Patenting Biotechnology Inventions

Author: Dr. Kalyan C. Kankanala1

Introduction

Biotechnology has the potential to transform humanity provided humanity wishes to be

transformed.2 It promises better drugs, medical treatment tailored to the individual patient's

biological make-up, new crops and new industrial processes. Biotechnology companies spend

hundreds of millions of dollars and sometimes decades to develop a product.3 Patents provide the

needed assurance for investors to risk the capital necessary in the long development process, so that

investment cannot only be recouped but also generates profits. In the absence of patent regime,

investor’s would not be interested in investing millions on long term R and D because their research

output can be exploited by any person, which jeopardizes their returns and profits. In this context,

biotechnology assumes very high importance when seen in the light of patent regime because of its

research and investment intensive nature. However, the application of patent system to

biotechnology as a field has been fraught with uncertainty and ambiguity because of the nature of

the field.

Unique nature of Biotechnology

One of the most unique features of biotechnology is its diversity. Biotechnology as a field has

number of sub fields. Though there is a common line running through all of them, each sub field has

characteristics and features which are different from the others that a broad set of general rules

cannot be framed for biotechnology as a whole. For example, genomics is different from tissue

culture in characteristics, applications, processes and products and even in tissue culture; plant

tissue culture has different characteristics when compared to animal tissue culture. Figure 3.1

provides an example of the diverse sub-fields that fall under the scope of biotechnology. As the

field is growing and evolving at a rapid pace, the list is a non-exhaustive one.

1 Email: kalyan@brainleague.com, Blog: www.sinapseblog.com

1Climbing the Helical Staircase, Geoffrey Carr, The Economist, March 27, 2003. 3 Biotechnology Industries Organization, USA, http://www.bio.org/ip/, visited on September 21, 2005.

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16. Figure 3.1 – Examples of sub-fields in Biotechnology

Source : www.bio.org visited on 21st September, 2005.

Because of diversity in the field and varying characteristics of its sub fields, it is very difficult to

devise or establish patent principles or rules for biotechnology as a whole and therefore, the

application of patent law to biotechnology is very complex.

As biotechnology has a direct interface with life, it gives rise to lot of moral, ethical and religious

issues. Most issues in biotechnology, from patenting of genes or genetically modified crops to

patenting life has been fraught with moral, ethical and religious controversies. Due to this reason,

public consciousness has for long been intertwined with the progress of biotechnology and policy

framers have been skeptical in applying the patent regime to promote a field that has the potential of

disturbing ethics and values that have been built into the society.

Furthermore, there has always been fear among people that biotechnology research might result in

environment hazards and the progress of the field has been controversial. One issue that expounded

b) BIOTECHNOL (1) BIOPROC

(2) HYBRIDO

MA AND

MONOCLON

(1) CELL

(2) RECOMBI

(3) CLONING

(4) GENOMIC

(5) MICROAR

(6) DNA

moral, ethical and environmental controversies was the recombinant DNA controversy, which led

to promulgation of safety guidelines for biotech research.4

In addition to the aforesaid issues, the meaning of the term biotechnology has since long been very

vague and ambiguous. It has been attributed different meanings based on context, place, etc.

The World Intellectual Property Organization (WIPO) defines biotechnology as any technology

using living entities, in particular animals, plants, or microorganisms, or causing change in them."5

The United States Office of Technology Assessment has defined Biotechnology as "any technique

that uses living organisms or substances from those organisms to make or modify a product, to

improve plants or animals, or to develop microorganisms for specific uses."6

The Organisation for Economic Co-operation and Development (OECD) has defined

biotechnology as: 'The application of science and technology to living organisms, as well as parts,

products and models thereof, to alter living or non-living materials for the production of knowledge,

goods and services.7

On review of the afore-mentioned definitions, it can be observed that each of the definitions have

different meaning and scope when compared to the others. While the WIPO definition is very broad

and covers any technology that uses living organisms, the definition of Office of Technology is

narrower as it is limited to only techniques using living organisms to make or modify products and

to improve plants or animals. On the other hand, the OECD definition has a different scope when

compared to other definitions because it defines the scope of biotechnology to include techniques

using living organisms for production of knowledge, goods or services, which is an economic view

of the field. Due to differences in the meaning attributed by different organisations or groups, the

scope of the field is not clear and therefore poses challenges for application of patent principles.

Patentability Requirements and Biotechnology Inventions

Any invention will be eligible for a patent grant only if it satisfies the patentability

requirements. The following section explains the scope of patentability requirements from the

perspective of biotechnology inventions. The principles underlying patentability of

biotechnology inventions in USA, Europe and India have been elaborated.

Patentable Subject Matter

USA

To be patentable subject matter in USA, an invention should be a process, machine, manufacture or

composition of matter or any improvement thereof.8 There are three judicially created exclusions to

patentable subject matter in USA. They are Laws of nature, physical phenomena, and abstract

4 Genetic Alchemy, The Social History of the Recombinant DNA Controversy, Sheldon Krimsky, The MIT Press

(1982). 5 Graeme T. Laurie, Biotechnology and Intellectual Property: A Marriage of Inconvenience?, in CONTEMPORARY

ISSUES IN LAW, MEDICINE AND ETHICS 237, 238 (Sheila A. M. McLean ed., 1996) (citing Committee of Experts

on Biotechnology Inventions and Industrial Property, Second Session (Geneva, Feb. 3-7, 1986), reported in

INDUSTRIAL PROPERTY, June 1986, at 251, 256. 6 Jasemine Chambers, Patent Eligibility of Biotechnological Inventions in the United States, Europe, and Japan: How

Much Patent Policy is Public Policy?, 34 Geo. Wash. Int'l L. Rev. 223 (2002). 7 http://www.stat.fi/tk/yr/ttbio_en.html?tulost visited on 16th September, 2005. 8 35 USC Section 101 (2005).

ideas.9 Biotechnology (Biotech) inventions are considered to be eligible subjects as Compositions

of matter or manufactures.

