Saturday, February 4, 2017

WIFE BATTERY: A SOCIO-LEGAL PROBLEM IN INDIA


Indian society is multi religious society. Each has their own sociological and cultural values. Marriage is common in every religion. In Indian culture, the girls enter into marital relationship. She is expected to shift her loyalties from parents and siblings to in her husband and in-laws. She has no independent social or economical status. Her social status is dependent on her husband’s status in the family. Husband uses violence against wife to reinforce his dominant position. The use of continues methods by husbands against wives have societal approval.

In a recent case of Mrs. Savita Bhanot v. Lt. Col. V. D. Bhanot , apex court is already felt that it is historical reality that the women in our society have been subjected to discrimination, misbehavior and ill-treatment, not only outside but also inside their houses.” Even working women, whether she is a construction worker who works side by side with her husband or a well–educated and a suitably employed professional is not always accorded the dignity and respect, which ought to be given to her on home front.

CONDITION OF THE WIFE IN ANCIENT PERIOD OF TIME:
In the Vedic period the social status of women was subordinate to her husband. In Puranas, picture of ideal wife is painted like this:-“Who speaks sweetly to her husband and is a clever manager of household affairs, is a true wife. She who is one in spirit with her Lord, and devotes her whole self to his happiness, is a true wife.”

Manu was the first man to lay-down the status of women in society. He averred that a mother is more revere than a thousand fathers. But the place of the women in a society is of very lower status. According to Manu the place of women should be in level with the lowest of all groups in Aryan society. Women are required to believe from that they are inferior to men. Thus a woman has to face gender discrimination from birth to death. The permissive gender discrimination is deeply rooted in the notion of patriarchy. Violence against women is a manifestation of historically unequal power relations between men and women, which have led to domination over and discrimination against women by men. Violence against women is one of the crucial social mechanisms by which women are forced into a subordinate position compared with men. The code of Manu directed that wife should be considered of no more importance than a chattel of her husband. Whether a drunkard, leper, sadist or wife beater, husband is to be worshipped as a God.

CONCEPT AND MEANING OF WIFE-BATTERY:
Wife-battery almost found in every society. In Europe, it is said that “a man had the right to beat his wife with a stick not thicker than his thumb.” In our culture we found a quotation of Tulsidas such as “Drums, donkeys and women need to be beaten.” It shows that problem of wife-battery is traditionally accepted in society.

Meaning of wife-battery is not given in Indian law. ‘Battery’ means higher degree of assault. According to Black’s Law Dictionary, ‘Battery’ is: "an intentional and offensive touching of another without lawful jurisdiction”. In other words, the meaning of battery is use of force against another, resulting in harmful or offensive contact. It also termed as criminal battery. “Criminal battery” sometimes defined briefly as the unlawful application of force to the person of another. There are three basic elements of it:-
1. The defendant’s conduct (act or omission);
2. His mental state; intention to kill or injure or doing of an unlawful act, or criminal negligence; and
3. The harmful result to the victim, a bodily injury or an offensive touching.

The word battery is used in law of torts, where ‘Battery consists in touching another’s person hostilely or against his will. It is the actual application of force to the person of another, done without justification, in a rude, angry, insolent or revengeful manner. In other words, the intentional application of force to the person of another without lawful justification constitutes the wrong of battery e.g. the least touching of a man in anger is a battery. In case of married women, it may be possible to argue that unwanted sexual contact forced upon her by her husband is battery.

Battery may include sexual abuse, emotional abuse, economic abuse, abusing children, threats, abusing male privilege, intimidation, isolation, and a variety of other behaviors used to maintain fear, intimidation and power. Battery happens when one person believe they are entitled to control another, and wife are most common victim of the violence. The problem of wife-battery is perhaps as old as the institution of marriage.

WIFE BATTERY IN OTHER COUNTRIES:
The United Nations defined the term "violence against women" in a 1993 Declaration as “Any act of gender based violence that results in, or is likely to result in physical, sexual or psychological harm or suffering to women including the threats of such acts, coercion or arbitrary deprivation of liberty whether occurring in public or private life." The domestic violence is prevalent throughout the world with women regardless of age, education level, socio-economic class and family living arrangement.

