What are smart pills?
In 1992, Jerome Schentag and David D’Andrea patented a computer-controlled medical device that could be ingested. The invention popularized with the term “smart pills.” Today, the phrase “smart pill” describes any ingestible microelectronic device that can be used to control the release of a drug in the body. Currently, smart pills, such as Abilify mycite®, developed by Proteus Digital Technology, and ID-CapTM, developed by etectRX, are only able to track the ingestion of the pill and are used to monitor changes in a patient’s treatment adherence. The pill also referred to as an “ingestible event marker,” contains a digital sensor and an active pharmaceutical ingredient (API). Once the pill is ingested by the patient, the digital sensor communicates to a receiver that is typically worn around the abdomen. The receiver then communicates this data to a mobile phone or computer application, which allows the patient and healthcare professionals to remotely track the patient’s adherence to the prescribed treatment.
What problems can smart pills address?
Since the COVID-19 pandemic, there has been an increase in the demand for remote medical monitoring systems making smart pills a suitable solution. Smart pills can improve remote treatment monitoring for those who need repeated drug delivery in complex therapeutic regimes, such as in the treatment of mental health, chronic pain, diabetes, hepatitis C, and HIV/AIDS. They can also help reduce the burden of non-adherence to treatment, which has a huge economic and social cost. For example, non-adherence to mental health drugs can lead to the institutionalization of patients, and non-adherence to hypertension medication can lead to hospitalization of patients. The estimated cost of non-adherence is USD 100–290 billion in the USA and € 125 billion across Europe[1]. In India, the cost is difficult to determine but it is estimated that non-adherence in the case of hypertension and cardiovascular complications was as high as 49.6% of the patients in 2021[2]. Therefore, the current state of technology of smart pills is highly valuable in improving treatment adherence, remote treatment monitoring, and reducing costs associated with non-adherence to treatments. However, it is not unreasonable to expect that as technology develops, the application of smart pills will grow to solve other therapeutic challenges, including dosage optimization and targeted drug delivery.
Challenges faced by the applicants in applying for patents for smart pills in India
Even though smart pills have a high potential to help improve medical treatments, there are very few developments in this technology. An analysis of the patent landscape of smart pills showed that globally the patent activity has dropped since 2018. Patents are a form of intellectual property rights (IPR) that aims to incentivize inventions by offering market exclusivity. As the world recovers from the COVID-19 pandemic and realizes the convenience of remote medical healthcare, efforts to develop smart pills are expected to increase soon[3]. There are currently no patents in India for smart pills, but the medical technology industry is expected to grow by USD 50 billion by the end of 2025. Subsequently, it is likely that some smart pill technology will be developed and change the patent landscape.
As per the Indian patent act, 1970 (referred to as “the act” herein), patentable inventions should be novel (section 2(1)(j)), have an inventive step (section 2(1)(ja)); and should be capable of industrial application (section 2(1)(ac)). Along with determining the merit of the invention as per sections 2(1) (j), (ja), and (ac), the examiner will also determine whether the invention attracts provisions of non-patentability from section 3. As smart pills are a complex product that contains several components, patent protection can exist in the API (unless it is off patent); sensor hardware; receiver hardware; application software; or combination of all the components. The act also states that one patent application should relate to a single invention. Therefore, a smart pill can be patented by filing one or more applications corresponding to one or more novel features.
Challenges in patenting the API
Evergreening describes a variety of practices that pharmaceutical manufacturers pursue to extend monopoly rights through patent protection. These strategies include making minor changes to the dosing or formulation of an existing drug, and the newer version offers little to no additional benefits to the patients. To allow a fair chance for all players to monopolize the market for a specific duration, section 3(d) in the act specifically prevents evergreening of this type. The controller will determine what changes are made to the compound and subject it to a test of efficacy. As clarified by Novartis AG vs. Union of India, the test of efficacy would be determined based on the function or utility of the product. In the case of pharmaceutical products, the enhancement of therapeutic efficacy should be validated by experimental data. Therefore, if alterations were made to the dosage or formulation of an existing medicine then the patent applicant should provide experimental evidence that shows enhancement in the therapeutic efficacy.
Section 3(e) was also included in the act to prevent evergreening of pharmaceutical products. This provision requires that for a combination invention to be patentable, it should satisfy the synergistic effect, i.e., the effect produced by mixing ingredients together is not the sum of the effects of the individual ingredients. For example, when lye is mixed with oil, soap is produced. The technical effect of soap is far greater than that of lye and oil, individually. Therefore, the burden lies on the applicant to highlight that the combination invention shows a synergistic effect in the description of the patent at the time of filing. However, subsequent submissions regarding synergism may be accepted by the controller[4].
