The Inventive Edge - July 2024

THOUGHT LEADERSHIP

Biopiracy – Can the international treaty combat this?

[Contributors: Meera Gupta]

A treaty relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources was proposed recently by WIPO and has been adopted by majority of member states.

This treaty is fundamental in upholding the rights of countries rich in biodiversity and traditional wisdom of global South such as India, Sri Lanka, Africa, South America, etc. and safeguarding from institutional “Biopiracy”. Biopiracy involves unethical or unlawful appropriation or commercial exploitation of biological materials (such as medicinal plant extracts) that are native to a particular country or territory without providing fair financial compensation to the people or government of that country or territory.

Many international events related to institutional biopiracy led to this treaty where a patent was issued without consideration of traditional knowledge or originality. ‘Brazzein’, a super-sweet protein extracted from the berries of a West African plant, Pentadiplandra brazzeana was patented by US scientists. In 1994, Larry Proctor, the owner of a small seed company and president of POD-NERS, L.L.C. patented Enola bean variety and claimed exclusive monopoly on any dry bean having a seed colour of a particular shade of yellow. It costed the Mexican government $200,000 in legal fees to challenge the validity of the patent.

An American firm registered a patent in the US for an insecticide extracted from Neem tree. In 1994 the European Patent Office also granted a patent relating to Neem based fungicides.

After ten years of legal proceedings, the European Patent Office eventually revoked the patent by establishing that the fungicidal effect of the neem seeds had been known in India for centuries. Rosy periwinkle which was well known to the natives of Madagascar for its medicinal properties was monopolized by a pharmaceutical giant Eli Lilly to use it in treatments of diseases like leukemia and malaria.

San peoples, native to South Africa, recognized the enormous market potential of appetite suppressant qualities of the Hoodia cactus, got a patent on it and sold the licensing rights to an English biopharmaceutical firm, Phytopharm, in 1997. Phytopharm then sold the license to American pharmaceutical giant Pfizer for 25 million dollars. The Hoodia works by mimicking the effect glucose has on the nerve cells in the brain, in effect providing a feeling of fullness and thus curbing the appetite. It was traditionally chewed to stave off hunger and thirst during long hunting expeditions in the desert.

In March 1995, two researchers from India at the University of Mississippi received a patent for using turmeric in wound ointments. Indian Council for Scientific and Industrial Research, India's largest research and development organization, filed suit against the United States Patent Office. The plaintiffs claimed turmeric had been used for centuries in India to treat wounds and rashes, and they drew support from an ancient Sanskrit text.

Further, there have been attempts on claiming traditionally cultivated plant varieties in India such as wheat, basmati rice, jasmine rice, etc.

In October 2010, the Nagoya Protocol was approved as part of the UN's Convention on Biological Diversity. An internationally legally binding treaty, it aims to divide profits from resources, such as medicinal plants, in a way that benefits the populations which originally used and grew them. However, the treaty did not find implementation in laws.

India amended its Patent Act in 2002 to introduce Section 3(p) prohibiting “an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components”.

The new treaty upholds the conviction of Indian patent law to prevent biopiracy, the new treaty requires contracting parties to adhere to mandatory disclosure obligations which require patent applicants to disclose the country of origin or source of the genetic resources when the claimed invention is based on genetic resources or associated traditional knowledge.

India already maintains a Traditional Knowledge Digital Library which is a comprehensive database of medicinal formulations in various languages. Established in 2001, the TKDL was created in response to India’s challenges in overturning patents on traditional remedies like turmeric and neem. It was a joint initiative of the CSIR and the Department of AYUSH and aims to safeguard India’s rich medicinal knowledge from being patented erroneously, which had become rampant. Also, establishment of TKDL has been pivotal in protecting India’s traditional medicinal systems from misappropriation globally.

According to the treaty, the states are required to create databases or repositories where information about genetic resources and traditional knowledge can be recorded. However, lack of incentivization may not motivate the indigenous communities, being major source of traditional knowledge, to provide their contributions. Thus, there is a requirement for government bodies to incentivise and proactively gather such knowledge in order to prevent it from falling prey to biopiracy.

Further, the treaty is not retroactive: it doesn’t apply to patents granted in the past. So whatever patents have been granted so far are to be challenged in the court of laws to stop them from monopolizing indigenous knowledge. Also, the treaty has no provision of denial of any future patent in case the applicant does not provide the alleged mandatory disclosure.

