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]
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Narendra B Zaveri, Advocate
E-mail: [email protected]
Tel: (022) 25163461
(Res) Sunflower, Rajawadi, Ghatkoper(E)
Mumbai – 400 077 (India).
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.
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 –
AZT - Insignificant innovation – co-inventor (NIH) ignored -
Wide excessive claim -
Heartless exploitation -
Patentees insignificant contribution & the heavy price -
The disastrous consequences of weak 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
Addressing US Congress on 28.01.2003 President Bush highlighted the gravity of HIV/AIDS problem & public health
50,000—are receiving the medicine they need’.
sentence, many do not seek treatment. Almost all who do
are turned away”.
(Source: Sec. 2 of HR 1298)
Addressing US Congress on 28.01.2003 President Bush highlighted the gravity of HIV/AIDS problem public health -
He says, ‘We have no medicines. Many hospitals tell people,
“you’ve got AIDS, we can’t help you. Go home and die.”
Anti-retroviral drugs can extend life for many years “
(Source: Sec. 2 of HR 1298)
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.
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.
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].
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
The list of few such frivolous patents are –
Title of patentDate
for making same
functionality & process for preparing 27.06.2000
The list of few such frivolous patents are –
Title of patentDate
hydrophilically coated filing
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.
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.
Imperative to provide pre-grant & post grant opposition &
no presumption of validity in the SPLT scheme.
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.
Unlike national POs under national laws SPLT will not have –
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
Amongst all POs, US PO has maximum facilities.
Despite its vast resources, USPO also has inherent problems in weeding out questionable claims & ensuring validity of patent grants
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:-
- Obligation to protect them necessarily follows
to any political power or system.
The pre/ post – grant opposition & no presumption of validity with right of appeal
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
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.
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.
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.