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Novartis’s challenge on validity of Indian patent laws was put down by Indian High Court August 7, 2007

Posted by mais in Drugs, India, IP Systems, Litigation, Patent, TRIPS.
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Swiss pharma giant, Novartis, faced another blow in India, when Chennai High Court rejected its writ petition challenging the validity of Indian Patent Laws.

Novartis had sought to declare Section 3 (d) of the Indian Patents Act as substituted by Patents (Amendment) Act (2005) as being “unconstitutional as it is vague, arbitrary and violative of Article 14 of the constitution (right to equality).”  The section denies patent protection to the discovery of new form of known substance which does not result in enhancement of the known efficacy of that substance.

Novartis also rasied concerns over the discretion of patent authorities to define and determine the “enhancement of efficacy”. The Bench rejected the concerns by saying that the amended section cannot be invalidated solely on ground that there was a mere possibility of misuse of power.

Since Novartis’s 1993 patent effectively disclosed both the free base, imatinib, and the acid-addition salt, imatinib mesylate and the crystalline forms of imatinib mesylate. The crystalline forms of imatinib mesylate claimed in the application in question does not differ significantly in properties with respect to efficacy. In fact, with respect to efficacy, the current specification of Novartis itself admits that wherever β-crystals are used the imatinib free base or other salts can be used. The various forms of imatinib mesylate can, therefore, very well be considered the “same substance” under section 3(d) of the Patents Act.   view of IP practitioner Swarup Kumar

Novartis unlikely to challenge High court ruling in Indian Supreme Court. Novartis faced first setback  in January last year, when the Indian Patent Office rejected a patent application of its leukaemia drug Gleevec. It had filed appeal against the patent office decision to Intellectual Property Appellate Board and a writ petition in Chennai High Court.


Indian firms and brazilian AIDS patients to be benefit from compulsory licensing May 9, 2007

Posted by mais in Drugs, India, Patent, TRIPS, WTO.
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The Brazilian government’s decision to override the patent rights of Merck’s HIV/AIDS drug Stocrin (efavirenz) and buy reverse engineered generic versions of the drug at low cost has come as a boon for Indian pharmaceutical companies manufacturing generic versions of efavirenz such as Cipla, Ranbaxy, Aurobindo Pharma and Strides Arcolab.

On Friday, Brazilian President Luiz Inacio Lula da Silva announced invoking the compulsory licensing provision for pharmaceuticals under the World Trade Organisation’s (WTO) agreement on intellectual property – the TRIPS (Trade-Related Aspects of Intellectual Property Rights) – to buy copycat versions of efavirenz from laboratories certified by the World Health Organisation.

With over 200,000 registered cases, Brazil has the most AIDS patients in Latin America. Of them, only 75,000 patients are currently treated with efavirenz.

Welcoming the Brazilian government’s move, Amar Lulla, joint managing director of Cipla, said it was heartening to note that Brazil has invoked the compulsory licensing provision to treat its HIV/AIDS patients with affordable generic drugs.

“The compulsory licensing provision of the TRIPS help countries to protect the rights of its citizens. We welcome the Brazilian move,” he said.

Lulla confirmed that the Brazilian government was negotiating with Cipla for the supply of these medicines.

US pushes bill to promote competitive presence of generic drug manft. March 7, 2007

Posted by mais in Drugs, USA.
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The bipartisan Preserve Access to Affordable Generics Act (S. 316) would prohibit brand-name drug companies from exploiting a loophole in the Hatch-Waxman Act to pay generic drug companies to delay entry of new generic medicines into the market.

The bill brought by Senator Patrick Leahy, (D-Vt.), and supported by Senators Herb Kohl (D-Wisc.), Chuck Grassley (R-Iowa), Russ Feingold (D-Wisc.), and Charles Schumer (D-NY).

The bill aims to end the trend of anti-competitive agreements between brand name pharmaceutical companies and generic companies to delay entry of affordable generics into the market.

Today, the law can’t stop the original patent holder from launching an “authorized generic” through a subsidiary or a third party. Sales of an authorized generic during the exclusivity period can cut the generic maker’s profits by 59 percent, according to research by Merrill Lynch analyst Greg Gilbert.

