Tribunals and CommissionsDivision Bench(2008) 03 IPAB CK 0011

Michigan State University vs Assistant Controller Of Patents And The Controller General Of Patents, Trademarks, Designs And Geographical Indications, Patent Office Branch

Intellectual Property Appellate Board · Decided on 19 March 2008

HON’BLE JUDGES
M.H.S. Ansari, J · S. Chandrasekaran, Technical Member
RESULT
Allowed
CASE NUMBER
TA/10/2007/PT/DEL (CM(Main)171 Of 2002)

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Judgment

132 paragraphs · 2,753 words

JUDGMENTTAG-JUDGMENT

S. Chandrasekaran, Technical Member

1.

This is a transferred appeal filed before the Hon'ble High Court of Delhi by the appellant Michigan State University, United States of America

wherein this appeal has been made under Section 116 of the Patents Act 1970 on 08.04.2002. The said application has been transferred to this

Appellate Board in terms of Section 117G of the Patents (Amendment) Act, 2002.

2.

The brief facts of the case are that an application for patent titled ""TRANSGENIC PLANTS PRODUCING POLYHYDROXYALKANOATES'

was filed on 27.07.1992 bearing patent application No. 661/DEL/92. Later a patent has been granted by the Patent Office on this application as Patent

No. 178865. During the examination of this application No. 661/DEL/92, the Patent Office objected to the claims of the appellant's application and

stated that there is plurality of distinct inventions and claim 20 was one of the claims relating to a distinct invention. By way of complying with the

office objections the appellants filed a divisional application on 30.07.1996 under Section 16 of the Patents Act, 1970 and same was numbered as

1699/DEL/1996. Another divisional application was filed and numbered as 1986/DEL/96. The said divisional application was accepted on 19.05.2000.

The relevance of the two divisional application Nos. 661/DEL/92 and 1986/DEL/96 appears to be that both related to plants having modified genes

through DNA coding. That, the said DNA coding sequence and plant promoter DNA sequence in Application No. 1986/DEL/96 had been obtained

through recombinant technique.

3.

The said divisional application No. 1699/DEL/1996 is the subject matter of consideration in this appeal, was duly examined by the Delhi Patent

Office in the year 2000 and the first examination report was issued on 09.05.2000. The main objections of the Patent Office was that subject matter

of claims does not constitute an invention under Section 2(1)(j) of the Patents Act, 1970 and also the invention falls under the category of non

patentable invention attracting the provisions of Section 3(b) and 3(i) of the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2002.

The relevant sections are reproduced below for easy reference:

Section 2(1)(j)...invention means any new and useful-

(i) art, process method or manner of manufacture;

(ii) machine, apparatus or other article;

(iii) substance produced by manufacture,

and includes any new and useful improvement of any of them and an alleged invention.

Section 3. The following are not inventions within the meaning of this Act

...

(b) an invention the primary or intended to use of which would be contrary to law or morality or injurious to public health

...

(i) any process for the medicinal, surgical curative prophylactic or other treatment of animals of plants to render them free or to increase their

economic value or that of their products.

4.

The appellant by way of complying with the office objection resubmitted stating that the subject invention is merely a process for producing a new

and useful chemical, namely the expression cassette i.e., chemically combining a gene coating both poly (3 hydroxy butyrate) synthase and the gene

coating for acetoacetyl-CoA reductase. There is a chemical reaction between the two genes and the promoter sequence to produce an expression

cassette. Such cassette is normally incorporated into a plasmid or some other vector which is then introduced into the plant cell. The appellant also

stated further that the forming of the chemical linkage between the promoter sequence and the gene is simple chemical reaction carried in-vitro. The

chemical so produced namely the expression cassette when present in a test tube is clearly ""not living"" since it cannot reproduce by itself. The

appellant further stated that the product of the reaction claimed cannot by itself reproduce itself. The appellants further observed that the ligation in the

claim is a normal chemical reaction and the product incorporated into a cell not for reasons relating to a viability of cell itself but to cause the cell to

produce particular products thereby using it as a factory. Hence the appellants observed that neither the present invention falls under the non-

patentable invention (Section 3 category) nor it is a treatment of plant to attract the provisions constituted therein.

5.

Subsequent examination report was issued by the Patent Office on 13.09.2001 maintaining the objection under Section 2(1)(j) of the Patents Act

1970.

6.

The appellants resubmitted the documents with amendments of observations on 30.10.2001 stating that the expression cassette can be distinguished

as a strand of DNA coding the expression of the genes however this DNA could not replicate on its own or in a living organism. To replicate a

sequence of DNA a replication origin is required. The applicants stated further that this replication origin is found in a variety of plasmid vectors which

are used to transfer expression cassette into organism when the cassettes are incorporated into the plasmid.