International community has created effective legal standards that address domestic violence. The rights of battered women may be asserted under international and regional human rights conventions that are legally binding upon ratifying states. The International Bill of Human Rights (IBHR) comprised of the Universal Declaration of Human Rights (UDHR) , the International Covenant on Civil and Political Rights (ICCPR), and the International Covenant on Economic, Social and Cultural Rights (ICESCR), set forth general human rights standards that victims of domestic violence may invoke against their state of citizenship.

WIFE BATTERY IN INDIA:
In India the domestic violence is prevalent because husband has been vested with superior status in society. Indian Penal Code, 1860 has declared a number of acts of violence against human body to be an offence, for example sections 313(causing miscarriage without woman’s consent), 314(death caused by act done with intent to cause miscarriage), 322(voluntarily causing grievous hurt), 340(wrongful confinement), 354(assault or criminal force to woman with intent to outrage her modesty), 375(rape) etc. These violent acts may be towards a person in public or domestically within the four walls of a house i.e. wife and children. Thus the law prohibits a husband/man in any social community to commit an offence with his women.

Dowry Death: Section 304B
The legislature has tried to protect such women by enacting many provisions of law in this regard as Dowry Prohibition Act. This describes dowry death as a death caused by burns or bodily injury or occurs otherwise than under normal circumstances within seven year of her marriage. And it is shown that soon before her death she was subject to cruelty or in connection with any demand for dowry and such husband or relative shall be deemed to have caused her death, shall be punished with imprisonment for a term which shall not be less than seven years but which may extend to imprisonment for life. Section 113A and 113B has been added in the Indian Evidence Act, 1873 because it is very difficult for an aggrieved lady to collect eye-witness of each and every incidence. So burden of proof has been placed on the accused husband to prove his innocence.

Grievous Hurt: Section 320: shall be punishable with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.

Cruelty: Section 498A: with an object to protect a woman who is being harassed by her husband or relative of husband, such cruelty shall be punishable with imprisonment for a term which may extend to three years and shall also be liable to fine.

Causing miscarriage without woman’s consent: Section 313: shall be punishable with imprisonment for life or with imprisonment of either description for a term which may extent to ten years, and shall also be liable to fine.

Intentional insult: Section 504: in this section law provides a remedy for using abusive or insulting language, abusive language must be used with an intention to abuse, shall be punished with imprisonment of either to two years or with fine or with both.

Assault or criminal force to women with intent to outrage her modesty: Section 354: shall be punishable with an imprisonment of either description for a term which may extend to two years or with fine or both.

Dowry Prohibition Act has also been passed to protect the interest of woman. Violence is being faced by every woman but many of women do not approach in the court at all. In our country wife beating is not considered to be a crime by the society. Violence against women in the four walls is not viewed as seriously as among strangers.
Though we do not identify wife battery as legal parameters, but such characteristics like beating, abusing and insulting women may fill this indentifying offence. This may constitute wife battery.

Section 3 of The Protection of Women from Domestic Violence Act, 2005 says that: "For the purpose of this Act, any act or omission or conduct of the respondent shall constitute domestic violence in case if it:-
(a) harms or injures or endangers the health, safety, life, limb or well being, whether mental or physical of the aggrieved person or tends to do so and includes causing physical abuse, sexual abuse, verbal and emotional abuse and economic abuse, or
(b) harasses, harms, injures or endangers the aggrieved person with a view to coerce her or any other person related to her to meet any unlawful demand for any dowry or other property or valuable security, or
(C) has the effect of threatening the aggrieved person or any person related to her by any conduct mentioned in clause (a) and clause (b), or
(d) otherwise injures or causes harm, whether physical or mental to the aggrieved person.

ROLE OF POLICE:
The marital violence as well as wife battery is directed by the husband against the wife. Normally eighty percent of the cases are not reported to the police or other authorities. Out of remaining twenty percent, ten percent or more cases are disposed of by the police without registering the case. Thus only ten percent of the cases of the domestic violence cases are reported to the police. Hundreds of women are battered or even tortured and killed in their homes, but they go on living in traumatic situations because they have no other place to go. By and large neighbors’ do not interfere, even if they here scream for help. When a man tries to intervene, he is asked, why he is so concerned and it is believed that he is perhaps himself involved with the women.

