scp_of_ge_06_zaveri.ppt-Standard essential

procedures on grant of various rights

1. EFFECTIVE MECHANISMS TO CHALLENGE
THE VALIDITY OF PATENTS
(PRE-GRANT & POST GRANT OPPOSITION
-REVISION OF THE PRESUMPTION OF VALIDITY OF PATENTS )
Presentation at
WIPO – Open Forum on Draft SPLT
Geneva - 2
nd
March 2006
BY
Narendra B Zaveri, Advocate
E-mail: [email protected]
Tel: [phone]
(Res) Sunflower, Rajawadi, Ghatkoper(E)
Mumbai – 400 077 (India).

2. Harmonization envisages much larger & more
extensive role & jurisdiction for WIPO/I.B.
PCT + POs of all members = SPLT
PCT – - international phase - facilitator / advisory
- preliminary search/examination
- no responsibility to third parties
Members POs - national phase - final search/examination
– opposition & grant of national patents as per national law

– accountable to national stake holders
WIPO/I.B. – international + national phase
– facilitator-grantor of global patent rights as per SPLT
– obligation to protect all other stake holders globally
has to be accepted as part of SPLT scheme.

3. Pre / Post grant oppn.& no presumption of validity
are correctives & safeguards
The precise mechanism to make them effective safeguards can only be
decided when the scheme of harmonization & the organizational set up
are finalised for implementing.
Whatever be the final scheme there can be no doubt that all the three
safeguards have to be effectively provided in view of –
i.Grave consequences for other stake holders from questionable
patent grants;
i.On consideration of principles of proportionality & quid pro quo;
ii.The need to balance rights & obligations of all stake holders;
iii.The actual past experience of working of POs & PCT;
iv.The inherent problems & limitations of patent system, PCT & SPLT.

4. Global patent system –
the disastrous consequences of weak patents
HIV/AIDS crises
AZT - Insignificant innovation – co-inventor (NIH) ignored -
•AZT – a drug known since 1965, its anti-viral effects known since 1975, Burroughs
Wellcome – ignoring co-inventors (NIH) contribution - claimed & secured product
patents in USA, & several African & other countries merely on basis of discovery of its
new use for treatment of HIV/AIDS
Wide excessive claim -
•While in USA product patent granted covering all formulations covering all uses, in
Ireland, granted for specific formulations limited to treatment of AIDS/HIV.
Heartless exploitation -
•Patentee selling the drug at US$ 10000/- plus & obstructing supply of generic
product @ 3% – millions dying / suffering untreated – appeals of UNO, WHO,
Doha Declaration ignored.
•Pre-grant opposition could have prevented questionable grant.
Patentees insignificant contribution & the heavy price -
The disastrous consequences of weak patents……..

5. Gross abuse of patent system –
AZT patent not an isolated case
Proliferation of ‘me-too’ drug patents

Alarmed by FTC Report of brand name companies resorting to
proliferation of drug patents & anti-competitive practices to maintain
outrageously high drug prices, in October 2002,
President Bush amended the FDA Regulations complaining:

“…... When a drug patent is about to expire, one method some companies
use is to file a brand new patent based on a minor feature, such as the
color of the pill bottle or a specific combination of ingredients
unrelated to the drug’s effectiveness. In this way, the brand name
company buys time through repeated delays, called automatic stays,
that freeze the status quo as the legal complexities are sorted out”
US Congress also concerned & acts -
Worried that anti-competitive practices adopted by brand name
companies to maintain outrageously high drug prices, which required
US consumers to pay 8 to 10 Bn $ per year, several Bills (S.812 etc.)
have also been proposed & are pending in US Congress to control the
abuse of patent monopoly
Pre-grant opposition - the remedy

6. ONLY 50,000 RECEIVING TREATMENT AGAINST
1 BILLION VICTIMS !!!
Does it benefit poor millions in developing countries?
Addressing US Congress on 28.01.2003 President Bush
highlighted the gravity of HIV/AIDS problem & public health
• nearly 30,000,000 (including 3,000,000 children) people
suffer from AIDS;
• more than 4,000,000 require immediate drug treatment.
• ‘Yet across that continent, only 50,000 AIDS victims—only
50,000—are receiving the medicine they need’.
• ‘‘Because the AIDS diagnosis is considered a death
sentence, many do not seek treatment. Almost all who do
are turned away”.
(Source: Sec. 2 of HR 1298)