In conclusion, the new international treaty spearheaded by WIPO came as a beacon of hope for the protection of biodiversity and traditional knowledge. It is a significant step towards rectifying the historical injustices of biopiracy, where the wealth of knowledge held by indigenous and local communities was exploited without due recognition or compensation. This treaty does acknowledge the intrinsic value of genetic resources and traditional wisdom but fails to ensure that the benefits derived from them are shared fairly and equitably.

It sends a message that the international community will no longer tolerate the appropriation of biological materials under the guise of innovation, without honoring the source communities' contributions.

Understanding Negative Limitations in Patent Claims: A Shift in Perspective

[Contributor: Devashish Agarwal]

In the world of patent law, negative limitations have historically been viewed with caution. These limitations, which define an invention by stating what it is not rather than what it is, were once considered improper except in exceptional circumstances. However, recent developments and court rulings have brought about a significant shift in how negative limitations are perceived and utilized.

The Evolution of Negative Limitations

The Manual of Patent Examining Procedure (MPEP) 2173.05(i) reflects the evolving stance on negative limitations. The current judicial view is that there is nothing inherently ambiguous or uncertain about a negative limitation. Consequently, negative limitations are now generally accepted, provided they are clear and precise.

Examples and Acceptability

Under this updated practice, descriptions like "halogen other than fluorine" are considered acceptable. Similarly, terms such as "noncircular," "nonmagnetic," or "colourless" have long been deemed acceptable because they concisely convey the intended limitation. These expressions often represent the most practical way to define specific characteristics of an invention.

MPEP 2173.05 (i) further illustrates acceptable negative limitations with examples such as "not in excess of 10% structure" and "incapable of forming a dye with...". These examples demonstrate how negative limitations can effectively convey precise constraints without ambiguity.

Strategic Use of Negative Limitations

Negative limitations can be strategically employed to avoid restrictive language such as "consisting" or "consisting essentially." For instance, if a patent claim covers a combination comprising elements A, B, and C, and the examiner cites a combination of A, B, C, and a large amount of D, it might be unobvious to eliminate D. In such cases, the claim could be amended to read "comprising A, B, C, and absent sufficient D to... [hurt the combination]," as seen in the Duva case.

This approach allows the claim to cover combinations where D is minimized without excluding additional elements that do not affect the overall invention.

Case Laws: The Use of Negative Limitations

Case Law 1: Ex parte Grasselli

In this case, the inventors were working on a catalyst for the oxidation of olefins. They used a negative limitation to exclude the presence of a specific metal that would interfere with the catalytic process. The claim read:

"a catalyst comprising... absent sufficient iron to substantially affect the oxidation process."

Outcome: The use of the negative limitation was upheld by the Board of Patent Appeals and Interferences. The decision was based on the clarity provided by the negative limitation, which precisely defined the invention's scope by excluding the unwanted metal.

Case Law 2: Allergan, Inc. v. Sandoz Inc.

Allergan's patent for the glaucoma treatment Combigan included negative limitations. The claims described the combination of specific active ingredients and excluded certain preservatives that could destabilize the formulation. The claim read:

"a pharmaceutical composition comprising... and absent sufficient benzalkonium chloride."

Outcome: The court upheld the patent, recognizing the clear and specific nature of the negative limitations. This case illustrates how combining both types of limitations can provide a robust definition of an invention's scope.

Case Law 3: In re Duva

The landmark case of In re Duva solidified the legitimacy of negative limitations in patent claims. In this case, the court upheld a negative limitation that stated:

"absent sufficient CN [cyanide] ions to prevent deposition...,"

even though a positive expression could have been used. This ruling established that negative limitations could be valid, even when they define a point of novelty.

Conclusion

While the historical opposition towards negative limitations has softened, it remains advisable to use them sparingly and judiciously. Negative limitations should be employed when they represent the clearest or only way to define a limitation. As a general rule, it's preferable to describe what an element is, rather than what it is not.

In summary, the modern view of negative limitations opens new avenues for patent claims, offering flexibility and precision. Understanding when and how to use these limitations can enhance the clarity and enforceability of your patent applications.