Since the social atmosphere about the battered women is clouded with gender-discrimination an aggrieved lady is unable to get the police help also. The position is similar in India viz-a-vis other countries. It is a reported case of Tracey Thurmans, whose husband Charles abused her even after she left him. Police Officer told Tracey that because her complaints were against her husband, they would have to witness some act of harassment before they would take action. Tracey obtained the injunction order from the court, but the police did not help her. Unfortunately this position is common to our country also. In fact the police do not recognize a domestic violence as a criminal matter.

The Common Law explicitly linked the right of the husband to use force in governing his wife’s behavior and the state policy of non-interference in the private family realm give force to such behavior .The doctrine of family privacy forbade interference and simultaneously condoned such beatings. The views of many police officers today are much like the old Common Law notions explicitly condoning men’s right to batter. Some officers still believe that men are the head of the house-hold and should therefore, have the prerogative to beat their wives. The act of wife battery is continuing in our society form ancient time and this evil practice still available day by day in society. In a recent case such a wife battering is seen in the high ranking social strata.

Recently a case has been reported about Mr. Anil Verma an Indian diplomat in United Kingdom. It is alleged that the diplomat beaten his wife at his London home and his wife Paromita Verma ran crying in to the street in their quiet neighborhoods in North London with blood dripping from her face. The Women and Child Development Minister of Government of India Shri Krishna Tripathi demanded strong action to be taken against the people in power, who commit offences like Verma and the Indian High Commission called domestic violence "totally unacceptable". Noor Jehan Safia niaz of Indian Muslim Women’s Movement sent her view by email that domestic violence continues “unabated” in India.

JUDICIAL APPROACH TOWARDS WIFE- BATTERY:
The Section 12 of the Protection of Women from Domestic Violence Act, 2005 provides a protection not only to a wife but also women who had been in a domestic relationship with any person. In a landmark case Surendra Pathak v. Maya Devi, respondent Maya Devi married to the petitioner (after the death of her late husband Shri. Harpal Singh) and living with him as husband and wife in a shared house. The respondent resorted under Section 12 of Domestic Violence Act. The petitioner challenged the protection order on the ground that there is no evidence of marriage. The apex court held that the petitioner had a relationship of husband and wife. She is entitled to get protection from her husband.

In another case Rakesh Sachdeva & others v. State of Jharkhand & others The Hon'ble Court at Jharkhand held that the acts of mental or physical cruelty, which was allegedly inflicted upon her during her sojourn at her matrimonial house and later such acts of cruelty include her forcible separation from the company of her husband and deprivation of her conjugal rights. Protection of Women from Domestic Violence Act 2005 is not applied. Enquiry Magistrate directed for enquiry within the period stipulated under sub section 5 of section 12 of the act.

In case of D. Velusamy v. D. Patchiammal, the maintenance order has been passed in favor of a lady who was living as wife but was not a married wife. The Hon’ble Court held "When a wife is deserted, in most countries the law provides for maintenance to her by his husband, which is called alimony. However, earlier there was no law providing for maintenance to women who was having a live-in relationship with a man without being married to him and then deserted by him.

In U.S.A. the expression ‘Palimony’ was coined which means grant of maintenance to a woman who has lived for a substantial period of time with a man without marrying him. The Hon’ble Court held that relationship in the nature of marriage is aligning to common law marriage.

In Lok Ranjan Goswami v. State of U.P. & Others, the wife lodged an F.I.R. against her husband Lok Ranjan Goswami under Domestic Violence Act. Thereafter the accused person came to her residence and started abusing and beating her and tried to turn her out from the house. The Hon'ble Court found that since the accused persons tried to forcibly evict her from the portion under her possession, therefore, such act may be covered under Section 498A IPC.

