Patentability of Biotech Products

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Patentability of Biotech Products Processes
Novelty, Inventiveness Industrial
Applicability

• Prof.(Dr.)V.C.Vivekanandan,
• NALSAR University of Law
• vivek_at_nalsarpro.org
• www.nalsarpro.org

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In this session

• Patentability- Limitations
• Novelty -issues
• Inventiveness- issues
• Industrial Applicability -issues

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Patentability- exclusions-

• Patents fall under the principle of territorial
  sovereignty
• TRIPS envisages minimum standards
• The Limitations are a matter of public policy
  choice and not on any factual validity or
  favourable opinion of specific lobby
• Thus Products and Processes could be excluded by
  Legislation of the Patent Law

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Patentability- Exclusions-Indian context

• The living entities of natural origin such as
  animals, plants, in whole or any parts thereof,
  plant varieties, seeds, species, genes and
  micro-organism are not patentable.
• Any process of manufacture or production relating
  to such living entities is also not patentable.

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Patentability- Limitations-Indian context

• Any method of treatment such as medicinal,
  surgical, curative, prophylactic, diagnostic and
  therapeutic of human beings or animals or other
  treatments of similar nature are not patentable.
• Gene sequences, DNA sequences without having
  disclosed their functions are not patentable for
  lack of inventive step and industrial
  application.

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Patentability- Limitations-Indian context

• Any biological material and method of making the
  same which is capable of causing serious
  prejudice to human, animal or plant lives or
  health or to the environment including the use of
  those would be contrary to public order and
  morality are not patentable such as terminator
  gene technology.
• Any invention which in effect is traditional
  knowledge or which is an aggregation or
  duplication of known properties of traditionally
  known components is not patentable.

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List of Patentable Biotechnological
Inventions-worldwide
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Patentability Universal Norm

• Novelty
• Non Obviousness- Inventive step
• Utility

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Prior Art- everything made available to the
public by means of
PRIOR ART
...before the FILING DATE
of the application...
Or any other way
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PRIOR ART

• Prior art is any body of knowledge that relates
  to your invention.
• Prior art would include previous patents, trade
  journal articles, publications (including data
  books and catalogs), public discussions, trade
  shows, or public use or sales anywhere in the
  world.
• Prior art basically means any disclosure of the
  contents of a claim, prior to the application for
  patent

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Determining Prior Art

• Publication
• any document from any source can in fact be used
  as prior art.
• It does not matter in which language the document
  is written, in how many copies it was made
  available, or whether any copies where in fact
  bought or read by third parties.
• The only thing that matters is that the document
  was available to the public before the critical
  date.

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Determining Prior Art

• Publicly available material
• It is irrelevant whether the public in fact
  accessed the document, or how easy it was to find
  the document.
• Publicly available products also count as prior
  art, even though it may be very difficult to
  determine exactly what the product is made of or
  how it works.
• If a device is put on the market before the
  patent application filed on a feature in that
  device, the feature is no longer novel
• If the product is not sold, but only demonstrated
  to the public, then only those features which the
  public could observe count as prior art.

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Determining Prior Art

• Oral disclosures
• Oral disclosures, such as lectures or non
  confidential discussions between the inventor and
  a third party, usually also count as prior art.
• The problem with oral disclosures is usually how
  to prove that they took place and what was
  disclosed exactly.
• In some cases a transcript or recording may be
  available.
• This can serve as evidence of what was orally
  disclosed, although establishing the date of the
  oral disclosure may still be difficult.

