Patents, Patentability and Infringement

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Patents, Patentability and Infringement

• B. Vijayaraghavan
• Director, IP
• Ranbaxy Laboratories Limited

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The Cycle of Innovation and Competition
Branded Company Innovates, Creating Value for the
Healthcare System via Breakthroughs
Branded Company Rewarded with Monopoly Position
Branded Company Loses Revenue on Older Products,
Necessitating Plan to Replace s
Patent Expiration Generic Industry Opportunity
to Create Value via Competition
RANBAXY
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Some Quotable Patent Quotes

• A country without a patent office and good
  patent laws is just a crab and can't travel any
  way but sideways and backwards
• Mark Twain
• The patent system added the fuel of interest to
  the fire of genius
• Abraham Lincoln (the only US president with a
  granted patent)
• Everything that can be invented has been
  invented
• Charles H. Duell, Commissioner, U.S. patent
  office, 1899 (attributed)

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NOTIONS OF INTELLECTUAL PROPERTY

• MOVABLE PROPERTY
• Owner has legal and exclusive rights to use his
  property.
• Owner may authorize others to use his property
  but requires legal authorization.
• Can be possessed, owned, donated, stolen.
• IMMOVABLE PROPERTY
• Land and property
• Limit to use of such property
• INTELLECTUAL PROPERTY (Creation of human
  intellect)
• An asset that can be possessed, owned, bought,
  sold, donated, and
• stolen.
• An asset that is cognizable under the basic laws
  governing the ownership and the monetary value.

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MODES OF PROTECTING INTELLECTUAL PROPERTY

• PATENTS
• Process
• Products
• Apparatus
• Capable of Industrial application
• DESIGNS
• Shapes
• Ornamental
• TRADE MARKS
• Marks used to distinguish goods - words, signs or
  combination
• An asset that is cognizable under the basic laws
  governing the ownership and the monetary value

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MODES OF PROTECTING INTELLECTUAL PROPERTY

• COPY RIGHTS
• Musical work
• Artistic work
• Literary work e.g. Books, periodicals, lectures,
  plays, maps, art reproductions and models

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WHY PATENT INVENTIONS ?

• To reserve for oneself rights on a short term
  basis.
• To be recognized as being the inventor or being
  an
• innovative company.
• To prevent third parties from obtaining patents
  for the same invention (defensive patent).
• To obtain a complete monopoly on the invention
  to
• exclude potential infringer
  (offensive patent).

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CAN I PUBLICLY DISCLOSE MY INVENTION?

• If you are thinking of applying for a patent you
  should not publicly disclose the invention
  before you file an application because this
  could be counted as prior art of your invention
• Any type of disclosure (whether by word of
  mouth, demonstration, advertisement or article
  in a journal), by the applicant or any one
  acting for them could prevent the applicant from
  getting a patent.
• It could also be a reason for having the patent
  revoked if one was obtained
• It is essential that the applicant only makes
  any disclosure under conditions of strict
  confidence

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WHEN SHOULD I FILE MY PATENT APPLICATION

• ADVANTAGES OF EARLY FILING
• You establish a priority date for your
  invention
• A disclosure of the invention either by
  yourself or
• someone else, can not now prevent you
  from getting
• the patent
• It maximizes the chance of beating
  competitors who
• may also file a patent application on
  the same invention
• If you delay, you run the risk of losing
  your ability to
• get a patent

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WHEN SHOULD I FILE MY PATENT APPLICATION

• ADVANTAGES OF DELAYED FILING
• You will have time to add refinements to your
  inventions
• You will have time to assess and broaden the
  scope (limits) of the invention
• You can discuss the commercial significance of
  your invention with a potential licensee who may
  be ready to make funds available to do more
  extensive research on the invention

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KEY STEPS INVOLVED IN OBTAINING A PATENT
IDEA (Conception)
INVENTION (Reduction to Practice)

• FILE PATENT APPLICATION
• Novel
• Non obvious
• Useful

Average Time 1. 5 3 Years
EXAMINED BY PATENT OFFICE
PATENT ALLOWED
PATENT REJECTED
OR
ISSUE PATENT
OR
ABONDON
RE-FILE
APPEAL
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STATUS IN 2006

• Countries in the world
  200
• Countries having patent laws
  157
• Country members of Patent Cooperation Treaty
  130

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WHAT IS A PATENT ?