In case of Matrimonial dispute v. The State of U.P. & Others, the Hon'ble High Court at Allahabad discussed the problem of the misuse of section 498A of IPC. It has been discussed with the High ranking officers and the Govt. Lawyers and the intervener "Sahyog". After hearing the different parties, the Hon'ble Court formulated the following principles as guide-lines: that relating to initial stage to trial of offence under section 498A, discussed various stages like lodge of F.I.R, arrest, mediation cell etc.

(A) Whether arrest of husband and family members mandatory once F.I.R. is lodged?
The Hon'ble Court is of the view that arrest may be necessitated if husband and other in-laws have given a grave beating to the wife endangering her life or where wife has been subjected to repeated violence etc. And in other cases attempt should be made first to bring about a reconciliation and mediation may be resorted.
(B) Whether the registration of an F.I.R. is mandatory?
The Hon'ble Court relied on the law laid down in State of Haryana & others Vs. Bhajan Lal held that Section 154(1) Cr.PC gives no option to the police officer to refuse to lodge the F.I.R. Once information of a cognizable offence is given to the police officer, the officer in charge of the police station is statutorily obliged to register the case and then to proceed with the investigation, if he even has a reason to suspect the commission of an offence.
(C) The Court also observed that there should be mediation cell in each district consist several Govt. & Non-Govt. persons.
(D) The Court was also of the view that the provisions of Section 498A IPC to be made compoundable with the permission of the court.

The Hon'ble Court has, thus, tried to give a guide-line to prevent a misuse of the provisions of 498A IPC most particularly when the in-laws are falsely implicated and they are put to face prosecution. But the above law has considered the only one aspect of the problem. The court did not consider the point, what should be remedy to wife who is battered off and on. Whether such a lady has got no remedy before the law courts? Where the police or law court will not help a lady who is battered by verbal and emotional abuse or is hurt by sexual abuse. If the police feel that a case is to be a petty one, then why it enters into any investigation and calls any person for mediation.

CONCLUTION:

Women Conferences and initiative taken by United Nations in 1993 in Beijing is remarkable efforts; the violence against women is prevalent in whole world. Every country according to own culture taking initiative to save women from violence. Its common belief is that marriage is made in the heaven. Alas! The alarming rise in the number of cases, involving harassment to the newly wedded girls, for dowry shattered their dreams it takes the form of wife-beating and domestic violence. While bride-burning is aggravate manifestation of wife-beating and domestic violence. Wife-beating and domestic violence are common phenomenon affecting the whole family. Even the dowry victims themselves are beaten for a long time before they are ultimately murdered. The genesis of such death lies in the tension created by persistent demands of dowry accompanied by beating and harassment. This problem is not confined to one particular strata of society but it exists everywhere though in different forms. So the above discussion reveals that existing laws to protect “violence against women either Indian Penal Code, 1860 or Domestic Violence Act, 2005, is not sufficient to prevent wife battery. Lots of deliberations are required to amend the existing laws, so that a woman may, including a wife, lead a respectable life with dignity within the four walls of her house and outside. Till such an atmosphere is created throughout the country, the social evil will continue and law will be deficient and the socio-legal problem will continue in our society.

EVERGREENING OF PATENTS

A patent consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time, in exchange for the public disclosure of the invention. The exclusive right granted to a patentee in most countries is the right to prevent others from making, using, selling, or distributing the patented invention without permission.
'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which patent owners utilize the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges.

In recent times, it has become a practice by a number of innovator companies to extend the patent term of their innovative molecules to maintain market dominance. The extension of monopoly term ‘Evergreening’ is a predominant aspect of pharmaceutical patenting. ‘Evergreening’ refers to different ways wherein patent owners take undue advantage of the law and associated regulatory processes to extend their IP monopoly particularly over highly lucrative ‘blockbuster’ drugs by filing disguised/artful patents on an already patent protected invention shortly before expiry of the ‘parent’ patent.

In India under the Patent Act 1970 the term of patent is given for 20 years. And the TRIPS Agreement also provides for a minimum length of 20 years for any patent. At the same time, Art. 1.1 of the TRIPS agreement recognizes every party’s right to implement more extensive protections in their laws. FTAs allows for an extended patent term in cases where an unreasonable delay occurs in granting the patent (e.g. Art. 15.9 CAFTA) are thus compliant with the TRIPS Agreement.

