An%20Introduction%20to%20IPR

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An Introduction to IPR

• S.V.N.Raju
• M.Pharm., M.B.A., DPL, DSM
• Kakatiya University Alumni
• 1992-1994

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• What is innovation ?
• What is intellectual property ?

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Innovation and Intellectual Property

• Think
• Imagine
• Create (Creations of the mind)
• WHAT WE CREATE OUT OF THIS PROCESS IS
  INTELLECTUAL PROPERTY VALUE

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Property

• Knowledge (IP Intangible property) is
  cumulative with each idea building upon the last,
  
• whereas
• Machines (Tangible property) deteriorate and must
  be replaced

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Types of IP

• Patents
• Copy Rights
• Trade marks
• Geographic Indications
• Protection of undisclosed information
• Layout designs of integrated circuits
• Industrial designs

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What is a patent?

• Is grant by a government or government agency.
• To an inventor
• Right to exclude others from
• Making
• Using
• Selling
• Offering for sale
• importing

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Type of patents?

• Utility patents
• Plant patents
• Design registration

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Utility patents

• Structural or functional aspects of
• Products
• Composition
• Process

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Plant patents

• New variety of living plants

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Design registration

• Ornamental designs of useful objects
• In US designs are patentable.

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Is this gives right to market

• No
• A separate permission is required to make use
• DCA or DCGI approval is required to market
  pharmaceutical products.

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Some common terms

• Application
• Best mode
• Claims
• Conception
• Dependent claim
• Examiner
• Failure of others

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Some common terms cont

• How to make
• Independent claim
• Invention
• Novelty
• Obviousness
• Preferred embodiment

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Some common terms cont

• Prior art
• Provisional application
• Specification

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Some common terms cont

• Application
• A written document seeking patent protection
  filed with patent office.
• Best mode
• A patent application is required to disclose the
  best means known to the applicant of practicing
  the invention as of the date of filing the
  application

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Some common terms cont

• Claims
• A claim is one of the numbered paragraphs that
  appear at the end of a patent and defines the
  scope of protection given to the owner of the
  patent
• Each claim is treated separately for purposes of
  determining validity and infringement. For
  example, claims may be directed toward apparatus,
  methods, products, and compositions of matter and
  new and useful improvements thereof.

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Some common terms cont

• Conception
• is the creation of the mental concept of the
  invention.
• Dependent claim
• is a claim that makes express reference to and
  depends on a prior claim
• thereby, incorporates by reference all of the
  recitals of the prior claim

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Some common terms cont

• Examiner
• An employee of a patent office to whom an
  application is assigned for handling prosecution.
• Failure of others
• A secondary test of patentability relevant to the
  issue of whether an invention is obvious is
  whether others have failed to come up with the
  solution previously.

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Some common terms cont

• How to make
• This is part of the obligation to provide a
  disclosure in the patent application that would
  enable one skilled in the art to practice the
  invention without engaging in undue
  experimentation.

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Some common terms cont

• Independent claim
• is a claim that stands by itself and must be so
  read in terms of infringement and validity
  evaluations. This is contrasted with a dependent
  claim.

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Some common terms cont

• Invention
• in order to have a patentable invention, one must
  have a development that is
• useful,
• novel (no single prior art reference shows the
  identical development), and
• unobvious to one skilled in the art
• at the time the invention was made,

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Some common terms cont

• Novelty
• is present if no single piece of prior art
  discloses every element of the claimed invention.

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Some common terms cont

• Obviousness
• If the invention could readily be deduced at the
  time the invention was made from publicly
  available information (prior art) by a person of
  ordinary skill in that art, it is obvious.
• Prior art may be combined to show that an
  invention would have been obvious.

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Some common terms cont

• Preferred embodiment
• The preferred embodiment of an invention can
  usually be interpreted as being recited as the
  best mode known to the inventor of carrying out
  the invention.

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Some common terms cont

• Prior art
• The existing body of technological information
  against which an invention is judged to determine
  if it is patentable as being novel and unobvious.
  
• It must be early enough in time to be cited
  against the application.

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Some common terms cont

• Provisional application
• an applicant can file a patent specification
  complying with standards and get the filing date
  as a priority date.
• for a complete patent application filed within
  one year thereafter claiming the benefit.

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Some common terms cont

• Provisional application
• The provisional application does not have to
  contain claims.
• The effective filing date of the full application
  for purposes of avoiding prior art will be the
  filing date of the provisional application.
• but will have the benefit of the date of filing
  the full application for purposes of the 20 year
  patent term.

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Some common terms cont

• Specification
• The part of the patent application that precedes
  the claims and in which the inventor specifies,
  describes, illustrates, and discloses the
  invention in detail.

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Areas of the field

• Infringement
• Invalidation
• Protection (Patent filing)

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Academic perspective
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• Intellectual Property
• It Starts With An IDEA (Sur Ji)

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To Become an Innovation Leader

• Development of
• self-reliance
• technological self-confidence

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Faculty thinking

• Most faculty in Indian university does not want
  to link research with IP generation or
  commercialization.
• In general if one is working with university
  inventors, the pressure to publish is intense,
  sometimes that drive to publish comes back to
  bite.

