Monday, December 8, 2008

Ongoing IP Opportunism in Brazil & India May Trigger Foreign Storks' (Patent Holders') Refusal to Save the Wolf!

http://www.miscositas.com/fontaine1
http://www.miscositas.com/fables1.html



The wolf was choking on a bone and asked the stork to help him. The stork used his long beak to help him get the bone out of his throat, but the ungrateful wolf threatened to eat him in return for his good deed.

Story text and images © Lori Langer de Ramírez




Marc Chagall, "Fables La Fontaine Le Loup et La Cicogne"Limited Edition PrintLithograph 1927

















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http://www.qworkbooks.com/AZ/AZsamples/AZ_RAS_RC_3.pdf
http://www.your-poetry.com/modules.php?name=pd&file=poetry&pdid=21957





“THE WOLF AND THE STORK”




By French Poet
Jean De La Fontaine




-------------
The wolves are prone to play the glutton.
One, at a certain feast, ‘tis said,
So stuffed himself with lamb and mutton,
He seemed but little short of dead.

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Deep in his throat a bone stuck fast.
Well for this wolf, who could not speak,

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That soon a stork quite near him passed.
By signs invited, with her beak
The bone she drew



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With slight ado,
And for this skillful surgery
Demanded, modestly, her fee.
“Your fee!” replied the wolf,
In accents rather gruff;
-----------

“And is it not enough
Your neck is safe from such a gulf?
Go, for a wretch ingrate,
Nor tempt again your fate!”


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[FOR A MODERN & ESPECIALLY RELEVANT APPLICATION OF THIS LA FONTAINE FABLE, CONSIDERING BRAZIL'S ONGOING 'IP OPPORTUNISM', See: Slavi Pachovski and Lawrence Kogan, The Wolf and the Stork: How Brazil's Breaking of Drug Patents Threatens Global Trade and Public Health, ITSSD (June 14, 2005), at: http://www.itssd.org/White%20Papers/TheWolf_and_theStork-Brazil_snon-patentabilitylaw.pdf ].

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http://timesofindia.indiatimes.com/HC_revokes_Roches_patent/rssarticleshow/3798630.cms

HC revokes Roche's patent


Rupali Mukherjee


The Times of India


December 6, 2008


NEW DELHI: In a first-ever instance of a patent being revoked after being granted, the Madras High Court has set aside pharma major Roche's patent on a key drug, valganciclovir on procedural grounds. A patent on valganciclovirwas granted to the company in June 2007.


Valganciclovir is a treatment for cytomegalovirus (CMV), a virus that oftenattacks the retina of people with lower immune systems, such as AIDS patients. In addition, it is crucial for prevention of CMV infection inpatients who have received organ transplant.

The court has cited the failure of the Indian patent office to comply with the patent law and remanded the matter back to the Patent Controller.
The judgment was delivered on a petition filed by civil society groups IndianNetwork for People Living with HIV/AIDS (INP+) and Tamil Nadu Networking People with HIV/AIDS (TNNP+), who had challenged the Indian Patent Offices decision to grant a patent without hearing the pre-grant opposition filed by them.

In July 2006, INP+ and TNNP+ had filed a pre-grant opposition before theChennai Patent Office objecting to the grant of patent to Roche andrequested for a hearing. Under the Indian law, if an opponent requests a hearing, the patent office is required to provide the opponent an opportunity to be heard. However, this was not done.

At Roche's maximum retail price of over Rs 1000 per tablet, a patient whohas to take a treatment course of approximately four months for CMVretinitis in India would have to pay over Rs 2.5 lakh. This puts thetreatment unafforable for those who need them.

The grant of patent to Roche allowed it to continue charging exorbitant prices and also prevented the entry of generic versions of valganciclovir.
However, in May this year, Cipla launched the generic valganciclovir in thedomestic market at a price of Rs 245 for a tablet. Under law, a generic producer can challenge the patent by taking the risk of launching a generic version after obtaining marketing approval. In response, Roche filed an infringement suit against Cipla in the Bombay High Court in September seeking an injunction, which is till pending.
The dispute between the companies hinges on "patentability'' of the drug. The validity of the patent is in question under the country's patent laws that do not allow patents on new forms of old drugs, also known as Section 3(d). Experts pointed out that valganciclovir is a hydrochloride salt of an olddrug `ganciclovir' and hence not patentable.

The generic producers of the drug, Matrix, Ranbaxy and Cipla have also filed post grant oppositions.