The exclusion most relevant for biotech inventions is 'Laws of nature' exclusion. US Courts have

consistently held that s per the exclusion anything that naturally exists or is a 'product of nature' is

not patentable. The question relating to patentability of micro-organisms first came before the US

Supreme Court in Funk Bros. Seed Co. v. Kalo Inoculant Co.10

The case involved an invention

relating to a mixed culture of Rhizobium bacteria capable of simultaneously inoculating the seeds of

plants belonging to several cross-inoculation groups.11

The court in this case held that the mere

aggregation of species fell short of invention within the meaning of the patent statute because the

combination of species produced no new bacteria and no change in the six species of bacteria.12

As

there was no change in the species, the court stated that qualities of the non-inhibitive strains were

the work of nature and therefore not patentable subject matter.13

Later, the US Supreme Court in Diamond v. Chakrabarty, a landmark biotech case, held that

everything under the sun made by man is patentable.14

The case related to patentability of a

genetically modified pseudomonas bacterium capable of degrading oil spills and a process by which

four different plasmids, capable of degrading four different oil components, could be transferred to

and maintained stably in a single Pseudomonas bacterium.15

The patent application relating to the

bacterium was rejected on the ground that the bacterium was a product of nature and that it is a

living organism.16

On appeal, the US Supreme Court held that the invention is patentable because it is a new bacterium

with markedly different characteristics from any found in nature. The Supreme court further stated

that the test for determining whether an invention falls within the scope of 'Product of nature' is

whether the invention in question involves a hand of man. If yes, the invention is not product of

nature or naturally existing. If No, it is naturally existing and therefore not patentable.

As the pseudomonas bacterium in the case involved the hand of man in inserting four different

plasmids into it, the court held that it was not naturally existing and therefore patentable.17

It also

stated that living organisms were not excluded from the scope of patentable subject matter in

USA.18

After the Chakrabarty’s decision, expounded the product of nature doctrine, patents have been

granted to various multi-cellular organisms. Patents were granted to polyploid oysters, genetically

modified mice, rabbits and so on. Furthermore, patents have also been held patentable.19

Furthermore, in USA, gene sequences, gene therapies and so on have also been held to be

patentable subject matter.

9 Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). 10 333 US 127 (1978) 11

Id. at 441. 12

Id. at 442. 13

Id. 14

Diamond v. Chakrabarty, 100 S.Ct. 2204 (1980). 15

Id. at 305. 16

Id. 17 Id. at 311. 18 Id. 19

Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124 (2001).

Though the scope of patentable subject matter is very broad in USA, human beings are not

considered to be patentable subject matter. A patent application filed by Dr. Stuart Newman of New

York Medical College covering fusion of embryonic human and animal cells to create chimeras for

medical research was rejected by USPTO and such rejection was approved by the Court.20

Europe

The discussion with respect to Europe has been limited to the European Patent Convention (EPC).

As per the European Patent Convention, any invention is patentable unless it falls within the list of

excluded inventions.21

According to Article 52 of EPC, any invention irrespective of the technology

to which it belongs can be considered as patentable subject matter so long as it is new, inventive

and has an industrial applicability and does not fall within the list of excluded inventions provided

in Article 53 of the EPC.22

Along with inventions contrary to public order or morality, the list of exclusions also include

plant and animal varieties, essential biological processes for the production of plants and animals

and methods of treatment. The EU Biotechnology Directive passed in 1998 clarified the scope

of patentability of biotech inventions to a large extent.23

Though the directive is not binding on

the European Patent Office, the implementing regulations have been modified to make the EU

Directive on Biotechnology as a supplementary source for interpreting patentability of biotech

inventions under the EPC.24

As per Article 53 (b) of EPC, plant and animal varieties and essential biological processes for the

production of plants and animals are not patentable subject matter but micro-organisms are

patentable.25

Rule 27b of the Implementing regulations of EPC provides that plants or animals

are patentable if the technical feasibility of the invention is not confined to a particular plant or

animal variety.26

In the light of the said rule, genetically modified animals and plants have been

held to be patentable as they fall outside the scope of animal or plant variety.

