a system that encompasses multiple hardware or software components including a medical device. As an example, a medical infusion system that comprises an infuser, an infusing pump and a monitoring device can be claimed as a system claim. System claims are allowed in India, provided that different components of the system interact with each other to produce a technical or real-world effect. However, if the system claims include only method steps performed by a conventional processor, they may be objected to for being related to a computer program per se under section 3(k). Further, if the system claims recite method steps related to diagnosis, they can also be objected to under section 3(i) in addition to section 3(k).

For further information on this topic please contact Goutam Bhattacharyya or Shweta Khurana at K&S Partners by telephone (+91 80 4042 7900) or email ([email protected] or [email protected]). The K&S Partners website can be accessed at www.knspartners.com.

Endnotes

(1) Page 15 of the Guidlines for Examination of Biotechnology Applications for Patent 2013.