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Lacunae in US Patent Law and Possible Solutions

Updated: Oct 18, 2022


Under the Patents Act of 1836, the patenting process in the United States was a secret one and, there was no direct or indirect interference of general public in the dialogue between the patent applicant and patent examiner. [1] Except in the past decade, the pending patent applications are not open to public inspections and the patent information was published only after the patent was actually issued.[2]

The issuance of patent was largely dependant on the confidential information shared by the patent applicant with the patent examiner, which is unavailable to general public.[3] The dependency made it imperative that the patent applicant vigilantly and diligently discloses all the relevant information in regards to the patent in a bona-fide manner. As there was no way by which the patent examiner can find out the best possible way, the patent can be executed and therefore in reality the patent can be enforced for an indefinite period of time because of non-disclosure of critical information.[4]

There was no mechanism to contest a patent examination after grant, even if there is a prima facie error in issuance of patent.[5]There were some drastic changes brought about by introduction of amendments by the patent act of 1980. The two main criteria of patentability were that the invention has to be novel and it has to be non-obvious. However while ascertaining novelty, it has been laid down that the examiner has to examine the patent application in the light of published prior art anywhere in the world giving due importance to the published traditional knowledge possessed by the indigenous people from different parts of the world. The America Invents Act, passed in 2011 made some drastic changes to these provisions and laid down that prior art anywhere in the world cannot be patented, existence of even unpublished prior art will nullify the chances of grant of patent in US, the Patenting system is converted to first to file rather than first to invent, etc.


Bio-piracy has been a cause of concern for developing and under-developed countries; it describes the situation in which developed countries acquire patents on inventions based on traditional knowledge of the indigenous people of less-developed countries with an intention to exclusively exploit the invention commercially.[6] Biopiracy is the theft of traditional knowledge held by indigenous people by emulating the same in commercial patents.[7] The peculiar example will include valuable uses of local plants or animals within a particular indigenous community. Companies become aware of these uses, then seek to patent and commercialize that knowledge for their own gain.[8]

In this situation, the patentee receives substantial financial compensation for their patent rights, while leaving the indigenous community with no gain.

Instances of Biopiracy

· Hoodia

Hoodia is a plant and the San people of the Kalahari Desert in South Africa have been using Hoodia as an appetite suppressant since ancient times.[17] Hoodia, on human consumption has the property to suppress appetite and thus enabling people to engage in longer hunting expeditions, carry fewer supplies, and consequently increasing their productivity in hunts.[18] In accordance with an international treaty, the Convention on Biodiversity (CBD), the San people are eligible to receive royalty payments for the sale of drugs containing Hoodia by pharmaceutical companies.[19] However questions can be posed on the fairness and propriety of such profit sharing agreements,[20] and more importantly the United States is not a party to CBD, therefore the San people do not receive any resultant benefit on profit gained through exploitation of US patents on Hoodia.[21] Numerous patents have been granted in United States and Europe, incorporating traditional knowledge of San people, accruing little or no benefits for San people.

Frame Work For Addressing the Issue of Biopiracy in US Patent Framework

Despite the perceived misappropriation of traditional knowledge of indigenous people, the new America Invents Act does not bar the patentability of extraction of new compounds based on the existing traditional knowledge. However, the expanded scope of prior art under the new Section 102 will negate the scope of claim but does not bar the new patents altogether.

Malagasy healers never used the rosy periwinkle for the uses to which Eli Lilly is putting it. They used it primarily in treating diabetes.[22] Because Eli Lilly used the plant to produce new compounds, for new

medicinal uses, they may be able to obtain patent protection even under the America Invents Act.[23] Consideration of the Malagasy use may force companies like Eli Lilly to narrow their patent claims, directing them only at the new innovation. Accordingly, even where prior art may not entirely bar new patents, its consideration may affect the reach of new patent claims.