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• An invention can only be protected by patent if
  it is novel
• (no prior publication of the invention).
• Grace period
• Therefore, it is essential not to disclose the
  invention publicly until after a formal patent
  application has been filed.

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• Any printed publication in
• a newspaper,
• scientific journal, or
• other written form
• available on an unrestricted basis is considered
  a public disclosure,
• as is an oral presentation at a public meeting.
• Note that an abstract and, in some cases,
• even a title may act to bar patentability if it
  discloses all the necessary elements of the
  invention.

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Rights and responsibilities

• Obtaining and maintaining IP, especially patents
  require many actions and funds.
• Patent search
• Patent filing
• Handle opposition and objections
• Renewal of patents
• Handle infringement
• Licensing and transfer of IP

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Nature of knowledge transfer from academics

• IP licensing is more common.
• This needs to be encouraged.
• Once licensed, renewal and maintenance should be
  the responsibility of the licensee.
• Academics should move quickly to new areas of
  knowledge.

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IP policy

• Many universities in the developed countries of
  the west have their IP policies and IP cells.
• Many cells are usually managed by lawyers having
  technical background.
• Some are also managed by technical people.

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IP policy

• IIT at Mumbai, Kharagpur, Delhi, Chennai and IISc
  have their IP policy in place.
• IIT Roorkee is in the process of formulating one.
  
• Some other academic institutions have their
  policies but most of them address royalty
  sharing.
• These are also the places having IP cells of
  their own.

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IP policy

• Will IP policy make a difference?
• Institutes ought to generate their own
  resources. Hence management will drive research
  programmes accordingly.
• Clarity will help faculty in making choices.
• Who doesnt like money?

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Sources of funds

• Self
• Government(s)
• Industry
• Financial institutes
• VCs
• Trusts
• Combination of two or more
• International agencies

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Issues in licensing / transfer

• Exclusive / non exclusive
• Territory of protection and exploitation
• Term
• Which IPR out of bundle of IP rights
• Renouncement of rights
• Maintaining IPR e.g., payment of renewal fees

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Issues in licensing / transfer

• Infringement
• Confidentiality
• Materials transfer agreements
• Ownership
• Sharing of rights
• Further improvements
• Remuneration to inventors

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Examples

• The University of Kansass development of IP
• 105 patents issued active
• 73 active licenses
• 48 US patents pending
• 20 active start up companies
• 19 equity positions

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Patent Filing Process
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Filing process

• Provisional application
• Non provisional application

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Provisional application

• Specific forms
• Form 1
• Form 2
• Form 3
• Fees
• Specifications

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Provisional application

• Specifications
• Title
• Introduction to the invention
• Drawings (if required)
• Model (upon request from PO)

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Non provisional application

• Specific forms
• Form 1
• Form 2
• Form 3
• Form 5
• Fees
• Specifications

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Non provisional application

• Specifications
• Title
• Introduction to the invention
• Drawings (if required)
• Model (upon request from PO)

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Non provisional application

• Specifications
• Detailed description
• Examples (best mode)
• Claim(s)
• Abstract

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Prior art search

• Patents
• Literature articles
• Journals
• Scientific Presentations

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Prior art search

• Patents
• http//www.uspto.gov/
• http//ep.espacenet.com/
• http//www.wipo.int/ipdl/en/search/pct/search-simp
  .jsp

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Prior art search

• Patents Published literature
• Scifinder
• STN
• Ensemble

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Prior art search

• Published literature
• www.sciencedirect.com (for elsevier journals)
• www.tandf.co.uk/journals/online.asp (for journals
  of dekker and taylor and francis publishing)
• www.ncbi.nlm.nih.gov/entrez/query.fcgi (med line-
  gives elsevier journals also)

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Prior art search

• Published literature
• www.aapspharmscitech.org (free full text articles
  published in AAPS Pharm Sci Tech, an online
  journal)
• http//pubwww.srce.hr/acphee/ (acta
  pharmaceutica-full text for last 2 years and
  abstracts for older journals)

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Prior art search

• Published literature
• http//www.ingentaconnect.com/contentjsessionid1
  3rvsr25ic2q1.victoria (many journals esp british)
• pubs.acs.org/journals (journals of American
  Chemical Society)
• www.blackwell-synergy.com (Blackwell Synergy
  Publications

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Comparison of cost
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Comparison of cost
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Cost time factor

• The cost to file, prosecute, grant and maintain a
  patent varies widely by country.

