The Six kinds of tasty foods

The Six kinds of tasty foods

Sweet: Rice, bread, honey, milk, ghee, oils, all meats, and most “sweets” are considered sweet Most legumes, lentils, and beans are considered sweet as well as astringent, urad dal (split black lentils), which are considered sweet and not astringent Grains and vegetables, which contain carbohydrates, are considered sweet, Foods with the sweet taste are considered heavy and therefore grounding.

Sour: Lemon, vinegar, yogurt, cheese, tomatoes, grapes, plums, and other sour fruits

Sour foods promote digestion, are good for the heart, and warm the body. But an excess of these foods can cause irritation, dizziness, or loss of vitality. Salty: Salt, Kombu (and all other seaweeds), soy sauce, pickles, chutneys, bouillon, and salty condiments little salt in our diets is essential for our health; it also aids digestion. But consumed in excess, salty foods can cause bloating and water retention, or lead to inflammatory conditions. Too little may result in illness, or leg cramps.

Pungent: Ginger, cumin, black pepper, cinnamon, cayenne, chilies, radishes, onions, and garlic

Pungent tastes heat the body, stimulate digestion, and eliminate excessive fluids, thereby relieving colds and bronchitis. They also help to get our metabolisms moving if we are feeling sluggish. Consumed in excess, they can cause anger and aggression, as well as burning sensations, dizziness, dryness, and increased thirst.

Bitter: Green leafy vegetables (e.g., kale, spinach), bitter gourd, turmeric, fenugreek, lemon and orange rind, dark chocolate, and Consumed in excess, bitter can produce envy, jealousy,

Astringent: Beans, lentils, apples, pears, cabbage, broccoli, cauliflower, and potatoes. Consumed in excess, they produce flatulence, constipation, and a dryness of the body.

MDR TB and INDIA

“ There’s no hiding from the fact that treating people with drug-resistant TB is a long, difficult and complex process. But it can be done – people who get treatment are cured and can go on with their lives once more – but it needs a firm political and financial commitment.” Dr. Frauke Jochims, MSF, TB Medical Advisor

Governments are not meeting the challenge of providing treatment for the rising numbers of people infected with drug-resistant tuberculosis (DR-TB), which has infected around five million people over the past ten years. DR-TB – which occurs when the TB bacterium becomes resistant to anti-TB drugs – can be cured in the majority of cases, but many people go undiagnosed and untreated because of the difficulties involved in getting a correct diagnosis, and the expensive and complex treatment. In what many hope will prove to be a breakthrough development, a new diagnostic test has been rolled out this year – including by MSF in seven countries – that can drastically reduce the time it takes to diagnose if a person has DR-TB, from several weeks to under two hours. Although the test is very expensive and is not as simple a test as is ultimately needed, the fact that it’s now a lot easier to diagnose people should spur governments into putting many more on treatment. This, in turn, may help break the vicious circle with DR-TB drugs. With few people on treatment, low demand means drug companies don’t invest in expanding production. And without economies of scale and competition, drug prices remain high, with treatment costing on average US$ 4,500 per patient – several hundred times more than a $19 treatment course for standard TB. It’s not surprising the numbers on treatment have so far stayed low.

In fact, over the last ten years, less than 1% of people with DR-TB have had access to appropriate treatment and 1.5 million have died. MSF has doubled the numbers of patients on treatment over the last decade, but the recent funding cuts announced by the Global Fund to Fight AIDS, TB and Malaria, have cast a shadow of uncertainty over expanding treatment in many countries affected by the disease.

kutchi kala

Endangered Kutchi embroidery styles such as Ahir, Pakko, Neran, Rabari, Soof, Kharek, Jat Garasiya, Jat Fakirani, Chopad, Gotav, Katri, Mukko, Chakan, Aari, Kambhira and Khudi Tebha, have also been revived.

http://kutchiwork.blogspot.com/2011/02/about-kutch.html

https://www.jatland.com/home/Jat_Belt

ulli cese mElu thalli cheyyadu

Bulbus Allii Cepae Definition Bulbus Allii Cepae is the fresh or dried bulbs of Allium cepa L. (Liliaceae) or its varieties and cultivars. Synonyms Allium esculentum Salisb., Allium porrum cepa Rehb. (1). Selected vernacular names It is most commonly known as "onion". Basal, basl, cebolla, cebolla morada, cepa bulb, cepolla, cipolla, common onion, cu hanh, hom hua yai, hom khaao, hom yai, hu-t'sung, hu t'sung t'song, hua phak bhu, i-i-bsel, kesounni, khtim, Küchenzwiebel, l'oignon, loyon, Madras oignon, oignon, palandu, piyaj, piyaz, pyaz, pyaaz, ralu lunu, red globe onion, sibuyas, Spanish onion, tamanegi, umbi bawang merah, vengayan, yellow Bermuda onion, white globe onion, Zwiebel (1–5). Description A perennial herb, strong smelling when crushed; bulbs vary in size and shape from cultivar to cultivar, often depressed-globose and up to 20cm in diameter; outer tunics membranous. Stem up to 100cm tall and 30mm in diameter, tapering from inflated lower part. Leaves up to 40cm in height and 20mm in diameter, usually almost semicircular in section and slightly flattened on upper side; basal in first year, in second year their bases sheathing the lower sixth of the stem. Spathe often 3-valved, persistent, shorter than the umbel. Umbel 4– 9cm in diameter, subglobose or hemispherical, dense, many-flowered; pedicels up to 40mm, almost equal. Perianth stellate; segments 3–4.5  2–2.5mm, white, with green stripe, slightly unequal, the outer ovate, the inner oblong, obtuse or acute. Stamens exserted; filaments 4–5mm, the outer subulate, the inner with an expanded base up to 2mm wide and bearing short teeth on each side. Ovary whitish. Capsule about 5mm, 2n 16 (6). Plant material of interest: fresh or dried bulbs General appearance Macroscopically, Bulbus Allii Cepae varies in size and shape from cultivar to cultivar, 2–20cm in diameter; flattened, spherical or pear-shaped; white or coloured (7). WHO monographs on selected medicinal plants 6 Organoleptic properties Odor strong, characteristic alliaceous; taste strong; crushing or cutting the bulb stimulates lachrymation. Microscopic characteristics The external dried leaf scales of the bulbs show a large-celled epidermis with lightly spotted cell walls; the cells are elongated longitudinally. The underlying hypodermis runs perpendicular to the epidermis and contains large calcium oxalate crystals bordering the cell walls. The epidermis of the fleshy leaf scales resembles that of the dried leaf scales, and the epidermal cells on the dorsal side are distinctly longer and more elongated than the epidermal cells on the ventral side. Large calcium oxalate crystals are found in the hypodermis; stomata rare; large cell nuclei conspicuous; and spiral vessel elements occur in the leaf mesophyll (8). Powdered plant material Contains mainly thin-walled cells of the mesophyll with broken pieces of spiral vessel elements; cells containing calcium oxalate crystals are scarce (8). Geographical distribution Bulbus Allii Cepae ("onion") is probably indigenous to western Asia, but it is commercially cultivated worldwide, especially in regions of moderate climate (1). General identity tests Macroscopic inspection, microscopic characteristics and microchemical examination for organic sulfur compounds (9); and thin-layer chromatographic analysis for the presence of cysteine sulfoxides (10, 11). Purity tests Microbiology The test for Salmonella spp. in Bulbus Allii Cepae products should be negative. The maximum acceptable limits of other microorganisms are as follows (12– 14). Preparations for oral use: aerobic bacteria—not more than 105 /g or ml; fungi—not more than 104 /g or ml; enterobacteria and certain Gram-negative bacteria—not more than 103 /g or ml; Escherichia coli—0/g or ml. Total ash Not more than 6% (3). Bulbus Allii Cepae 7 Acid-insoluble ash Not more than 1.0% (3). Water-soluble extractive Not more than 5.0% (3). Alcohol-soluble extractive Not more than 4.0% (3). Pesticide residues To be established in accordance with national requirements. Normally, the maximum residue limit of aldrin and dieldrin for Bulbus Allii Cepae is not more than 0.05mg/kg (14). For other pesticides, see WHO guidelines on quality control methods for medicinal plants (12) and guidelines for predicting dietary intake of pesticide residues (15). Heavy metals Recommended lead and cadmium levels are no more than 10 and 0.3mg/kg, respectively, in the final dosage form of the plant material (12). Radioactive residues For analysis of strontium-90, iodine-131, caesium-134, caesium-137 and plutonium-239, see WHO guidelines on quality control methods for medicinal plants (12). Other purity tests Chemical, foreign organic matter, and moisture tests to be established in accordance with national requirements. Chemical assays Assay for organic sulfur constituents, cysteine sulfoxides and sulfides by means of high-performance liquid chromatographic (16, 17) or gas–liquid chromatographic (18) methods, respectively. Quantitative levels to be established by appropriate national authority. Major chemical constituents Sulfur- and non-sulfur-containing chemical constituents have been isolated from Bulbus Allii Cepae; the sulfur compounds are the most characteristic (1, 4, 7). The organic sulfur compounds of Bulbus Allii Cepae, including the thiosulfinates, thiosulfonates, cepaenes, S-oxides, S,S-dioxides, monosulfides, WHO monographs on selected medicinal plants 8 disulfides, trisulfides, and zwiebelanes occur only as degradation products of the naturally occurring cysteine sulfoxides (e.g. (

