Patent eligibility in medical diagnostics
Innovators around the world spend millions each year on the latest discoveries in diagnostics, making strong IP protection a must
Arguably no other sector in the United States has been affected by ongoing uncertainty in the laws on patent-eligible subject matter to the same extent as life sciences and, specifically, medical diagnostics. With the Supreme Court declining to take another Section 101 case and the Federal Circuit admitting that its hands are tied by existing case law, companies in this field continue to ponder just what is patent eligible. And while the picture is clearer in many other jurisdictions, innovators there still have to negotiate a complex web of case law, legislation and best practice if they are to receive the strongest possible patent grants.
This roundtable brings together experts from some of the world’s key jurisdictions to offer their insights – including Saya Choudhary Kapur from Singh & Singh LLP in India, Michele Van Patten Frank and Alper Ertas from Venable in the United States and Gabriela Salerno and Ana Paula Brito from Brazilian firm Montaury Pimenta. Together they describe how the patent eligibility landscape is evolving in their respective markets and demonstrate how high-quality prosecution advice can help companies to craft the best possible patent applications with the highest chance of success.
Q: What is the nature of your patent practice in the life sciences?
Michele Van Patten Frank (MVPF): I specialise in patent prosecution and counselling, diligence and litigation, with about 30 years of experience, starting as a patent examiner at the USPTO.
Alper Ertas (AE): I have deep experience in IP litigation, contested USPTO proceedings, IP protection and diligence.
Saya Choudhary Kapur (SCK): Singh & Singh handles prosecution, litigation, transaction and advisory work pertaining to life sciences patents. Since most patent applications in life sciences relate to the health and welfare sectors, objections are invariably raised under Section 3, Chapter II of the Patents Act 1970, which precludes from patentability:
- inventions that can cause serious prejudice to plant, animal or human health;
- the mere discovery of living or non-living substances occurring in nature;
- the discovery of a new form of a known substance;
- processes for medicinal, surgical, curative, diagnostic, therapeutic treatment of human beings or animals;
- plants or animals other than micro-organisms; and
- essentially biological processes for the production or propagation of plants or animals.
We therefore advise clients and innovators to carefully outline the scope of patent protection to which their inventions are entitled.
Gabriela Salerno (GS) and Ana Paula Brito (APB): Montaury Pimenta is one of the top Brazilian firms specialising in pharmaceutical patent litigation, especially before the state and federal courts of Rio de Janeiro and Sao Paulo. Our patent department is highly experienced in the prosecution and enforcement of pharmaceutical and biotechnology patents. Apart from our work in prosecution and litigation, our specialist team also provides prior art searches, freedom to operate reports and patent landscapes, as well as competitive intelligence reports for domestic and international companies. We have an unmatched record of delivering insightful advice and services to renowned clients.
Q: What is your experience in the medical diagnostics field?
SCK: In India, ‘diagnostic processes’ or ‘processes for treatment’ cannot be patented, although patent protection can be secured for diagnostic kits or devices used for detection rather than treatment. Singh & Singh has handled several matters before the Patent Office, the IP Appellate Board and various high courts relating to medical device patents. The said patents were duly granted and overcame the objections under Section 3(i) relating to patentability of diagnostic processes. Our firm has rich experience of representing clients on patent matters relating to therapeutic drugs, pharmaceutical products, processes, diagnostic kits, diagnostic strips and medical apparatus such as inhalation devices and syringes.
GS and APB: Our firm has handled several patent applications related to medical diagnostics over the past few years. These applications usually seek protection for medical devices and apparatus used in the diagnosis of diseases and/or methods for diagnosing diseases. Most of these applications come from foreign companies, which originally filed one or more corresponding applications abroad. Most domestic applications in the medical diagnostics field come from Brazilian universities and research centres. It is thus crucial to analyse in detail the claimed subject matter of the applications coming from abroad, since Brazil has a more restrictive interpretation of what is patentable in the medical diagnostics field, particularly when compared to the United States and Europe.