In the Novartis case relating to patentability of transgenic plants into which DNA had been

inserted using recombinant technology, the Technical Board of Appeals stated that if a genetic

modification can be applied to more than one variety then the invention is patentable subject

matter as it falls outside the scope of exclusion of plant variety. 27

In the Oncomouse case, the Technical Board of Appeals held that a genetically altered mouse,

which involved inserting an activated oncogene to develop cancer in the mouse was patentable

20 No Patent On Embryonic Human-Animal Chimera, 24 Biotechlr 290 (June, 2005). 21

Article 52, European Patent Convention. 22

Article 52, European Patent Convention 1973 as amended in 2000. 23

Council Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnology inventions. 24

Rule 26 of the Implementing Regulations to the Convention on the grant of European Patents of 5 October 1973 as

last amended by Decision of the Administrative Council of the European Patent Organisation of 7 December, 2006. 25

Article 53(b), European Patent Convention 1973 amended in 2000. 26 Rule 27 b of the Implementing Regulations to the Convention on the Grant of European Patents of 5 October 1973 as

last amended by Decision of the Administrative Council of the European Patent Organisation of 7 December, 2006. 27

Novartis/Transgenic Plant, Technical Board of Appeal 3.3.4, [1999] E.P.O.R. 123.

subject matter.28

In the light of Oncomouse case, non human multicellular organisms including

rodents and mammals can be considered to be patentable subject matter in Europe.

Gene sequences have also been held to be patentable subject matter in Europe. As per the

implementing regulations, biological material, which is isolated from its natural environment or

produced by means of a technical process even if it previously occurred in nature, is patentable.29

Rule 29 (2) specifically mentions that gene sequences are patentable.30

It provides that though the

sequence or partial sequence of a gene, cannot constitute a patentable invention, an element

isolated from the human body or otherwise produced by means of a technical process, including

the sequence or partial sequence of a gene, may constitute a patentable invention, even if the

structure of that element is identical to that of a natural element. Human beings or parts of human

beings are not patentable subject matter in Europe.

India

The scope of eligible subjects is very broad in India. Any product or process irrespective of the

technology is patentable subject matter in India.31

However, the Act provides a long list of

inventions that are excluded from patentable subject matter, which includes biotechnology

inventions.32

Discovery of any living thing occurring in nature is not patentable subject matter in India.33

Prohibited biotech subjects further include plant and animals in whole or any part thereof including

seeds; varieties, species and essentially biological processes for production or propagation of plants

and animals.34

However, microorganisms and microbiological processes are patentable subject

matter.35

Genetically modified multicellular organisms including plants, animals, human beings and

their parts are excluded from patentability in India.

Gene sequences and DNA sequences having disclosed functions are considered patentable in India.

However, human beings and embryonic stem cells are not patentable. Furthermore, methods of

medical treatment are also prohibited from patentability in India.36

Utility/Industrial Applicability

USA

28 Decision T 19/90. 29 Rule 27 (a) Implementing Regulations to the Convention on the Grant of European Patents of 5 October 1973 as last

amended by Decision of the Administrative Council of the European Patent Organisation of 7th

December, 2006. 30

Id. 31

Section 2(j), Indian Patent Act, 1970 as amended in 1999, 2002 and 2005) or process, machine, manufacture,

composition of matter or improvements as in USA. (35 USC Section 101 (2005). 32

Section 3, Indian Patent Act, 1970 as amended in 1999, 2002 and 2005. 33

Section 3(c), Indian Patent Act, 1970 as amended in 1999, 2002 and 2005. 34 Section 3(j), Indian Patent Act, 1970 as amended in 1999, 2002 and 2005. 35 Id. 36

Section 3(i), Indian Patent Act, 1970 as amended in 1999, 2002 and 2005.

Utility requirement assesses the usefulness of an invention. The standards of utility have been

heightened for biotechnology inventions due to lack of maturity of the field.

Considering the unique nature of gene based inventions more particularly Expressed Sequence

Tags, commonly known as ESTs, USPTO revised its utility examination guidelines for patent

examiners in 1999. The guidelines were later amended in 2001.37

As per the guidelines, an invention should establish specific, substantial and credible utility from

the point of view of a person with ordinary skill in the art. Although, all the three conditions must

be cumulatively satisfied for qualifying the utility requirement, the most important condition for

biotech inventions is establishment of specific utility. Specific utility necessarily means a use

specific to the claimed subject matter rather than a general utility. The guideline defines specific

utility as a practical utility having real world use38

.

Any invention that requires further research to ascertain its practical utility was considered to be not

useful because it lacked specific utility.39

In re Fisher, the inventor claimed several uses of the ESTs including its use as a molecular marker,

primer and so on among other general uses. 40

The court in this case stated that since genes encoded

by the claimed ESTs had no known functions, they were considered to be not useful.41

It inferred

that utility should be directed to a particular disease or aspect and cannot be very general.

To summarize, a biotech invention must satisfy substantial, credible and specific utility in order to

satisfy the utility requirement. General uses of the invention will not be accepted for purposes of

utility and specific uses must be shown.

Europe

According to Article 57 of the EPC, it is sufficient that the invention is capable of being industrially

produced in order to fulfill the industrial application requirement.42

The ascertainment of industrial

applicability for biotechnology inventions is challenging because the field is filled with ambiguities.

According to the Implementing regulations, partial and complete gene sequences are considered to

be patentable under the EPC. However, Rule 29 (3) of the Implementing regulation explicitly poses

a requirement that the industrial application of a sequence or a partial sequence of a gene must be

disclosed in the patent application.43

Moreover, the preamble of the directive specifically mentions

that a mere DNA sequence without indication of a function does not contain any technical

information and is therefore not a patentable invention.44

Thus, it can be concluded that biotech

inventions and specifically gene sequences are patentable under the EPC only if the function of the

invention is explicitly mentioned in the application and with respect to gene sequences, the

protection is limited to the function thus mentioned.