---

)-S-propyl-L-cysteine sulfoxide). When the onion bulb is crushed, minced, or otherwise processed, the cysteine sulfoxides are released from compartments and contact the enzyme alliinase in adjacent vacuoles. Hydrolysis and immediate condensation of the reactive intermediate (sulfenic acids) form the compounds as indicated below (1). The odorous thiosulphonates occur (in low concentrations) only in freshly chopped onions, whereas the sulfides accumulate in stored extracts or steam distilled oils. Approximately 90% of the soluble organic-bound sulfur is present as γ-glutamylcysteine peptides, which are not acted on by alliinase. They function as storage reserve and contribute to the germination of seeds. However, on prolonged storage or during germination, these peptides are acted on by γ-glutamyl transpeptidase to form alk(en)yl-cysteine sulfoxides, which in turn give rise to other volatile sulfur compounds (1). Bulbus Allii Cepae 9 Dosage forms Fresh juice and 5% and 50% ethanol extracts have been used in clinical studies (1). A "soft" extract is marketed in France but is not recognized as a drug by French authorities (7). Dried Bulbus Allii Cepae products should be stored in well-closed containers, protected from light, moisture, and elevated temperature. Fresh bulbs and juice should be refrigerated (2–10°C). Medicinal uses supported by clinical data The principal use of Bulbus Allii Cepae today is to prevent age-dependent changes in the blood vessels, and loss of appetite (19). Uses described in pharmacopoeias and in traditional systems of medicine Treatment of bacterial infections such as dysentery, and as a diuretic (2, 7). The drug has also been used to treat ulcers, wounds, scars, keloids (3), and asthma (20, 21). Bulbus Allii Cepae has also been used as an adjuvant therapy for diabetes (4, 22, 23). Uses described in folk medicine, not supported by experimental or clinical data As an anthelminthic, aphrodisiac, carminative, emmenagogue, expectorant, and tonic (3), and for the treatment of bruises, bronchitis, cholera, colic, earache, fevers, high blood pressure, jaundice, pimples, and sores (3). Pharmacology Experimental pharmacology An aqueous extract or the juice of Bulbus Allii Cepae inhibited the in vitro growth of Escherichia coli, Serratia marcescens, Streptococcus species, Lactobacillus odontolyticus, Pseudomonas aeruginosa, and Salmonella typhosa (24–28). A petroleum ether extract of Bulbus Allii Cepae inhibited the in vitro growth of Clostridium paraputrificum and Staphylococcus aureus (24). The essential oil has activity against a variety of fungi including Aspergillus niger, Cladosporium werneckii, Candida albicans, Fusarium oxysporium, Saccharomyces cerevisiae, Geotrichum candidum, Brettanomyces anomalus, and Candida lipolytica (5, 29). The hypoglycaemic effects of Bulbus Allii Cepae have been demonstrated in vivo. Intragastric administration of the juice, a chloroform, ethanol, petroleum ether (0.25g/kg) or water extract (0.5ml), suppressed alloxan-, glucose- and epinephrine-induced hyperglycaemia in rabbits and mice (30–35). Inhibition of platelet aggregation by Bulbus Allii Cepae has been demonstrated both in vitro and in vivo. An aqueous extract inhibited adenosine diphosphate-, collagen-, epinephrine- and arachidonic acid-induced platelet WHO monographs on selected medicinal plants 10 aggregation in vitro (36, 37). Platelet aggregation was inhibited in rabbits after administration of the essential oil, or a butanol or chloroform extract of the drug (38–40). An ethanol, butanol or chloroform extract or the essential oil (10–60µg/ml) of the drug inhibited aggregation of human platelets in vitro (41, 42) by decreasing thromboxane synthesis (39). Both raw onions and the essential oil increased fibrinolysis in ex vivo studies on rabbits and humans (1). An increase in coagulation time was also observed in rabbits (1). Intragastric administration of the juice or an ether extract (100mg/kg) of the drug inhibited allergen- and platelet activating factor-induced allergic reactions, but not histamine- or acetylcholine-induced allergenic responses in guinea-pigs (43). A water extract of the drug was not active (43). A chloroform extract of Bulbus Allii Cepae (20–80mg/kg) inhibited allergen- and platelet aggregation factor-induced bronchial obstruction in guinea-pigs (44). The thiosulphinates and cepaenes appear to be the active constituents of Bulbus Allii Cepae (1). Both ethanol and methanol extracts of Bulbus Allii Cepae demonstrated diuretic activity in dogs and rats after intragastric administration (45, 46). Antihyperlipidaemic and anticholesterolaemic activities of the drug were observed after oral administration of minced bulbs, a water extract, the essential oil (100mg/kg), or the fixed oil to rabbits or rats (47–52). However, one study reported no significant changes in cholesterol or lipid levels of the eye in rabbits, after treatment of the animals for 6 months with an aqueous extract (20% of diet) (53). Oral administration of an ethanol extract of the drug to guinea-pigs inhibited smooth muscle contractions in the trachea induced by carbachol and inhibited histamine-, barium chloride-, serotonin-, and acetylcholine-induced contractions in the ileum (20). Topical application of an aqueous extract of Bulbus Allii Cepae (10% in a gel preparation) inhibited mouse ear edema induced by arachidonic acid (54). The active antiallergic and anti-inflammatory constituents of onion are the flavonoids (quercetin and kaempferol) (55). The flavonoids act as antiinflammatory agents because they inhibit the action of protein kinase, phospholipase A2, cyclooxygenase, and lipoxygenase (56), as well as the release of mediators of inflammation (e.g. histamine) from leukocytes (57). In vitro, an aqueous extract of Bulbus Allii Cepae inhibited fibroblast proliferation (58). A 0.5% aqueous extract of onion