7. “seldom has history offered a greater opportunity
to do so much for so many” – President Bush
The Challenge before global patent system
Addressing US Congress on 28.01.2003 President Bush highlighted
the gravity of HIV/AIDS problem public health -

•“A doctor in rural South Africa describes his frustration.
He says, ‘We have no medicines. Many hospitals tell people,

“you’ve got AIDS, we can’t help you. Go home and die.”
•“In an age of miraculous medicines, no person should have to
hear those words.” - AIDS can be prevented.
Anti-retroviral drugs can extend life for many years “
•* * * Ladies and gentle-men, seldom has history offered a
greater opportunity to do so much for so many.’
(Source: Sec. 2 of HR 1298)

8. EMR grant for Glivec –
Disaster for blood cancer patients in India
There being no pre-grant opposition, against
Exclusive marketing Right (EMR), Novartis could
secure EMR for insignificant innovation in
imatinib mesylate (Glivec) formulation in
November 2003, enabling them to obstruct
production & supplies by generic manufacturers
& block treatment to thousands of victims - of
deadly blood cancer – many of them children,
already receiving treatment by generic drugs
available at less than 10% of Novartis’s price.

9. EMR grant for Glivec –
Disaster for blood cancer patients in India
However pre-grant opposition provided by law &
preferred against Novartis’s same patent
application for Glivec, was allowed & patent
claim was rejected by PO enabling six generic
manufacturers to resume production & more
blood cancer patients to receive treatment.
Absence/provision of pre-grant opposition can be
a matter of life & death for many – particularly
the poor millions in developing countries.

10. Global patents - quid pro quo
Rights & interests of other stake holders -

Grant of a patent, directly results in denial of, not only production,
distribution and trading opportunities to all other than the patentee,
but more importantly, it also denies to the consumers, community and
the nation, alternate sources of supplies at fair and reasonable prices
and in adequate quantities. It also blocks up for long periods, large
areas for further R&D for the scientist and research workers working
on the subject.

Quid pro quo required -
Creation and grant of an extensive statutory monopoly can be justified only
on quid pro quo basis, i.e. on basis of the claimant making and disclosing an
invention involving ‘important technical advance of considerable
economic significance’ [TRIPS – Art. 31(l)] and satisfying the
patentability criteria of novelty, inventive step and utility for the same
[TRIPS – Art. 27].

11. Frivolous claims - questionable patents
- serious problems
Unscrupulous, irresponsible, fraudulent claims
Many unscrupulous and irresponsible claimants are known to make false,
frivolous, repetitive or excessive claims.
Some of the patent grants by USPTO prompted, Mr. Levin of Yale University
to submit before US Congress Sub-Committee on IPR in 2005 -
“One can always find patents that appear dubious & some that
are even laughable – the patent for cutting & styling hair using
scissors or combs in both h&s.”
Reference of few such ‘laughable’ patent grants depriving other citizens of
their lawful rights fully justifies introduction of all the three safeguards –
pre/post grant opposition & no presumption of validity

12. Laughable - frivolous patents
only insignificant improvements
The list of few such frivolous patents are –
Title of patent Date
•Food sclices & method 10.07.2001
for making same
•Filled potato product
17.02.2004
•Extruded potato casing
7.05.2002
•Preservation of exposed cut fresh fruit
12.12.2000
•French fry potato with improved
functionality & process for preparing 27.06.2000
•Drops of honey 26.08.2003
•Ice-cream with fat containing coating 10.04.2001
•Composite ice-cream cone 4.05.2001
•Food slices & method & apparatus 5.01.1999

13. Laughable - frivolous patents
issued by US Patent Office
The list of few such frivolous patents are –
Title of patentDate
•Filled snack product having a28.04.1987
hydrophilically coated filing
•Use of turmeric in wound healing 28.03.1995
•Crispy chip sandwich 19.03.1996
•Sealed crustless sandwich21.12.1999
Grant of frivolous/questionable patents deprives other stake holders of their
legitimate right with no reciprocal benefit

The facility of acquiring global patents at least cost will provide a strong
inducement for such frivolous claims
The correctives of pre/ post – grant opposition & no presumption of validity
have to be provided as effective deterrents to discourage & control such
tendency & questionable claims & patent grants.
There can be no presumption of validity for such patent grants also because of the
inherent unavoidable problems of search & examination at all POs (including US
PO) & under PCT.