37 Revised Interim Utility Guidelines, 64 FR 71440, Dec.21, 1999; 1231 O.G.136(2000);and correction at 65 FR 3425,

Jan.21, 2000;1231 O.G. 67 (2000). 38

Definition, Chapter III Asserted Specific Utility, Guidelines for Examination of Applications for Compliance with the

Utility Requirement (1995). 39

Id. 40

In re Fisher, 421 F.3d 1365 (C.A.Fed.,2005). 41

Id. 1372 42

Article 57, European Patent Convention 1973 as amended in 2000. 43 Rule 29 (3) Implementing Regulations to the Convention on the Grant of European Patents of 5 October 1973 as last

amended by Decision of the Administrative Council of the European Patent Organisation of 7th December, 2006. 44

Preamble 23 Directive

In the Max Planck decision, which related to a Brain Derived Phosphatase, the board stated that

industrial applicability could be satisfied only if a "practical" application of the invention was

disclosed. 45

The Board inferred in the case that a vague and speculative indication of possible

objectives that might or might not be achievable by carrying out further research with the tool

described in the patent application was not sufficient for fulfillment of the requirement of industrial

applicability.46

To summarize, biotechnology inventions can satisfy industrial applicability

requirement only if they have known uses, which are practical and specifically mentioned in the

patent application.

India

In India, for an invention to be industrially applicable, it is necessary to prove that the invention can

be made, Can be used in at least one field of activity and Can be reproduced with the same

characteristics as many times as necessary.47

Since, no specific mention with regard to industrial

applicability of biotechnology patents have been provided for in the act, it is reasonable to apply the

general industrial applicability standards to biotechnology inventions. As biotechnology inventions

can be made and used in an industry and can be reproduced as many times as required, they would

satisfy the Industrial Applicability requirement in India. The guidelines for examining

biotechnology inventions in the Manual of Patent Practice provide that gene sequences and DNA

sequences whose functions are not disclosed do not satisfy the Industrial Applicability requirement.

Novelty

USA

The novelty requirement in USA has been lowered to a certain extent in order to accommodate

patent grants to biotechnology inventions. Courts have held that isolated and purified gene

sequences were novel even if they are identical to the sequences in nature. It has been held that

isolation and purification of a naturally existing gene sequence lends novelty to the sequence. Most

cases with respect to novelty of biotechnology inventions in USA relate to conception and reduction

of a gene sequence to practice.

In Amgen v. Chugai48

, one of the most important novelty cases, the court stated that a gene was a

chemical compound, albeit a complex one and is therefore patentable. The Court then pointed out

that it was well established in US law that conception of a chemical compound required that the

inventor was able to define it so as to distinguish it from other materials, and to describe how to

obtain it.49

The court further said that conception of a generalized approach for screening a DNA

library that may be used to identify and clone the Erythropoetin (Epo) gene of unknown constitution

was not conception of a "purified and isolated DNA sequence" encoding human EPO.50

A

biotechnology invention for purposes of novelty is said to be conceived only if it is reduced to

practice.

Europe

45 Max Planck/BDP1 Phosphatase, Legal Board of Appeal 3.3.8 ,[2006] E.P.O.R. 14, (2004).

46 Id.

47 Page 13, Para 2.4, Chapter II, Manual of Patent Practice and Procedures 2005.

48 Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200 (C.A.Fed. (Mass.),1991). 49 Id. at 1206. 50

Id. at 1207.

Novelty of biotechnology inventions has been the subject of uncertainty at the European Patent

Office. The Implementing regulations to EPC provide that biological material which is isolated

from its natural environment or produced by means of a technical process even if it previously

occurred in nature, is patentable. The regulations specifically provide that an element isolated from

the human body or otherwise produced by means of a technical process, including the sequence or

partial sequence of a gene, may constitute a patentable invention, even if the structure of that

element is identical to that of a natural element. As per the regulations, a gene sequence isolated

from nature would be considered to be novel in the light of what exists in nature even if its structure

is same as the one existing in nature.51

The principle was applied by the board in the Relaxin Decision.52

The Relaxin case dealt with a

process for obtaining H2-relaxin, the DNA encoding it, their chemical structure and use of the

protein. The Board pointed out in the case that isolation of a gene of a known protein for the first

time through conventional methods would make the gene sequence novel. 53

The Board further

stated that natural existence of genes would not anticipate their isolation, as the isolated genes

containing only the coding regions were different from their natural counterparts. It can be inferred

from the case that just like in USA, the threshold for novelty determination for biotechnology

invention is relatively low and an isolated gene sequence with slight difference from the prior art

can be considered as novel.

India

The Patents Act does not have any explicit provisions with respect to novelty of biotechnology

inventions. Since most biotechnology inventions are products of nature inherently present in living

organisms, they could be construed as discoveries and not patentable. However, the Manual of

patent practice and procedure provides that biological material such as recombinant DNA, Plasmids

and processes of manufacturing thereof are patentable provided they are produced by substantive

human intervention. As there are no decided cases on the subject, the interpretation of the Manual

is being used to analyze novelty of biotechnology inventions. Several patents have been granted for

isolated gene sequences in India and such sequences have been considered to be novel by the patent

office in the light of their natural counterparts.