inhibited the growth of human fibroblasts and of keloidal fibroblasts (enzymically isolated from keloidal tissue) (59). In a comparative study, an aqueous extract of Bulbus Allii Cepae (1– 3%) inhibited the proliferation of fibroblasts of varying origin (scar, keloid, embryonic tissue). The strongest inhibition was observed with keloid fibroblasts (65–73%) as compared with the inhibition of scar and embryonic fibroblasts (up to 50%) (59). In human skin fibroblasts, both aqueous and chloroform onion extracts, as well as thiosulfinates, inhibited the platelet derived growth factor-stimulated chemotaxis and proliferation of these cells (60). In addition, a protein fraction isolated from an onion extract exhibited antimitotic activity (61). Bulbus Allii Cepae 11 Clinical pharmacology Oral administration of a butanol extract of Bulbus Allii Cepae (200mg) to subjects given a high-fat meal prior to testing suppressed platelet aggregation associated with a high-fat diet (62). Administration of a butanol extract to patients with alimentary lipaemia prevented an increase in the total serum cholesterol, -lipoprotein cholesterol, and -lipoprotein and serum triglycerides (63, 64). A saponin fraction (50mg) or the bulb (100mg) also decreased serum cholesterol and plasma fibrinogen levels (65, 66). However, fresh onion extract (50g) did not produce any significant effects on serum cholesterol, fibrinogen, or fibrinolytic activity in normal subjects (67, 68). Antihyperglycaemic activity of Bulbus Allii Cepae has been demonstrated in clinical studies. Administration of an aqueous extract (100mg) decreased glucose-induced hyperglycemia in human adults (69). The juice of the drug (50mg) administered orally to diabetic patients reduced blood glucose levels (22). Addition of raw onion to the diet of non-insulin-dependent diabetic subjects decreased the dose of antidiabetic medication required to control the disease (70). However, an aqueous extract of Bulbus Allii Cepae (200mg) was not active (71). The immediate and late cutaneous reactions induced by injection of rabbit anti-human IgE-antibodies into the volar side of the forearms of 12 healthy volunteers were reduced after pretreatment of the skin with a 50% ethanol onion extract (1). Immediate and late bronchial obstruction owing to allergen inhalation was markedly reduced after oral administration of a 5% ethanol onion extract 1 hour before exposure to the allergen (1). In one clinical trial in 12 adult subjects, topical application of a 45% ethanolic onion extract inhibited the allergic skin reactions induced by anti-IgE (72). Contraindications Allergies to the plant. The level of safety of Bulbus Allii Cepae is reflected by its worldwide use as a vegetable. Warnings No warnings have been reported. Precautions Carcinogenesis, mutagenesis, impairment of fertility Bulbus Allii Cepae is not mutagenic in vitro (73). Other precautions No general precautions have been reported, and no precautions have been reported concerning drug interactions, drug and laboratory test interactions, WHO monographs on selected medicinal plants 12 nursing mothers, pediatric use, or teratogenic or non-teratogenic effects on pregnancy. Adverse reactions Allergic reactions such as rhinoconjunctivitis and contact dermatitis have been reported (74). Posology Unless otherwise prescribed: a daily dosage is 50g of fresh onion or 20g of the dried drug; doses of preparations should be calculated accordingly (14).

One more example of drug company greed

$89,000 Drug Has Congress Fuming

Kaiser Health News · February 16, 2017Original Article 

 1 1 15

The latest flashpoint in the ongoing debate over high drug prices is Emflaza, an $89,000-a-year drug that treats Duchenne muscular dystrophy.

People who have been watching the drug price issue closely, however, can reasonably ask why there is so much heat at that price tag? Late last year, two drugs went on the market for six-figure prices. Exondys 51 sells for $300,000 a year and Spinraza for a whopping $750,000.

While they did draw headlines, neither of those drugs sparked the bipartisan congressional firestorm and patient outcry that Emflaza ignited this week. Here are five reasons why:

1. It’s not a new drug.

Emflaza, the brand name for deflazacort, has never been approved for sale in the United States, but the steroid has been sold for decades in other countries — at much lower prices.

Some Duchenne patients in the U.S. have imported deflazacort from Europe and Canada for years for just $1,000 to $1,600 annually. Mohammed Haider, 27, of Mount Laurel, N.J., said he’s been buying it from European pharmacies since he was seven years old.

In medical circles, deflazacort is often compared with the widely used steroid, prednisone, which has been around since 1955.

2. It’s not a scientific breakthrough.

Exondys 51 and Spinraza are medical breakthroughs that target genes to treat underlying diseases.

Emflaza, on the other hand, addresses symptoms of muscle weakness and deterioration by decreasing inflammation and suppressing the immune system in Duchenne patients.

Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, questions why Marathon won approval using the Orphan Drug Act, which was created by Congress to motivate companies to develop drugs to treat rare diseases.

Instead, Kesselheim said, this is a steroid that could be used more broadly.

“There’s no indication to me that this is a steroid specific to muscular dystrophy,” he said.

Marathon had considered researching whether Emflaza could treat patients with juvenile arthritis, but the company said last week it has no plans to pursue that use.

3. Emflaza doesn’t work alone.

The drug needs to be part of a cocktail of drugs Duchenne patients take, said Pat Furlong, the founder of the advocacy group Parent Project Muscular Dystrophy. She questions how many high-priced drugs insurers will pay for.

