March 2009

Current Status of Biotech PatentingIn India

Kausalya Santhanam Ph.DPatent Agent USPTO, IPO

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Patents

Legal monopoly limited in scope and duration (20 years)

National in scope

Exclusionary in nature

Commercial Attributes

Novelty

Inventive Step (Non-obviousness)

Industrial Application (utility)

Patentability

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Composition

Nucleic acid sequence

Protein sequences

Antibodies

Small Molecules

Protectable Inventions in Biotech

Method of Use Treatment

Diagnosis

Screening

Tools Machines

Devices

Process Method of Making

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3(d) Mere discovery of - a new form - a new property - a new use of a known compound not patentable unlessdiffer significantly with regard to efficacy

Article 27 of TRIPS provides the basis for patentability

US patent law grants patent to microorganisms when modified by human intervention (Diamond v Chakraborty, US Supr. Court, 1980)

EPO has similar law with regard to patenting microorganisms

Patentability Criteria – Novelty, Inventive step (Non-Obvious in US), Industrial applicability (Utility in US)

Patenting of transgenic animals – Allowed in the US (ex: oncomouse); treated on a case by case basis elsewhere

Dimminaco A.G. v Controller of Patents & Designs (Calcutta High Court, 2002)

History and Facts

Biotech Inventions

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Section 3 (Patent Amendment 2003) establishes Patentability Criteria for microbiological processes

Microbiological process that can be established as ‘inventions’ are patentable

Patentability Criteria – Novelty, Inventive step, Industrial applicability

Biological material deposited at MTCC and Gene Bank, IMTech, Chandigarh - all characteristics for identification of the microbial sample - access to material allowed after publication of the application - disclose the geographical source of the biological material

Indian law does not allow patenting of animal, whole or part

Indian Patent Act

Biotech Inventions

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Biotech Inventions

What is patentable?

Taq polymerasenaturally-occurring

Purification from T. aquaticus

PCR

Recombinant form of Taq polymerase

Novel?Obvious? Useful?

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Biotech Inventions

The catch… Expressed Sequence Tags (ESTs)

Gene Fragments

SNPs

Genetic Tests (screening, diagnostic)

Proteins

Stem Cells

Novel?Obvious?

Enablement? Written Description?

Useful?

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Specific Substantial Credible

Utility - US

Industrial Applicability – EP and others

Real World Well establishedOR

Biotech Inventions

Patentability

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35 USC § 112, 1st paragraph

The specification shall contain a written description of the invention and of the

manner and process of making and using it, in such full, clear, concise, and

exact terms as to enable any person skilled in the art to which it pertains…to

make and use the same, and shall set forth the best mode contemplated by the

inventor of carrying out his invention

Three Prong requirement in the specification

Written Description

Enablement

Best Mode

Patentability - US

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Written Description Requirement

A patent specification must describe an invention in sufficient detail that one skilled in the art can conclude that the inventor had possession of the claimed invention

Possession can be shown by

i. Actual reduction to practice

ii. Reduction to drawings

iii. Describe relevant identifying characteristics

- structure

- functional characteristics (with a correlation between structure

and function)

- physical characteristics

- chemical characteristics

- combination of the above

Patentability - US

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Enablement Requirement

Disclosure of information sufficient for the ordinary skilled person to make and use the full scope of the claimed invention

Disclosure should facilitate the making and using [of the invention] without undue experimentation

Due to unpredictable nature of biotech, enablement requirement is high

Patentability - US

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Written Description and Enablement (35 USC § 112)

Ex:The composition of claim 1 wherein said nucleotide sequences are selectedfrom the group consisting of:- the N. gonorroheae DNA insert of ATCC 53409, ATCC 53410 and ATCC 53411 and discrete nucleotide subsequences thereof…

Ex:An isolated polypeptide comprising an amino acid sequence of SEQ ID NO: XXselected from the group consisting of:- a mature form of the amino acid sequence of SEQ ID NO: XX- a variant of the mature form of an amino acid sequence of SEQ ID NO: XX- a fragment of the mature form of the amino acid sequence of SEQ ID NO: XX

Written Description can be satisfied by depositing the biological material (Enzo Biochem. Inc. v Gen-Probe Inc., Fed. Cir. 2002)

Biotech InventionsPatentability Requirements

Yes

x No

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Biotech InventionsPatentability Requirements

Enablement (35 USC § 112)

Ex: US5,756,349 Vertebrate cells which can be propagated in vitro and which are capable upon growth in culture of producing erythropoietin in the medium of their growth in excess of 100 U of erythropoietin per 10.sup.6 cells in 48 hours as determined by radioimmunoassay, said cells comprising non-human DNA sequences which control transcription of DNA encoding human erythropoietin

Enabled?By Describing ‘a way’ to make EPO… Can Amgen claim all cells that propagate in vitro comprising non-human DNA sequence that control transcription of DNA encoding human erythropoietin?