MEANING AND DEFINITION OF EVERGREENING OF PATENTS:

Evergreening of patents refers to increasing the life of the patent or the patent term beyond 20 years to reap the benefits for much longer period of time. Drug patent evergreening is the single most important strategy that multinational pharmaceutical companies have been using since 1983 in the US (and since 1993 in Canada) to retain profits from “blockbuster” (high sales volume) drugs for as long as possible. When the original patent over the active component of a brand name drug is about to expire, these drug companies often claim large numbers of complex and highly speculative patents.

Evergreening" refers to the idea of continually extending patents and making knowledge-sharing more difficult by making incremental changes that would permit the issuance of a new patent.[1] In response to the risk of 'evergreening', the scope of patentability by “modifying the definition of an inventive step” is restricted. An “inventive step” is now defined as “a feature of an invention that involves a technical advancement.” In other words a “new invention” is defined as “any invention or technology that has not been anticipated by publication or used in the country or elsewhere in the world before the date of the filing of the patent application.”

Evergreening "is a potentially perjorative term that generally refers to the strategy of obtaining multiple patents that cover different aspects of the same product, typically by obtaining patents on improved versions of existing products.[2]

Medicine patent evergreening is an important strategy that multinational pharmaceutical companies use to extend excessive profits from so-called "blockbuster" medicines for as long as possible. Medicine companies try to extend the patent by slightly modifying the formulation of existing medicines.

APPLICABILITY OF THE PATENT EVERGREENIG CONCEPT IN WORLD-WIDE:

India alongside Brazil, Thailand, South Africa and Israel is one of the few countries with laws against evergreening.  Prior to the TRIPS agreement, India did not provide patent protection for pharmaceutical products.[3] Instead, India only protected the drug manufacturing process, and only for up to a seven-year term. India's first independent Patents Act sought to create a domestic pharmaceutical market and decrease the cost of medication. Thus, the Patents Act turned away many foreign pharmaceutical companies and resulted in a larger market share for domestically owned companies. India flourished at reverse-engineering drugs and selling them both domestically and in other developing countries that did not honor patent protection for pharmaceutical products. However, once TRIPS became fully effective in India in 2005, the country was obligated to honor patent protection of pharmaceutical compositions.[4]

Indian Patents Act requires that, to satisfy the non-obvious standard, an invention be non-obvious and either involve the advance of technology or be economically significant.[5] However, the Patents Act does not specify the standard that should be used to determine whether technology is advanced or whether the invention is economically significant.[6] While scholars have criticized the definition as “vague and arbitrary”. It appears that India has successfully implemented a high standard of non-obviousness that will enable judicial flexibility in protecting competition and driving down market costs.[7]

Preamble of the TRIPs Agreement says, “Recognizing the underlying public policy objectives of national systems for the protection of intellectual property including developmental and technological objectives.” Article 1 (1) says, “Members shall give effect to the provisions of this Agreement. Members may, but shall not be obliged to, implement in their law more extensixe protection than is required by this Agreement.”

Article 27 (1) says, “ …patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”

Article 27 (2) says, “Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect public order or morality, including to protact human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.”

When India amended its patent law to comply with the TRIPS agreement, it also added a controversial provision intended to curtail evergreening of pharmaceutical patents.[8][9] The provision, Sec. 3(d), bars companies from patenting new forms of known substances unless the new form demonstrates a significant enhancement in efficacy.[10] But Section 3 (d) does not define ‘efficacy’; it is still questionable that what constitute sufficient improvements in a drug to qualify as substantial increase in efficacy. In January 2006, the Patent Controller in Chennai used Sec. 3(d) in refusing to grant pharmaceutical manufacturer Novartis a patent on its beta crystalline salt form of an existing anti-cancer drug.[11]

Section 3(d) of Patents Amendment Act, 2005 says, “The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”

Explanation - For the purpose of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Novartis argued that the more stable salt form could be absorbed more easily into the bloodstream, resulting in an increase in bio-availability of up to 30 percent. The Assistant Controller saw the difference as "only" 30 percent and ruled that the free base form could be used wherever the salt was used. Novartis has challenged the ruling, arguing that Sec. 3(d) of the 2005 Patents Act does not comply with TRIPS.

