Category Archives: Drug Regulation

Competition Law Drug Regulation

Is Patent Enforcement Anti-competitive? Delhi HC Expresses Some Caution!

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The Roche: Biocon saga over Herceptin took a dramatic new turn recently. Before getting into the details, here is a short timeline for those interested (I have not included a list of all the suits filed, for the sake of brevity). The Timeline Roche sued Biocon and Mylan before the Delhi High Court, seeking to restrain their sales of a biosimilar of Roche’s breast cancer medication, Trastuzumab. Rahul carried an analysis of that order over here and here. In this…


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Drug Regulation Patent

XTANDI Updates: Cancer Union and 56 others request UCLA to back down from Delhi HC review of IPO’s patent rejection order; Delhi HC refuses to hear the matter on priority

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In a positive development, the Union for Affordable Cancer Treatment (UACT), along with 56 other organizations, has requested the University of California (UCLA) to withdraw from its proceedings before the Delhi High Court against the IPO’s rejection of its patent[1] in XTANDI. In its letter dated 24th May 2017, UACT reminds UCLA that its research for the blockbuster drug for prostate cancer was supported by US taxpayer dollars through the National Cancer Institute at the National Institutes of Health and…


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Drug Regulation

Delhi High Court Grants Biocon-Mylan Permission to Market New Biosimilar For Additional Indiciations

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As reported in the Economic Times on March 4, 2017 a Division Bench of the Delhi High Court has passed an interim order allowing Biocon and Mylan to market their biosimilar of Roche’s drug, Herceptin, for two additional indications: early breast cancer and metastatic gastric cancer. (Although this order was passed on March 3, 2017 it took the High Court’s registry almost 13 days days to make available the order on its website. It is not clear why it took…


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Drug Regulation Others

Plain Apathy or Sheer Incompetence? Govt. Sets New Lows by Running Out of Child Anti-HIV Drugs

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Roughly two years back, Kartik had brought up the role of non-IP factors, specifically government apathy, in impeding “access to medicines”. The discussion came up in the context of National AIDS Control Programme (NACO) facing reverses due to the dwindling of stocks of anti-retroviral medication. Two years hence, the government and its bureaucracy, in a shocking display of indifference towards the children living with HIV, have turned a blind eye towards the running out of stocks of syrup containing the…


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Competition Law Drug Regulation

Poorly Drafted Regulatory Laws are Becoming the New Barrier for Indians to Access More Affordable Biotech Products

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In highly regulated industries like pharmaceuticals and biotechnology, where all market players are required to prove the safety and efficacy of their products to government regulators, the lack of an efficient regulatory mechanism can act as a substantial hurdle to competition and greater accessibility. In such cases, poor regulation provides IP owners a window to further delay competition even after their patent rights expire. To facilitate better competition in these sectors, it is necessary for governments to create new regulatory…


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Drug Regulation

In a Deeply Flawed Judgment, Delhi High Court Quashes Government’s Decision to Ban 344 FDCs

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In a judgment that could have far-reaching implications for the safety of large numbers of Indian patients, a single judge of the Delhi High Court quashed the Government’s decision to ban 344 fixed dose combination (FDC) drugs earlier this month. On 10th March, 2016, the Central Government had prohibited the manufacture, sale and distribution of 344 FDCs, most notably the famous cough syrup Corex, in exercise of the powers conferred upon it by Section 26A of the Drugs and Cosmetics…


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Data Exclusivity Drug Regulation

Killing Me Softly: Of Data Exclusivity and Deadly Drugs!

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In a recent post, Prashant took issue with the IPA’s contention that the Indian governments’ latest move to extend the moratorium for state drug regulatory approvals from 4 years to 10 years results in a long and damaging data exclusivity. Who is right? And who is wrong? Once one begins to trudge down this rabbit hole in search of answers, one realises that the alleged data exclusivity norm is the least of our worries. We have a far more deadly…


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Drug Regulation

Major Changes on the Cards for Drug Pricing Policy?

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In a week when the cash in your hand was turned to pulp and the possibility of the planet itself being turned into pulp in the next four years became alive, it is hard to see any other news grabbing the headlines. Nevertheless, we have news which could potentially capture reader attention once the dust settles on the current events and life (hopefully) goes back to normal. As per reports (see, here and here) an “overhaul of drug policy” is…


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Data Exclusivity Drug Regulation Patent

IPA Alleges that New Rule Change will Bring in a Data Exclusivity Regime – Here’s Why I Think it Does no Such Thing

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In a report published yesterday in the Bombay edition of the Times of India it has been alleged that the government is proposing a rule change to the Drugs & Cosmetics Rules, 1945 to introduce:  “a form of ‘data exclusivity’, a provision which will potentially give protection to Big Pharma, thereby delaying generic competition and hence impacting access and affordability of drugs.” The source of this information as per the news report is D.G. Shah, the spokesperson of the Indian Pharmaceutical…


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Drug Regulation Patent

Dozing DoP Wakes Up: Consults Ministries on Price Regulation of Patented Drugs

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Vasundhara had recently alerted us about the Parliamentary Committee on Government Assurances pulling up the Department of Pharmaceuticals (‘DoP’) for their inaction on the control of patented drug prices. As reported by Live Mint, the chastising seems to have worked for the time being as DoP has now sought the views of different ministries on price regulation of patented drugs. Apparently, the Department of Industrial Promotion and Policy (‘DIPP’) is simultaneously examining if there needs to be a change in…


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