On the other hand Branded drug companies are lobbying with Bush administration to impose a new fees for the drug application filed by generic drug companies

Glaxo’s patent on AIDS drug opposed by INP+ in India April 25, 2006

Posted by mais in Drugs, Patent.
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Glaxo's patent on AIDS drug opposed by INP+ in India
The World Trade Review: "Intellectual Property Rights (TRIPs), 16-30 April 2006

Mumbai: People living with HIV/AIDS are taking on drug major GlaxoSmithKline's efforts to patent its AIDS-medicine Combivir in India.

The Manipur Network of Positive People (MNP+), under the aegis of the Indian Network of People Living with HIV/AIDS (INP+) has filed a pre-grant opposition to GSK's patent application at the Indian Patent office in Kolkata. The pre-grant opposition has been filed for the patient organisations by Lawyers' Collective.

Combivir is the backbone of AIDS therapy and is used in the first-line of treatment, Mr Loon Gangte, a HIV-positive person with INP+, told Business Line. GSK's patent application is being opposed on technical and health grounds, he said.

Combivir is a fixed-dose combination of two existing AIDS drugs – zidovudine and lamivudine, technically that is not a new invention, Mr Gangte said. GSK officials were not available for comment.

A pre-grant opposition allows people to oppose patent applications filed by a company. A decision on the patent is given after the Patent Controller's office hears arguments from different stakeholders. Only recently, the Patent Office in Chennai had rejected Novartis' patent on cancer drug Glivec.

Generic or copycat versions of Combivir are available in India from drug-makers such as Cipla, Ranbaxy, Aurobindo, Emcure and Strides. They are priced at about Rs 1,100 per patient, per month. These drug-makers supply to patients to other developing countries too, he said. GSK's Combivir is not available in the local market, said Ms Priti Radhakrishnan of Lawyers' Collective.

But international aid organisation Medecins Sans Frontieres (MSF) purchases it at about $237 per patient per year compared to the cheapest generic at $182, said Ms Leena Menghaney with Campaign for Access to Essential Medicines and MSF.

Generic competition has brought down the price on Combivir-clones. If GSK gets a patent, it becomes a monopoly and could control the price, Mr Gangte said.

Though the present product-patent regime in India may allow Combivir-clones to sell provided they pay a royalty to GSK, there is a risk of a price increase. There is no clarity in the law on the royalty to be paid. Either way a price increase is on the cards, he said.

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TRIPS & Convention on Biological Diversity (CBD) Alaince worries Western Pharma/ Biotech Companies January 11, 2006

Posted by mais in Drugs, TRIPS.
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TRIPS & Convention on Biological Diversity (CBD) Alaince worries Western Pharma/ Biotech Companies

Tuesday, January 10, 2006
By Stephanie Weinberg

U.S. biotech firms representing a variety of industries are working to ward off efforts by India, Brazil and other developing countries that want to amend World Trade Organization rules to require patent holders to disclose the origin of their patents and share benefits when those patents are based on genetic plant material or traditional knowledge from developing countries. Failure to meet these new rules would result in the loss of patents if these changes to WTO rules were approved.

The firms expect to create an education campaign this spring to build opposition among other WTO members to demands from India and Brazil, and argue that developing countries could actually be disadvantaged by such rules. In addition, the group hopes to find allies within India’s biotech industry, which also could be disadvantaged by the new requirements, they said. This could include Indian companies making patented health care and personal grooming products based on ayurveda, or Hindu traditional medicine.

The U.S. biotech firms have been brought together under the recently formed American BioIndustry Alliance, which includes pharmaceutical companies Merck, Pfizer, Bristol Myers-Squibb and Eli Lilly, as well as General Electric and Procter & Gamble. The membership of companies not strictly in pharmaceuticals shows the issue is important to firms beyond the drug industry, industry sources said. Procter & Gamble, for example, is chiefly interested in how new WTO rules requiring benefits sharing and disclosure of origin could adversely affect its skin care products, an industry source said.

The goal of the group is to prevent such requirements from being incorporated into the WTO Agreement on Trade-Related Aspects on Intellectual Property Rights, as demanded chiefly by Brazil, India and Peru. At the December 13-18 WTO ministerial in Hong Kong, those countries successfully negotiated language into the final ministerial text that calls for the WTO director general to intensify his consultations on all outstanding implementation issues, including the relationship between TRIPS and the Convention on Biological Diversity, which covers the use of biological materials.