MVPF: I have experience working with companies ranging from early-stage start-ups to multinational corporations that are involved with neurological, vascular and spinal indications including technologies relating to stimulation, spectroscopy and imaging.
AE: I have represented corporations and universities to enforce, defend and protect intellectual property directed to magnetic resonance imaging and ultrasound instruments for breast cancer diagnostics, electrocardiography electrode systems, therapeutic drug and glucose monitoring systems, and high-performance liquid chromatography-mass spectrometry and nuclear magnetic resonance spectrometers.
Q: What have been the most significant recent legal decisions relating to the sector?
GS and APB: There is relatively little case law in Brazil on the patentability of diagnostic methods. However, in 2013 in Associacao Brasileira Interdisciplinar de AIDS – Abia v Microdiag, the Federal Court of Rio de Janeiro nullified Patent PI1101126-2 aimed at “means for quantitative retrovirus dosage, preparation process and diagnosis comprising said means”, in accordance with the understanding of the National Institute of Industrial Property (INPI)) and the IP Law.
In this case the patent was invalidated because, among other things, one of its claims indicated that the quantitative dosage of retrovirus happens in vivo (ie, on living organisms, rather than on tissue extracts or dead organisms), which is prohibited under the IP Law.
According to Article 10(VIII) of this, diagnostic methods aimed at human and animal bodies are not patentable. As a result, INPI has consistently denied patent applications aimed at diagnostic methods that consist of in vivo tests or tests in which the in vivo and in vitro (ie, not involving living organisms) parts cannot be dissociated. However, there are a number of exceptions to this, which will be discussed in more detail later. The lack of case law on the patentability of diagnostics methods indicates how unified INPI’s view is of this area.
MVPF: In Exergen, the US Federal Circuit held that a patented invention for measuring a person’s deep body temperature was found to be patent eligible. The claims incorporated a new way of measuring deep body temperature by correlating it with temporal-arterial temperature. The court deemed this new method and device to be unconventional in the field.
AE: The Federal Circuit’s decision in Athena Diagnostics reinforced the district courts’ power to dismiss diagnostic patent cases at the pleading stage based on Section 101. The Federal Circuit affirmed the patent ineligibility of a method for diagnosing neurological disorders by detecting previously undiscovered but naturally occurring antibodies of a protein associated with the disease. The court deemed the detection methods to be conventional in the field.
SCK: In India, a patent has been granted for medical devices for the treatment of human beings on the grounds that it satisfied the triple test of patentability. Under this, no monopoly was granted for a method or process of diagnosis and treatment of human beings or animals – it was simply a product patent for a medical device. The Delhi High Court’s judgment in J Mitra and Co Pvt Ltd v Kesar Medicaments involved a patent for a diagnostic kit for the detection of the hepatitis C virus (HCV) in human serum and plasma. The device was designed to ensure specificity and sensitivity in carrying out tests making them viable to detect HCV. The court granted an interim injunction in favour of the plaintiff, prima facie rejecting various grounds challenging the validity of the patent. In this case, what was claimed to be inventive about the medical diagnostic kit was that it led to more precise and accurate diagnosis. No monopoly was sought over the process of diagnosing HCV, which could be achieved by other devices in the market. The objection as to the method of diagnostics was not raised in respect of the above patent and the matter was adjudged on the basis of the triple test of patentability only.
However, the following inventions were rejected under Section 3(i) by the Indian Patent Office on the grounds of disclosure of diagnostic methods:
- Application 1086/MUMNP/2011, which relates to a method of diagnosing liver fibrosis in a human subject and obtaining a blood sample from a human subject suspected of having liver fibrosis;
- Application 6616/DELNP/2010, which relates to biomarkers for the diagnosis of chronic obstructive pulmonary disease to determine a course of treatment;
- Application 52/DELNP/2010, which relates to determining a correlation between high blood pressure and prediction of severe sepsis – this was held to be a method of diagnosis; and
- Application 4981/DELNP/2008, which relates to an in vitro method of detecting the fragmentation of an adiponectin receptor, where the presence or absence of certain soluble fragments in bodily fluids was interpreted as predictive of disease and hence categorised as a diagnostic method of treatment – it was rejected by the controller under Section 3(i), on the grounds that even an in vitro method, whether diagnostic or therapeutic, is not patentable.