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Determining Prior Art

• Internet publications
• Internet publications are special case. As most
  patent offices perform their search and
  examination several months after filing of the
  application, a search on the Internet will not be
  of much use.
• In the intervening months pages on the Web may
  have been updated, added or removed, which makes
  it impossible to determine whether the invention
  was published on the Internet before the day of
  filing.
• But if it can be proven that a web page with
  particular contents was publicly accessible the
  day before the filing date, then that web page
  will count as prior art.
• A site such as The Internet Archive could be very
  useful in such cases

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Oral Disclosure

• Case-law Visx Inc v. Nidek Co. Ltd (1999), FSR
  405
• Involved the issue of oral disclosure where the
  disclosure was made during a journey in the
  train.
• Will that amount to prior art ?
• Can it kill the novelty ?
• Court held that it was disclosed in confidence
  and hence not a prior art

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Public Use

• Windsurfing Intl. Inc v. Tabur Marine (Great
  Britain) Ltd. (1985) RPC 59
• The case involves the use of a boat built by a
  boy which was put to use for week ends twice
• Can this be considered as public use ?
• The court held that it was sufficient disclosure
  for purpose of public use
• Hence there is no novelty

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Non Obviousness- Inventive Step

• Inventive step is a feature of an invention that
  involves technical advance
• as compared to existing knowledge or having
  economic significance or
• both, making the invention non obvious to a
  person skilled in art.
• Here definition of inventive step has been
  enlarged to include economic significance of the
  invention apart from already existing criteria
  for determining inventive step.

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Non Obviousness- Inventive Step

• To judge the inventive step, the following
  question is to be borne in mind-
• Would a non-inventive mind have thought of the
  alleged invention?. If the answer is No, then
  the invention is non-obvious.

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Industrial Utility

• An invention is capable of industrial application
  if it satisfies three conditions, Cumulatively
• Can be made
• Can be used in at least one field of activity
• Can be reproduced with the same characteristics
  as many times as necessary

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Utility Usefulness of an Invention

• Specific Utility
• Is the utility specific for the claimed
• invention?
• - Forensic diagnostic but cannot be used on
  specific evidence
• Credible Utility
• Is that specific utility credible?
• Perpetual motion probe with no specific gene to
  look for
• Substantial Utility
• Does the utility have real world value?
• A therapeutic method of treating a known or
  newly discovered disease and an assay method for
  identifying compounds that themselves have a
  substantial utility define a "real world" context
  of use. Does not need more work.
• Proteins as nutritional supplement or for use in
  shampoo

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Issues in Novelty

• Microbiological inventions generally involve the
  use of a new strain of microorganism to produce
  a new compound or to produce a known compound
  more efficiently (for example, in higher yield or
  purity).
• The new organism may have been found in nature
  (for example, by screening of soil samples) or
  may have been produced in the laboratory by
  artificially induced random mutation or by more
  specific techniques such as genetic engineering.

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Novelty- Micro organisms are patentable

• Plant and animal varieties are excluded from
  protection, as is any biological process for
  their production, but not excluded is a
  microbiological process or the product of such a
  process-which may, of course, be a
  micro-organism.

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Defining Microorganisms

• If the micro-organism is one which occurs in
  nature, it will be necessary to claim it in the
  form of an isolated strain, in order to avoid
  possible novelty objections
• It must be remembered that the term
  micro-organism is interpreted broadly- even
  trips has no clear definition- legal issue

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Reproducing the Invention

• Budapest Treaty of 1977, which came into force in
  1980 and as of 2003 has been ratified by 55
  countries and is also followed by the EPO,
  establishes a list of International Depository
  Authorities and provides that a single deposit
  made at any of these will suffice for all
  signatory states

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Issues in Inventiveness- Non Obviousness

• in the early days of genetic engineering the work
  involved to obtain a product was enormous and
  there was no guarantee of success, so that the
  presence of an inventive step could readily be
  established.
• However, the rate of progress in this field is so
  extraordinarily rapid that what was once
  revolutionary-very quickly becomes standard
  practice.
• The fact that the state of the art changes so
  dramatically within the time a patent application
  is pending makes it very difficult to judge the
  invention in the light of what was the state of
  the art at the filing date

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Issues in Utility

• For the purpose of utility the element of
  commercial or pecuniary success has no relation
  to the question of utility in patent law.
• The usefulness of the invention is to be judged,
  by the reference to the state of things at the
  date of filing of the patent application, if the
  invention was then useful, the fact that
  subsequent improvement have replaced the patented
• invention render it obsolete and commercially of
  no value, does not invalidate the patent.