Challenges in patenting the sensor and receiver hardware
Currently, Bluetooth® is the most suitable wireless technology that is used to build the sensor. Bluetooth® employs ultra-high frequency radio waves, which allows exchanging data over short distances. From within the body, the sensor transmits data to a receiver using Bluetooth®. The receiver then transmits the information to a computer/mobile device. Both the sensor and the receiver’s hardware are patentable unless sections 3(f), (i), and (o) are applicable.
Section 3(f) requires that patentable devices should not be a mere arrangement of known devices that work independently of each other. The subject matter is also patentable if it makes a technical improvement (such as a new device, being better or cheaper than before).[5] Therefore, the receiver’s hardware has a large scope for patentability considering this provision. Patenting the sensor would also be patentable; however, as the sensor is ingested, it may attract objection from section 3(i).
Section 3(i) of the act states that “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings […] is not an invention.” This provision ensures that on the grounds of morality, if methods improve the current state of treatment, then the knowledge should be made available to prevent causing harm to any living being. Methods of treatment by surgery or therapy and diagnostic methods practiced on the human body are not patentable, while methods outside the human body are patentable. Therefore, to avoid section 3(i) objections, it is best not to disclose any feature in which the invention is used for treatment from inside the body and include specific parts of the process that function independently of the human body.
Section 3(o) states that the “topography of integrated circuits is not an invention” as the layout designs of integrated circuits are governed separately under the Semiconductor Integrated Circuit Lay-out Designs Act, 2000, three-dimensional configurations of electronic circuits used in microchips and semiconductor chips are not patentable. However, the receiver hardware can also have software embedded in it to transmit data for processing by the computer/phone-based app. The embedded software in the device can be patented.
Challenges in patenting the receiver and application software
Software inventions can be purely computer programmes or software that is embedded in a device. As per section 3(k), “computer programmes per se or algorithms are not inventions.” In Ferid Allani vs. Union of India, the courts explained their legal position on the term “per se” and compared it with Article 52 of the European Patent Act. The courts reiterated that computer programs are prevalent across various fields and patents should be granted based on whether the invention results in a “technical contribution” in their fields. Therefore, a software invention may be patentable if it is necessary and provides a technical effect (such as improved data compression techniques, improved user interface, and improved reception/transmission of a radio signal) and if it is a collection of tangible elements and software.
In a smart pill, the software in the receiver would be classified as a software invention that is a collection of tangible elements and software. Meanwhile, the phone/computer-based software application can be classified as an invention that is a computer program. Both types of software are patentable; however, the patent eligibility of the software embedded in the receiver is higher than that of the phone/computer-based program. The courts will also observe software-embedded hardware as new hardware and so patents for these inventions are easier to claim. The phone/computer software application may be more challenging, but the patenting landscape is changing as the courts recognize that these types of technology are becoming more prevalent in various fields. Generally, software that processes data and presents it to guide human decision-making is less patent-eligible because section 3(k) states that algorithms are not patentable[6] and (n), which states that “a presentation of information is not an invention.” In 2017, OLA filed a patent application for an in-vehicle entertainment mobile phone application that can stream media content both offline and online. The patent application received no objections, which is encouraging for smart pill software developers. Moreover, with advances in artificial intelligence, objections from sections 3(k) and (n) are less likely to arise.
Challenges in patenting the combination of all the components
Smart pills are essentially a new way of administering medical treatment orally. A smart pill is a complex product with several components working together to monitor the oral administration of a drug. It is more akin to a therapeutic process on the human body and may attract objection from section 3(i). Therefore, in the description, it is best to avoid phrasing the combination as a medicinal treatment in the body.
Other challenges
Digital evergreening: Digital evergreening is a term coined to describe evergreening by adding a digital component to an existing medicine[7]. At this early stage, the technology for smart pills needs to be developed. Firstly, it is important to develop ingestible sensors that can perform the required task in physiological conditions, without causing unnecessary complications in the body. For this reason, smart pills are likely to be developed using drugs that are already tried and tested on the market. Consequently, pharmaceutical companies have an incentive to obtain intellectual property rights for such smart-pill technologies as means of digital evergreening old products instead of developing new therapeutic modalities. For example, Otsuka pharmaceuticals are the original patent holders for Abilify (aripiprazole), and its patent expired in 2010. In 2019, when Proteus Digital health declared bankruptcy, Otsuka pharmaceuticals bought the remaining assets and currently sells Abilify mycite® at a high cost of USD 1,700 (the generic version of aripiprazole is sold at USD 20). Therefore, smart pills are a new strategy for digital evergreening old products as companies try to retain their market exclusivity.