Thus, provided that a patent application is not looking to monopolise a process for the diagnosis of a human being or animal, and merely pertains to a device or method of detection of the said disease, a patent may be granted for it in India, subject to the invention meeting other patentability criteria.
Further, in Monsanto Technology LLC v Nuziveedu Seeds Ltd, a division bench of the Delhi High Court invalidated Monsanto’s patent pertaining to a method of producing a transgenic plant with increased levels of bacillus thuringiensis endotoxins and a higher rate of recovery of morphologically normal plants, resulting in the development of insect-resistant plants, stating that this was non-patentable under Section 3(j). However, the decision was overturned on appeal by the Supreme Court.
Q: What is the upshot of this case law for diagnostics innovators and what inventions are now eligible for protection?
MVPF and AE: New diagnostic devices with new components or new methods of detection are patent eligible. When the patent claims are directed to detecting a naturally occurring event in the human body using an old method of detection, the claims are susceptible to a Section 101 attack, even if the naturally occurring event is previously undiscovered.
SCK: The Section 3(i) bar does not extend to patenting medical devices or kits as it specifically excludes processes. ‘Medical devices’ have not been defined under the act and reference may be made to the Medical Devices Rules 2017, wherein a substance used for in vitro diagnosis is considered to be a medical device. Further, methods of working or operating such devices can be patented, provided that they do not result in the diagnosis or treatment of a disease. Applications filed for a device making a process of diagnosis more efficient and accurate, or for a process that may not result in a prognosis but simply helps to identify potential indicators of a disease faster, are patentable. As long as public interest in having access to the best method for diagnosis or treatment is not affected, a patent can be granted.
Litigation related to Section 3(i) is at a nascent stage in India and guidance is generally taken from the international position on the patentability of methods of diagnosis or treatment. However, in view of increasing developments in the field of life sciences (eg, AI and robotics), this area is likely to emerge as extremely contentious in patent litigation in the near future.
GS and APB: The protection of medical devices and apparatus used to diagnose diseases does not represent an obstacle for diagnostic innovators, since Brazilian examiners analyse claims related to them in the same way as any other product claims.
On the other hand, diagnostic methods, together with therapeutic and operating or surgical methods, for use on the human or animal body are not patentable in Brazil. This is because, according to Article 10(VIII) of the IP Law, they are not deemed to be inventions.
According to INPI’s Examination Guidelines, a diagnostic method for application in the human or animal body is not patentable in Brazil when it meets the following criteria:
- It has direct application in the human or animal body (eg, determining allergic conditions by diagnostic examination applied in the body) or requires the presence or participation of the patient for its interpretation.
- It allows for the conclusion of the clinical state of the patient or indicates various possible clinical states, based on data processing, analysis or interpretation, information and/or clinical results associated with the patient.
However, if a diagnostic method does not include the conclusive step and is not carried out inside the human or animal body, it can be considered an invention and therefore subject to patent protection in Brazil.
Moreover, methods for obtaining information from the human or animal body when the data collected merely represents an intermediate result that, by itself, is not enough to define a diagnosis are not considered diagnosing methods and are therefore entitled to protection.
For instance, blood count and serology tests, as well as electrocardiograms and X-ray imaging, may be subject to a patent since they are not aimed at the human or animal body and do not result in conclusions about the patient’s clinical condition.
Q: What are the major pitfalls to be avoided when drafting medical diagnostics patent applications?
GS and APB: The main obstacles to the protection of a method of diagnosis in Brazil are as follows:
- The method is carried out in vivo.
- There is no way of separating in vitro and in vivo steps.
- The inventive step of the method is the conclusive step of diagnosis.