“Where is the breaking point where any given insurer says [that’s] too much,” and stops covering the drugs, Furlong said.

Marathon said the price was set based on a number of factors, including recouping its research costs. The FDA required the drug to be submitted as a new drug — regardless of its approval in other countries. A company spokeswoman said Marathon funded 17 studies for Emflaza’s approval.

4. Marathon has cultivated relationships in the Duchenne patient community.

At a heated meeting with patient advocates on Monday, Marathon CEO Jeff Aronin announced a delay in the rollout of the drug and later released an open letter saying the company would “not move forward with commercialization” until discussing options with Duchenne community leaders.

The company, which is a corporate sponsor for Parent Project Muscular Dystrophy, announced it will continue offering an expanded access program to patients. He also said patients currently receiving the drug from other countries can continue importing.

Joel Wood, whose Duchenne foundation has received money from Marathon, said he believed the company will uphold financial promises to patients.

“I will be the first one to pick up a pitch fork” if the company fails to do so, said Wood, who has a son with Duchenne.

5. Timing is everything.

There was muted criticism when Spinraza’s $750,000 price was announced over the Christmas holiday.

Perhaps emboldened by President Donald Trump who recently said drug makers are “getting away with murder,” lawmakers from both sides of the aisle are expressing anger about Emflaza’s price and demanding answers from the drugmaker.

Rep. Robert Aderholt, a Republican from Alabama who chairs the subcommittee that oversees FDA’s appropriations, said Monday that Emflaza is a “tipping point” on the issue.

Last week, Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, announced he has opened an inquiryinto potential abuses of the Orphan Drug Act that may have contributed to high prices on commonly used drugs.

Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) sent a letter to Marathon Monday calling Emflaza’s price “unconscionable.” They asked the company to explain itself and lower the price.

“

Michael Rogawski NeurologyPosted Feb 17

Congress created the system that allows companies to charge high drug prices and they could fix the problem by tweaking the rules. Instead of passing effective legislation that sets a level playing field, they seem to prefer to shame individual companies while others continue to jack up prices year after year. Congressional "fuming" at "evil" drug companies may score points with voters, but make no mistake -- Congress is to blame for high drug prices and only Congress can craft an effective solution.”

why every single word ,comma, period matter may be 10 to 15 times more

  Novartis set the price of Gleevec at USD 2666 per patient per month; generic companies were selling their versions at USD 177 to 266 per patient per month

Novartis v. Union of India & Others

From Wikipedia, the free encyclopedia

Novartis AG v. Union of India
Court	Supreme Court of India
Full case name	'Novartis AG v. Union of India (UOI) and Ors.; Natco Pharma Ltd. v. UoI & Ors.; M/S Cancer Patients Aid Association v. UoI & Ors.
Decided	1 April 2013
Citation(s)	Civil Appeal No. 2706-2716 of 2013
Case history
Prior action(s)	Application for patent by appellant denied by Assistant Controller of Patents and Designs on 25 January 2006; Intellectual Property Appellate Board (IPAB) partially reversed the decision by the Assistant Controller but still denied patent on 26 June 2009.
Holding
Upheld the rejection of the patent application (1602/MAS/1998) filed by Novartis AG for Glivec in 1998 before the Indian Patent Office.
Case opinions
Majority	Mr. Justice Aftab Alam [1], joined by Ms. Justice Ranjana Prakash Desai
Laws applied
Sections 2(1)(j), 2(1)(ja) and 3(d) of Indian Patent Act, 1970 (as amended in 2005)

Novartis v. Union of India & Others is a landmark decision by a two-judge bench of the Indian Supreme Court on the issue of whether Novartis could patent Gleevec in India, and was the culmination of a seven-year-long litigation fought by Novartis. The Supreme Court upheld the Indian patent office's rejection of the patent application.

The patent application at the center of the case was filed by Novartis in India in 1998, after India had agreed to enter the World Trade Organization and to abide by worldwide intellectual property standards under the TRIPS agreement. As part of this agreement, India made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, while afterwards they were, albeit with restrictions. These changes came into effect in 2005, so Novartis' patent application waited in a "mailbox" with others until then, under procedures that India instituted to manage the transition. India also passed certain amendments to its patent law in 2005, just before the laws came into effect, which played a key role in the rejection of the patent application.

The patent application claimed the final form of Gleevec (the beta crystalline form of imatinib mesylate). In 1993, during the time India did not allow patents on products, Novartis had patented imatinib, with salts vaguely specified, in many countries but could not patent it in India. The key differences between the two patent applications, were that the 1998 patent application specified the counterion (Gleevec is a specific salt - imatinib mesylate) while the 1993 patent application did not claim any specific salts nor did it mention mesylate, and the 1998 patent application specified the solid form of Gleevec - the way the individual molecules are packed together into a solid when the drug itself is manufactured (this is separate from processes by which the drug itself is formulated into pills or capsules) - while the 1993 patent application did not. The solid form of imatinib mesylate in Gleevec is beta crystalline.

As provided under the TRIPS agreement, Novartis applied for Exclusive Marketing Rights (EMR) for Gleevec from the Indian Patent Office and the EMR were granted in November 2003. Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India. Novartis set the price of Gleevec at USD 2666 per patient per month; generic companies were selling their versions at USD 177 to 266 per patient per month. Novartis also initiated a program to assist patients who could not afford its version of the drug, concurrent with its product launch.

When examination of Novartis' patent application began in 2005, it came under immediate attack from oppositions initiated by generic companies that were already selling Gleevec in India and by advocacy groups. The application was rejected by the patent office and by an appeal board. The key basis for the rejection was the part of Indian patent law that was created by amendment in 2005, describing the patentability of new uses for known drugs and modifications of known drugs. That section, Paragraph 3d, specified that such inventions are patentable only if "they differ significantly in properties with regard to efficacy." At one point, Novartis went to court to try to invalidate Paragraph 3d; it argued that the provision was unconstitutionally vague and that it violated TRIPS. Novartis lost that case and did not appeal. Novartis did appeal the rejection by the patent office to India's Supreme Court, which took the case.

The Supreme Court case hinged on the interpretation of Paragraph 3d. The Supreme Court decided that the substance that Novartis sought to patent was indeed a modification of a known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent application and in scientific articles), that Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib, and that therefore the patent application was properly rejected by the patent office and lower courts.

Although the court ruled narrowly, and took care to note that the subject application was filed during a time of transition in Indian patent law, the decision generated widespread global news coverage and reignited debates on balancing public good with monopolistic pricing and innovation with affordability. Had Novartis won and gotten its patent issued, it could not have prevented generics companies in India from continuing to sell generic Gleevec, but it could have obligated them to pay a reasonable royalty under a grandfather clause included in India's patent law.

