Patents (Amendment) Rules, 2024: How may the new patent modifications impact the healthcare industry in India

 

Recently, the Patent (Amendment) Rules, 2024 were released on March 15, 2024, by the Department of Industrial Policy and Promotion (DIPP), under the Ministry of Commerce and Industry, Government of India. These rules have brought about significant changes to Indian patent practice and procedure, addressing issues faced by patent applicants in the Indian patent system.

The Indian Patent Office implemented these changes to enhance its operations. Applicants must now adhere to the updated procedures and fees outlined in the rules, which came into effect on March 15, 2024.

Nonetheless, corporate legal firms, who received notification of the modifications on March 15, have praised them. These "significant changes (made by India) were necessary to be in line with international standards," according to their belief. They argue that since the time it was taking to obtain a patent was getting unnecessarily lengthy, this was both acceptable and possibly even necessary. There have also been significant fee reductions for startups (but it's not clear if these benefits are necessary for global corporations). Broad exemptions from the obligations for filing information have also been implemented. Even in situations when the necessary information is not provided, the delay will be excused in exchange for a small price.

However, there are also worries about these shifts, especially in the health sector. Public health organizations and experts are afraid of what is next. They contend that these changes may erode public health protections and complicate the process of obtaining reasonably priced generic drugs. The modifications may result in an increase of patents that are not meritorious, which might impede generic competition and drive up the cost of medications. Both patent applicants and the pharmaceutical business may be significantly impacted by such changes. Furthermore, applicants may become confused by the amended dates, which only permit particular actions (such filling out Form 3) in compliance with the updated criteria. Some contend that big pharmaceutical corporations may make significant profits in this situation.

It's also important to keep in mind that some technologies or sectors can be impacted more than others. A shift that benefits some industries or technologies at the expense of others can cause imbalances and impede the advancement of technology as a whole.

'The healthcare sector relies heavily on patents to produce novel therapies and life-saving medications. Patents are essential in this fiercely competitive and research-driven profession. They are vital instruments that affect many facets of the pharmaceutical business in addition to being legal paperwork.'

Are their guesses correct?, Let's discuss the possible potential drawbacks of these changes.

There may be a number of problems with the Patents (Amendment) Rules, 2024:

Hasty Patent Examination: The shorter time frame for submitting a Request for Examination (RFE) may result in less exhaustive reviews, which can result in the patenting of non-innovative medications.

Limited Opposition: One important measure to prevent patents that are not worthy of being granted is to restrict the capacity of third parties to oppose patent applications. Modifications to the opposition procedures may accomplish this.

Decreased Transparency: It may become more difficult to track whether patented inventions are being worked in India as a result of the decreased frequency of functioning patent filings.

Procedural irregularities: The Controller's ability to ignore procedural irregularities and approve document revisions in the absence of a specified Act provision is currently limited to a few activities and deadlines.

Increased Complexity: It can be difficult for inventors, applicants, and even patent examiners to comprehend and manage the patent system when new complexities and legal nuances are introduced by revisions to patent rules. This may cause misunderstandings, hold ups, and even mistakes in the patent application procedure.

Limited Patentability: Modifications to the patent legislation may result in tighter requirements for patentability, which would make obtaining patent protection more challenging. Innovation may be hampered and inventors may be dissuaded from seeking patent protection if the new regulations raise the bar for invention or restrict the range of topics that qualify for patent protection.

Protracted Examination Process: Changes to the patent regulations may unintentionally lengthen the examination process. Longer waiting periods for applicants to receive a patent grant or rejection may arise, for instance, if the modifications cause an increase in applications or add to the workload of patent examiners.

Increased expenses: Modifications to patent regulations may result in higher filing, prosecution, and maintenance expenses. Modifications that necessitate further paperwork, translations, or formalities, for example, may result in higher costs, especially for small enterprises or individual inventors.