In May 2006, Novartis petitioned before the Madras High Court, contending that the Patent Controller erroneously rejected its patent application for the drug beta crystalline form of imatinib mesylate under Section 3(d) of the Patents Act.[12] According to Section 3 (d) of the Patent Act 1970, a new form of a known medicine can only be patented if it shows significantly improved therapeutic efficacy over existing compounds. Novartis also argued that the provision violated Article 14 [13] of the Constitution of India because the wide breadth of discretion given to the patent controller could lead to discriminatory results. The case was split up between the Madras High Court and the Intellectual Property Appellate Board ("IPAB").[14] The challenges on TRIPS compliance and the constitutionality of Section 3(d) were heard by the Madras High Court, which issued a judgment against Novartis. The issue dealing with patentability was heard by the IPAB, which also ruled against Novartis.[15]

The High Court had to examine three issues. The first was whether Indian courts had jurisdiction to review Section 3(d)'s consistency with Article 27 of TRIPS, and to grant declaratory relief if the section was not consistent with TRIPS. The second issue involved examining whether Section 3(d) was consistent with Article 27 of TRIPS. The third issue was whether Section 3(d) violated Article 14 of the Constitution of India because it was vague, arbitrary, and conferred uncontrolled discretion to the Patent Controller.

The Court held that it did not have jurisdiction to adjudicate a case dealing with the compliance of a domestic Indian law with an international treaty. And declined to deal with the issue of whether Section 3(d) was compliant with TRIPS. Thus, it did not grant any declaratory relief to Novartis.

On the third issue, the Court held that Section 3(d) did not violate Article 14 of the Indian Constitution. And it was not vague or arbitrary, and did not confer uncontrolled discretion to the Patent Controller. The Court concurred with the contention of the Indian Government that it had a constitutional duty to provide good health care to its citizens by giving them easy access to life-saving drugs. The Court also agreed that in doing so there should be suitable legislative measures put in place to prevent evergreening of patents, which could have disastrous consequences with respect to availability of affordable medicines.[16]

International agency Oxfam has hailed the Indian High Court's ruling against a patent protection petition filed by multinational pharmaceutical company Novartis as a huge victory for public health. By dismissing the Novartis application which was seeking to patent the anti-cancer medicine Gleevec, the Court “has put public health before commercial profits” said Nisha Agrawal, CEO of Oxfam India. The ruling allows Indian makers of generic medicines to continue making affordable versions of the medicine, used to treat chronic myeloid leukaemia, which kills 80-90 per cent of sufferers.

Nisha Agrawal, CEO of Oxfam India said: “We're not against companies making profits, but against companies charging exorbitant amounts for life-saving medicines in the name of patents. Patenting this medicine would have defeated the very purpose of it – “to treat patients” suffering from cancer. This important medicine would be of no use to cancer survivors if they can't afford to buy it.”

Currently, Gleevec is priced at $2200 (120,000 Indian rupees) for a monthly dosage. This ruling will make way for generic version of the medicine which will cost about $184 (Rs.10,000) a month - more than 90 per cent cheaper than the patented version. However, even the generic version may still not be affordable to millions of patients in India where health expenditure is one of the most important reasons for indebtedness.

After the decision of the Madras High Court an appeal was made by the Novartis to the Supreme Court. But on 1 April 2013 The Supreme Court also denied Novartis a patent for its anti-cancer drug Gleevec. For seven years Novartis tried and failed to challenge this provision.  This leaves the door open for Indian pharmaceutical companies to produce their own versions of the drug. Since these are sold at roughly one tenth of the patented brand price, for thousands of cancer patients it means the difference between medicine and no medicine at all.