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Issues in Utility

• Speculation or imaginary industrial uses are not
  considered to satisfy the industrial application
  requirement.
• gene sequence can "function as different types of
  markers, probes, and primers for various genetic
  research."

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Naturally Occurring Product- Funk Bro v Kilo
Inoculant

• In Funk Bros., the plaintiff, Kalo Inoculant
  Company ("Kalo") brought a patent infringement
  action against Funk Brothers Seed Company.
• Kalo alleged that its patent on an inoculant for
  leguminous plants was being used by the defendant
  without authorization.
• The inoculant was comprised of six bacterial
  species, each of which physically existed in
  nature.
• The advantages of Kalos mixture were that it
  had the capability to inoculate a wide variety of
  leguminous plants. Kato had created a mixture of
  these six bacteria using specified strains that
  would not impede the efficacy of the other.
• Speaking for the majority of the Court, Justice
  Douglas reasoned that "the combination of species
  produces no new bacteria, no change in the
  species of bacteria, and no enlargement of the
  range of their utility.
• The Patent was invalidated

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Naturally Occurring _ Diamond V Charabarty

• Microbiologist, Ananda Chakrabarty sought to
  patent his genetically engineered bacterium that
  had the capacity to break down crude oil.
• Supreme Court ruled 5-4 that Chakrabartys
  genetically modified "oil eating" bacteria was
  deserving of a patent.
• The Court reasoned that a genetically modified
  organism may qualify for patent protection as a
  new manufacture or composition
• The Court distinguished Funk Brothers on the
  grounds that Kato had created a mixture of
  naturally occurring bacteria whereas Chakrabarty
  had created a new bacterium with characteristics
  not found in nature.
• In its opinion the Court expressed its conviction
  that Congress intended the patent laws to
  encompass anything under the sun made by man.

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AMGEN V Chugai

• Amgen v. Chugai Pharmaceuticals
• Amgen brought suit contending that Chugai (GI)
  had infringed on its patent for recombinant Epo,
  a protein that stimulates the production of red
  blood cells.
• Who was the first company to actually make the
  protein?
• Amgen patented purified and isolated DNA
  sequence encoding Epo
• Since the Epo covered by the patents claims
  couldnt actually be produced
• GI patented Epo derived from classical
  biochemical methods
• On appeal Amgen wins rights due to the court
  finding that GI patent didnt sufficiently enable
  one to produce Epo. by the methods described, the
  claims were ruled invalid.

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Famous Biotech patents
4,237,224 1980 S. Cohen and H. Boyer Process
for producing biologically functional
molecular chimeras 4,259,444 1981 Ananda
Chakrabarty Engineered microbe
4,270,182 1981 Satya Asija Program (first
software patent) 4,736,866c 1988 P. Leder
T. Stewart Transgenic non-human mammal
(Harvard oncomouse) 4,987,071 1991
Thomas Cech Ribozymes 6,100,270 1996
Pfizer Sildenafil citrate inhibition cGMP
specific PDE5 6,207,829 5,395,760 1990
2001Immunex, Amgen Etanercept 5,605,690
DNA encoding tumor necrosis 5,945,397
factor-.a and -.b receptors 6,201,105
6,572,852
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A Last Word

• Thank you for your time
• Any discussion ?questions?
• Sources-
• Manual of Indian patent office
• /Phillip W Grubb, Patents for Chemicals,
  Pharmaceuticals and Biotechnology, Oxford,/I
• P Guide to Inventors-ip office phillipines/
• http//www.iusmentis.com/patents/priorart/
• See About.com- Mary Bellis, Your Guide to
  Inventors