Ambiguity and confusion: New regulations may create confusion in the patent system if they are not precisely stated or allow for interpretation. Ambiguities may make it difficult to define the parameters of patent protection, which may result in disagreements, legal action, and a slowdown in the pace of invention.

In what ways does the health industry suffer from the 2024 patent modification rules?,

Following these changes, patient health groups seeking to use the patent system to increase access to life-saving drugs are facing steep costs. These patient collectives, which are not even official organizations, have limited access to official funds. Nevertheless, the modifications now demand that these individuals and patient networks pay significant costs in order to submit pre-grant oppositions. Prior to now, there were no fees. Even worse, even though the Indian legal system has already determined the legality of pre-grant opposition petitions, the Controller of Patents now has the power to approve or deny them.

In the healthcare industry, the following general drawbacks of the 2024 patent rule revisions could occur:

Shorter time frame for submitting a Request for Examination (RFE): After the priority date, the RFE must now be submitted within 31 months instead of 48. This might hasten the inspection process for patents, which could result in faster patent approvals. But doing so would also expedite the review process, which could result in less exhaustive reviews and possibly result in the patenting of non-innovative medications.

Modifications to Pre- and Post-Grant Opposition Processes: There has been a modification to the timeline for recommendations submitted by an Opposition Board and the time it takes for applicants to respond. This might make it harder for outside parties to object to patent applications, which is an essential protection against inventions that are not meritorious.

Statement filing frequency: Working patents were only filed once every three fiscal years, as opposed to once in a fiscal year. This may lessen the patent system's openness and make it more difficult to keep track of whether or not patented inventions are being developed in India.

Concerns about how these revisions would affect the Indian Patent Act's public health protections—like mandatory licenses, pre-grant opposition, and patent system transparency—have been voiced by civil society organizations. These modifications may have an effect on the availability of medications since they may result in a rise in unwarranted patents, which could impede the competition from generic manufacturers and drive up the cost of medications.

Decreased Access to Medicines: Stricter patentability requirements or longer patent protection periods resulting from healthcare industry patent regulation modifications may restrict generic competition and postpone the release of reasonably priced generic medications. This may negatively impact patients' ability to obtain necessary medications, particularly in developing nations or for those with low incomes.

Elevated Medical Expenses: Modifications to patent regulations that broaden the scope of patent protection or simplify the process of obtaining patents in the medical field may result in increased medical expenses. Prolonged monopolies on pharmaceuticals or medical technologies can cause generic versions of those items to take longer to reach the market, which raises the cost of cutting-edge therapies and medical equipment.

Innovation can be stifled by changes to patent rules that make patent claims in the healthcare industry unduly broad or unclear. Overly protective patents can stifle innovation by making it more difficult for future researchers and inventors to expand on previously discovered information or create novel solutions.

Patent Thickets and Licensing Issues: Patent thickets may arise from a proliferation of overlapping or conflicting patents resulting from healthcare industry patent regulations. Patent tangles can impede innovation and cooperation in the healthcare industry by making it challenging for businesses or researchers to navigate and license essential technologies.

Delayed Access to New Technologies: Modifications to patent regulations that impose stricter conditions for patentability or lengthier review periods may cause a delay in the issuance of patents for innovative medical technology. The introduction of novel medical devices, diagnostics, or treatments may be slowed down by delays in patent approvals, which may have an effect on patient outcomes and care.

To what extent may this amendment assist large pharmaceutical companies?,

The Patents (Amendment) Rules, 2024 could be advantageous to large pharmaceutical corporations in a number of ways:

Big Pharma has reaped significant benefits from the adjustments in numerous other areas. The companies are no longer required to file Form 27, which requires patent holders to reveal annually whether or not their parents are employed in India, along with information about the quantity and value of their labor. Under earlier regulations, the form also obliged innovative enterprises to provide import data, including quantity and cost specifics. Form 27 must now be submitted without demanding specifics, and only once every three years.