14. Laughable - frivolous patents
Principles of proportionality
& quid pro quo cannot be ignored

Grant of such patents under SPLT will only deprive poor
millions in developing countries of their existing rights &
obstruct their normal lives & subject them to costly litigations
but no development.
There is no quid pro quo – such patents are granted with no
corresponding benefit to the other stake holders for the
sacrifice of their rights.
The benefit to patentee from such patent grants is totally
disproportionate to the technological or innovative contribution
made by them, & sacrifices to be made by other stake holders.

15. Laughable frivolous patents-
SPLT must protect developing countries
•Grant of such laughable, frivolous or ‘me-too’ drug patents most
disastrous for peoples in developing countries.
•To protect their interests, SPLT should ensure stricter standards of
patentability as recommended by U.K.CIP Report (2002):
“Limiting the scope of subject matter that can be patented”
“Applying standards such that only patents which meet strict
requirements for patentability are granted & that the breadth of each
patent is commensurate with the inventive contribution & the
disclosure made”
“Providing extensive safeguards to ensure that patent rights are not
exploited inappropriately.”
Imperative to provide pre-grant & post grant opposition &
no presumption of validity in the SPLT scheme.

16. The Pre/post grant opposition & no presumption of
validity are correctives & safeguards necessary to:
(i)Ensure that patents are granted only for qualifying inventions &
claims;
(ii)Eliminate & discourage false, fraudulent, frivolous, excessive,
repetitive claims;
(iii)Provide effective remedy for revocation of questionable patent
grants;
(iv)Protect other stake holders against deprivation of their rights by
wrongful patent claims & questionable patent grants.

These cannot be discounted as unnecessary procedural
requirements, delaying patent grant or as weapons in hands of
unscrupulous rivals for delaying / harassing bonafide patent
claims.

17. Inherent limitations of SPLT/WIPO/I.B
Unlike national POs under national laws SPLT will not have –
•Jurisdiction or powers to require oaths declarations / disclosures or enforce them
(as in US & Australian Pat. Laws)
•Powers to punish claimants making false /fraudulent /frivolous / repetitive /
excessive patent claims – a serious handicap.
•Such strong deterrent & disincentive against wrongful claims & questionable
patents.
•The benefit of independent search & examinations by several national POs will not
be available.
•The benefit of review by way of appeal against decisions of national POs will not
be available.
•Power to limit scope of adverse impact on other stake holders by excluding some
patentable subjects (business methods, methods for treatment etc)

18. Limitations of PCT – also of SPLT
Problems of language & delayed information
(source – PCT/R/WG/7/7dt. 11.04.05)
•“no Office in the world is capable of thoroughly searching disclosures
written in all languages, even if it has access to them in its search
databases;
•the most relevant prior art for a particular invention will sometimes be in a
language in which the International Searching Authority is not specialized --- ----
leaving a significant risk that its relevance will not be fully appreciated;
•any International Searching Authority whose official languages do not include
Japanese, Russian or Spanish is entitled not to include in its documentation such
language patents for which no abstracts in the English language are available.
•at the time that the international search is performed, some relevant
documents may not yet have reached the search databases
•Documents published shortly before the filing date of the international application
may also be missed because, ….. there will usually be a delay between
publication and classification (where applicable) and loading into the search
databases.”

19. Problems of National Pos
in eliminating questionable patents
•Increasing volume of work
•Massive record of previous patents
•Maintaining & updating records, classified indices, & search facilities &
scientific & technical literature & references in different fields
•Complexities of advanced technologies in different fields
•Applications filed in different languages from the language of the examiner
languages & translations
•Documentation & updating prior art & traditional knowledge Increasing size
of each application & number of claims
•Extending patent protection for new technical fields like – biotechnology,
genetic engineering, information technology, & to new subjects like business
methods etc.
•Tremendously increased workload at POs.
•Inexperienced untrained examiners – with limited technological capabilities.
It is absolutely necessary to supplement resources & expertise at
POs through pre-grant opposition & to provide protection against
questionable patents through post grant opposition & no presumption

20. Resources & problems of
US Patent Office
Amongst all POs, US PO has maximum facilities.
•occupies total of over 1,400,000 sq.ft in 18 buildings
•workforce is comprised of 6,939 Federal employees, including 3,538
patent examiners & approximately 4,000 contract employees.
•the USPTO received 333,688 patent applications, published
169,729 pending applications 18 months after filing and issued
162,221 patent grants in 2002.
Despite its vast resources, USPO also has inherent
problems in weeding out questionable claims & ensuring
validity of patent grants

•review of granted patents showed error rate of about 5%, i.e.
about 7000 to 8000 questionable patents had been issued.