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Applicants expectations

• Applicant is always interested in
• Low cost to file
• Less time in prosecution
• Less time in granting
• Minimum cost in maintainance
• All of this is only possible with PCT filing
  process

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What is PCT

• Patent cooperation treaty
• A United Nations treaty
• Signed in June 1970
• Became operational in June 1978
• Administered by the International Bureau (IB) of
  the World Intellectual Property Organization
  (WIPO) in Geneva, Switzerland

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What PCT provides

• There is no international patent.
• The Patent Cooperation Treaty (PCT) functions as
  a patent application filing system.
• The applicant must still prosecute the
  international application in each national or
  regional office in order to obtain a patent.

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Traditional filing
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Purpose of PCT

• To simplify the process of filing foreign patent
  applications
• To give every regional and national patent office
  the benefit of a search and a preliminary report
  on patentability by a major patent office

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PCT

• This system provides
• A common filing process.
• Minimizes the expenses in filing process.
• Gives enough time for an applicant to think and
  choose the territory he would like to cover.

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Number of international applications
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PCT Filing
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Active Pharmaceuticals
Different ways of claiming
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Claims..

• By Chemical structure or chemical name
• Solid/crystalline/hydrated forms (Physical form)
• Purity of the API
• Alternate salts
• Process
• Physicochemical characteristics
• Technology

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1. By Chemical structure or Name
1.1. Claim by large Markush structure
Atorvastatin (US 4,681,893)
Atorvastatin

• Generally possible for innovators
• Entire genus is novel
• No clarity on the final target.
• Broadest claim possible.

• No design around possible.
• Invalidation is the only option

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1. By Chemical structure or Name
1.2. Claiming by simple structure Paroxetine
intermediate

• Covers limited no of novel compounds.
• Covers possible protecting groups and
  derivatives.
• Generally possible when a novel scheme is
  designed for a known product.

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1. By Chemical structure or Name
1.3. Claiming by Chemical name Atorvastatin
Calcium (US 5,273,995)

• Covers one or two specific compounds and its
  salts.
• Narrow in scope
• Covers the actual commercial product.
• Highly difficult to invalidate the patent.
• Generally extends the life cycle of the product.

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2. By physical form
2.1. By Solid form Montelukast Acid (US
2005/107426)

• Broad claim possible, if the compound is already
  known in a non-solid state.
• Provide great value if some of the impurities
  are washable only by purification of the solid
  intermediate.

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2. By physical form
2.2. By Crystalline form Amlodipine free base
(US 6680334)

• Broad claim possible, if the compound is already
  known in a non-crystalline form.
• Provide great value if non-crystalline form is
  significantly unstable for processing and pure
  product can be obtained only from crystalline
  material.
• Can be used as alternate to API salt form if
  possible.
• Generally stands in the litigation even-if the
  genus claim of compound claim is invalidated.

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2. By physical form
2.3. By Specific parameters Alfuzosin Base (WO
2006/090268)

• Considered as the narrow claim.
• Has value only if the known solid forms are
  protected or all of them are unstable for
  processing.

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3. By Purity
3.1. By Purity of the API Candesartan (US
20050250827 A1)
3.1. By Chiral Purity of the APIArmodafinil (WO
2007/103221)

• API is known but with less purity.
• Provide value if the impurity is a critical
  difficult to remove or forms in stability.
• Competitors will have to use impure materials
  and end up regulatory issues

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4. Alternate salts
4.1. Alternate salts (Desvenlafaxine US7001920)
4.1. Alternate salts (Sitagliptin US2005032804)

• Narrow in scope
• Covers the actual salt of product.
• Considered as easy to invalidate the patent if
  other salts are already known.
• Generally extends the life cycle of the product.

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4. Diasteriomer salts
4.1. Diasteriomer as compound (Eszopiclone
-WO07/088073)
4.1. Diasteriomer in crystalline form
(Eszopiclone -WO07/088073)
4.1. Diasteriomer with purity (Duloxetine-WO06/099
459)
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5. Process for Preparation of API
5.1. Generic process (Ramelteon)
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5. Process for Preparation of API
5.2. Simple process (Paroxetine)
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5. Preparation of API
5.3. Specific process (Duloxetine HCl)
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5. Preparation of API
5.4. Specific process (Ziprasidone HCl)
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6. Physicochemical properties
6.1. PSD of API compound (Ziprasidone HCl
-US6150366)
1. A composition comprising crystalline
ziprasidone free base or crystalline ziprasidone
hydrochloride particles having a mean particle
size equal to or less than about 85 µ and a
pharmaceutically acceptable diluent or carrier.
6.2. PSD of API compound (Escitalopram -US6916941)
6.3. PSD BD of API compound (Atorvastatin
-WO2007100614)
Covers non-crystalline solid Atorvastatin salt
having bulk density from about 0.05 to 0.4 g/ml
and mean particle size of about 0.5 to 50 microns
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7. Technology
Synthesis of Piperizine ring (Mirtzapine-US
6852855)
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7. Technology
Synthesis of Amino acid amides (Levitiracetum-US
2005/0182262)
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• Thank You

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Examples

• Some examples of different formulation patents
• Exhibit
• Some examples of weak vs strong patents
• Exhibit