While the opportunity to oppose the application is only granted to the patient groups, it is likely that Roche's injunction proceedings against Cipla for launching the generic version will no longer have a legal basis as the patent is now revoked.
Whether the Mumbai court will keep the infringement proceedings pending remains to be seen, legal experts say.
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http://www.ip-watch.org/weblog/index.php?p=1344

Brazilian Draft Law Would Curb Expanded Patents On Pharmaceuticals


By Claudia Jurberg


Intellectual Property Watch


December 2, 2008


RIO DE JANEIRO - Brazil’s lower house of Congress held a recent hearing to discuss proposed changes to rules on pharmaceutical patents that would limit patents on two types of pharmaceuticals.


Under proposed legislation, patent rights would not be permitted in two modalities: second-use drugs and polymorphs.


A second-use drug patent refers to when another function is discovered in a drug for which the pharmaceutical industry holds the patent on a substance. The situation could be explained as a positive side effect.


In the case of polymorph patents, the substance is made with the same material and shows the same effects as the medicines protected by a patent, according to legislation author Deputy Paulo Teixeira. It is like a substance with the same crystalline forms.


The authors of the legislation are congressional deputies Teixeira and Dr. Rosinha (Florisvaldo Fier) of the Workers Party, the same political party as the Brazilian president.


According to Luis Carlos Wanderley Lima, coordinator of intellectual property at the Brazilian National Health Surveillance Agency (Anvisa), both cases lack novelty - one of the principles required to issue a patent.


Wanderley Lima said that applying patents to polymorphs has been identified as a pharmaceutical industry strategy to expand patents and gain a monopoly on some substances important to the commercial market. In his view, it could be valid to developed countries but it could prejudice developing countries such as Brazil because it causes a delay of generic drugs’ entrance in the market.


The president of the Brazil Patent Office (INPI), Jorge Avila, said during the 31 October hearing that in his view “there is space for an [positive] environment for business initiatives in the country while at the same time it is possible to promote the strengthening of production of generics and encourage Brazilian research in the pharmaceutical area.”


Researcher Claudia Chamas, representative of the Health Ministry, said “there is a profound difference in understanding between the INPI’s guidelines and the opinion of the deputies.” According to her, the project of the deputies is better, because it incentivises the innovation and curb the excesses.

In general, the acceptance of pharmaceutical patents in Brazil should be very carefully done, said Wanderley Lima, as patents can limit the access to drugs.


The attention to protection of drug patents is significant because it could have implications for public health. Access to medications by governments and consumers can be restricted to a single producer who monopolises production and could choose to charge high prices, thereby causing a problem to the public health system, according to Wanderly Lima.


[HOWEVER, THE MERE ACT OF DEVELOPING AN INNOVATIVE LANDMARK DRUG FOR WHICH A PATENT HAS BEEN GRANTED IN A DEVELOPED COUNTRY OR AT THE WIPO, DOES NOT, BY ITSELF, WITHOUT MORE, INDICATE THAT ILLEGAL MONOPOLISTIC PRACTICES HAVE OCCURRED, ARE OCCURRING OR WILL OCCUR IN THE FUTURE. THESE BRAZILIAN BUREAUCRATS AND LEGISLATORS ARE TRYING TO CREATE A LEGAL FICTION - A FALSE PRESUMPTION OF ILLEGALITY (MONOPOLISTIC PRACTICES) - i.e., THAT MARKET LEADERS IN THE PHARMACEUTICAL INDUSTRY HOLDING VALUABLE DRUG PATENTS & TRADE SECRET KNOW-HOW ARE, BY VIRTUE OF THEIR OWNERSHIP OF SUCH RIGHTS, EXPLOITING OR PLANNING TO EXPLOIT SOCIETY FOR PECUNIARY GAIN. THESE PIECES OF LEGISLATION ARE NOTHING MORE THAN A COORDINATED EFFORT AT LEGITIMIZING THE PLANNED EXPROPRIATION OF FOREIGN DRUG PATENTS!!]


Every nation has the right to define patent concession criteria for pharmaceutical companies, he said, adding that public health can be adversely affected by broad application of patent rights, such as in the case of second-use drugs.


[WHILE THIS IS TRUE, IT IS ANOTHER MATTER ENTIRELY TO REDEFINE THE INTERNATIONAL STANDARD FOR 'NOVELTY' AS AN ELEMENT OF 'PATENTABILITY'. THIS IS NOT SANCTIONED BY THE WTO TRIPS AGREEMENT, NOTWITHSTANDING WHAT THE LEFT-LEANING BRAZILIAN, U.S., & EUROPEAN 'INTELLECTUALS' SAY.]

