API and IP Newsletter

 Contents

• ANDA approvals in November 2022

• General information

• API crisis, again: PLI in key pharma ingredients was supposed to reduce dependence on China. But the job’s only partly done

• U.S. Supreme Court has busy year ahead for intellectual property law

• Intellectual Property

• Sun Pharma Vs DWD Pharmaceuticals (Trademark Decision by Delhi HC)

ANDA approvals in November 2022

We monitor ANDA approvals by Indian companies. In the month of November, there are about 83 ANDA approvals, including 12 tentative approvals. 

Aurobindo was top of the list with 4 ANDA approvals in November, followed by Mankind, Alembic and Amneal, three each. Many companies are trying to seek Competitive Generic Therapy (CGT) designations and secure 180 days exclusivity. More details about CGT could be found here. 

Glimpses of our observations are as below. 

Drug Name	Company	Submission Status	Sidvim comments
MIDAZOLAMANDA  #216048	CIPLA LTD	Tentative Approval	This spray was first approved in May 2019 for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity. ODE exclusivity till 2026. Cipla’s launch would be driven by litigation outcome.
SODIUM PHENYLBUTYRATEANDA  #216462	GLENMARK PHARMS LTD	Approval	This is an old product, 500 mg tablet, there are only two are active products in US market. This seems to be small product, According to IQVIA for the 12-month ended September 2022, the Buphenyl (Brand) market achieved annual sales of approximately $8.7 million.
TRIAMCINOLONE ACETONIDEANDA  #212567	MYLAN LABS LTD	Approval	This is 40MG/ML injection, Four other ANDAs approved. an estimated market size of around USD 73 million for the 12 months ended May 2022.
KETOROLAC TROMETHAMINEANDA  #214456	ALEMBIC PHARMS LTD	Approval	Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedures. These are 15 MG/ML and 30 MG/ML injections. This is an old products and several other approvals listed in OB. Ketorolac Tromethamine Injection  has an estimated market size of US$ 59 million for twelve months ended June 2022.
CLINDAMYCIN PHOSPHATEANDA  #215219	AMNEAL	Approval	This gel (1%), it is approved under CGT and Ameal could secure 180 Days exclusivity.

General information

API crisis, again: PLI in key pharma ingredients was supposed to reduce dependence on China. But the job’s only partly done

As a wave of infections sweep China, some of the patterns are familiar. Multiple media reports said that Chinese were stocking up on basic medicines, leading to shortages. This was corroborated by an announcement that China will speed up imports of relevant medicines. Given both the scale of China’s population and the criticality of their pharmaceutical industry in the supply chain, the impact has been felt in India. The prices of key active pharmaceutical ingredients (APIs), which are the essential ingredients in making medicines, have increased recently by 12-25%.

News here.

U.S. Supreme Court has busy year ahead for intellectual property law

Drug makers are closely watching a Supreme Court case involving Amgen Inc, Sanofi SA and Regeneron Pharmaceuticals Inc that could affect the cutting-edge field of biologic drugs. The high court will consider Amgen's request to revive patents on its blockbuster biologic Repatha, in what the company calls a key test for the pharmaceutical industry.

Amgen says upholding a decision that invalidated its "genus claims" -- which describe a broad "genus" of related monoclonal antibodies that lower cholesterol -- would be "devastating" for innovation. Other major pharmaceutical companies including Biogen, Bristol Myers Squibb, and Merck have filed briefs supporting the company.

News here.

Intellectual Property 

 

Sun Pharma Vs DWD Pharmaceuticals (Trademark Decision by Delhi HC)

The plaintiff Sun Pharma has filed the suit contending that Sun Pharma’s  predecessor- namely, Ranbaxy Laboratories Ltd., coined and adopted the trade mark 'FORZEST' in the year 2003 and has been using the same since then.

Sun asserted in the first week of May, 2022, that they came across DWD Pharmaceuticals’ application seeking registration of the impugned mark 'FOLZEST'

(Photos are from public domain)

Based on the assertions of Sun Pharma  and the documents filed with the plaint, this Court on 19.05.2022 passed an ad-interim ex-parte order of injunction against DWD  restraining DWD  from selling its medicinal preparations under the impugned mark 'FOLZEST'. 

Please note, FOLZEST is multivitamins for pregnant women to lower the risk of pre-term birth.                

DWD had asserted that Sun obtained the ad-interim ex-parte order of injunction by concealing various material facts from this Court. It is asserted that they are the leading manufacturer and distributor of pharmaceutical products in the domestic and international markets. It is a registered proprietor of the trade mark 'ZEST' since the year 1983, and has a family of registered trademarks, with 'ZEST' forming a part of them.

It is further asserted that Sun was well-aware of not only the registration of the mark 'ZEST' in favour of DWD, but also of the other marks registered and used by the DWD, inasmuch as, Sun had earlier applied for the registration of the mark 'EXEZEST', which was opposed by DWD way back in the year 2009.

Sun thereafter applied for registration of its mark 'TRIOLMEZEST', which was also opposed by DWD on 30.12.2014 on the ground of DWD being the registered proprietor of the 'ZEST' Family of Marks. 

DWD submitted that these facts were material to be disclosed by Sun in the plaint as they would have clearly disproved the assertion of Sun that it came to know of DWD and their use of the mark 'FOLZEST' only in the first week of May, 2022. 

DWD further submitted even otherwise, Sun is not entitled to the relief because the mark of Sun, that is, 'FORZEST', is descriptive in nature. 

Sun’s counsel was not available at the time of oral submissions, by way of written submissions, Sun has asserted that the marks of Sun and DWD are deceptively similar and, therefore, Sun is entitled to the ad-interim protection as had been granted by this Court vide order dated 19.05.2022.

Sun argued in written statement that the present suit/applications relate to pharmaceutical goods, wherein the threshold of confusion is low, the test of deceptive similarity is stringent, with public interest being paramount.

Sun further submitted that not only DWD has other registrations with the mark 'ZEST', but there are also third parties co-existing in the market using different trademarks with the word 'ZEST' as either a prefix or a suffix, therefore, DWD cannot claim any exclusivity over the word 'ZEST'. 'ZEST', even otherwise, is a common dictionary word over which no one person can claim exclusivity.

The Court opined

1. In the present case, prima facie, the mark of Sun (the plaintiff), that is 'FORZEST', is deceptively similar to the mark of DWD (the defendant), that is 'FOLZEST'; with the only difference being in the alphabet 'R' being replaced in the mark of DWD by the alphabet 'L'.  Since, these marks are deceptively similar, and any confusion could lead to serious consequences.

2. It is also important to note that the medicine of Sun is for treating erectile dysfunction in men, while the medicinal preparation of the defendant is a multivitamin for pregnant women. 

3. Sun must bear consequences of having concealed material facts from this Court to obtain an ex-parte order of injunction. Sun cannot be absolved from the consequences of not making such disclosure of material facts. 

4. It is irrelevant whether with the disclosure of material facts, the Court would have still granted the ad-interim ex-parte order of injunction or decided otherwise.

5. Such a practice not only has to be deprecated but must also be penalised. Sun was 

therefore, is saddled with costs of Rupees Ten Lakh to be deposited with Delhi High Court Legal Services Committee within two weeks from the date of the judgment.

Decision here