Amgen v Hoechst (Fed. Cir. 2003)

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For those skilled in the art it is relatively simple to determine - whether a certain promoter will work within a specific vertebrate cell - whether a particular vertebrate cell will produce human EPO in culture - whether a particular promoter could be operatively linked to control the transcription

Outcome…

Those skilled in the art can readily use various cell cultures (vertebrate) to produce human EPO

Publications (in the given area) that demonstrate the extent of the enabling disclosure

Biotech InventionsPatentability Requirements

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EnablementWands Factors (In re Wands, Fed. Cir. 1988)

- Nature of the invention- State of the Prior Art- Level of ordinary skill in the art- Level of predictability- Amount of Direction- Presence of working examples- Breadth of claims- Quantity of experimentation

Biotech InventionsPatentability Requirements

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Nucleotide, Protein sequences

Promoters

Vectors

Epitope sequences and Antibodies

Processes used for making the protein

Method of Use(s): diagnostic, treatment, screening

Pharmaceutical Product

Gene Inventions and exemplary claims

Biotech Inventions

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Improvement Strategies (ex: transgenics, knock-outs)

Gene expression methodology (ex: antisense, target specific expression)

Gene expression materials (ex: specific promoters)

Gene Constructs

Biotech Inventions

Enabling Technologies

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Bioinformatics

Genomics Proteomics Clinical/Regulatory

HighthroughputTools

Data Mining

Data Storage

Data Analysis Pattern Recognition

MolecularModeling

Predictive Tools

Biotech Inventions

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Biotech Inventions

Client oriented – Diverse needs: breadth of claims?

Anticipate and prevent competition is difficult

Scarce judicial precedent

Invention obsolete?

Bioinformatics – Challenges in Patenting

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Other Issues…

Bits and pieces: Allowing a single genomic gene to be patented in several ways (ex: fragments, SNPs, peptides)

Preventing knowledge sharing (decrease in publications) and impeding research activities

Social, ethical and religious issues (ex: stem cell research)

Biotech Patenting

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Source: Indian Patent Office , Annual Report 2004-2005

Biotech Patents - India

Indian Patent Applications Filed/Granted between 2000 to 2005 in allied areas

Year Biotech Chemical Drug

2000-01 4/0 787/353 883/276

2001-02 2/0 778/483 879/320

2002-03 46/0 776/399 966/312

2003-04 23/0 2952/609 2525/419

2004-05 1214/71 3916/573 2316192

Biotech Patents - India

First Product Patent Granted (post 2005 era) Pegasys (Roche) – Pegylated IFNα 2a

Increase in no. of Biotech Application FilingsHomegrown company filings less in no.?

Homegrown companies filed outside India pre-2005?

Product vs Process Applications

Process Product

Patent Examiners About 130-150

Dwindling

Patent Examining Process Training in specific fields/art

Oppositions

Goal: Tie Applications to Appropriate Process Points

Identification Cell Validation Animal Validation/Preclinical

Clinical

Drug Discovery

Provisional Updated Provisional/Utility Utility/CIP Utility

Composition and MOU Formulation and Dose

12 months

12 months

Integration of IP and Research

Product

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Portfolio Management

Identification of >25 Compounds

Biology

Validation In vitro Studies

Chemistry

IP

Preclinical Animal Studies, Pk, Tox

Clinical Phase I, II

<2 Products

Licensing or Partnering dealsIP Audits

Project Management

Disease Groups IP

RegulatoryAffairs

Formulation/Manufacturing

Marketing

- Patent Application

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IP Strategies – Related Applications

Building a fortress around the basic Invention/ technology

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Gillette

Mach 3 Core Technology(Diamond like Coating)

Use of 3 staggered Blade getting progressively

closer to skin

Rubberized contour grip for better handling

Vacuum chamber in which the DLC blade

coating was applied

Indicator strip signaling when the shaver is no

longer experiencing ‘the optimal shave’

Single point cartridge loading system - Avoiding upside down attachment

New forward pivot design positioning the blades in

an optimal shaving position

Thank You!

March, 2009