nanobiotechnology & patents

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CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL [email protected] Nanobiotechnology & Patents BY SRUTHI S RAGHAVAN

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Page 1: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

Nanobiotechnology & Patents

BY

SRUTHI S RAGHAVAN

Page 2: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

What is biotechnology?

The exploitation of biological processes for industrial and other purposes, especially the genetic manipulation of microorganisms for the production of antibiotics, hormones, etc – Oxford Dictionary

Eg: genetic engineering, transgenic plants, pharmacogenomics etc

Page 3: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

What is nanotechnology?

Nanotechnology is the science and technology of small things,

particularly things that are less than 100nm in size.  One

nanometer is 10^9 meters or about 3 atoms long - National

Nanotechnology Infrastructure Network.

Eg: A human hair is about 60-80,000

nanometers wide.

Key features of nanotechnology:

• Small size, measured in 100s of nanometers or less

• Unique properties because of the small size

• Control the structure and composition on the nm scale in order to control the properties.

Page 4: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

Nano & Bio: Emergence of a convergent technology

• Biological processes are driven by interactions at the molecular level

• Nanoscale devices can thus become the perfect partner to study these interactions.

• Can meet nature at its own interface

The result of intersection of nanotechnology and biology = Nanobiotechnology or Bionanotechnology

Page 5: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

Patenting Nanobiotech Inventions

Can build tools from the ground up, which may make it more reliable and predictable than biochemical molecules.

Change the dynamics of diagnosis and treatment by interacting at the molecular level. Eg: cancer

Can develop therapeutic nanomaterials that are highly specific thereby reducing side effects Eg: caner

Eg: scanning probe microscopes, quantun dots, Dendrimers.

Page 6: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

Confronting the Big 3

Patent Law at the forefront of BionanotechnologyNovelty – inherent properties of a known material vs unique properties at the nano-scale.

Inventive Step/non-obviousness – it may be obvious to make materials smaller, but the properties at nanoscale may not be obvious

Industrial applicability – the scope of the nanobiotech inventions in industry is huge. The nano product itself may not be patentable, but the process for making it may be patentable.

But analysts wonder whether undue experimentation would be necessary to teach those with ‘ordinary skill’ how to make and use the invention, in the future.

Novelty Inventiveness Applicability

Page 7: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

Roadmap to IP protection

Factors that influence bionanotech patents in medicine

Applicant IP Counsel Patent Office

Lucrative alternative to stagnant/weak drug pipelines

Effective solution to patent cliffs

Securing broad patents

Construct claims that will secure valid defensible patent protection

Multidisciplinary knowledge and expertise required to adviset patent clients

Lack of prior art making search difficult

Examiners are required to possess knowledge in diverse disciplines to carefully evaluate application.

Identifying broad patent claims

Page 8: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

BIONANOTECH IN USA

Class 977 for categorising nanotech patents

~ 6000 nanotech patents granted in 2013 alone. Number of bionanotech patents granted is not known.

Issues raised – patent thickets/overlapping patents, broad patents, litigations, revocation of patents due to invalidity.

Page 9: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

BIONANOTECH IN INDIA

Modest investments in Nanobiotech in India - industry still finding a

foothold.

Nanomedicines and nanodevices focusing on 5 therapeutic areas: Oncology, neuropsychiatry, diabetes mellitus, cardiovascular and arthritis.

Dabur Pharma’s Nanoxel – a novel drug delivery system for the anti-cancer drug ‘Paclitaxel’

Biocon & Abraxis Biosciences launched Abraxane – the nanotech based anti-cancer drug.

Some of the most prolific companies exploring these avenues: Lupin Ltd, Cipla Ltd, Cadila Healthcare Ltd, Shasun Pharmaceuticals

Few companies are involved in patenting nanobio inventions in India.

Page 10: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

CAN IPO HANDLE BIONANOTECH PATENT APPLICATIONS?

Nanobio research in India is focused primarily on the healthcare sector and is gaining more attention.

Patenting activity is low and is at an early stage.

Trigger – impossibility in predicting the future commercial success or viability of an issued patent

Blurring of invention and discovery interface, convergence of biotech and nanotech may challenge the IPR regime.

Page 11: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

POSSIBLE ROADBLOCKS: Section 3d & 3e

Invention or discovery?Most nano inventions are based on basic science discoveries.

Discovery of new form of a known substance (not resulting in an increase in efficacy), discovery of a new property of a known substance or new use of a known process, machine or apparatus (that does not result in a new product or employs atleast one new reactant) (s. 3d)

A substance obtained from/process of producing a substance which is a mere admixture which results in only the aggregation of the properties of its components (s. 3e)

Page 12: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

EXAMINER WOES

No defined examining group – could result in broad patents or patenting basic research due to the nature of nanobio.

Inadequate or lack of training or examination guidelines

Inadequate engagement with outside legal or technology experts.

Lack of prior art

Page 13: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

FUTURE OF NANO-BIO

Touted to be the next biggest technology with nanotechnology based products worth $1 trillion by 2015 – by National Science Foundation.

Could bring breakthrough treatments to taper down the disease burden of India

Increase affordability and access to medicines & contribute to the economic growth

BUT...

Page 14: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

POSSIBLE REPURCUSSIONS

- patent thickets

- patent cliffs - increase in application pending period due to the complex nature of the application

- application backlog at the IPO

- broad patents or worse – low quality patents

Page 15: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

When the going gets tough, the tough gets going

For the IPO: Exploiting the current provisions of the IP legislation to make room for nanobio inventions

Experimental use exemption, disclosure standards, learn from biotech patents

Engage with outside legal and technical experts undertake training where possible

Page 16: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

Contd...

For the Applicant:

Triple-Helix Model

Collaborating, publishing and sharing of knowledge

Trend watching

Creating synergies Triple-Helix-Model

Page 17: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

Contd...

For the IP counsel/patent agents:

- training and undertaking courses in nanotech where possible

- build expertise

- advise clients by gaining a thorough understanding of the nano patent landscape.

Page 18: Nanobiotechnology & Patents

CHENNAI3rd Floor, ‘Creative Enclave’,

148-150, Luz Church Road,Mylapore,

Chennai - 600 004.Tel: +91 - 44 - 2498 4821

BANGALORE Suite 920, Level 9,

Raheja Towers,26-27, M G Road,

Bangalore - 560 001.Tel: +91 - 80 - 6546 2400

COIMBATOREBB1, Park Avenue,

# 48, Race Course Road,Coimbatore - 641018.

Tel: +91 - 422 – 6552921

EMAIL

[email protected]

WEBSITE

www.altacit.com

Look out, its coming!!The Small is Getting Big!

THANK YOU