• A patent for an invention is granted by the
  Government to the inventor, giving the inventor
  the right to stop others from making, using or
  selling the invention without the permission of
  the inventor for a limited period.
• Owning a patent does not of itself give the
  patent owner the right to practice his own
  invention because practicing ones own invention
  may infringe some one elses patent.
• When a patent is granted for an invention , it
  becomes the property of the inventor or its
  assignee. Patents are territorial rights
• US patent will give the holder rights within the
  United States and rights to stop others from
  importing the patented products into the United
  States

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CONDITIONS OF PATENTABILITY

• An invention must meet the following criteria if
  it is to be eligible for patent protection.
  These include
• 1 Patentable subject Matter (Statutory
  requirement)
• 2 Novelty
• 3 Inventive step ( Non Obviousness)
• 4 Industrial applicability (Utility)

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POTENTIAL CHEMICAL INVENTIONS

• Compound per se .
• Pharmaceutical composition of new compounds.
• New pharmaceutical compositions of old
  compounds.
• Method of treatment or method of use.
• Compound for use (broad first use).
• New medical use for old compound (second use).
• Process per se. (when novel and inventive).
• Intermediates .
• Processes for preparing composition.
• Different salt forms,hydrates,or polymorphs
• Drug non specific patents (platform technology)

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NOVELTY

• Fundamental requirement for patentability.
• Novelty is not something which can be proved or
  established, only its absence can be proved.
• An invention is new if it is not anticipated by
  the prior art.
• Novelty exists if there is any difference between
  the invention and the prior art.

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INVENTIVE STEP (NON - OBVIOUSNESS

• Establishing the non-obviousness or the inventive
  stepis the most difficult task in the examination
  as to the substance.
• Invention should not be obvious to a person
  having
• ordinary skill in the art.
• The person having ordinary skill in the art is a
  person with appropriate training and practical
  experience but "ordinary skill" intends to
  exclude the "best expert" in that field in the
  country concerned.
• "Inventive" implies result of "creative idea" and
  "step" means there is noticeable difference
  between the state of the art and the claimed
  invention. This gives the progress or advance
  over the prior art and this progress should be
  significant.

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INVENTIVE STEP (NON OBVIOUSNESS) contd

• During the evaluation of the difference
  between the invention under examination and the
  prior art, an account has to be taken as a whole
  i.e. the invention is compared not only with
  each publication or other disclosure
  separately, but with the combinations thereof.
• In the nut shell not only the combination,
  but also the choice of the combined elements
  should not be obvious.

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INDUSTRIAL APPLICABILITY (UTILITY)

• In order to be patentable,the invention must be
  of the kind 
• - which can be applied for practical
  purposes
• - which can be carried out in practice   
• - which can not be purely theoretical
•  
• In common language, an "industrial" activity
  means a technical activity on a certain scale
  while in the terminology of patent laws
  industrial applicability of an invention means
  the application (making,use)

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PRIOR ART

• All knowledge that existed prior to the relevant
  filing or priority date of a patent application,
  by way of written or oral disclosures or
  disclosures by use.
• Written disclosures Physical carriers for
  information like publications e.g. patents,
  published patent applications, writings
  (manuscript, typescript, printed matter),
  pictures, including photographs, drawings,
  films, recordings (discs or tapes) in either
  spoken or coded language.
• Oral disclosure Words or form of the disclosure
  which are not necessarily recorded as such and
  includes lectures and radio broadcasts
• Disclosure by use Public visual disclosure by
  display, sale, demonstration, unrecorded
  television broadcasts and actual public use

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LIFE OF A PATENT

• EUROPE
• - 20 years from date of filing.
• USA
• - Before GATT (June 08, 1995)20 years from
  date of filing or 17 years from date of
  grant whichever is longer
• - After GATT 20 Years from date of
  filing.
• INDIA
• Till May,2003
• (a) Pharmaceuticals / Food 7 years from date
  of filing,
• (b) others like engineering etc 14 years from
  date of filing
• - After May, 2003 20 years from filing
  date.

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INFRINGEMENT

• A patent prevents others from utilizing the
  invention without the consent of the patentee or
  its licensee.
• Any act of trespassing this property constitutes
  an act of infringement, which is a tort in the
  sense of direct invasion of the right of the
  patentee or its licensee.
• A patentee or its licensee approaches the court
  of the country where the patent is in force for
  legal redress for invasion of one or more claims
  of the patent by the infringer.

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LITERAL INFRINGEMENT(ALL ELEMENTS RULE)

• A claim with several elements is infringed if
  every element is found in the accused device /
  product / process. For literal infringement, all
  elements present in the claims must be present in
  the accused product /process.

