Patent Protection in the field of Nanotechnology: The Position with respect to the European Patent Office

Nanotechnology is the design, characterization, production and application of structures, devices and systems by controlling shape and size at the nanoscale. It is the understanding and control of matter at dimensions of roughly 1 to 100 nanometres, where unique phenomena enable novel applications.

There is no single field of nanotechnology. The term broadly refers to such fields as biology, physics or chemistry, any scientific field, or a combination thereof, that deals with the deliberate and controlled manufacturing of nanostructures.

Nanoscience is the study of phenomena and manipulation of material at the nanoscale, in essence an extension of existing sciences into the nanoscale
Materials reduced to the nanoscale can suddenly show very different properties compared to what they show on a macroscale. With Nanotechnology, a large set of materials with distinct properties (optical, electrical or magnetic) can be fabricated. The smaller a nanoparticle gets, the larger its relative surface area becomes. Its electronic structure changes dramatically, too. Both effects lead to greatly improved catalytic activity but can also lead to aggressive chemical reactivity.

The mere presence of nanomaterials (materials that contain nanoparticles) is not in itself a threat. It is only certain aspects that can make them risky, in particular their mobility and their increased reactivity. Potential risks of nanotechnology can broadly be grouped into three areas: (1) the risk to health and environment from nanoparticles and nanomaterials; (2) the risk posed by molecular manufacturing (or advanced nanotechnology); (3) societal risks, such as possibility of military applications of nanotechnology as well as enhanced surveillance capabilities through nano-sensors.

Patentability Requirements:

The standards required for patenting of nanotechnological inventions are the same as in any other invention, namely:
# Novelty,
# Inventive Step, and
# Industrial Application.

Novelty:

An invention is considered novel if, prior to the filing date of the patent, it has not been made available to the public by any means:
- oral description,
- written description, or
- prior use.
The size of the nanoscale component should be sufficient to distinguish that component from that of the prior art.

Novelty as a requirement for patentability is embodied in:

# Article 54, European Patent Convention
# Section 2, UK Patent Act, 1977
# Section 102, US Code Title 35 ¡V Patents
# Section 2 (1)(l), Indian Patents Act, 1970 ( as amended in 2005)

The novel properties characterising a material in nanoparticle form are not detectable on the same material at macro scale though purposely looked for. It cannot be affirmed that the novel property exhibited by the material at nanoscale was inherent in the same material known at macroscale.

The prefix Nano, unlike the prefix ¡§Recombinant¡¨ in biotechnology, may be able to reinstate the novelty of a known substance or material, specifically when accompanied by a novel technical effect.

Case study (decisions of the EPO Enlarged Board of Appeal):

1. Decision in the T 0006/02 (Photodegradable Cellulose Ester Tow) Case:

The increased photodegradability of cellulose ester by the addition of nano particle size Titanium Dioxide is novel as a generic disclosure like ¡¥plastics materials¡¦ as laid down in the prior art does not normally take away the novelty of any specific example (cellulose esters) falling within that disclosure¨

2. The Decision in the T 0915/00 (Nanocrystalline Metals) Case:

The nano crystal Nickel material, obtained by electrode position and having crystalline size of less than 11 nm, is novel over a substantially identical material disclosed in the literature, comprising macro crystalline Nickel obtained by electrodeposition¨

3. Decision in the T 0509/92 (Dipeptide Crystals) Case:

The Board is of the opinion that there was no disclosure in any of the said prior art documents of aspartame type IIa crystals having the given X-ray characteristics and moisture content. For these reasons the novelty is acknowledged¨.

Inventive Step:
The claimed subject-matter implies an inventive step if for a person ordinarily skilled in the art, it is not obviously derivable from the state of the art (the test of non-obviousness). It must focus on previously unattainable size, structure, compositions, organization, methods of measurement and methods of changing the property of materials, as well as applications of the new properties.

The "skilled person", in the context of nanotechnology would comprise of a team of persons, each expert of a different technical field. This requirement is in order with the multi-disciplinary nature of nanotechnology, which brings together many varied fields of science.

In nanotechnology, the results of the experimentation are mostly unpredictable and based on the presumption of a suggested outcome. If there is success in achieving the suggested outcome through experimentation, the resulting invention (the nanoparticle) can be said to involve an inventive step.