Non obviousness/Inventive Step

USA

The Non-obviousness standards required for biotechnology inventions have been interpreted by

courts to be different from the generally accepted principles. In Hybritech v. Monoclonal54

, a case

involving a patent over "Immunometric Assays Using Monoclonal Antibodies", the court held the

patent non-obvious despite the existence of twenty prior art references because the prior art as a

whole did not make the invention obvious at the time the invention was made. Though some

references seemed to anticipate the invention, the Court pointed out that they were made after the

date of conception of the invention, thus taking them out of the scope of prior art. The court in this

case reiterated the importance of secondary indicia by determining the sandwich assays using

monoclonal antibodies to be nonobviousn because of the commercial success, unexpected

advantages and praise from experts of the diagnostic kits made by Hybritech.

51

Rule 23c(a) and Rule 23e(2)- Patentable biotechnological inventions, PART II – Implementing regulations to Part II

of the Convention. 52

Howard Florey/Relaxin (Oppositions by Fraktion der Grunen Im Europaischen Parlament; Lannoye), Opposition

Division, 8 December 1994, (1995) E.P.O.R. 541. 53

Id. at 542. 54

Hybritech, Inc.,v..Monoclonal Antibodies, 802 F.2d 1367 (Fed. Cir. 1986).

In Amgen v. Chugai55

, a patent for DNA sequences encoding erythropoetin (Epo) was claimed to be

invalid based on obviousness along with other claims. The Federal Circuit held the patent

nonobvious by reasoning that it might have been feasible, perhaps obvious to try, to successfully

probe a human gDNA library with a monkey cDNA probe but it does not indicate that the gene

could have been identified and isolated with a reasonable likelihood of success. Neither the DNA

nucleotide sequence of the human Epo gene nor its exact degree of homology with the monkey Epo

gene was known at the time the claimed invention was made. According to the court, though the

idea of using the monkey gene to probe for a homologous human gene might have been obvious to

try, but the realization of that idea was not obvious. Finally, the court stated that hindsight is not a

justifiable basis on which to find that ultimate achievement of a long sought and difficult scientific

goal was obvious.

In 'In re Deuel56

', a case involving an invention relating to isolated and purified DNA and cDNA

molecules encoding heparin-binding growth factors, the Federal Circuit held the invention non

obvious despite Bohlen and Maniatis references disclosing a group of protein growth factors and a

general gene cloning method. The issue raised in this case was whether the combination of a prior

art reference teaching a method of gene cloning, together with a reference disclosing a partial amino

acid sequence of a protein, would render DNA and cDNA molecules encoding the protein prima

facie obvious. The court held that the subject matter of the invention could not be conceived based

on the teachings in the references because, until the claimed molecules were actually isolated and

purified, it would have been highly unlikely for one of ordinary skill in the art to contemplate the

claimed invention. The court further stated that 'What cannot be conceived cannot be obvious.'

In In re Kubin’s57

case, the invention dealt with an amino acid sequence of Natural Killer Cell

Activation Inducing Ligand also referred to as NAIL which plays a major role in activation of

the Natural Killer cells that are instrumental in fighting tumors and viruses.58

The patent

office stated that the claimed amino acid sequence was obvious in light of combination of two

prior art references namely Valiante’s patent bearing the U.S. Patent No. 5,688,690 which

discloses a receptor protein called p38 receptor which the board found was essentially the

same protein as NAIL and the Laboratory Manual on Cloning authored by Joseph Sambrook

which provided information with regard to conventional techniques to isolate and sequence

any gene. The federal circuit affirmed the Board’s decision stating that in light of the specific

teachings of Sambrook and Valiante, artisans in this field had every motivation to seek and

every reasonable expectation of success in achieving the sequence of the claimed invention.

As per the Court, the claimed invention was reasonably expected in light of the prior art and

was held to be obvious.

Due to lack of maturity in the field, the non-obviousness requirement in USA was lower for

biotechnology inventions when compared to other inventions. The reasonable expectation of

success was considered to be lower and anything obvious to try was generally considered

non-obviousns. However, the differing decisions in Deuel and Kubin cases, which have

similar facts indicates that the non-obviousness standards are also not applied uniformly.

Europe

55

Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200 (Fed Cir. 1991) 56

IN RE THOMAS F. DEUEL, YUE-SHENG LI, NED R. SIEGEL and PETER G. MILNER, 51 F.3d 1552,

34 U.S.P.Q.2d 1210 (Fed Cir. 1995). 57 In re Kubin, 561 F.3d 1351 (2009). 58

Id at 1353.

Tests for Determination of inventive step of biotechnology inventions have been ambiguous

due to uncertainty in the field. The European Patent Office and Boards have been striving to

frame clear guidelines for determining inventive step of biotechnology inventions. In the