Paragraph 39 also calls for the WTO General Council to review progress and “take any appropriate action” no later than July 31, 2006 on the implementation issues. Implementation refers to issues during the Uruguay Round that developing countries argue were not effectively implemented, but the only two issues specifically highlighted in paragraph 39 are the traditional knowledge and genetic material issue, and the European Union’s demands for protections for foods with geographic names or indications such as Parma ham. Some fear the EU may ultimately support talks on negotiating new rules on the use of traditional knowledge and genetic material if this also allows the GIs issue to move.

U.S. firms would have preferred to see language calling for open-ended consultations rather than a date indicating some decision could be made by this summer, sources said. However, one industry source said open-ended language was too much to expect given the push by Brazil and India for an endorsement of talks on amending WTO rules to be included in the ministerial text. At the same time, the source acknowledged it would be better to have more than six months to consult with other WTO members and potential allies in India as a way to counter the current demands from India, Brazil and Peru.

The July 31 date corresponds to deadlines for members to submit comprehensive draft schedules of commitments in agriculture and industrial market access, although this depends on members meeting a separate deadline agreed in Hong Kong to establish specific negotiating terms or modalities in those areas by April 30. Still, it is conceivable that Brazil and India could use the deadline on these schedules as leverage to win concessions on the TRIPS issue.

However, U.S. industry sources indicated they are hopeful of softening the position of India, which in Hong Kong indicated to the U.S. that its position was based on domestic political reasons, and that its biotechnology and pharmaceutical industry had not raised its voice on the issue, sources said. The ruling party in India shares power with several minority parties, including the Communists, who support introducing WTO requirements for benefits sharing and origin disclosure.

As a result, industry sources said it could be possible to get India to lower its demands if industry groups in that country announced their opposition to rules that would threaten to invalidate a patent if a patent holder failed to share benefits or disclose the origin of related traditional knowledge or genetic material. These sources indicated U.S. groups would reach out to potential supporters in India in the hopes of changing the dynamics there.

Such a scenario, however, is unlikely with Brazil, which is seen as more interested in advocating fundamental changes to TRIPS, sources said.

The alliance will argue to developing countries that creating a mandatory patent disclosure obligation would make it less likely that industry would invest in bio-prospecting in developing countries, which would add to uncertainty in the bio-industry and make it less likely that genetic resource inventions would become commercially viable. This would go against the interest of countries rich in traditional knowledge and genetic material, since these countries would not get to share in any benefits unless products appear on the market.

Determining where genetic material comes from can also be complicated, and is another reason why linking patents to disclosure or benefit sharing would be a bad idea, the alliance argues. For example, questions could be raised about the origin of bio-materials found in the Brooklyn Botanical Garden. Another possible complication could occur if a company disclosed that the country of origin for its material was India, but it turned out the same material could be found in, for example, China. This could lead to conflicts over how benefits should be shared among various countries.

U.S. firms and the U.S. government have advocated a contractual system for sharing benefits, and have urged members to reject a linkage between patents and benefit sharing, these sources said.

Finally, the alliance argues the goals that would need to be captured in an international regime on access and benefit sharing related to genetic resource inventions go beyond the expertise of the WTO TRIPS Council. It argues the better forum for an agreement would be under the Convention on Biological Diversity, which the U.S. has not ratified. There is also no dispute settlement mechanism under the CBD.

Stephanie Weinberg
Trade Policy Advisor
Oxfam America

US again threatns to suspend patent rights on health hazard grounds.. November 11, 2005

Posted by mais in Drugs, TRIPS, USA.
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Apprehension about offering the stringent Product Patent protection to Pharma inventions during the TRIPs negotiations are turning the to be true.

Even in developed world, companies holding the key patented medicine were reluctant to offer the medicines to the needy people at the time of community health crises and in order to avoid any catastrophy might govts like US has literally threat to them suspend/ revoke their patent rights over the life saving medicine.

Perhaps, most of developing countries are not strong enough to compel any such patent holder to make available the life saving drugs to the public on reasonable prices.

We have to ensure that natural human lives are always placed above the profit making motives of legal entities.