As section 3(d) is unique to the Indian jurisdiction and there have not yet been any challenges to digital evergreening, it is difficult to assess whether there will be objections on these grounds. However, if the provision aims allow a fair chance for all players in the market, smart pill patent applicants should expect some objection as digital evergreening might serve as a new way for giant pharmaceutical companies to hold onto their patent rights. To avoid 3(d) objections, it is best to provide data showing the enhancement of the therapeutic efficacy of the smart pill compared to the existing version of the drug.
Device hopping: Device hopping is another evergreening strategy that is frequently used by giant pharmaceutical companies to retain their market position after their patents for pharmaceutical products expire. Thus far, device hopping has been observed for inhalers for asthma and chronic obstructive pulmonary disease, where pharmaceutical manufacturers place old ingredients into new devices to extend patent protection instead of innovating new therapeutic modalities[8]. As smart-pill technology develops, pharmaceutical companies may use smart pills as a way of device hopping to extend monopoly rights on orally administered medication.
Future of smart pills: As the digestive tract is a closed system in the body, targeted drug delivery outside the gastrointestinal tract would need substantial leaps in technology. Specifically, the technology should enable the smart pill to hold its structure and pass through the stomach to the small intestines, where it can permeate through the mucosal membrane into the bloodstream. The pill would also need to maintain its structure in the bloodstream until it reaches its target site, where it releases the drug. RoboCap, developed by researchers at the Massachusetts Institute of Technology, has a smart pill technology that allows the pill to tunnel through the mucosal layer of the small intestines. In the tunnel, the pill then releases the drug, making it available for circulation by the blood. In animal studies, RoboCap is effective in increasing the bioavailability of drugs, namely insulin and vancomycin; however, the pill has not yet reached clinical trials. Therefore, targeted-drug delivery to other parts of the body is a significant technical hurdle for smart pill technology.
Currently, smart pills designed for targeted drug delivery along the digestive system are being developed and expected to appear in the market soon. Phillips’ intelligent pill (iPill) has been designed for the treatment of Crohn’s disease, where the pill collects data on its transit time through the gastrointestinal tract and the pH to release the drug in the small intestines. Similar technologies might be developed in the future to treat other maladies affecting the digestive tract.
Conclusion: For the grant of a patent, an invention should be novel, inventive, industrially applicable, and should not attract any of the provisions of non-patentability as described in section 3 of the act. Even though smart pills can help to improve treatments of difficult-to-treat diseases, there seems to be little incentive to develop them. By offering exclusivity, patents are incentives for inventors to invent. Smart pills may gain patent protection for one or more of its innovative features. However, the cost of the product is unnecessarily inflated when a product is protected by several patents. While these aspects remain to be clarified through case law, it is important to assess the possible challenges that arise for patenting smart pills.
References:
[1] https://ilcuk.org.uk/125-billion-lost-each-year-due-to-non adherence/#:~:text=The%20estimated%20overall%20cost%20of,AU%247%20billion%20in%20Australia.
[2] https://indianexpress.com/article/cities/pune/lack-of-adherence-to-medical-aid-is-a-critical-public-health-challenge-7555016/
[3] According to a market research, the global ingestible sensor market is expected to grow by USD 4,365.12 million by 2027. https://www.globenewswire.com/news-release/2021/09/24/2302944/0/en/Ingestible-Sensor-Market-Size-to-Reach-USD-14-365-12-Million-by-2026-at-21-36-CAGR-Report-by-Market-Research-Future-MRFR.html
[4] Manual of patent office practice and procedure, 2019
[5] Manual of patent office practice and procedure, 2019
[6] https://excelonip.com/non-patentability-objection-u-s-3-k-of-the-indian-patent-act-and-the-controller-decisions/
[7] https://ebm.bmj.com/content/24/6/203
[8] https://www.formularywatch.com/view/study-manufacturers-device-hop-to-extend-patent-protection
Disclaimer: The present article intends to provide general guidance on the subject, and you can also consult us in your specific case.