In Roche v. Cipla[19], The plaintiff here who happened to be Roche, attempted prohibiting the defendant company Cipla from manufacturing the former’s anti-cancer drug formulation “Erlotinib”. This drug’s generic equivalent costs the 1/3rd the amount of the protected and patented drug formulation available as, over the counter antidote in the markets, thereby running the risk of relatively less adoption or possibly, rejection by the consumers. The plaintiff then sought an interim injunction against the defendants. But the prime hassle arose with the morphed or an altered substitute, here in this case, a Polymorphic Form B belonging from the same class of drug but wasn’t one of Roche’s patented drug, thereby rendering the court to decide in favor of the defendant along with the light of the provision mentioned in the leading statute of Section 3 (d) of the Indian Patents Act, 1970 following a stance that Cipla didn’t infringe Roche’s Indian Patent IN 196774.

Like India, Israel endorses a demanding non-obviousness requirement for patentability. Israel's use of non-analogous art as references for obviousness rejections stretches the bounds of what is considered obvious. Consequently, pharmaceutical companies run the risk of developing a drug therapy that is genuinely innovative, but that still is denied patent protection by the court system. The uncertainty in Israel's non-obviousness standard would not support the U.S. pharmaceutical industry.
Israel's strict non-obviousness requirement is based in the country's status as a dominant producer of generics. Israel is home to Teva Pharmaceutical Industries, the world's largest generics company, and its pharmaceutical exports constitute 3 percent of the country's gross domestic product. Israel also has a strong domestic pharmaceutical market. Israel pushed the development of the generics pharmaceutical industry in order to provide healthcare to its citizens at the cheapest possible cost. Accordingly, the domestic industry is supported by “sick funds” which provide medical insurance and hospital services for Israelis and constitute 70 percent of domestic pharmaceutical sales.

Section 5 of Israel's Patent Act indicates that, to be eligible for patent protection, an inventor must achieve an inventive step that is not obvious to the PHOSITA at the time of filing. Additionally, Appendix G of Israel's Patent Office Guidelines for Examination indicates that an “inventive step” requires a “quantum” advancement over the prior art.[25] In 2011, the Israeli Supreme Court confirmed that an “inventive step” requires a significant contribution to the relevant art and possesses the “spark of invention”. Therefore, like India, Israel requires an inventor to overcome a greater threshold than mere likelihood of success and mandates that a patentable invention contribute to the progress of science by providing a significant advancement to the technical field.

The problem is a severe one in the United States. Evergreening began in the US in 1983 with the so-called Hatch-Waxman legislation.[26]  In 2002 an extensive and lengthy inquiry by the US Federal Trade Commission (FTC) found that as many as 75% of new drug applications by generic drug manufacturers suffered legal actions under patent laws by the original brand name patent owner. These were driving up US drug costs by keeping the cheaper generic versions off the market. The FTC recommended that only one “evergreening” injunction against a potential generic market entrant be permitted per product  and this change was  implemented in legislation in December 2003. The US legislature passed its Medicare Prescription Drug Improvement and Modernisation Act 2003. This included, in Sec. 1101 a complicated process of early declaratory relief to assist remedying the problem of brand name pharmaceutical patent “evergreening.” This implemented a specific recommendation in the report of the US Federal Trade Commission (“FTC”) in 2002. The FTC recommendation was that only one “evergreening” injunction against a potential generic market entrant be permitted per product.

35 United States Code of Patent Law 101,102,103 state that the requirements for patentable subject matter are utility, novelty and non-obviousness. 35 USC 101 “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of the title.” United States of America allows patents to be granted for “new and useful improvements” to already patented inventions. But the United States Patent and Trademark Office (USPTO) places limits on what may be patented on the grounds of obviousness.

Graham v. John Deere[27] : TSM & RES: In this case US Supreme Court announced a 3 factors test for analysis of non-obvious:
Ø  Scope and content of prior art.
Ø  Difference between prior art and the claims at issue.
Ø  Level of ordinarily skill in the pertinent act.

KSR Intern Co. v. Teleflex Inc.[28] : In this case the patent validity of Teleflex’s patent for an adjustable automobile accelerator pedal was in issue. The US Supreme Court recognized that the fact based TSM test was a helpful insight and warned against mere conclusory statements and called for both “articulated reasoning” and conclusions of “when prior art teaches way” as emphasis on flexibility and common sense. On this result US Supreme Court made the requirements for patentability more strict. But the Court did not clearly define the requirements for determining obviousness. This leaves the standard for patentability ambiguous.