According to him, “It is important that the INPI discusses the organisational guidelines and the examination of patents, but it is fundamental that they do not forget the interests of society.”

This subject should be resolved quickly by an Intellectual Property Interministerial Group, Chamas said. For her, patents such as on second-use drugs and polymorphs do not have support in Brazilian law, which provides rights only for patents on products and processes with novelty, inventive activity and industrial application.




“These undue monopolies could cause an increase in medicine prices and bring obstacles to development assistance programmes and to the pharmaceutical industry in general,” Chamas told Intellectual Property Watch. “It is a barrier to free competition, plus an unjustified monopoly.”


Prior Informed Consent



A further discussion regarding patents is occurring between Anvisa and INPI on prior informed consent. For approval of the right of a drug patent in Brazil, both Anvisa and INPI give their opinion.



Anvisa has established stiff rules on obtaining this kind of privilege and the agency showed this position to INPI. The agency says it understands the importance of the patent system to pharmaceutical companies, but believes that this protection of patent could be given only to drugs that meet the basic requirements and not just for any kind of patent. The concern is that there are a lot of made-up situations that do not bring any benefit to the country and prejudice the public interest.






[ACTUALLY, THE GRANT OF A PATENT IS A RIGHT, NOT A PRIVILEGE, PROVIDED THE STATUTORY REQUIREMENTS ARE SATISFIED. BUT, THIS DOES NOT VEST GOVERNMENTS WITH THE UNFETTERED DISCRETION TO DEPART FROM LONG-ACCEPTED LEGAL PRINCIPLES TO EFFECTIVELY CONVERT WHAT IS INTERNATIONALLY RECOGNIZED AS A 'PRIVATE PROPERTY RIGHT' INTO A 'PUBLIC INTEREST' RIGHT, & CONSEQUENTLY, A GOVERNMENT PRIVILEGE].




On the other hand, there are many critics of prior informed consent, many arguing that the mechanism delays the patent processing system. For this reason, at the lower house of Congress there is proposed legislation from Deputy Rafael Guerra that would eliminate the prior informed consent mechanism realised by Anvisa. If the legislation were approved, the agency would no longer analyse all patent requirements.





[THE 'INFORMED CONSENT' REQUIREMENT, IF ADOPTED, WOULD EFFECTIVELY INJECT OTHER THAN LEGAL & ECONOMIC PATENTABILITY CRITERIA (i.e., HUMAN & SOCIAL RIGHTS THEORIES), INTO THE PATENT REVIEW PROCESS, & THUS, RESULT IN THE LOSS OF VALUABLE PRIVATE PROPERTY RIGHTS & THE 'EXACTING OF RENTS' FROM FOREIGN PATENT HOLDERS & BRAZILIAN PATENT APPLICANTS BY GREEDY BRAZILIAN GOVERNMENT BUREAUCRATS. AFTER ALL, AS NUMEROUS MEDIA REPORTS REFLECT, BRAZILIAN GOVERNMENT BUREAUCRATS & LEGISLATORS ARE NO STRANGERS TO CORRUPTION!!].






Wanderly Lima said that the Anvisa had created a special coordination with professionals to perform this task, and the period of analysis is about 120 days. After this period, if the patent is granted, the holder shall have the exclusive rights to exploit the object protected by the period of 20 years. Therefore, he said there is a need for a careful review because they are giving a monopoly, and must take into account that this implies a lack of competition and, consequently, the final price of the product to the public and for Health Ministry programs.






According to him, 1002 applications were sent for analysis by Anvisa from 2001 to 2007, and 752, or 68 percent, were approved. Around 30 percent stumbled on requirements before being granted permission, which he said proves the accuracy of the mechanism.






[THIS REASONING HAS NO VALIDITY SINCE IT IS A TAUTOLOGY - CIRCULAR REASONING - WHEREIN 'THE ENDS JUSTIFY THE MEANS' AND 'THE MEANS JUSTIFY THE ENDS'.]






About 5 percent of the applications were denied permission due to purely legal aspects, such as the lack of novelty or inventive activity. This shows that the prior informed consent process is aimed at granting the patent according to Brazilian law while preventing the suffering of society by undue restrictions on drugs, such as high prices.






If this initiative of the Deputy Guerra advances, it will change one of the most important articles of the patent system and weaken the Brazilian system, said Wanderley Lima. If approved, he added, it could cause a serious drop in the quality of the examination of pharmaceuticals patents, generating worrisome economic and social consequences to society.






Claudia Jurberg may be reached at info@ip-watch.ch.

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