Patent

Merck’s (Atomic Energy) Patent – Fizzles!!


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We are happy to bring to you another guest post by Sribindu Chivukula. Sribindu graduated in Chemistry from State University of New York, Buffalo in the year 2012. She is a registered Indian patent agent and is presently associated with a leading law firm based out of Delhi. All views expressed in the post are her personal views.

 

 

 

Merck’s (Atomic Energy) Patent – Fizzles!!

Sribindu Chivukula

This post discusses the case where a national phase patent application (2996/KOLNP/2009) filed by Merck was denied a patent grant by the IPO under section 4 of the Patents Act, 1970 that excludes patenting of inventions relating to atomic energy. Against this backdrop, the post further questions the relevance of not granting national phase patent applications, particularly when the corresponding applications are published/granted in other jurisdictions, under section 4. The relevant extract from the section is provided below:

“No patent shall be granted in respect of an invention relating to atomic energy falling within sub-section (1) of section 20 of the Atomic Energy Act, 1962”

Background

A national phase patent application (PCT), claiming priority from an EP application, was filed by Merck in the year 2009. The EP application was subsequently granted (EP 2146944 B1) in the year 2014. The subject matter of the invention pertains to 18F-folate radiopharmaceuticals. Radiopharmaceuticals are drugs composed of a radioisotope of fluorine (18F or F-18) bonded to a folate molecule. These drugs can be used as tracers in diagnosis/therapy of abnormal biochemical processes in the body, such as cancer and other inflammatory disorders, with the help of imaging techniques. Since the invention relates to the use of a radioactive isotope (18F), the Controller directed the patent application to the Department of Atomic Energy (DAE) for its opinion on patentability. Nonetheless, Merck was given an opportunity of being heard, even after the receipt of the orders from DAE. After extensive prosecution, the Controller refused the grant of patent by stating that, “the present application relates to Atomic Energy and is refused by DAE, India. I hereby refuse to proceed further under section 15 of the Patents Act”.

This decision kept me wondering on the relevance of invoking section 4 to the present case for the following two reasons –

1. The patent application (read the EP application, the Indian patent application is not available online) discloses that the complexes of the invention are used for radiotherapy and diagnosis, and does not state or suggest the use of complexes for production of atomic energy. Even if one intended to generate energy by nuclear reaction, the short half life of 18F (which is about less than 2 hours), and the miniscule amount of energy generated, seemingly makes this choice of process unfavourable. 18F has long been known for its use in nuclear medicine. In the absence of knowledge on use of 18F in any application where a measurable amount of atomic energy is generated by a nuclear reaction; invoking section 4 seems irrelevant. The DAE ought to have supported the assertion that the radiofolate pharmaceutical in question may be used in the generation of atomic energy. Also, the Controller’s referring the patent application to the DAE, and unquestioned acceptance of its recommendation to deny the patent grant comes as a surprise given that a number of patents have been granted by the IPO in the past on the compounds/complexes/ compositions involving radionuclides.

2. Section 4 is result of an interim report submitted by Justice Ayyangar in April 1959; and basis for which could be for reasons of national security, among other reasons. Withholding the publication of patent applications on atomic energy inventions, thereby limiting general public accessibility, was a way to safeguard the safety & security in the country. This was introduced at a time when the accessibility to patents in other jurisdictions, and publicly available publications was rather limited. With the way technology has helped us in disseminating knowledge provisions such as section 4 seems obsolete. So, the issue under question is – if withholding the publication or declining a patent grant for inventions whose subject matter is available in a public domain, under section 4, be a route to safeguard the security in the country. I beg to differ here. Merck’s PCT application has been in the public domain by way of publication and grant (granted in EP, published in US, China and Canada) before the Controller issued the FER for the national phase application. Therefore, any interested party can freely access the subject matter of the invention by referring the corresponding granted EP patent; and practise the same in India (atomic energy invention or not), which falls outside the patented territory. So, the whole argument concerning non-grant of patents under section 4, in the present case, for reasons of national security reasons/ for welfare of people/ for peace is moot.

The decision by the IPO may not be sustainable, and may well be reversed, if appealed at a higher court, in light of the discussed points. Also, it is time we amend provisions such as section 4 to ensure that the inventors are given due rights for their inventions.

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