However, the US government along with international institutions can take substantial steps to prevent bio-piracy and theft of traditional knowledge of indigenous people:

Compulsory royalty to indigenous stakeholders:

There has to be provision incorporated in the act that indigenous people shall receive compulsory royalties on the sale of the products based on their knowledge. Ratification of Convention of Biological Diversity by the United States Government will be a good step in this direction. And the royalty should also be extended to the compounds extracted on the basis of that knowledge. Social, environmental and spiritual concern should also be accounted for in the profit-sharing agreement.[24]

Traditional Knowledge databases:

The most obvious and effective means of preventing the grant of patents based on traditional knowledge is to ensure that the traditional knowledge will be considered as prior art. At the most basic level, if those opposing the issuance of a patent can demonstrate that the “invention” is already known to the public, the invention is ineligible for patent protection either because it is not novel or because the invention’s improvement over the prior art would have been obvious to person of ordinary skill in the art.[25] Many governments are actively participating in the codification of traditional knowledge and the United States should take the lead by infusion of funds to accelerate the process.

Sui-Generis Intellectual Property Rights in Traditional Knowledge:

Enacting a law to provide intellectual property rights to the stakeholders of traditional knowledge will be giant leap against bio-piracy. This sort of system, which creates new categories of intellectual property rights for traditional knowledge, has been characterized as a sui generis regime.[26] For example, Thailand has extended intellectual property protection to traditional Thai medicine through the Act on Protection and Promotion of Traditional Thai Medicinal Intelligence. A similar law in United states shall be step forward for the protection against bio-piracy.

[1] See Patent Act of 1836, §§ 7-8, 5 Stat. 117, 119-21 (describing the patent examination process). [2] Congress acted in 1999 to make pending patent applications open to public inspection. See Act of Nov. 29, 1999, Pub. L. No. 106-113, § 4001, 113 Stat. 1501, 1501A-552. [3] See 35 U.S.C. §§ 102(b) and (g) (2006). [4] See 37 C.F.R. §§ 1.97-98 (2011), providing for “information disclosure statements” to be submitted by patent applicants, and 37 C.F.R. § 1.56, otherwise setting out an affirmative requirement to provide information “material” to the patent examination. [5] See Act of Dec. 12, 1980, Pub. L. No. 96-517, §§ 301 et seq., 94 Stat. 3015, 3015. [6] Baruch A. Brody, Traditional Knowledge and Intellectual Property, 20 KENNEDY INST. OF ETHICS J. 231 (2010). [7] Id. [8] 232 [9] DANIEL F.ROBINSON,CONFRONTING BIOPIRACY: CHALLENGES,CASES AND INTERNATIONAL DEBATES 55 (2010). [10] Id. [11] Id. [12] U.S. Patent No. 6,673,377 (filed Aug. 28, 2000) [13] ROBINSON, supra note 35, at 55 [14] See id [15] 59 [16] See id [17] Fritz Dolder, Traditional Knowledge and Patenting: The Experience of the Neem fungicide and the Hoodia Cases, 26 BIOTECHNOLOGY L.REP. 583, 587 (2007) [18] Id. [19] Saskia Vermeylen, Contextualizing ‘Fair’ and ‘Equitable’: The San’s Reflections on the Hoodia Benefit-Sharing Agreement, 12LOC.ENV’T 423, 428 (2007) [20] See generally id. (discussing the San people’s perceptions of the fairness of the Hoodia Benefit Sharing Agreement); see infra Part I.C. [21] List of Parties, CONVENTION ON BIOLOGICAL DIVERSITY, (last visited Mar. 29, 2015) (listing the parties to the CBD) [22] Hassemer, supra note 48 at 168 [23] The AIA would consider medicinal uses of the plant that were known to the public to be prior art. 35 U.S.C. §102 (2012) [24] Vermeylen, supra note 45, at 425-26. [25] See 35 U.S.C. §§102–103 (2012) [26] See J. Janewa OseiTutu, A Sui Generis Regime for Traditional Knowledge: The Cultural Divide in Intellectual Property Law, 15 MARQ.INTELL.PROP.L.REV.147, 150–

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