Contents

  [hide] 

<![if !supportLists]>·         <![endif]>1Background

<![if !supportLists]>o    <![endif]>1.1History of Patent laws and pharma industry in India

<![if !supportLists]>o    <![endif]>1.2Initial patent filings and product launches

<![if !supportLists]>o    <![endif]>1.3Initial patent prosecution and litigation

<![if !supportLists]>·         <![endif]>2Arguments before the Supreme Court

<![if !supportLists]>o    <![endif]>2.1Novartis

<![if !supportLists]>o    <![endif]>2.2Respondents

<![if !supportLists]>·         <![endif]>3Supreme Court decision

<![if !supportLists]>·         <![endif]>4Reception

<![if !supportLists]>o    <![endif]>4.1Support

<![if !supportLists]>o    <![endif]>4.2Opposition

<![if !supportLists]>·         <![endif]>5References

<![if !supportLists]>o    <![endif]>5.1External links to text of judicial opinions

Background[edit]

History of Patent laws and pharma industry in India[edit]

See also: Indian Patent System and Indian Patent Office

As part of the Commonwealth, India inherited its intellectual property laws from Great Britain. However, after gaining independence in 1947, there was a growing consensus that to boost manufacturing restrictive product patents must be temporarily removed.^[2] In 1970, amendments to the Indian Patents Act abolished product patents but retained process patents with a reduced span of protection.

During the absence of any product patent regime, the Indian pharmaceutical industry grew at a remarkable pace, ultimately becoming a net exporter, the world's third-largest by volume, and fourteenth-largest by value.^[3]

However, in the 1990s, during the Uruguay Round negotiations of the World Trade Organisation (WTO), India pledged to bring its patent legislation in tune with the TRIPS mandate in a phased manner.^[4] Consequently, in 1999 India allowed for transitional filing of product patent applications, with retrospective effect from 1995. Full product and process patent protection was re-introduced beginning in 2005 when all transitional regulations ended.^[5]

India's patent law also contained a "grandfather clause" in section 11A, subsection (7),^[6] that created "a special regime for generic versions of medicines if the initial patent application was made between the 1st of January 1995 and the 31st of December 2004 and if these medicines were already on the Indian market before the 1st of January 2005.... Generics that enter into this category can stay on the Indian market even if their pharmaceutical substance is patented. However, the Indian law requires that the producers of those generics then pay a "reasonable royalty" to the patent holder."^[7][8]

The case hinged on a section of the new Indian patent law dealing with whether incremental inventions would be patentable, namely Section 3d.

The initial version read as follows: "The mere discovery of any new property or new use of 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."^[9]

This was amended twice, the last time in 2005. The final version reads as follows (amendments in italics): "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 purposes of this clause, salts,esters, ethers, polymorphs, metabolites, pureform, 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."^[9]

As discussed below, Novartis filed its initial patent application on imatinib (the raw material in Gleevec) in 1993, and at that time India did not confer product patents.^[10] As mentioned above, in 1995 India joined the World Trade Organization and signed onto TRIPS; Switzerland joined the WTO later that same year.^[11][12] Novartis filed its initial patent applications on Gleevec itself in 1997, after both India and Switzerland had joined the WTO but while both were still in transition.

Initial patent filings and product launches[edit]

In the early 1990s a number of derivatives of N-phenyl-2-pyrimidineamine were synthesized by scientists at Ciba-Geigy (now part of Novartis), one compound of which was CGP 57148 in free base form (later given the International Nonproprietary Name 'imatinib' by the World Health Organisation (WHO)). A Swiss patent application was filed on April 3, 1992, which was then filed in the EU, the US, and other countries in March and April 1993^[13][14] and in 1996 United States and European patent offices granted a patent to Novartis claiming imatinib and its derivatives, including salts thereof (but not mentioning mesylate). The patent does not specify any crystal forms of the compounds or discuss their relative advantages and disadvantages.^[15][16]

On July 18, 1997, Novartis filed a new patent application in Switzerland on the beta crystalline form of imatinib mesylate (the mesylate salt of imatinib). The "beta crystalline form" of the molecule is a specific polymorph of imatinib mesylate; a specific way that the individual molecules pack together to form a solid. This is the actual form of the drug sold as Gleevec/Glivec; a salt (imatinib mesylate) as opposed to a free base, and the beta crystalline form as opposed to the alpha or other form.^[17]:3 On July 16, 1998, Novartis filed this patent application in India, which was given application number No.1602/MAS/1998, and on July 16, 1998, it filed a PCT, each of which claimed priority to the 1997 Swiss application.^[18][19] The application showed that compared to the alpha form, the beta form had (i) more beneficial flow properties, (ii) better thermodynamic stability, (iii) lower hygroscopicity.^[19] Novartis did not however provide any data showing improved efficacy (showing that this form of the drug actually worked better in treating cancer than the amorphous form of the drug they had earlier patented) - that part of Indian patent law was created in 2005, years after Novartis' initial filing. Later, during the course of prosecution, appeals, and the litigation that ensued in India, Novartis undertook studies to compare the properties of the beta crystalline form of imatinib mesylate (described in its new patent application), with the freebase form of imatinib (described in the older patent), and submitted them in affidavits. The studies showed that the beta crystalline form of the drug had increased bioavailability in rats.^[20] A United States patent was granted in 2005.^[21]

In 2001 the United States Food and Drug Administration (FDA) approved imatinib mesylate in its beta crystalline form, sold by Novartis as Gleevec (U.S.)^[22] or Glivec (Europe/Australia/Latin America). TIME magazine hailed Gleevec in 2001 as the "magic bullet" to cure cancer.^[23][24] Both Novartis patents - on the freebase form of imatinib, and on the beta crystalline form of imatinib mesylate - are listed by Novartis in the FDA's Orange Book entry for Gleevec.^[25]

As provided under the TRIPS agreement, Novartis applied for Exclusive Marketing Rights (EMR) for Gleevec from the Indian Patent Office and the EMR was granted in November 2003.^[26] Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India. Novartis set the price of Gleevec at USD 2666 per patient per month; generic companies were selling their versions at USD 177 to 266 per patient per month.^[27] Novartis also initiated a program to assist patients who could not afford its version of the drug, concurrent with its product launch.^[28]

Initial patent prosecution and litigation[edit]

As mentioned above, Novartis' patent application on the beta crystalline form of imatinib mesylate was filed in India in 1998 and put in a "mail-box" as per the TRIPS agreement.^[29] The application was processed in 2005 once the law in India allowed for product patents.^[30] The Assistant Controller of Patents and Designs rejected the application on 25 January 2006 as failing to satisfy requirements for novelty and non-obviousness. As the appellate board was not yet convened, Novartis filed several appeals before the Madras High Court in 2006.

The free base form of anti-cancer agent imatinib. Imatinib mesylate is a salt formed by a 1:1 reaction of imatinib and methanesulfonic acid.

