The recent buzz going on in the patent world questioning the patentability of the Melon extract patent got me interested in the issue and forced me to check the prosecution history of the patent application provided in the EPO register. One thing led to another and I found my self analyzing the patentability of the invention which I though t is worth sharing with you all. Your critical comments and feedback are welcome.
The Patent application no.EP1747786 filed by a Spanish enterprise by the name PERDIX EUROGROUP S L deals with a natural product based on vegetal ingredients with anti-vitiligo therapeutic properties. The patent seeking composition includes ingredients such as extracts of Pimiemta racemosa (West Indian Bay tree), Citrus aurantifolia (Lime) and Cucumis melo (melon) among others.
The application initially consisted of 7 claims which were objected to as they were not submitted in the required claim format. Also, inventive step related objections were raised by the EPO. In order to overcome the objections raised by the EPO during prosecution, a new set of 3 claims were submitted on 16th of December, 2008. The first two claims were focused on the medicinal preparation and the third claim dealt with the use of the said medicinal preparation for treatment of Vitiligo. In response to the amended application on 4th June, 2009 the EPO communicated to the applicant its intention to grant the patent.
On 8th July, 2009 a third party observation was sent by Council of Scientific and Industrial Research, India (CSIR) for consideration by the EPO, stating that the use of Cucumis melo (melon extract) for treatment of leucoderma or vitiligo through local application was traditionally known in India and has been entered in the Traditional Knowledge Digital Library (TKDL) which is accessible to the EPO. Relevant prior art with regard to the same from printed books of Ayurveda, Unani and Siddha were also submitted.
For readers who haven’t heard of TKDL, TKDL is a repository of traditional knowledge provided in the Ayurveda, Siddha and Unani medicine which includes over 2 lakhs formulations. Access agreement for the same has been signed with USPTO and EPO. EPO was granted the TKDL access starting February 2009. The CSIR website claims that four EPO patents were withdrawn in the light of the information provided in TKDL in between August to November 2009.
(To Read more: http://www.tkdl.res.in/tkdl/langdefault/common/Abouttkdl.asp?GL=Eng)
Focusing on the purpose of this blog post, I would like to discuss the patentability of EP1747786 in the light of the prior art relating to the use of melon extract for treatment of anti-vitiligo. Being an EPO application, the patentability standards provided by the EPO shall hold true for this analysis.
In the light of Article 52(1) EPC, patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application. I have restricted my analysis to Novelty and Inventive step analysis.
As per Article 54(1) of EPC, an invention is considered to be new or novel if it does not form part of the state of the art. It must be noted that novelty analysis is carried out by comparing the invention with a single prior art reference at a time. If all elements in the invention forms part of a single prior art reference, then such an invention would lack novelty in the light of that prior art reference. A similar analysis has to be done for each relevant prior art reference.
The invention of the patent application deals with a medicinal composition comprising of extracts of Pimiemta racemosa, Citrus aurantifolia and Cucumis melo along with Coenzyme Q10 and Pyridoxine Chlorhydrate.
The TKDL reference describes the use of Melon extract for treatment of anti-vitiligo. Since the composition provided in the patent application comprises of other essential components in addition to the melon extract, all elements of the invention are not present in the prior art. Hence, in the light of this prior art the patent application can be considered as Novel.
Furthermore during prosecution, the examiner identified several prior art references which provided for each of the component stated to be part of the formulation provided in the invention. Since none of the prior art reference had all the components, a novelty objection was not raised.
Moving forward to the requirement of Inventive step, Article 56 of EPC states that an invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art. In other words, to ascertain inventive step, the invention should not be obvious to a person having ordinary skill in the art, in the light of combination of prior art references.
Objections were raised by the examiner during prosecution stating lack of inventive step in the light of combination of prior art references. However, the applicant provided sufficient information to distinguish the invention from the other prior art references cited in the search report. To mention a few, the applicant pointed out that prior art concerning to Pimiemta racemosa would not be of relevance since the prior art claims the extract for its anti inflammatory properties where as in the patent application it is used for its antioxidative properties which was not known in the prior art.
With regard to the prior art identified by EPO with regard to the use of melon extract, the applicant stated that melon extract in the patent application is used for its catalase activity as opposed to the superoxide dismutase activity claimed by the prior art patent.
Furthermore, the applicant amended the application to include purpose limited restrictions to the claims thus reducing the scope of protection seeked by the claim.
Coming back to the TKDL reference, detailed information with regard to the TKDL reference needs to be provided to conduct a fair analysis with regard to inventive step. Unfortunately, since the TKDL access is restricted to Indian patent office, EPO and USPTO, patent enthusiasts like us may not be able to study the issue in its complete spirit.
Based on my analysis in the light of limited information, I believe that, since the applicant has successfully managed to show inventive step in the light of all other prior art references which also includes a US patent application relating to the use of melon extract for treatment of anti-vitiligo, it should not be difficult for the applicant to prove inventive step in the light of the melon extract reference provided by TKDL as well.
After all, the TKDL reference may not be successful in negating the inventive step of the Patent application no. EP1747786. However, the Patent Offices never fail to surprise me. Let’s wait and watch!