With regard to the second obstacle, if it is possible to clearly separate the in vitro and in vivo steps (ie, by using body tissues, cells or fluids after their removal from the body), the method is entitled to protection.
MVPF and AE: A useful tip is to beware of making admissions regarding conventional diagnostic techniques and prior art in the specification of your patent application.
Q: What strategies and tactics can increase your chances of success when prosecuting medical diagnostics patents?
SCK: In India, patent attorneys must ensure that the complete specification and claims are drafted in such a manner that the provisions under Section 3 do not apply. Thus, specifications and claims must be drafted focusing on the niche and specific device or process, and how it is advantageous over other alternatives, and must specifically disclose how the said invention aims to achieve this. Further, regard must be given to the fact that the grant of the patent may adversely affect competition in the market and public interest in receiving the best treatment for a particular disease. It must be clearly stipulated in the specification and claims that the patent is not being sought to monopolise the complete field by patenting a process of diagnosis or treatment. Terms such as ‘diagnosis’, ‘diagnostic method’ and ‘process of treatment’ must be avoided as they would instantly invite an objection under Section 3(i). Further, if the patent relates to a method of working a detection kit or device, efforts should be made to distinguish this from a diagnostic method.
The applicant must also be mindful of certain unique patentability compliance requirements that have been prescribed under Indian law, such as routine filings of details pertaining to identical or similar foreign applications and working statements.
GS and APB: The best strategy when prosecuting any diagnostic method patent application is to remove any conclusive step from the claims and to make it as clear as possible that the method is carried out outside a human or animal body. In this sense, it is highly recommended that the in vitro expression be inserted at the beginning of the claims and then repeated whenever possible, in order to avoid any misunderstanding.
Further, in cases where, for instance, a compound or substance is used for diagnostic purposes, one possible strategy would be to add a claim drafted in the Swiss-type format (use of a compound X in the manufacture of a product for the diagnosis of disease Y), bearing in mind that, even in this format, no conclusive step can be presented.
If it is possible to separate in vitro and in vivo steps, it is important to make this clear. For instance, if a sample removed from a patient needs to be used, any mention of the removal itself should be omitted. In other words, instead of writing: “removing a sample from a patient and measuring the amount of X”, the claim should read: “measuring the amount of X in a sample removed from a patient”.
MVPF and AE: Patent owners and practitioners should focus patent protection on the unconventional aspects of the device, components or detection methodology.
Q: Do you have any tips on how to best defend existing medical diagnostics patents in litigation?
MVPF and AE: Assess the eligibly of asserted claims under Section 101 during the pre-suit diligence phase of the litigation and expect the validity of the asserted patent to be tested at the USPTO via an inter partes review. This will allow litigation counsel to set realistic expectations for the client and prepare an accurate budget, as well as the likely timeline of the litigation.
In addition, it is a good idea to maintain a continuation patent application pending for the purposes of additional claiming.
SCK: There is not a great deal of jurisprudence related to Section 3(i) in India. Inventors must be mindful of the fact that while asserting patents in litigation, the following must be detailed and clarified in the complaint itself.
First, the features of the asserted patent that might help to overcome any objection under Section 3(i) should be emphasised. Second, it should be highlighted how the patented invention does not monopolise the complete process or field of diagnosis related to a particular disease. Further, it must be established that the invention is not merely a diagnostic method or method of treatment in order to answer any public interest or health issues.
Courts and the Patent Office have granted relief, protection and interim orders to patentees in certain cases related to diagnostic devices, inhalers and syringes on the basis that these do not relate to a process for medical treatment. While India is yet to undergo an evolution of jurisprudence on the patentability of all aspects of medical devices and diagnosis, Indian laws are substantially aligned with the Agreement on Trade-Related Aspects of Intellectual Property Rights, with sufficient legal recourses available to an inventor.
GS and APB: First and foremost, in contrast to the common law, the civil law system in Brazil does not enable parties to call on independent experts to analyse a medical diagnostic patent in a litigation case; according to the Brazilian Code of Civil Procedure, this is the sole remit of a judge.