Before the High Court could decide on the issue of patentability, the Intellectual Property Appellate Board (IPAB) was formed and in 2007 the case was transferred before the IPAB in line with section 117G of the Indian Patent Act. The IPAB on 26 June 2009 modified the decision of the Assistant Controller of Patents and Designs stating that ingredients for grant of patent novelty and non obviousness to person skilled in the art were present in the application but rejected the application on the ground that the drug is not a new substance but an amended version of a known compound and that Novartis was unable to show any significant increase in the efficacy of the drug and it, therefore, failed the test laid down by section 3(d) of the Indian Patents Act.^[31][32]

Novartis mounted a separate and concurrent litigation before the Madras High Court arguing that section 3(d) of the Indian Patents Act is violated Article 14 of the Indian constitution because the definition of "enhanced efficacy" was too vague and left too much power in the hands of the patent examiner, and was in violation of India's obligations under the TRIPs agreement because it rendered inventions that should be patentable, unpatentable, and argued that the Court was the proper venue for hearing the claim concerning violation of TRIPS. Counsel for the Indian government argued that any violation of TRIPS belonged before the Dispute Settlement Board established by TRIPS, not before the Court, and that in any case, TRIPS allowed national laws to address the needs of its citizens; with respect to the claim that the amended law was arbitrary, counsel argued that "enhanced efficacy" is well understood in the pharmaceutical arts. In 2007 the High Court decided, agreeing with Novartis that it had the right to hear the case, and agreeing with counsel for the Indian government that the law was not vague, and that the law complied with TRIPS, and observed that section 3(d) aims to prevent evergreening and to provide easy access for Indian citizens to life saving drugs.^[9] Novartis did not further challenge this order.

After IPAB rejected the patent application in 2009, Novartis appealed directly before the Supreme Court through a Special Leave Petition (SLP) under Article 136 of the Indian Constitution;^[33] under normal circumstances, an appeal from IPAB should have been before one of the High Courts before it could proceed to the Supreme Court. However the patent if granted on appeal would expire by 2018 and thus any further appeal at that stage would be pointless. Considering this urgency and the need for an authoritative decision on section 3(d) (other cases on this issue were pending before various High courts), the Supreme Court granted special leave to bypass the High Court appeals process and come directly before it.

Arguments before the Supreme Court[edit]

Novartis[edit]

The legal team of Novartis was led by ex-Solicitor General of India Gopal Subramaniam and senior advocate T. R. Andhyarujina.^[34] Novartis had attempted to patent imatinib mesylate in beta crystalline form (rather than imatinib or imatinib mesylate), thus they sought to prevent extant literature on imatinib or imatininb mesylate from being considered as prior art. The thrust of the arguments by Novartis' legal team was two-fold: firstly, that the Zimmerman patents and the journal articles published by Zimmerman et al. do not constitute prior art for the beta crystalline form as it is only one polymorph of imatinib mesylate, thereby providing the required novelty and inventive step; and secondly, that imatinib mesylate in beta crystalline form has enhanced efficacy over imatinib or imatinib mesylate to pass the test of section 3(d).

To prove novelty and inventive step it was argued that the Zimmermann patent did not teach or suggest to a person skilled in the art to select the beta crystalline form in preference to other compounds of which examples were given in the Zimmermann patent. Further, even if the beta crystalline form was selected, the Zimmermann patent did not teach a person to how to prepare that particular polymorph of the salt. Having arrived at the beta crystal form of methanesulfonic acid addition salt (mesylate salt) of imatinib, Novartis contended that the inventors had to further research to be able to ensure that particular salt form of imatinib was suitable for administration in a solid oral dosage form. Hence, the coming into being of the beta crystalline form of imatinib mesylate from the free base of imatinib was the result of an invention that involved technical advance as compared to the existing knowledge and brought into existence a new substance. Research was required to define and optimise the process parameters to selectively prepare the beta crystalline form of imatinib mesylate. As the Zimmermann patent contains no mention of polymorphism or crystalline structure, the relevant crystalline form that was synthesized needed to be invented. There was no way of predicting that the beta crystalline form of imatinib mesylate would possess the characteristics that would make it orally administrable to humans without going through the inventive steps.^[35]

To prove that the beta crystalline form enhanced efficacy over other polymorphs, it was stated that beta crystalline form has (i) more beneficial flow properties, (ii) better thermodynamic stability, (iii) lower hygroscopicity, and (iv) increased bioavailability.^[20]

Respondents[edit]

There were seven named respondents who were represented before the court along with two Intervenor/Amicus. The respondents were led by Additional Solicitor General of India Paras Kuhad.^[34]

Various arguments were brought before the court but primarily focussed on proving imatinib mesylate in beta crystalline form is neither novel nor is it non-obvious due to publications about imatinib mesylate in Cancer Research and Nature in 1996, disclosures in Zimmerman patents, disclosures to FDA and finally that efficacy as referred to in section 3(d) should be interpreted as therapeutic efficacy and not merely a physical efficacy.^[36]

The respondents quoted extensively from Doha Declaration, excerpts from parliamentary debates, petitions from NGOs, WHO, etc. to highlight the public policy dimension of arguments in regards to easy affordability and availability of life saving drugs.

Supreme Court decision[edit]

Supreme Court decided the matter de novo looking into matters of both fact and law.

The court first analysed the question of prior art by looking into Zimmerman patent and the related academic publications. It was clear from the Zimmerman patent that imatinib mesylate itself was not new and did not qualify the test of invention as laid down in section 2(1)(j) and section 2(1)(ja) of the Patents Act, 1970.^[37] The court then examined the beta crystalline form of imatinib mesylate and wrote that it, "for the sake of argument, may be accepted to be new, in the sense that it is not known from the Zimmermann patent. (Whether or not it involves an "inventive step" is another matter, and there is no need to go into that aspect of the matter now). Now, the beta crystalline form of Imatinib Mesylate being a pharmaceutical substance and moreover a polymorph of Imatinib Mesylate, it directly runs into section 3(d) of the Act with the explanation appended to the provision".^[38]

In applying 3(d) of the Act, the Court decided to interpret "efficacy" as "therapeutic efficacy" because the subject matter of the patent is a compound of medicinal value. Court acknowledged that physical efficacy of imatinib mesylate in beta crystalline form is enhanced in comparison to other forms and that the beta crystalline form of imatinib mesylate has 30 per cent increased bioavailability as compared to imatinib in free base form.^[39] However, as no material had been offered to indicate that the beta crystalline form of imatinib mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with imatinib free base in vivo animal model, the court opined that the beta crystalline form of imatinib mesylate, does not qualify the test of Section 3(d).^[40][41]

Thus in effect, Indian Supreme Court upheld the view that under Indian Patent Act for grant of pharmaceutical patents apart from proving the traditional tests of novelty, inventive step and application, there is a new test of enhanced therapeutic efficacy for claims that cover incremental changes to existing drugs.^[42]