Here, it's important to remember the dispute between Bayer Corp. and Natco Pharma:

 

The medicine Nexavar (sorafenib tosylate), which is used to treat kidney cancer, was at the core of the dispute. Based on Bayer's Form 27 submission, Natco Pharma requested a compulsory license (CL) for Nexavar in this. According to this filing, Nexavar was neither inexpensive nor free.

Then, in 2013, Controller of Patents PH Kurien made a landmark ruling that led to Natco Pharma receiving the first compulsory license in India. This gave Natco permission to produce and market Nexavar in exchange for royalties from the purchaser. More affordable and easier access to medicine was achieved.

Form 27 was crucial in determining the medicine's pricing and accessibility in this case. In the protracted legal battles over mandatory licensing in India's pharmaceutical industry, the case marked a turning point. (The Indian Patent Act requires an annual statement, Form 27, to ensure that patents fulfill their intended functions of encouraging innovation for the public good and providing the advantages of patented inventions to the general public at reasonable, affordable rates.)  

Accelerated Patent Examination: The shorter time frame for submitting a Request for Examination (RFE) may result in a quicker patent examination. This could result in faster patent approvals, enabling pharmaceutical businesses to launch their goods more quickly.

Flexibility with Deadlines: Through extension fees, the amendment permits flexibility with some previously non-extendible deadlines. Pharmaceutical businesses might have additional time as a result to get ready to submit patent applications and reply to examination reports.

Simplified Paperwork: There has been a simplification of the criteria for working statements and accompanying international filing particulars. Pharmaceutical businesses may have less administrative work to do as a result, which would make managing their patent portfolios simpler.

Diminished Opposition: The amendment intends to limit the amount of pointless pre-grant oppositions that are filed. This may lessen the difficulties pharmaceutical companies encounter when attempting to get patent protection.

Decreased Statement Filing Frequency: Working patents were only filed once every three fiscal years as opposed to one per a fiscal year. Pharmaceutical businesses may have less administrative work as a result of this. The aforementioned modifications have the potential to optimize and accelerate the patent application procedure, creating a more advantageous atmosphere for major pharmaceutical corporations to safeguard their intellectual property.

Here’s a concise overview of the recent amendments in Indian patent regulations:

Request for Examination (RFE) Timeline: The due date for submitting an RFE in a patent application has been reduced from 48 months to 31 months from the earliest priority date. This adjustment aims to expedite the patent examination process.

Foreign Filing Details (Form-3): Applicants must now provide details of corresponding foreign applications twice using Form-3. The timeline for submission has been shortened: within 6 months from filing or within 3 months from the First Examination Report (FER).

Divisional Applications: Divisional applications are now allowed for inventions disclosed in provisional or complete specifications. These divisional applications need not be restricted to the claims of the parent application only.

Renewals/Annuities: A 10% reduction in official fees for renewal is applicable if the fee is paid in advance for 4 years or more.

Pre-grant and Post-Grant Oppositions: Official fees have been introduced for pre-grant oppositions. Timelines have been reduced to expedite the procedure, and prima facie assessment is now part of pre-grant opposition.

Introduction of ‘Certificate of Inventorship’: Inventors’ contributions to patented inventions can now be officially recognized. Previously, Indian patent certificates did not specify the inventors, causing ambiguity.

Commercial Working Statements (Form-27): The submission of working statements (Form-27) has been relaxed to once every 3 years (instead of annually).

Modifications to Pre- and Post-Grant Opposition Processes: The duration for submitting suggestions to the Opposition Board and the applicant’s response period has been rescheduled. An invention disclosed in a further divisional application or in the provisional or complete application can now be the subject of a divisional application.

Extent of Allowable Modifications to Patent Claims : Section 59(1) of the Patents Act limits modifications to disclaimers, corrections, or explanations. Changes introducing claims or information not previously stated or demonstrated in the specification are prohibited.