Case Study (decisions of the EPO Enlarged Board of Appeal):

1. The Decision in the T 0070/99 (Fluid handling in micro fabricated analytical devices) Case:

When the miniaturisation of a device is accompanied by an unpredictable effect, the result of the miniaturization should always be regarded as inventive regardless of the apparent obviousness of the means used to achieve it. The board is convinced that the prior art disclosed in the other documents cited by the appellant does not come closer to the invention and that these documents do not contain any more relevant information¨

2. The Decision in the T 0915/00 (Nanocrystalline Metals) Case:

The method of the claim was distinguished from the continuous electroplating method of prior art essentially in that it comprised passing direct current at pulsed intervals and under peak current density and timing conditions selected in the ranges set out in the claim so as to deposit nanocrystalline material of size less than 100 nm on the cathode, instead of passing direct current in a continuous manner. The Board affirms that the skilled person had no obvious reason to foresee that the prior teaching could still be successfully extrapolated to structures smaller by at least two orders of magnitude, if not with the benefit of hindsight¨

3. The Decision in the T 0453/97 (Antireflective Coating for use in Photolithography) Case:

.The technical problem underlying the subject-matter of the claim as objectively defined in view of this nearest prior art is to
still further reduce the optical reflectance of the antireflective film of titanium nitride disclosed in the prior art. The skilled person could not, in the Board's view, be expected to discover the claimed range in an obvious way in the course of routine experiments he would perform when putting into practice the teaching of the prior art¨

4. The Decision in the T 0952/01 (Method of coating a Substrate) Case:

The prior art does not suggest the use of particles in the claimed size range of 20 to 70 nm because it recommends a preferred size range of 100 to 500 nm and thus clearly teaches away from the use of particle sizes below 100 nm

Industrial Application:
In order to fulfill this criteria, the invention must be one of utility, must be industrially applicable and operable. The technology must illustrate a real-world benefit. The invention must also be feasible, not merely speculation or science fiction.

 Apart from these, the patent application in order to be admissible must also sufficiently disclose the invention and set out the claims with clarity.
The focus of the claims must be on the nanotechnology aspects. The claims must particularly point out and distinctly claim the invention to be patented. They shall define object of the protection and shall be clear, concise and based on the description. Each and every technical term used in a claim should be properly explained in the disclosure.

The patent application shall provide sufficient detail of the best method of performing the invention so that a skilled worker in the field is able to do so. Sufficiency is to be determined by the repeatability of the invention. The skilled person should be able to realise the invention essentially over the whole claimed ambit. The realisation of the invention, and therefore the achievement of the declared effects should not depend on chance. An arbitrary generalization of sizes or parameters would lead to the loss of repeatability of the invention. If the application comprises examples of one sole embodiment of the invention, no protection shall be given for ¡§equivalent¡¨ embodiments, not sufficiently investigated.

Case Study (decisions of the EPO Enlarged Board of Appeal):

1. The Decision in the T 0915/00 (Nanocrystalline Metals) Case:

Generalization was accepted only because two subsequent documents substantiated the repeatability of the process also with metals other than Nickel: otherwise no generalization is accepted. The board is satisfied that the process of the claim is disclosed in the patent in a manner sufficiently clear and complete for it to be carried out by the person skilled in the art.

2. The Decision in the T 0288/02 (Atomic and molecular radicals of Nitrogen) Case:

(Process of epitaxy using as doping agent atomic or molecular Nitrogen radicals.)
The sole use of molecular Nitrogen radicals was described with all experimental details and examples. The Board considers the embodiment molecular radicals¨ is the only embodiment actually disclosed, whereas atomic radicals is merely speculative thus not sufficiently disclosed¨.

3. The Decision in the T 1250/01 (Methods and Test Tools) Case:

The lack of analytical means for monitoring one single parameter of the invention amounts to a lack of sufficiency of disclosure of the invention. All analytical methods, tests, essays and analytical tools necessary to check the realisation of the invention should be described with all details in the application.

Conclusion:
Nanotechnology brings together many disciplines of science. Filing a patent application relating to an invention in nanotechnology requires careful consideration of the potential end uses so that they are adequately covered by the patent, an exercise which may draw upon expertise in several different fields.
Unique legal issues will arise, that require an understanding of case law from diverse areas. Nanotechnology poses some challenges to current conceptualizations of law. The previously recognized principles of novelty, unobviousness etc. need to be diluted in order to fit the need for a science like nanotechnology.

Strong patent protection may spur research and invention, but it may also lead to a patent thicket¨ and expensive litigation over seminal patents. Patent thicket, a phenomenon peculiar particularly in patents in nanotechnology, basically refers to a situation where though a patent is granted to a nanotechnological invention, it becomes unworkable due to the operation of a previously granted patent for a similar invention. The subsequent patent holders, in order to make their patent workable, have to first obtain licenses from the previous patent holders.

Patent law Articles:
Patenting of Micro-Organisms in India
Patentability
Patent & Its Effect In India
Challenges to India Patent Regime
Whether Patent Law Protects Biotechnological Inventions

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