The evidence phase has crucial relevance in this type of lawsuit, as judges seldom have a technical background. Hence, the best way to defend the validity of a patent in court is to focus efforts on the court expert’s analysis by supporting them with relevant technical documents, submitting sharp queries and designating a qualified technical assistant. In addition, it is vital to analyse the expert’s qualifications and, if necessary, to challenge their designation in order to ensure that they are the best qualified professional in the field of the relevant technology.
Q: What can be done to mitigate the commercial and strategic impact of patent eligibility restrictions on medical diagnostics innovators?
SCK: The historical reason for excluding processes of diagnosis and treatment of human beings from patents is the underlying public interest involved in such cases. Patenting the best method of treatment or diagnosis of diseases severely limits accessibility and affordability, and thus can have an adverse effect on public health, if this is allowed without regulation. Therefore, necessary changes must be carried out by the government at the policy level for mitigating the commercial impact of patent eligibility restrictions. These include the following:
- Suitable guidelines may be framed detailing the kinds or classes of inventions that might qualify as diagnostic processes – such clarifications would not only aid the innovator in filing patent applications but would also help the Patent Office and courts to better understand the patent eligibility of such inventions.
- Awareness programmes must be launched by the government detailing the distinction between a diagnostic process and medical device performing a diagnostic process, as well as their method of working.
- Training programmes could be organised for judges, patent examiners and patent attorneys detailing the scope of a suit or other proceedings that may take place for medical diagnostic patents.
- A panel of experts skilled in the medical diagnostics field should be created to aid and advise the Patent Office and judges alike on the eligibility of such inventions.
GS and APB: The Brazilian IP Law has no provisions similar to those in Section 101 of the US Patent Act, which limits patentable inventions to any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof. However, the IP Law does contain an article setting out subject matter that is not patentable in Brazil. Therefore, any restrictions on the patentability of inventions in the medical diagnostics field is specifically related to the protection of methods of diagnosis.
In view of this, the best strategy to mitigate the commercial and strategic impact of patent eligibility in Brazil is to amend the set of claims of a Brazilian application while bearing in mind the aforementioned prohibitions and in line with recommendations as to the deletion of any conclusive steps – this includes inserting in vitro expressions, adding Swiss-type claims (if applicable) and deleting any in vivo steps.
MVPF and AE: My advice would be to hire an experienced patent prosecutor and/or litigator who has studied the Federal Circuit’s jurisprudence and the USPTO’s guidelines and who has tailored their approach in view of the evolving law.
Q: What are the chances of further change that affects the sector either from the courts or through legislation?
GS and APB: INPI has a taken a strong position regarding the patentability of diagnostic methods; the Brazilian IP Law echoes this approach and is quite explicit with regard to the non-patentability of such methods. There are currently no projects for legislative reform in this respect. When it comes to case law, the courts are handling very few cases on this matter. Thus, the chances of further changes that affect the sector either through the courts or by legislation are low.
MVPF and AE: There has been a push to recodify Section 101, which may create further uncertainty.
SCK: In the past two decades, the medical devices industry has undergone a complete transformation. Technology is developing at a breakneck pace and growing innovation in this sector is bound to draw the attention of the government, resulting in better regulation and policies for registering patents in the medical diagnosis and life sciences sectors. Small businesses are being encouraged to protect their intellectual property under schemes such as Make in India and Start-Up India, which are designed to encourage innovation and would result in an increase in the number of patent applications filed by small innovators. This may have a trickledown effect and encourage young doctors and researchers to start filing medical patents.
The astounding growth of the IP regime alludes to its ubiquitous effect on the Indian market, which is likely to become even more significant in the years to come. Litigation relating to medical devices is also likely to increase, which would result in greater clarity of the scope of medical diagnostic patents, much like pharmaceutical and SEP-related litigation. Further, Indian courts may take guidance from case law emanating from foreign jurisdictions to interpret cases in India. At this crucial juncture, while India can learn from the experiences of more developed jurisdictions, it needs to adapt these experiences to suit its own needs.