The Court took pains to point out that the subject patent application was filed during a time of transition in Indian patent law, especially with regard to striking Section 5, which had barred product patents and adding section 3(d), for which there was no case law yet.^[43] The Court also took care to state the decision was intended to be narrow: "We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment."^[44]

Reception[edit]

The decision received extensive coverage from Indian and international media.^{[28][45][46][47][48]}

It reignited debates on balancing public good with monopolistic pricing and innovation with affordability.^[49][50][51]

Several commenters, including Novartis, noted that a decision either way would not have affected the ability of generics companies in India to continue selling generic Gleevec. The new patent law India adopted in 2005 contains a grandfather clause that allows generic copies of drugs launched before 2005, which includes Gleevec, to continue to be sold, albeit with payment of a reasonable royalty to Novartis.^[8][52] Other commenters noted that the case was unique with respect to its timing and the importance of the drug, and that large generalizations should not be taken from it. "As a case study, Glivec is peculiar and unlikely to be representative going forward. Had it been invented a few years later (or TRIPS implemented a few years earlier), Glivec likely would be patented in India, even under 3(d) standards. Newly discovered compounds are likely to receive basic patents and to be less vulnerable to 3(d) rejections."^[53] Prashant Reddy, author of the Spicy IP blog and postgraduate student at Stanford University Law School, was quoted in Nature Drug Discovery as saying: "It was a very limited ruling in most aspects and very fact-specific. Although the Court has interpreted efficacy to mean only therapeutic efficacy, it has left the exact scope of therapeutic efficacy to be defined in future cases....Most importantly, the Court made the nuanced distinction between the rent-seeking practice of evergreening and the beneficial practice of incremental innovation, and has clarified that Indian patent law forbids only the former."^[54][55]

There were however strong negative and positive reactions.

Support[edit]

The judgement garnered widespread support from international organisations and advocacy groups like Médecins Sans Frontières,^[56] WHO, etc. who welcomed the decision against evergreening of pharmaceutical patents.

Most news item contrasted the huge price difference between patented Gleevec of Novartis and the generic versions of Cipla and other generic companies.^[57][58] Some commentators have stated that this strict patent requirement would actually enhance innovation as the pharmaceutical companies would have to invest more in R&D to come up with new cures rather than repackage known compounds.^[59] Others have suggested that exclusions under section 3(d) present the hard cases that lie at the margins of the patent system due to the eternally unsettled nature of the definition of the term 'invention'.^[60] Several patent law experts have also pointed out that stringent conditions for patentability are followed in many jurisdictions around the world, and there is no reason India should not follow the same standards, given the extent of poverty and lack of availability of affordable medicines in the country.^[61]

Opposition[edit]

Ranjit Shahani, vice-chairman and managing director of Novartis India Ltd is quoted as saying "This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."^[62] He also said that companies like Novartis would invest less money in research in India as a result of the ruling.^[46] Novartis also emphasized that it continues to be committed to access to its drugs; according to Novartis, by 2013, "95% of patients in India—roughly 16,000 people—receive Glivec free of charge... and it has provided more than $1.7 billion worth of Glivec to Indian patients in its support program since it was started...."^[28] The New York Times quoted Chip Davis, the executive vice president of advocacy at the Pharmaceutical Research and Manufacturers of America, the industry trade group: "It really is in our view another example of what I would characterize as a deteriorating innovation environment in India. The Indian government and the Indian courts have come down on the side that doesn't recognize the value of innovation and the value of strong intellectual property, which we believe is essential."^[46]

References[edit]

<![if !supportLists]>1.     <![endif]>Jump up^ "Novartis v. Union Of India & Ors on 1 April 2013".

<![if !supportLists]>2.     <![endif]>Jump up^ "Patenting Landscape in India 2009".

<![if !supportLists]>3.     <![endif]>Jump up^ "Pharma to topple IT as big paymaster". The Economic Times. 8 June 2010. Retrieved 8 Jun 2010.

<![if !supportLists]>4.     <![endif]>Jump up^ "History of Patent Law in India".

<![if !supportLists]>5.     <![endif]>Jump up^ "Product v. Process Patent in India".

<![if !supportLists]>6.     <![endif]>Jump up^ Controller General of Patents Designs and Trade Marks, Department of Industrial Policy and Promotion, Ministry of Commerce and Industry The Patents Act 1970 (incorporating all amendments till 26-01-2013)

<![if !supportLists]>7.     <![endif]>Jump up^ Erklärung von Bern. May 8, 2007 Short questions and answers about the court case initiated by Novartis in India

<![if !supportLists]>8.     <![endif]>^ Jump up to:^a b Kevin Grogan for PharmaTimes. February 27, 2012 Novartis explains stance over India patent law challenge

<![if !supportLists]>9.     <![endif]>^ Jump up to:^a b c W.P. No.24759 of 2006

<![if !supportLists]>10.  <![endif]>Jump up^ Finally, the patients prevail, Sarah Hiddlestone, The Hindu, 7 April 2013

<![if !supportLists]>11.  <![endif]>Jump up^ Switzerland page at WTO

<![if !supportLists]>12.  <![endif]>Jump up^ Note: Further complicating matters, India's 1993 notification to the WTO indicating that it would join, included a list of countries whose priorities dates it would recognize for patenting, and Switzerland was not on the list as it was not a member of the WTO at that time.(Sudhir Ahuja, D P Ahuja & Co, Calcutta, India. India Decides to Join the Paris Convention and Ratify the Patent Cooperation Treaty. So What? Patent World Issue #106, October 1998). Additionally the EPO was not mentioned in the notification from India; it was not until 2003 that EPO became officially recognized by India, fully normalizing patent reciprocity between India and Europe. (G 0002/02 (Priorities from India/ASTRAZENECA) of 26.4.2004)

<![if !supportLists]>13.  <![endif]>Jump up^ US Patent Application No. 08/042,322). This application was abandoned and another continuation-in-part application was then filed on April 28, 1994 which matured into (US Patent 5,521,184).

<![if !supportLists]>14.  <![endif]>Jump up^ See here for worldwide filings]

<![if !supportLists]>15.  <![endif]>Jump up^ US Patent 5,521,184

<![if !supportLists]>16.  <![endif]>Jump up^ EP0564409

<![if !supportLists]>17.  <![endif]>Jump up^ Staff, European Medicines Agency, 2004. EMEA Scientific Discussion of Glivec

<![if !supportLists]>18.  <![endif]>Jump up^ Note: The Indian patent application does not appear to be publicly available. However according to the decision of the IPAB on 26 June 2009 (page 27) discussed below, "The Appellant's application under the PCT was substantially on the same invention as had been made in India."