Relaxin case59

which dealt with a process for obtaining H2-relaxin and the DNA encoding it,

the Board pointed out that as the proprietor was not preparing a known substance by

conventional means, but providing to the public for the first time a product whose existence

was previously unknown, the claimed invention must be regarded as inventive irrespective of

the methods used to prepare the product.60

The non-obviousness determination is always done from the point of view of a person with

ordinary skill in the art. The knowledge of the person skilled in the art in case of biotech

inventions had been aptly discussed in R. v. Genentech61

, a case concerned with interferon-

gamma and the DNA sequence coding for it. In this case the Board stated that Skilled person

in the art must be considered as that of a team of the appropriate specialists, who know all the

difficulties still to be expected when considering cloning a new gene. The board also inferred

that a skilled person must be assumed to lack the inventive imagination to solve problems for

which there do not exist already routine methods of solution, the appropriate comparison

being not with a team but with a highly skilled technician carrying out a project where the

initial instructions received were already adequate to tell the technician how to overcome any

problems likely to arise.62

Also in R. v. Chiron63

decision, which dealt with inventive step of a DNA molecule

comprising a specified nucleotide sequence encoding insulin-like growth factor II (IGF-II),

the court inferred that lack of sufficient information in prior art can be supplemented by the

knowledge of the person skilled in the art while determining obviousness. In this decision the

board stated that an invention would lack inventive step even if the prior art reference lacks

complete description, provided the reference can be supplemented by information available to

a person with ordinary skill in the art. As per the Board, reasonable likelihood of success can

make an invention obvious and showing low expectation of success can rebut it. The Board

pointed out that reasonable likelihood of success can be proved by prior art information,

experiments, expert testimony and so on.

While determining inventive step of biotechnology inventions under EPC various factors such

as obviousness in the light of combination of prior art to a person with ordinary skill in the art,

reasonable expectation of success and secondary considerations such as commercial success

and expert testimony are considered. The standards of non-obviousness are higher in Europe

when compared to USA and it is therefore comparatively difficult to satisfy this requirement

in Europe.

India

Due to dearth of case law, the approach to inventive step with regard to biotechnology

inventions in India is not clear. As per the Manual, it can be safely concluded that isolated

gene sequences and protein sequences will be considered to have an inventive step in the light

of their naturally existing counter parts. Furthermore, the economic significance requirement

is relatively easy to prove for biotechnology inventions due to their various applications in

drugs and diagnostics sector. Principles such as reasonable expectation of success,

59

Howard Florey/Relaxin(Oppositions by Fraktion der Grunen Im Europaischen Parlament; Lannoye), Opposition

Division, 8 December 1994, [1995] E.P.O.R. 541. 60

Id. at 548. 61 R. v. Genentech/HIF-Gamma, Technical Board of Appeal 3.3.2, July 20, 1993 [FN1], [2003] E.P.O.R. 12. 62 Id. 63

R. v. Chiron/IGF-II, T475/93,Technical Board of Appeal 3.3.4, July 17, 1997 [FN1], [2003] E.P.O.R. 48.

predictability of the field and so on are applied to determine inventive step in India as well

and would be applied to biotechnology inventions. However, as it stands now the law does not

indicate any differing standards for biotechnology inventions when compared to other

inventions.

Enablement and Written Description

The Courts and Patent Offices have set different standards of written description and

enablement requirements for biotech inventions when compared with other inventions due to

their unique nature. Considering the uncertainties in the field, patent offices generally insist

on detailed description of the invention with research data and examples. Enablement is

commonly not assessed through supplementation of prior art unless specific reference is made

in the written description. The written description and enablement requirements may be

satisfied by deposit of biological materials or submission of sequence listings in case of

genetic inventions.

USA

Unlike in Europe and India, USA considers written description and enablement as two

different requirements. The US Courts have laid down differing standards for written

description and enablement requirements. The standards are generally higher when compared

to other inventions and require specificity, reduction to practice, examples and experimental

data. A short note on a few cases explaining the differing standards adopted for biotech

applications have been provided hereunder.

In Amgen v. Chugai64

, a case relating to an infringement of a patent over DNA sequences

encoding Erythropoietin, the court stated that generic claims to genetic sequences could be

valid where they were of a scope appropriate to the invention disclosed by an applicant.65

The

court further stated that claims in a patent application have to be adequately supported by the

written description and stating a few gene analogs would not support a claim over all gene

analogs of a protein.

In another case, Fiers v. Revel,66

a case relating to patent applications for DNA coding for

human fibroblast beta-interferon, the court pointed out that claiming all DNA's that achieve a

result without defining what means would do so was not in compliance with the description

requirement and that it was an attempt to preempt the future before it had arrived. 67

In

Regents of the University of California v. Eli Lilly & Co68

, a case relating to recombinant

plasmids and microorganisms that produce human insulin, the court held that the claim of the

patent directed to recombinant prokaryotic microorganism modified to encode human insulin

was invalid, because patent specification did not fulfil statutory written description

requirement.69

The court in this case inferred that description of DNA sequences by function

without pointing out the structure or physical characteristics would not be sufficient to satisfy

the written description requirement. It also laid down that disclosure of structure of a few

species in a genus would not be sufficient to support a claim of the entire genus unless

substantial features of the genus and substantial common physical characteristics were

described.

64

Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200 (C.A.Fed. (Mass.),1991). 65

Id. 66

Fiers v. Revel, 984 F.2d 1164 (C.A.Fed.,1993). 67 Id. 68 Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, (C.A.Fed. (Ind.),1997). 69

Id. at 1569.

The USPTO passed the revised guidelines for written description in 2001, which are largely in

conformity with case law. 70

The guidelines explain how biotechnology inventions such as

genes, ESTs, antisense, ORFs, etc., would be considered for purposes of written description.

