final ipr

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8/8/2019 final ipr


PROS & CONS OF IPR IN DRUG DEVELOPMENT

PROS CONS

Instrument for promotion and innovation Lack of clarity in the intellectual propertyregime

Stimulates and rewards creativity Patent examiners ill-equipped to appreciate theefficacy standards

Triggers important research that leads to better discoveries

Limits the access of the drug to the poor nations

Entails a tradeoff between profit and socialneeds

Patents give companies a powerful financialincentive to invest in the risky and expensive

process of drug development

Pharmaceutical applications are usually filed atthe initial stage of drug discovery, and it is

much later in the development cycle, thatefficacy and safety data is generated during

clinical trials.

Fosters Both Breakthrough and Incremental Innovation:by stopping development of new formulations or new

combinations of compounds already approved

Contributes to drug development Spending: When thepatent on a brand name drug is extended or a drug is

granted a period of market exclusivity, consumers pay

more for the product over a longer period. The result isincreasedoverall spending on prescription drugs

Encourages industry to bring Collaboration of market

drug development with Federal Laboratories : IPP also

applies to drugs developed at public expense, enabling

private companies to secure patent and other types of IPPfrom discoveriesfunded in part by taxpayers

Shields Branded Drugs from Price Competition: IPP

promotes an oligopolistic market for brand name drugs,where as few as two or three products can dominate a

therapeuticcategory

IMPORTANCE

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RECOMMENDATION

y Implementing public health and domestic industry friendly patent Laws

TRIPs should allow flexibility for countries to define what an invention is Implement patent laws that safeguard public health needs and allow domestic

industries to develop technical knowledge to µcatch-up¶

y Improving the patent information asymmetry and expertise of examiners at patent

offices

Improving access to patent information (information asymmetry) to make informed

decisions on whether to enter the market with generic products

Many patent offices in the region need better qualified examiners and examination

systems to improve patent quality

y Challenging of poor quality patents by domestic companies, science community and

public

On closer scrutiny, a number of pharmaceutical patents are unmerited because of procedural irregularities at filing, broad claims, are inventions already in the public

domain or are not inventive

FINDINGS

y PATENTS AND MONEY is not the only cause of creativity, the idea that bettering

society as a whole would be motivation enough to spur new innovations.

y The provision for the grant of compulsory licenses under Article 30 & 31 also

emphasize the need for ensuring availability of patented products, when the patent

holder is unable to meet the consumers demand.

y The high costs of drugs are related to limited monopoly and exclusivity in the market

place for patent protected drugs.

y TRIPS make it clear in Article 1, 7 & 8 that nothing in the agreement should stand in

the way of ensuring public welfare and social benefit arising out of creation of

Intellectual Property.

y IPP activity will increase as manufacturers seek to protect the $20 billion worth of

drugs coming off patent in 2012.

CONCLUSION

y The consensus amongst the World Trade Organization (WTO) is that public health

precedes intellectual property rights during national emergencies. y As spending on drugs continues to rises the repercussions of current patent laws and

other protections for pharmaceuticals now warrant scrutiny.

y It is safe to say that the benefits of patents outweigh the cost over the long run as long

as the patent holders don¶t use loop holes to gain more patents on essentially the same

products.

y As the safe guard and flexibilities in the IPR/TRIPs which have wide latitude for

legislation, interpretation and implementation by the member states need to be

properly understood and effectively used by the members to derive maximum benefits.

y The number of people world-wide who have access to medicine is staggeringly low, and

allowing patents on drugs, although increase the number of advancements in life-

saving technologies, will decrease the number of people who has access to them.

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International efforts should focus on allocating monetary motivation to provide people

to access drugs.

APPROACH TO COUNTER THE IMBALANCE

1) Patent pool

y It involves collective management of IP to expand access to needed medical, technology and

products

y License the patent to one of them or to a third party under predetermined licensing terms for

exploitation by a sponsor.

2) Open Source Drug Development

y It is basically a system of pooling global information sources, expertise, facilities and

management system for drug discovery.

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y In this system, individuals, groups and organizations pitch in to develop new drugs by

offering their resources & services in an open format.

y Free access to all required information and their use in an integrated manner by designated

groups will accelerate the process of drug delivery.

OPPORTUNITIES AND CHALLENGES OF IPR IN DRUG

DEVELOPMENT

OPPORTUNITY CHALLENGES

Price leadership: They occasionally give

absolute command of the market, enabling

the owner to name the price without regard

to cost of production.´

Expiration of patents can significantly reducedrug prices by ~30%

The best and most effective means of

controlling the competition

Section 3(d) discriminates between patents on

inventions specifically relating to pharmaceutical compounds and other

technology areas by creating an additionalhurdle for pharmaceutical inventions alone

Provides exclusive rights to patent holder on

the patented drug

Balance between the high prices of patented

drugs and availability of drug to needy patientsat affordable prices

Provide incentive to invest in R&D to invest

in new medicines

Extension of patent life by the patent holder -loop hole to hold back further advances in

technology for a generic company

Allow to recoup any cost they incurred in

the development of the product

Higher prices can slow the diffusion of new

technology by making the product moreexpensive for some who would benefit

3 STATUTES

IN WHICH

IPR HASHELPED

EXTENDED THETERM OF THE

ORIGINALPATENT

SHORTENED THE

PERIOD OF TIME

CONSUMED BYCLINICAL TESTING

AND REGULATORY

REVIEW

GRANTED

MARKET

EXCLUSIVITY TODRUGS UNDER

CERTAIN

CIRCUMSTANCES

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