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INFRINGEMENT UNDER DOCTRINE OF
EQUIVALENTS (DOE)

• Infringement beyond claim boundaries
• It is judicially constructed equivalence and
  non- statutory
• Designed to prevent injustice to patent holder
  to catch a would be infringer who escapes the
  literal language of the claim by making cosmetic
  changes to the claim
• Equivalent of each element / feature of claim
  must be found in the accused device / product /
  process
• To determine whether equivalence is actually
  present, one method is to see whether
  replacement achieves substantially the same
  function in substantially the same way to give
  substantially the result, known as the
  function - way result test first codified in
  Graver tank v Linde Air Prods (1950)

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INFRINGEMENT UNDER DOCTRINE OF EQUIVALENTS (DOE)
contd.

• Prosecution History Estoppel(PHE) is one tool
  that prevents the doctrine of equivalents(DOE)
  i.e.if during the patent prosecution applicant
  narrows the claim for any reason except to
  correct the typo he is barred from asserting
  infringement under DOE
• In Glaxo vs. Ranbaxy, CAFC held Glaxo estopped to
  assert DOE as it had narrowed the claims during
  the prosecution of the 181 patent , therefore,
  infringement under DOE in the present case is
  precluded by Prosecution History Estoppel

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THE MOST EXPENSIVE EXAMPLE OF IP MISMANAGEMENT
(POLAROID VS EASTMAN KODAK)

• 1948, Erwin H. Land invented a Camera that would
  develop the picture almost immediately after it
  was taken
• First film was made by Kodak for Polaroid
• Instant camera technology had been developed
  largely by Polaroid supported number of patents
• Kodak entered into an agreement to produce the
  colour negative for Polaroid. The agreement
  lasted till 1969
• In 1976 Kodak decided to move on its own into
  instant camera and film by working around the
  Polaroid patents

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THE MOST EXPENSIVE EXAMPLE OF IP MISMANAGEMENT
(POLAROID VS EASTMAN KODAK)

• Immediately after Kodak entered the market in
  April, 1976, Polaroid filed an infringement suit
  on Kodak for 12 of its instant camera patents.
• On October 12, 1990 the court ordered Kodak to
  pay Polaroid 454,205,801 in compensation for 10
  years its instant camera products were in the
  market. An additional 455,251,761 was added on
  as interest, (total - approx. 920 million).
• Total cost to Kodak of its misguided patent
  strategy was about 920 million.
• Kodak was forced to shut down its 1.5 billion
  manufacturing plant and lay off 700 workers.
•  

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MAINTENANCE OF LABORATORY NOTE BOOKS

• SOME USEFUL GUIDELINES
•      Laboratory records of inventive work can be
  used to prove the date of
• invention.
• Two concepts that need to be understood are
• (a) Evidence
• (b) Diligence
•  
• EVIDENCE
• Evidence goes to establish the date of
  conception of the invention which can
• be achieved by instituting a formal system of
  recording who conceived the
• idea and when
• Ideas should be documented as minutes of a
  research review meeting /
• project planning exercise, recordings of a
  brain storming session, etc.
• The evidence should be singed and dated by both
  the inventor and a
• corroborating witness.

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MAINTENANCE OF LABORATORY NOTE BOOKS

• Ø    DILIGENCE
• Is used to prove that the idea was actually put
  into practice
• Requires one to keep records of the progress or
  even gaps in the activity in
• the well established laboratory note -books.
• Laboratory note book must be hardbound (so that
  it can not be tampered)
• and the pages numbered.
•   Every Laboratory Note Book should also be
  numbered which should be
• followed by "Preface recording relevant
  details of the inventor such as his
• name, department, project name, etc.
• The title page lists the contents and a page
  listing the abbreviations being
• used in the note book is also recommended

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MAINTENANCE OF LABORATORY NOTE BOOKS

• Every page has to be dated and the entries signed
  by the inventor, with each page countersigned by
  an independent witness.
•  Experimental results, their interpretations,
  experimental strategy, development of ideas are
  expected to be documented in the Note Book with
  appropriate signatures and counter signatures
• Analytical data such as IR, NMR, UV, Mass
  spectra, HPLC, GLC graphs, XRD, DSC data should
  be kept in a separate file which is
  systematically indexed, allowing easy retrieval
• There should be a central laboratory note-books
  issuing authority which is responsible for
  maintaining records of the issues.
• A system should also be created to archive the
  complete note books when these are required at a
  future date to serve as legal document for any
  patent related litigation.

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The only thing that keeps us alive
is our brilliance The only
thing protecting our brilliance
is our patents.

Edwin H. Land, 1976
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Thank you