Before 1990, Gene sequence data was being submitted in different formats by different

applicants due to absence of a standard format recommended by the USPTO. To resolve the

inconvenience caused during examination of gene based invention due to the lack of

uniformity with regard to submission of gene sequence data the Office amended its

regulations to establish a standardized format for descriptions of nucleotide and amino acid

sequence data.71

Europe

The threshold for disclosure and enablement requirement in Europe is much higher for

biotechnology inventions when compared to other technologies. Assessment of the

sufficiency of a disclosure depends on the correlation of the facts of the case to certain general

parameters such as the character of the technical field, the average amount of effort necessary

to put into practice a certain written disclosure in that technical field, the time when the

disclosure was presented to the public and the corresponding general knowledge and the

amount of reliable technical details disclosed in a document.72

In the Weyershaeuser Case that

dealt with microbiologically produced reticulated cellulose the board stated that the disclosure

should be sufficiently clear such that it can be enabled by a person skilled in the art without

undue burden on that person.73

Further, in R. v. Massachusetts Institute of Technology decision, 74

the board stated that in

case of gene based inventions, the requirement of trial and error to carry out the invention

would make the disclosure non-enabling. To work biotechnology inventions involves several

molecular biology techniques and requires extensive experimentations for standardization of

experiments. Also, the time taken for successful completion of an invention would depend on

the level of skill of the technician performing the experiment. Thus, in many cases, several

attempts may be required to complete an enabled invention. This issue has been addressed in

R v. Genentech case, which related to sufficiency of disclosure in a patent concerning amino

acid sequence and DNA sequences of interferon-gamma.75

In this case the Board stated that a

patent application relating to a gene would be enabling even if the experimentation required is

burdensome, so long as undue experimentation is not required. It further stated that deposit of

biological materials is not compulsory as long as an application can be enabled based on

written description.

Later, in the Biogen Decision the Board laid down that disclosure can rely on functional

characteristics in case of genetic inventions.76

This decision reduced the burden of patent

disclosure for biotechnology inventions. To summarize, the written description and

enablement requirement for biotechnology inventions must satisfy higher standards than other

inventions with a few exceptions. While deposit of biological materials can supplement a

70 USPTO Guidelines and Training Materials on Written Description, Federal Register /Vol. 66, No. 4/Friday, January

5, 2001. 71

Manual of Patent Examining Procedure, 2420 The Requirements for Patent Applications Containing Nucleotide

Sequence and/or Amino Acid Sequence Disclosures - the Sequence Rules. 72

Dr. Kalyan C. Kanakanala, Genetic Patent Law and Strategy (1stedition 2007), pp 123-124.

73 Eyershaeuser/Cellulose, Technical Board of Appeal 3.3.4, [2001] E.P.O.R. 35.

74 R. v. Massachusetts Institute Of Technology/Biopolymers, Technical Board of Appeal 3.3.4, [2003] E.P.O.R. 16.

75 R. v. Genentech/HIF-Gamma, Technical Board of Appeal 3.3.2, [2003] E.P.O.R. 12. 76 Biogen/Recombinant Dna(Oppositions by Hoffmann la Roche; Upjohn; Boehringer Ingelheim Zentrale; Bender;

Cetus; Hoechst; Boehringer Mannheim, Technical Board of Appeal 3.3.2, [1990] E.P.O.R. 190.

written description, it is not compulsory to deposit materials. Furthermore, disclosure of

biotech inventions must be specific and broad disclosures are not sufficient.

India

In India, for biotechnology inventions, which describe biological material in the specification,

the law provides for deposit of such biological materials at a recognized depository. The

manual of patent practice and procedure requires the invention to be described completely in

the specification to enable a person skilled in the art to be able to carry out the invention by

reading the specification. 77

However, there are no cases in India that talk about differing

written description or enablement standards for biotechnology inventions.

Morality

Moral and ethical issues have since long been playing a very important role in defining the progress

of biotechnology. Right from the recombinant DNA controversy, ethics and morals have either

impeded or slowed biotech progress. Issues surrounding ownership of genes and genetically

modified humans, moral and identity dangers inherent in human cloning and genetic modification

of human beings, suffering to animals due to genetic intervention, potential hazards to environment

due to genetic manipulation, ecological balance and other issues have been cited as serious issues

for granting patents on biotechnology inventions. The involvement of moral and ethical issues in

patenting biotech inventions depends on the social, ideological, religious and economic conditions

in a country. Variances in the role of morals and ethics in determining patentability in different

countries, which is dependant on social and ideological conditions gives rise to differences in the

scope of patent protection.

USA

The US patent statute does not contain any provisions relating to morals. Patentability analysis of

an invention in USA does not involve determination of morality as none of the patentability

requirements deal with morality. Despite the fact that morality is not a part of patentability analysis,

the USPTO has laid down in its guidelines for examiners that patents would not be granted for

subject matter relating to human beings as granting such patents would be against Amendment 13

of the US Constitution, which prohibits slavery.78

Based on the guidelines, the patent application

filed by Jeremy Refkin for a human-animal chimera was rejected.

Europe

Unlike the US Patent Law, the European Patent Convention provides provisions relating to morality

for grant of patents. Article 53 of EPC provides that European patents shall not be granted in respect

of inventions the publication or exploitation of which would be contrary to "ordre public" or

morality, provided that the exploitation shall not be deemed to be so contrary merely because it is

prohibited by law or regulation in some or all of the Contracting States.79

The EU Biotechnology

Directive also lays sufficient emphasis on morality as a factor to be considered before granting

patents in biotech inventions.

