API and IP Newsletter
Contents
Tetra Bio-Pharma Provides Update on Its REDUVO™ New Drug Submission
Instead of Drug Spending Caps, Medicare Should Try Value-Based Contracting
DMF filed in the month of July 2022
We analyse DMF filings by Indian companies. We had not it for a while and in this week we analysed DMFs filed in the month of July.
Total 77 DMFs were filed in July 2022 and as usual more than 50% of them were from Indian companies. We are not publishing all our observation for all DMFs but some of our comments are in Sidvim comments section in the table below.
General information
Tetra Bio-Pharma Provides Update on Its REDUVO™ New Drug Submission
The last response to Health Canada was end of May 2022. On November 16, the Company received a Clarification Request (Clarifax) from Health Canada regarding the product labels. The Company will be submitting the response to Health Canada within the allowed timeframe.
About REDUVO™
REDUVO™ is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV). It is also used to treat weight loss and severe nausea in people living with HIV infection. The active pharmaceutical ingredient in REDUVO™ is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis. REDUVO™ 5-year cumulative gross sales expected to reach $121M.
News here.
Instead of Drug Spending Caps, Medicare Should Try Value-Based Contracting
Few issues raise the ire of Americans more than the high cost of prescription drugs–and the Biden administration is seeking to tackle the issue through provisions in the recently passed Inflation Reduction Act. According to advocates, the law offers an effective way to begin the process of curbing high drug prices, thus making medical care more available and reducing costs to society. According to opponents, the new rules will harm innovation.
A value-based pricing system would benefit all parties. Medicare would be paying more for the most effective treatments, and far less for the ones that would not save the agency money over time. Drug makers would be able to reap fair profits from their best offerings, and use that money for R&D while ensuring profitability–and the prospects of further profitability from well-performing drugs would further increase incentives for companies to develop innovative and cost-effective treatments. And of course patients would benefit, as Medicare could maintain its out-of-pocket patient payment cap while working with pharmaceutical companies to ensure fair prices and encourage innovation.
News here.
Intellectual Property
Cadila Healthcare Ltd. v. Cadila Pharmaceuticals
For a change, this is trademark case but maybe interesting for our readers.
Many trademarks in pharmaceutical products are very similar. Most of the time they are derived from names Active ingredients (API). If API is same, then interchanging trademark will not have serious consequences to patients but if API is different than it could be life threatening.
Supreme Court now set standards for which to be followed by lower courts in pharmaceutical trademark infringement and passing off disputes.
The present proceedings arise from the suit for injunction which had been filed by the Cadila Healthcare against the Cadila Pharmaceuticals in the District Court at Vadodara.
The suit related to a medicine being sold under the brand name Falcitab by the Cadila Pharmaceuticals which, according to the Cadila Healthcare, was a brand name similar to the drug being sold by it under its brand name Falcigo
The case of the Cadila Healthcare was that its drug Falcigo contains Artesunate for the treatment of cerebral malaria commonly known as Falcipharum.
After the introduction of this drug, the Cadila Healthcare on 20th August 1996 applied to the Trademarks Registry, Ahmedabad for registration in Part-A, Class-5 of the Trade and Merchandise Marks Act. On 7th October 1996 the Drugs Controller General (India) granted permission to the Cadila Healthcare to market the said drug under the trademark of Falcigo.
Since October 1996 the Cadila Healthcare claimed to have started the manufacture and sale of drug Falcigo all over India.
The Cadila Pharmaceuticals company is stated to have got permission on 10th April 1997 from the Drugs Controller General (India) to manufacture a drug containing Mefloquine Hydrochloride.
The Cadila Pharmaceuticals was also given permission to import the said drug from abroad. According to the Cadila Healthcare, it came to know in April 1998 that the said drug, which was also used for the treatment of Falcipharum Malaria, was being sold by the Cadila Pharmaceuticals under the trademark of Falcitab.
The Cadila Healthcare then filed a suit in the District Court at Vadodara seeking injunction against the Cadila Pharmaceuticals from using the trademark Falcitab as it was claimed that the same would be passed off as Cadila Healthcare’s drug Falcigo for the treatment of the same disease in view of confusing similarity and deception in the names and more so because the drugs were medicines of last resort.
The Cadila Pharmaceuticals company stated in the defence that the word Falci, which is the prefix of the mark, is taken from the name of the disease Falcipharum Malaria and it is a common practice in pharmaceutical trade to use part of the word of the disease as a trademark to indicate to the doctors and chemists that a particular product/drug is meant for a particular disease.
It was also the case of the Cadila Pharmaceuticals that admittedly the two products in question were Schedule L drugs which can be sold only to the hospitals and clinics with the result that there could not even be a remote chance of confusion and deception. (Please note that Schedule H drugs are those which can be sold by the chemist only on the prescription of the Doctor, but Schedule L drugs are not sold across the counter but are sold only to the hospitals and clinics)
Now guidance is issued by SC as follows.
In an action for passing off based on unregistered trademark generally for deciding the question of deceptive similarity the following factors to be considered:
The nature of the marks i.e., whether the marks are word marks or label marks or composite marks, i.e., both words and label works.
The degree of resembleness between the marks, phonetically similar and hence similar in idea.
The nature of the goods in respect of which they are used as trademarks.
The similarity in the nature, character, and performance of the goods of the rival traders.
The class of purchasers who are likely to buy the goods bearing the marks they require; on their education and intelligence and a degree of care they are likely to exercise in purchasing and/or using the goods.
The mode of purchasing the goods or placing orders for the goods and
Any other surrounding circumstances which may be relevant in the extent of dissimilarity between the competing marks.
Weightage to be given to each of the aforesaid factors depends upon facts of each case and the same weightage cannot be given to each factor in every case.
The trial court will now decide the suit keeping in view the observations made in this judgment.
Decision Here