Under the 1984 Hatch-Waxman amendments to the Food, Drug and Cosmetics Act, generic manufacturers can get regulatory authority to market copies of brand-name drugs by submitting an "Abbreviated New Drug Application" (ANDA). While makers of new drugs must show their product is safe and effective in a New Drug Application, ANDA applicants must only show that the generic version is chemically equivalent to, and works the same as, the brand-name product. This enables the generic manufacturers to avoid duplicative, unnecessary and expensive testing that would deter many from ever entering the market.

In filing an ANDA, the generic manufacturer must note the patent status of the brand-name version of their product. If the generic maker hopes to sell the drug during the term of the brand-name drug's patent, it must certify that the patent is either invalid or will not be infringed by the generic product. This is known as a "Paragraph IV Certification," and it triggers a right for the brand-name company to sue to enforce its patent and prevent the generic from coming to market.

In 1985, Barr Laboratories, a major generic manufacturer, submitted an ANDA seeking FDA approval to market a generic version of tamoxifen. In 1987, it amended the ANDA to include a Paragraph IV Certification. Imperial Chemical, which held the patent, sued to enforce the patent. In 1992, following a trial, a federal judge ruled the patent invalid.

In Canada, a similarly extensive investigation by the Competition Bureau revealed similar problems with drug patent “evergreening” arising from the Patented Medicines (Notice of Compliance) Regulations in 1993 required as an obligation of entering the North American Free Trade Agreement (“NAFTA”). It found that over 200 legal actions involving “evergreening” claims had been brought and that this was having an adverse effect on the sustainability of the Canadian generic drug industry and drug prices in that country.

In Australia, Patents Act 1990, already permits non-use-related patent extension for up to five years (section 77) for delayed pharmaceutical marketing approval but AUSFTA has “locked-in” this monopoly protection and for the Preservation and promotion of the so-called ‘anti-evergreening’ amendments were passed by the Australian Parliament.

In the Indian geography, after the patent on the main compound is obtained, firstly it is extremely difficult to get a subsequent selection patent on polymorph (or other forms) on ground of Section 3(d) and secondly and importantly the marketed drug based on polymorphic form would easily be prone to generic competition without infringement of the main patent.

In India, for example, only 215 generic drugs received marketing approval during 1998-2004, despite nearly 5,000 patent “claims” being made in the same period through a “mail box” system. One reasons was that the Indian government passed legislation required by the World Trade Organisation (WTO) Trade-Related Intellectual Property Rights (TRIPS) agreement, allowing brand name patent claims for new “uses,” rather than new chemical entities.

CONCLUSION:

Critics of evergreening assert that the ability to obtain multiple patents on a product, over a period of many years, effectively extends the term of exclusivity that the patent holder obtains. They further assert that this practice is abusive, impedes the introduction of generic medications, and has a negative effect upon public health.

Patent evergreening promotes development of unfair means of competition and related abuse. Enhanced IP scrutiny may remove the curse of these unfair practices which are widely followed by the innovator companies to create a roadblock for generic companies that are trying hard to provide safe and efficacious medicines to the masses at cost effective prices. Landmark case decisions may serve as an aid to understand the complex domain of ‘Evergreening’. There is a need for developing countries to develop and foster effective mechanisms to counter evergreening practices of innovators. It is important to promote innovations of big companies and at the same time honor efforts put down by the generic companies so that with equal balance, cost effective products are launched in the market, thereby benefiting the masses.

Given the limited term of patent duration, the patent system is, at least theoretically, of a fundamentally deciduous character. However, in practice, a constantly replanted patent thicket can appear the biological equivalent of an evergreen. Over time we should expect to see the shade provided by such cover deepen rather than lessen. The ever-increasing reach of the proprietarian trend in intellectual property seems set to continue, with evergreening practices in relation to drug patents being merely one example. In terms of end results, not all such instances of extended protection will be inimical to downstream innovation and health costs, but it is hard to envisage a future without instances of abuse.