7.

Thereafter subsequent examination report was issued by the patent office on 02.11.01 stating that the claims do not constitute an invention under

Section 2(1)(j) of the Patents Act, 1970 maintaining the view that the expression cassette includes a living substance which cannot be allowed to be

patented under the provisions of Patents Act, 1970. Thereafter the appellants who were the applicants for the divisional application requested for

amendments in the specification by filing observations for the same on 05.11.2001.

8.

The Patent Office examined the amendment documents and the learned Assistant Controller issued subsequent examination report still maintaining

the objection ""that the claims do not constitute an invention under Section 2(1)(j) of the Patents Act, 1970"". Further the learned Assistant Controller

also communicated the opinion of the Expert Committee which was constituted by the Controller General of Patents, Designs and Trademarks that the

invention relates to a process for producing expression cassette involving DNA coding which offends the then office instructions and guidelines issued

in the year 1991 (Controller General Instruction No. 1 of 1991) and hence the claims are not allowable. The appellants resubmitted on 09.11.2001 the

documents with the observation that the invention as claimed resides in the linking of the promoter with a sequence of amino bases which does not

have any property of replicating but is restricting only to the linking of the promoter to amino based sequence. Thus the promoter is purely a chemical

compound and is neither a living gene nor does it have replicable properties and the end linking product is also chemical compound having neither living

nor replicable properties. Finally, the learned Assistant Controller of Patents by office letter No. 1699/DEL/96/14799 DATED 09.01.2002 informed

the appellants who were the applicants in the divisional application that the claims and the subject matter contained in the said complete specification

filed in the said divisional application was carefully examined along with all the submissions forwarded to him from time to time and also referring to

the discussions and submissions made by the appellant's attorney in this regard, maintained that the subject matter and claims do not constitute an

invention and hence not patentable under Section 2(1)(i) of the Patents Act, 1970. The learned Assistant Controller also referred to the technical

objections raised in the first examination report dated 09.05.2000 thus stating that the application has not been placed in order for grant of patent after

complying with the office technical objections. Accordingly the said divisional application is deemed to have been abandoned under Section 21(1) of

the Patents Act, 1970.

9.

Aggrieved by this impugned order dated 09.01.2002, the appellant being the applicant for the said divisional application filed review petition under

Section 77 of the Patents Act, 1970 stating that they have complied with all the requirements of various office objections but no reason has been

assigned by the learned Assistant Controller of Patents while abandoning the application thus not following the well settled propositions of law. In that

review petition the appellant referred to the judgment of the Hon'ble High Court of Calcutta dated 15.01.2002 IPLR 2002 July. 255 Dimminaco A.G.

v. Controller of Patents Designs and Ors. wherein it was held that ""the word 'manufacture' has not been defined in the Act. In such situation since the

word 'manufacture' has not been defined, the dictionary meaning of this word or the meaning attributed to in the particular trade or business must be

accepted, if the end product is a commercial entity. It is also admitted that there is no statutory bar to accept a manner of manufacture as patentable

even if an end product contains a living organism"". The appellant in their review petition before the learned Controller of Patents also referred to the

decision of the Hon'ble Supreme Court reported in Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries stating that since the claims for

patent leads to a vendible product it is certainly a substance after going through a process of manufacture.

10.

The review petition filed by the appellant who was the applicant in the said divisional application was turned down by the learned Assistant

Controller on the ground that a request for review is not applicable in the instant case as the application has been deemed to have been abandoned

under Section 21(1) of the Patents Act, 1970 due to non-compliance of the office requirements. Immediately the appellant herein and the applicant for

the said divisional application preferred an appeal under Section 116 of the Patents Act, 1970 before the Hon'ble High Court of Delhi maintaining that

the invention resides in the process of ligation of two non-living substances resulting into the non-living tangible and vendible product. The process

claimed therein is the simple chemical reaction and is, therefore, patentable under the Act. Further case of the appellant is that the learned Assistant

Controller has completely ignored the well settled proposition of law and no reasons have been assigned while issuing the impugned order dated

09.01.2002. The appellant also pointed that the learned Assistant Controller has erred in objecting the divisional application No. 1699/DEL/1996 on the

basis of the opinion of the Expert Committee. The appellant also questioned the Expert Committee's authority.

11.