21. Resources & problems of
US Patent Office
Despite its vast resources, USPO has inherent problems -
Special problems of biotech applications.
In 1996, some 350 gene patent applications, claiming over 500,000 sequences
were pending in U.S. Patent Office. It reported:-
•“Processing these applications presents unprecedented search and
examination challenges, even with the most modern equipment.
The PTO estimates that it would take one patent examiner 200
years to initially examine these applications, and it would take
the entire biotechnology group of 200 examiners a full year at a
cost of over $34 million..”
•“We simply don't have the resources to tackle this challenge
under current policy,” vide PTO press statement of 23.10.1996.

22. SPLT – WIPO/I.B – Harmonization scheme
All powers but no accountability !!!
•Assumption of jurisdiction & powers to grant global patent rights – binding
on all stake holders in all member countries including –
–Consumers/users of patented invention; Research workers
–Small & big industries; International trade
–Governments of member countries

• Deprives member countries of their powers / obligations to protect other
stake holders – restricts rights of other stake holders
- Obligation to protect them necessarily follows
•But there is no accountability for SPLT/WIPO/I.B actions
to any political power or system.
•Need & obligation to provide built-in effective safeguards against
wrongful grants to protect interests of other stake holders has to be
accepted.
•Only safeguards under SPLT for other stake holders –
The pre/ post – grant opposition & no presumption of validity
with right of appeal

23. Principle of proportionality requires all
three safeguards to be provided
Pre-grant opposition –
The circumstances justifying post grant opposition also fully supports pre-grant
opposition. The only objections to pre-grant opposition is based on
apprehension that it will delay the grant of patents for bonafide claimants,
put them to additional costs & may be abused by unscrupulous rivals to
harass them. It will act as disincentive for research.
The inconvenience delay & loss caused to any bonafide claimant is totally
insignificant compared to the tremendous loss (including loss of lives) that
can be caused by questionable patent grants to millions of stake holders in
several countries for long periods.
The rights & interests of millions in several countries cannot be sacrificed to
benefit one applicant – individual or corporatation.
On applying principles of proportionality, the pre-grant opposition has to be
allowed

24. Principle of proportionality requires all
three safeguards to be provided
Post grant opposition -
Patent Laws of most countries contain this provision.
In USA in view of adverse experience of weak
reexamination procedures, the post grant reexamination
procedure has been progressively made more effective &
stronger by amendments in 1999 & 2002 & a 2005 Bill to
further amend the law to make the post grant opposition
procedure more effective is pending in US Congress. The
statements of expert witnesses made before IPR Sub-
Committee fully endorsed the need for such safeguards.
The need for post grant opposition is universally
accepted.

25. Validity of patents not
guaranteed
It is for this reason and the inherent
complexity of the problems in examination
and enforcement of patents, that the form of
patent under the Indian Patent Act, 1970,
specifically states that “the validity of this
patent is not guaranteed” and specific
provisions are made to that effect in Section
13(4) of P.A. 1970, Sec. 116(1) of U.K. Act,
1977 and Section 20 of Australian Act,
disowning, and claiming immunity from, any
responsibility of guaranteeing validity of a
patent.

26. No presumption of validity
Burden of Proof only on patent holder
U.S. Law on Burden of Proof -
Burden is on the party asserting the right to exclude.
Generally, the party seeking to establish a right to exclude
another from using a creation or marketing tool has the burden
to prove its entitlement to one of the forms of intellectual
property. The burden of proving validity and infringement of an
intellectual property right is on the party wishing to exclude.
[Ref: Durham Inds. Inc. v. Tomy Corp., 630
F.2d 905, 908, 208 USPQ 10, 13 (2d Cir. 1980)]
The law must clearly and specifically spell out that the primary
and sole responsibility to support his claim or patent is on the
inventor/ applicant. It must also spell out the consequences of
suppression or failure to disclose.

27. Time being short this presentation avoids
dealing with other organizational &
procedural problems relating to pre/post
grant opposition which would arise &
require careful consideration before final
adoption of SPLT & harmonization
scheme.

28. Thanks