IPBiz: Washington Post on Tamiflu: U.S. bullies IP owners: “Monday, November 07, 2005
Washington Post on Tamiflu: U.S. bullies IP owners
But the U.S. isn’t a model of respect for intellectual property, either. Panicked by its own lateness, the Bush administration has bullied Roche into opening a new production operation in the United States; if Roche had refused, the administration was ready to break the patent. Sen. Chuck Schumer has gone further, denouncing Roche for elevating profits above health and demanding that the firm license its technology to other drugmakers or face legislation compelling it to do so. Coming on top of similar bullying four years ago of Bayer, the maker of an anti-anthrax drug, this browbeating sends a clear signal: If you make a drug that turns out to be really important, don’t expect patent laws to protect you.

Anchen files ANDA for Wellbutrin XL (buproprion) November 22, 2004

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Anchen files ANDA for Wellbutrin XL (buproprion)

Anchen files ANDA for Wellbutrin XL (buproprion)

By Lawrence B. Ebert

Taiwan-based generic company Anchen Pharmaceuticals has submitted an abbreviated new drug application (ANDA) to the FDA for Biovail’s Wellbutrin XL (once daily dose of bupropion for depression).

Litigation over bupropion has been extensive. Current issues are NOT about the drug itself (the composition of which is off patent) but about the formulations for controlled delivery of the drug. The Excel and Impax decisions of the Court of Appeals for the Federal Circuit have involved interpretation of the foreseeability prong of the US Supreme Court decision in Festo (535 US 722 (2002)).

Wellbutrin is a drug used to treat depression, but the underlying chemical is also used for smoking cessation (marketed as ZYBAN). Of depression, the chemical is different from Paxil, Prozac and Zoloft, and as a result, Wellbutrin can often successfully treat people with depression whose condition has not improved from taking these other drugs.

Although the chemical of Wellbutrin and Zyban has been off patent as a composition of matter for a long time, in 1995 Glaxo received a patent for the extended release formula of Wellbutrin SR. In 1999, generic drug manufacturer Andrx filed two ANDAs with the FDA seeking to sell generic versions of extended release Wellbutrin and Zyban. Andrx argued that because its generic used a different method of extended release, that it did not infringe on Glaxo’s patent. Four other generic manufacturers followed Andrx’s lead, and several have received tentative approval to manufacture and market their generic versions. In February of 2002, the US District Court for the Southern District of Florida ruled that Andrx did not violate Glaxo’s patent and therefore should be allowed to manufacture and market its generics. On appeal, however, the Federal Circuit Court of Appeals held that the district court in Florida erred in its construction of the patent infringement claims.

Glaxo owns U.S. Patent No. 5,427,798 (the ’798 patent) directed to controlled sustained release tablets containing bupropion hydrochloride. Pharmacologically, bupropion (m-chloro--t-butylaminopropiophenone) is a monocyclic aminoketone antidepressant. See U.S. Patent No. 4,393,078 (issued July 12, 1983) (the ’078 patent). These compounds treat depression and inebriation. In addition, they facilitate the cessation of smoking by producing neural stimulation in mammalian systems. See ’798 patent, col. 1, ll. 5-10; ’078 patent, col. 1, ll. 29-39; U.S. Patent No. 3,819,706 (issued June 23, 1974). To avoid the need for multiple dosages with the attendant fluctuations in plasma bupropion concentrations, Glaxo invented a sustained release formulation of the compound. While bupropion hydrochloride itself was separately patented, Glaxo obtained the ’798 patent to protect its sustained release formulation of the drug. Glaxo markets this patented sustained release formulation as Wellbutrin®SR for treatment of depression and as Zyban® for smoking cessation. The key ingredient for achieving sustained release in this invention is hydroxypropyl methylcellulose (HPMC), which is a partly O-methylated and O-(2-hydroxypropylated) cellulose. In oral preparations, HPMC extends drug release by transforming into a gel that swells upon ingestion. The hydrogel state of HPMC releases bupropion hydrochloride from an ingested tablet over a period of time.

The ’798 patent claims a sustained release tablet containing an admixture of bupropion hydrochloride and HPMC. However, many of the claims as originally filed did not recite HPMC as a limitation. During prosecution on the merits in the United States Patent and Trademark Office (Patent Office), the examiner rejected the claims that did not recite HPMC for lack of enablement under 35 U.S.C. § 112, 1. Glaxo amended those claims to overcome the rejection.

