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Judgment
Prabha Sridevan, J
1 . This appeal has been filed against the order refusing to proceed further on the patent application No. 2254/DELNP/2005. The request of patent is
for ""A New Crystalline Form of Adefovir Dipivoxil and its Composition"". Hearing was held on 20.8.2009. The Assistant Controller held that claims 1-4
could not be allowed in view of section 3(d) of the Patents Act, 1970 and no proof has been furnished to show enhanced efficacy. The impugned
order also records that there is no data to show clinical trial on human beings to support the case of therapeutical efficacy. Thereafter, the Assistant
Controller held that claims 4-7 are not allowable under section 3(e) of the Patents Act, 1970 and claims 7-10 are being beyond the scope of claim 1.
The learned counsel for the appellant submitted that the entire order is a collection of materials taken out from the information obtained from Internet
without any independent application of mind. The learned counsel submitted that in the First Examination Report, the only objection raised was
regarding section 3(d) and the appellant was also asked to address the Controller only on the ground of section 3(d) and section 3(i). The learned
counsel also submitted that it is not correct to state that no experimental clinical data was furnished.
The order is a short order and reads as follows:
The present invention relates to a new crystalline form of a compound and its composition, and in particular, to a new crystalline form of adefovir
dipivoxil with the nomenclature of 9-[2-[bis(pivaloyloxy)-methoxy] phosphinyl] methoxy) ethyl] adenine and a composition containing that new
crystalline form. The claim 1-4 could not be allowable under section 3(d) of patent act 1970, and the agent have not able to prove enhance efficacy.
There is no data submitted in the complete specification for clinical trial on human being, ""for the support of therapeutical efficacy. ""The
experimentation must be done with the human body, for testing a drug on a lion or a horse or monkey might not prove anything about its effect on
man"".
What is the clinical trial?
A clinical trial (also called a clinical study) is a medically supervised procedure in which investigational drugs are given to patients for a set period of
time while changes in the patients' disease and overall health are monitored through physical examinations and laboratory tests. Typically, during the
time patients are taking a drug, they make periodic visits to the doctors in charge of the trial. On these visits, patients usually provide information about
how they are feeling, undergo physical examinations, and are given diagnostic tests meant to measure how their condition is responding to the drug.
Clinical trials can vary in length from days to years, depending on how long it takes to measure the effect of the investigational drug on the disease
being treated.
Five (5) different types classifying trials:
• Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These
approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
• Screening trials: test the best way to detect certain diseases or health conditions.
• Diagnostic trials: conducted to find better tests or procedures for diagnosing a particular disease or condition.
• Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Quality of life trials: explore ways to improve comfort and the quality of life for individuals with a chronic illness (a.k.a. Supportive Care trials).
The applicant failed to submit any experimental clinical data done on human being in support of therapeutic efficacy.
Claims 4-7 are not allowable under section 3(e) of the patent act 1970 as amended in 2005.
Claims 7-10 are beyond the scope of claim 1.
In view of my findings, I refuse to proceed further on this patent application 2254/delnp/2005.
Dated 05/10/2009.
(Saroj Kumar)
Asst. Controller of Patents & Designs.
3 . It is seen from the paper book that the sentence starting from the word ""The experimentation must be done.........."" and ending with the words ""its
effect on man'''' has been taken from the extracts taken from the Internet which is a published article in Internet by one David W. TSCHANZ,
MSPH, Ph.D. giving historical evidence of the work of earlier Islamic scholars with regard to pharmaceutical knowledge. In the Para headed ""Ibn
Sina and Clinical Trials"", we found this sentence word for word except an addition of a word ""monkey"".
Next we come to the 2nd para of the impugned order which starts with the word ""what is clinical"" and ends with ""the disease being treated"". We
find from the paper book that this is a web printout from Procter & Gamble's website, where this paragraph is found in the same font and it has been
extracted in the impugned order verbatim.
5 . Next we come to the 3rd para, which starts with ""Five (5) different types classifying trials;"". These are extracted word by word from the
Wikipedia under ""Clinical Trial"" where just above the word-design the words in the paragraphs were extracted except for the photo. Instead of five
different types of classifying trials, Wikipedia reads ""Another way of classifying trials is by their purpose"". The US National Institute of Health (NIH)
organizes trials into Five (5) different types.
After linking these three collection of materials from Internet, the impugned order comes to the conclusion that the claims 4-7 are not allowable and
claims 7-10 are beyond scope of claim 1. As regards failure to submit clinical data, the learned counsel for the appellant submitted that this had been
submitted to them but not considered.
This is not how an order shall be passed by the Patent Office. The Controller has the duty to examine the claims and test them for patentability.
This order must be set aside. The application is sent back to the Controller who shall consider it independently. On examination and before holding the
hearing, the Controller shall examine, if, apart from section 3(d), there are other objections. If so, the Controller shall inform the applicant that other
objections shall also be addressed. After hearing the applicant, reasoned order shall be given. The fact that this impugned order has been set aside
does not mean that we have considered the merits of the patent application to found the invention patentable. We have not examined the merits at all.
This shall be considered independently and in a judicial manner by the Controller. Such an order shall be passed in accordance with law within a period
of three months from the receipt of this order. The Appeal is allowed as above and the matter is remanded back to the Controller.