<![if !supportLists]>19.  <![endif]>^ Jump up to:^a b Published PCT application WO1999003854

<![if !supportLists]>20.  <![endif]>^ Jump up to:^a b Novartis v UoI, para 168

<![if !supportLists]>21.  <![endif]>Jump up^ US Patent 6,894,051

<![if !supportLists]>22.  <![endif]>Jump up^ Investigational New Drug Application (IND # 55,666) for Gleevec was filed on 9 April 1998 and on February 27, 2001, the original New Drug Application (FDA Drug Approval Package for Gleevec NDA # 21-335) was filed before the US Food and Drug Administration for imatinib mesylate for the treatment of patients with Chronic Myeloid Leukemia

<![if !supportLists]>23.  <![endif]>Jump up^ Closing In On Cancer by Alice Park, TIME Magazine, 21 May 2001

<![if !supportLists]>24.  <![endif]>Jump up^ Novartis' Gleevec Cancer "Magic Bullet" Extends Life In GIST Patients, 6 June 2011

<![if !supportLists]>25.  <![endif]>Jump up^ FDA Orange Book; Patent and Exclusivity Search Results from query on Appl No 021588 Product 001 in the OB_Rx list.

<![if !supportLists]>26.  <![endif]>Jump up^ Novartis v UoI, para 8-9

<![if !supportLists]>27.  <![endif]>Jump up^ Staff, LawyersCollective. September 6, 2011 Novartis case: background and update – Supreme Court of India to recommence hearing

<![if !supportLists]>28.  <![endif]>^ Jump up to:^a b c R. Jai Krishna and Jeanne Whalen for the Wall Street Journal. April 1, 2013 Novartis Loses Glivec Patent Battle in India

<![if !supportLists]>29.  <![endif]>Jump up^ Application No.1602/MAS/1998

<![if !supportLists]>30.  <![endif]>Jump up^ The patent application attracted five pre-grant oppositions by M/s. Cancer Patients Aid Association, NATCO Pharma Ltd., CIPLA Ltd., Ranbaxy Laboratories Ltd. and Hetro Drugs Ltd. The Assistant Controller of Patents and Designs heard all the parties on December 15, 2005, as provided under rule 55 of the Patent Rules, 2003.

<![if !supportLists]>31.  <![endif]>Jump up^ Intellectual Property Appellate Board decision dated 26 June 2009, p 149

<![if !supportLists]>32.  <![endif]>Jump up^ Shamnad Basheer for Spicy IP March 11, 2006 First Mailbox Opposition (Gleevec) Decided in India

<![if !supportLists]>33.  <![endif]>Jump up^ Article 136 of the Indian Constitution

<![if !supportLists]>34.  <![endif]>^ Jump up to:^a b "Supreme Court rejects Novartis patent plea for cancer drug Glivec".

<![if !supportLists]>35.  <![endif]>Jump up^ Novartis v UoI, para 105-108

<![if !supportLists]>36.  <![endif]>Jump up^ The Novartis Patent Intervention by Prof. Shamnad Basheer

<![if !supportLists]>37.  <![endif]>Jump up^ Novartis v UoI, Para 157

<![if !supportLists]>38.  <![endif]>Jump up^ Novartis v UoI, Para 158

<![if !supportLists]>39.  <![endif]>Jump up^ Novartis v UoI, Para 187, 188

<![if !supportLists]>40.  <![endif]>Jump up^ Novartis v UoI, Para 189, 191

<![if !supportLists]>41.  <![endif]>Jump up^ Novartis A.G. v. UOI & Ors. – Hon'ble Justice Aftab Alam's Swansong, Rudrajyoti Nath Ray, RDA, 8 April 2013

<![if !supportLists]>42.  <![endif]>Jump up^ Novartis and Health - An analysis, Rajeev Dhavan, 11 April 2013

<![if !supportLists]>43.  <![endif]>Jump up^ Novartis v UoI, Para 24-25

<![if !supportLists]>44.  <![endif]>Jump up^ Novartis v UoI, Para 191

<![if !supportLists]>45.  <![endif]>Jump up^ Rama Lakshmi for the Washington Post April 1, 2013 India rejects Novartis drug patent

<![if !supportLists]>46.  <![endif]>^ Jump up to:^a b c Gardiner Harris and Katie Thomas for the New York Times. April 1, 2013 Published: April 1, 2013 Top court in India rejects Novartis drug patent

<![if !supportLists]>47.  <![endif]>Jump up^ Sarah Boseley for The Guardian, April 1, 2013 Novartis patent ruling a victory in battle for affordable medicines

<![if !supportLists]>48.  <![endif]>Jump up^ Staff, BBC. April 2, 2013 Novartis case: Media hail 'key victory' for India

<![if !supportLists]>49.  <![endif]>Jump up^ "How the Indian judgment will reverberate across the world".

<![if !supportLists]>50.  <![endif]>Jump up^ "Patented drugs must be priced smartly".

<![if !supportLists]>51.  <![endif]>Jump up^ Patent with a purpose, Prof. Shamnad Basheer, Indian Express, 3 April 2013

<![if !supportLists]>52.  <![endif]>Jump up^ M Allirajan, TNN April 4, 2013 SC decision on Glivec is negative credit for branded drug firms: Moody's

<![if !supportLists]>53.  <![endif]>Jump up^ Sampat BN et al. Challenges to India's Pharmaceutical Patent Laws Science 27 July 2012: Vol. 337 no. 6093 pp. 414-415

<![if !supportLists]>54.  <![endif]>Jump up^ Charlotte Harrison Patent watch Nature Reviews Drug Discovery 12, 336–337 (2013)

<![if !supportLists]>55.  <![endif]>Jump up^ "Supreme Court rejects bid by Novartis to patent Glivec".

<![if !supportLists]>56.  <![endif]>Jump up^ Major victory on affordable drugs

<![if !supportLists]>57.  <![endif]>Jump up^ Salve on cheaper medicine Patent blow to Big Pharma, The Telegraph

<![if !supportLists]>58.  <![endif]>Jump up^ "Drug price cut signal after court victory".

<![if !supportLists]>59.  <![endif]>Jump up^ Why Novartis case will help innovation, Achal Prabhala and Sudhir Krishnaswamy, The Hindu, 15 April 2013

<![if !supportLists]>60.  <![endif]>Jump up^ A New Template for Pharma Research, Yogesh Pai, The Hindu Business Line, 11 April 2013

<![if !supportLists]>61.  <![endif]>Jump up^ Nothing wrong with setting high standards of patentability, Srividhya Ragavan and Aju John, myLaw.net, 10 May 2013

<![if !supportLists]>62.  <![endif]>Jump up^ Shift in Novartis Strategy, The Telegraph

External links to text of judicial opinions[edit]

<![if !supportLists]>·         <![endif]>Supreme Court judgement dated 1 April 2013

<![if !supportLists]>·         <![endif]>Intellectual Property Appellate Board decision dated 26 June 2009

<![if !supportLists]>·         <![endif]>Madras High Court decision on constitutionality of section 3(d) dated 6 August 2007

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