The first independent claim of the ’798 patent states:

1. A controlled release tablet comprising 25 to 500 mg of bupropion hydrochloride and hydroxypropyl methylcellulose, the amount of hydroxypropyl methylcellulose to one part bupropion hydrochloride being 0.19 to 1.1 and said tablet having a surface to volume ratio of 3:1 to 25:1 cm-1 and said tablet having a shelf life of at least one year at 59deg to 77deg F. and 35 to 60% relative humidity, said tablet releasing between about 20 and 60 percent of bupropion hydrochloride in water in 1 hour, between about 50 and 90 percent in 4 hours and not less than about 75 percent less in 8 hours.

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IPKat – fishing for IP stories for YOU: “Friday, October 29, 2004
Yesterday in Case C-53/03 Synetairismos Farmakopoion Aitolias & Akarnanias (Syfait) and Others v Glaxosmithkline AEVE Advocate General Francis Jacobs gave his Opinion as to whether a drug company may plead the threat of parallel trade as an excuse for limiting the amount of IMIGRAN, LAMICTAL and SEREVENTIT it sends to pharma wholesalers in ‘cheapo’ regimes. In his conclusion he recommends that the European Court of Justice rule as follows:
‘(1) A pharmaceutical undertaking holding a dominant position does not necessarily abuse that position by refusing to meet in full the orders sent to it by pharmaceutical wholesalers only by reason of the fact that it aims thereby to limit parallel trade.
(2) Such a refusal is capable of objective justification, and thus of not constituting an abuse, where the price differential giving rise to the parallel trade is the result of State intervention in the Member State of export to fix the price there at a level lower than that which prevails elsewhere in the Community, given the combined circumstances of the European pharmaceutical sector at the current stage of its development, and in particular:
�- the pervasive and diverse State intervention in the pricing of pharmaceutical products, which is responsible for price differentials between the Member States;
�- the regulation by the Community and the Member States of the distribution of pharmaceutical products, which establishes nationally demarcated obligations upon pharmaceutical undertakings and wholesalers to ensure the availability of adequate stocks of those products;
�- the potentially negative consequences of parallel trade for competition, the common market, ”

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ANDA filing doesn’t constitute Willful patent infringement August 16, 2004

Posted by mais in Drugs, Litigation, Patent, USA.
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Glaxo Group Limited v. Apotex, Inc., 2004 U.S. App. LEXIS 15489 (Fed. Cir., July 27, 2004)
Apotex, Inc. (‘Apotex’) appeals the judgment of the United States District Court for the Northern District of Illinois, which found that Apotex’s filing of an Abbreviated New Drug Application (‘ANDA’) for a generic version of the antibiotic CEFTIN willfully infringed U.S. Patent No. 4,562,181 (the ”181 patent’) and U.S. Patent No. 4,820,833 (the ”833 patent’) owned by Glaxo Group Limited and SmithKline Beecham Corp. (collectively ‘Glaxo’). The Federal Circuit affirmed the district court’s determination that Apotex’s ANDA infringes both the ‘181 and ‘833 patents pursuant to 35 U.S.C. � 271(e)(2), and also affirmed that the patents at issue are not invalid. The Federal Circuit, however, reversed the district court’s finding that Apotex’s ANDA filing constituted willful infringement. The Federal Circuit held that the mere filing of an ANDA cannot constitute an act of willful infringement compensable by attorney’s fees under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Federal Circuit explained that 35 U.S.C. � 271(e)(2) and 35 U.S.C. � 271(e)(4) create only an ‘artificial’ act of infringement for a ‘very limited and technical purpose that relates only to certain drug applications.’ This purpose is to permit patent holders to bring suit against generic companies despite the fact that the generic companies have not yet infringed the patents at issue. The Federal Circuit eloquently wrapped up its analysis by saying: ‘[t]he district court therefore erred in hanging a finding of willfulness on such a special-purpose peg.'”

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WAR FOR DRUGS…….. August 16, 2004

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Drug Wars: six lawyers discussing genrics Vs big Pharma drug war
In our roundtable, pharma lawyers dissect the changes in Hatch-Waxman, the costs of patent litigation, and the blurring line between generic and branded drug companies.
IP Law & Business/August 2004 ”

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