The respondent No. 2 in their reply filed to this appeal before the High Court stated firstly that the present appeal is not maintainable as the order

appealed against, is arising out of the appellants abandonment of the divisional application No. 1699/DEL/1996 under Section 21(1) of the Patents Act,

1970. The respondents further stated that the office technical objections have not been complied with and/or removed by the appellants and/or

removed within the time limit as specified under Section 21 of the Act. Therefore, the said divisional application is rendered abandoned under Section

21(1) of the Act and so this appeal under Section 116 of the Act is not an appealable one. Respondent No. 1's case on merits appears to be that the

petitioner's application does not constitute invention under Section 2(1)(j). It was stressed that the expression cassette is in fact a living thing, cannot

be either considered as an article and/or substance so manufactured and therefore, a patent cannot be granted on such method or manner of

manufacture. The respondents No. 1 and 2 in their reply also submitted that the Patents Act, 1970 does not allow the patenting of any living substance

by moving repeated applications to which the respondents duly took objection and therefore, the applications were split out of the appellant's

application as a present divisional application which is still not allowable. The respondents 1 and 2 further submitted in their reply that the expression

cassette which is the subject matter of this present divisional application is in fact a genetically engineered nucleotide sequence which in the genetic

parlance is called a gene which can replicate and express itself and therefore it cannot be called as a nonliving substance.

12.

The appellant in their rejoinder to the reply given by the respondents submitted that the expression cassette is single strand nucleotide sequence

that cannot replicate unless and until incorporated into a vector which has an origin of replication DNA sequence. He further submitted that an

isolated and purified nucleotide sequence does not occur in nature and the said nucleotide sequence being synthetic and having same sequence as a

naturally occurring sequence is a composition of matter or article of manufacture, thus becoming a patentable subject matter under the Act.

13.

The matter came up before this Board on 31.01.2008 at Chennai. Ms. Anuradha Salhotra, learned Counsel appeared on behalf of the appellant.

None appeared on behalf of the official respondents.

14.

Ms. Anuradha Salhotra, learned Counsel for the appellant argued that the Delhi Patent Office had never raised the objection regarding the

compliance with the office instructions of Controller General of Patents, Designs and Trade Marks dated 15.07.1999, at any stage earlier i.e., either at

the first examination report or in the subsequent ones. She further contended that only in the last few days before the last date, it was pointed out by

the Patent Office that the invention claimed is not in compliance with the requirements of the office instructions mentioned therein. She further

contended that the learned Assistant Controller had not offered any opportunity of hearing before taking an adverse decision in this regard, thus

referring to the well established theory of 'audi alteram partem' (hear the other side before taking any adverse decision) and she also referred to

Section 80 of the Patents Act, 1970 in this regard. The counsel for the appellant further argued that the learned Assistant Controller of Patents has

neither given an opportunity of hearing nor has he given any reasons for refusing the application for patent but the learned Assistant Controller

proceeded to directly abandon the application under Section 21(1) without assigning any reason.

15.

Having heard the counsel for the appellant, none having appeared of the respondents we are of the opinion that the learned Assistant Controller

should have, first, offered an opportunity of hearing to the appellant as required under Section 80 of the Patents Act, 1970 before taking any decision

which would be adverse to the applicant. It is clearly understandable that if the invention claimed does not meet the requirements of patentability

criteria as laid down under Section 2(1)(j) or if attracts the provisions of Section 3 (non-patentable inventions category), the Controller of Patents

cannot grant a patent for the said invention. Nevertheless, the Controller of Patents being the custodian of patent rights, according to law, shall always

offer an opportunity of hearing to the applicant complying with the principles of law of natural justice. The Hon'ble Supreme Court in Union of India

and Ors. v. Jaiprakash Singh and Anr. held, that the right to reason is an indispensable part in any adjudication and spelling out the reasons in any

order is a basic requirement. In the said case, Supreme Court has held that the adjudicating authority should, while issuing an order set forth the

reasons, however so brief, indicating the application of the mind and all the more when that order is amenable to further avenues of challenge for any

redressal to the parties. In Alexander Machinery (Dudely) Ltd. v. Crabtree 1974 LCR 120 it was observed ""Failure to give reasons amounts to denial

of justice. Reasons are live links between the mind of the decision taker to the controversy in question and the decision or conclusion arrived at"". The

aggrieved party can come to know why the decision in his case has gone against him. Therefore, one of the salutary requirements of principles of

natural justice is spelling out reasons for the order made. In other words, it shall be speaking and reasoned order.

16.

As already observed, this is a transferred appeal from the Hon'ble High Court of Delhi against the order of the Controller of Patents under Section

21(1) of the Patents Act, 1970. We are not satisfied that the order of abandonment is sustainable. Having stated in the impugned order that the subject

matter and claims are not patentable under Section 2(1)(j) the reasons in support thereof ought to have been stated, instead of relying upon

abandonment under Section 21(1). The impugned order for the said reasons is not sustainable. We are, therefore, of the view that this divisional

application for patent be remanded back to the Patent Office with a direction that the learned Controller of Patents shall offer an opportunity of

hearing to the party as per the provisions of law then decided the matter in accordance with the law. The appeal is allowed in part, in terms as above.

However, there shall be no order as to the costs.