77

2.6 Sufficiency of Disclosure, Manual of Patent Practice And Procedure, 2005. 78

Slavery and Involuntary Servitude, 13th Amendment, The Constitution of United States of America (2006). 79

Article 53(a), Convention On The Grant Of European Patents (European Patent Convention) of 5 October 1973 text

as amended by the act revising Article 63 EPC of 17 December 1991 and by decisions of the Administrative Council

of the European Patent Organisation of 21 December 1978, 13 December 1994, 20 October 1995, 5 December 1996

and 10 December 1998.

The European Patent Office has expounded the morality provision under Article 53 in its decisions

involving biotechnology inventions. In the Harvard Mouse Case ,80

the invention relating to a

genetically modified mouse was held patentable despite moral concerns. After reviewing the

morality concerns, the Board held that the mouse was patentable though it is put through suffering

because the benefit to human beings outweighs the suffering of the animal. The Board in this case

stated that the utility of the mouse model for cancer treatment makes it moral and therefore,

patentable.

Another important case on morality is the Relaxin case. The Relaxin case81

related to a process for

obtaining H2-relaxin and the DNA encoding it.82

It was argued that the claimed invention was not

patentable under Article 53(a) as the patent required taking of the tissue from a pregnant woman. It

was argued that it amounted to an immoral act, which was against human dignity because it

involves making use of a female condition (pregnancy) in a technical process oriented towards

profit.83

It was also argued that the patenting of human genes such as that encoding H2-relaxin

amounted to a form of modern slavery since it involved the dismemberment of women and their

piecemeal sale to commercial enterprises throughout the world and that the patenting of human

genes means that human life was being patented, which was intrinsically immoral.84

The Opposition Division rejected the arguments stating that there was no reason to perceive the

isolation of mRMA from the tissue of pregnant woman as immoral because it was taken by

consent.85

As human tissue, blood, bone and so on have been the subject of isolation for medical

purpose, the Opposition Division pointed out that such practice was accepted by the public.86

It then

pointed out that patents covering DNA encoding human H2-relaxin, or any other human gene do

not confer on their proprietors any rights to individual human beings and therefore, no woman

would be affected in any way by the present invention and was free to live her life as she wished

and had exactly the same right to self-determination as she had before the patent was granted.87

In

addition, the Opposition Division stated that the exploitation of the invention does not involve

dismemberment and piecemeal sale of women because gene cloning could be done in unicellular

organisms and a woman was only required initially for isolating the tissue for which consent was

taken.88

Finally, the Opposition Division pointed out that the allegation that human life was being patented

was unfounded because DNA was not 'life', but a chemical substance, which carried genetic

information and could be used as an intermediate in the production of proteins, which might be

medically useful.89

It further stated that the patenting of a single human gene had nothing to do with

the patenting of human life.90

In the light of its reasoning, the Opposition Division concluded that

the invention was not against widely-accepted moral standards of behaviour by promoting slavery,

the sale of women, and so on, nor was there a clear consensus among members of the public in the

80

Harvard/Onco-Mouse, Examining Division, [1990] E.P.O.R. 4. 81 Howard Florey/Relaxin(Oppositions by Fraktion der Grunen Im Europaischen Parlament; Lannoye), Opposition

Division, [1995] E.P.O.R. 541. 82

Id. 83

Id. at 549. 84

Id. 85

Id. at 550. 86

Id. 87

Id. at 551. 88 Id. 89 Id. 90

Id.

Contracting States that patenting human genes such as that encoding H2-relaxin was immoral and

therefore could be patented.

The cases elucidate that morality determination forms an integral part of patentability analysis with

regard to biotechnology inventions. This provision has been invoked regularly by the European

Patent Office while deciding upon patentability of such inventions. An invention will not be granted

a patent if evidence can be shown that it or its exploitation is against public order or morality.

Patents will be granted over genetically modified animals only if the benefit to mankind outweighs

the suffering caused to the animals. Potential unknown danger to society or environment will not be

fatal to patentability of an invention.

India

Section 3(b) of the Indian Patent Act provides that an invention the primary or intended use or

commercial exploitation of which would be contrary to public order or morality or which causes

serious prejudice to human, animal or plant life or health or to the environment is not patentable.91

As per the section an invention would not be patentable if it is immoral or against public order,

harmful to human, animal or plant life or harmful to environment. The Manual of Patent Procedure

provides that Any biological material and method of making the same which is capable of causing

serious prejudice to human, animal or plant lives or health or to the environment including the use

of those that would be contrary to public order and morality are not patentable. It further provides

that the processes for cloning human beings or animals, processes for modifying the germ line,

genetic identity of human beings or animals, uses of human or animal embryos for any purpose are

not patentable as they are against public order and morality. The Indian Patent Law has strong

prohibitions against patenting of biotechnology inventions based on morality and public order.

Summary

It can be seen from the review of patentability requirements for biotechnology inventions in USA,

Europe and India that the requirements are applied differently when compared to other inventions.

While some requirements like subject matter, utility and written description have heightened

standards, non-obviousness standards have generally been lowered to accommodate ambiguities in

the field. Morality plays an important role in determining patentability of biotech inventions. The

role of morality is higher in Europe and India when compared to USA.

91

Section 3(b) of the Indian Patent Act, 1970 as amended in 1999, 2002 and 2005.