INDIA IP NEWS & DEVELOPMENTS

• Union health minister J P Nadda on Friday said that Bharat Biotech initially did not mention ICMR and NIV as co-inventors in the patent application for Covaxin and the application was corrected after objections were raised by the government. READ MORE HERE
• NITI Aayog, on Monday, signed a Joint Letter of Intent (JLoI) with the World Intellectual Property Organization (WIPO) under its Atal Innovation Mission (AIM) aimed at building programs for innovation, entrepreneurship and intellectual property (IP) for countries in the global south. READ MORE HERE
• The Organisation of Pharmaceutical Producers of India (OPPI), which represents prominent multinational pharma companies, has sought exemption for patented and orphan drugs from the government-set price controls, people in the know told ET. READ MORE HERE
• Union Budget: Outlining the sector's wish list for the upcoming Union Budget, Organisation of Pharmaceutical Producers of India (OPPI) Director General Anil Matai urged the government to explore methods to incentivise R&D investments, such as deductions on R&D expenses, research-linked incentives for MNCs, and corporate tax concessions. READ MORE HERE

WORLD IP NEWS & DEVELOPMENTS

• Apple is exploring a groundbreaking security feature that could allow users to unlock their devices using their unique heart rhythms. This innovative approach, described in a newly granted patent, leverages the natural ECG capabilities of the Apple Watch and potentially future iPhone models. READ MORE HERE
• In a significant move to streamline operations and reduce costs, Stellantis NV has announced a broad voluntary buyout program for its U.S. salaried employees. This decision comes in the wake of a substantial decline in net income during the first half of the year,, prompting the automaker to take decisive actions to maintain its competitive edge and ensure long-term sustainability. READ MORE HERE
• U.S. technology firm InterDigital and a patent licensing platform on Monday won their bid to throw out a London lawsuit by Tesla, which was seeking a patent licence ahead of the automaker's launch of 5G vehicles in Britain. READ MORE HERE
• According to the Office’s recent Notice of Proposed Rulemaking (NPRM) on Setting and Adjusting Patent Fees, the present backlog is predicted to increase to 820,200 by FY 2026 before decreasing to 780,000 by FY 2029. READ MORE HERE

PATENTLY ABSURD

• Make a Heart with your Hand (US8558759B1): Patenting hand gestures seems to be an overreaction of sorts, but currently in the commercial world, every little action has economic value. The gesture, working as a visual cue for Google glasses, the patent was filed by Google with the title, "Hand Gesture to Signify what is Important". The gesture when seen by the glasses will mark the object in between as something important or perform certain actions for the object in question.

• Flaming Trumpet (US4247283A): Jazz up jazz band practice with a trumpet that emits real flames. On second thought, probably better you don’t. In fact, please don't.

BRIEF OVERVIEW ON EMERGING TECHNOLOGIES

Ring lets you voice chat with AI anytime, anywhere!

• An AI-enabled smart ring that facilitates the user voice interaction with AI assistants. The WIZPR ring is a personalized AI interaction tool that connects the user with the AI assistant anytime. The WIZPR ring allows the user to instruct or command without providing wake words and also provides an auto-unlock feature by detecting the user’s proximity. The user needs to bring the ring closer to the mouth and whisper the commands and the user can interact with the AI assistant discreetly and efficiently anytime even in a noisy environment. The WIZPR smart ring’s microphone uses noise-resistant proximity speech recognition for high accuracy and fewer false positives. The ring stops recognizing the voice when the user removes it from the mouth, which prevents undesired responses to everyday conversations.
• The WIZPR ring is designed and developed in such a way that it cannot only answer the simple query generated by the user but also initiate conversations based on the information provided by the user. The ring can also notify the user about upcoming messages and allows the user to acknowledge the notification by pressing buttons designed on the ring without the need to use the mobile phone.

• The WIZPR smart ring comes with an SOS feature by combining a button on the ring for immediate instruction. The SOS feature can be triggered by pressing the button five times in a row to record your surroundings through the ring's microphone and send it to an emergency contact along with your location. The ring allows the user to control home automation by connecting the ring with the mobile phone of the user.
• The WIZPR ring serves as a compact AI assistant, replacing the functionality of traditional mobile devices. Its design provides convenient, whisper-activated assistance anytime, anywhere, streamlining daily routines with an intuitive and portable solution.

Reference: - https://www.youtube.com/watch?v=49rLm9tDFGc

TECH BITS

• Designer Gaurav Gupta takes on fashion fakes. READ MORE HERE
• 24 Comics and 20 Novels Shortlisted for Top IP Awards at the 3rd Best IP Awards. READ MORE HERE
• IP Australia to form Indigenous Knowledge Panel, welcomes applications from Indigenous community. READ MORE HERE
• Interesting argument in copyright infringement case involving Harper’s Bazaar India, celebrity news agency. READ MORE HERE
• Adobe Gets E-Signature Patent Claims Erased as Ineligible at CAFC. READ MORE HERE