API and IP Newsletter

 Contents

• Paragraph IV filings as of 07 August 2023

• General information

• Delhi HC denies interim relief to Sun Pharma against Finecure in trademark dispute

• Will PLI schemes lead to a manufacturing renaissance?

• Intellectual Property

• Court found 'Mankind' and 'Novakind' marks confusing

Paragraph IV filings as of 07 August 2023

FDA publishes list of Paragraph-IV filings. This list is here. We analyze new P-IV filings in this published list. Some of our observations are as below. 

Drug Name	Dosage Form	No of ANDAs	Sidvim Comments
Dalbavancin HCl	Powder For Injection 500 mg/vial ANDA submission 5/23/2023 RLD Dalvance FDA approval May 23, 2014	3	FDA approved dalbavancin in May 2014, for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by certain susceptible bacteria such as Staphylococcus aureus including methicillin-susceptible and methicillin-resistant strains of Streptococcus pyogenes.  It had GAIN Exclusivity, that explains why generics had to wait for 9 years to file ANDA. Dalbavancin is manufactured by fermentation of a selected Nonomuraea strain. As per DMFs filed at USFDA, it seems there could be only two sources of API.  Though exact sales of Dalvance is not available in public domain it could be about USD 100 mio product in USA based on our educated guess.
Solriamfetol HCl	Tablets 75 mg and 150 mg ANDA submission 6/20/2023 RLD: Sunosi FDA approval Jun 17, 2019	6	Six ANDAs filed on NCE-1 date. Solriamfetol was approved in the United States to improve wakefulness in adults with narcolepsy or obstructive sleep apnea (OSA). It was granted orphan drug designation till 2026. The drug was discovered by a subsidiary of SK Group, which licensed rights outside of eleven countries in Asia to Aerial Pharma in 2011. Aerial ran two Phase II trials of the drug in narcolepsy before selling the license to Jazz in 2014; Jazz Pharmaceuticals paid Aerial $125 million up front and will pay Aerial and SK up to $272 million in milestone payments, and will pay double-digit royalties to SK. Since there's no compound patent claim and innovator samples perhaps were available from other countries, many generic companies could file ANDA on NCE-1 date and secured F2F status. Information about current US sales is not available in public domain, but RBC Capital Markets analyst Randal Stanicky's team predicted 2024 Sunosi sales of $314 million.
Trientine Tetrahydro-chloride	Tablets 300 mg ANDA submission 6/21/2023 RLD  Cuvrior FDA approval Apr 28, 2022	1	There are two salts of trientine. Trientine dihydrochloride salt (TETA 2HCl) is unstable at room temperature and requires storage at 2–8 °C. Several generics approved for TETA 2HCl. Trientine tetrahydrochloride (TETA 4HCl) is a more stable salt of trientine that can be stored at room temperature. It is used to treat Wilson’s disease. Crystalline forms are protected till 2039 and it would be interesting to know which API was used by the ANDA filer. There are three DMFs filed for TETA 4HCl. SS Pharma, MSN and Biophore.  In OB there is New Product exclusivity until April 2025, but more importantly there's Orphan Drug Exclusivity for treatment in adults who are de-coppered and tolerant to penicillamine.

General information

Delhi HC denies interim relief to Sun Pharma against Finecure in trademark dispute

The court said Sun Pharma knew of the trademark issue for 13 years but filed a plea only after it found that Finecure had become a formidable market player

News here.

Will PLI schemes lead to a manufacturing renaissance?

The success of the PLI scheme in augmenting India’s manufacturing is most visible in electronics, which has seen a multi-fold jump in exports. Product choices could have been more comprehensive or exhaustive for specialty steel, key starting material/active pharmaceutical ingredient and telecom instruments

News here

Intellectual Property 

Court found 'Mankind' and 'Novakind' marks confusing

Usually, we cover Patent litigations. Foe a change let us analyse one recent trademark decision handed down by Delhi HC.

Mankind (Plaintiff) is the fifth largest pharmaceutical company of India. 

The chairman and founder of Mankind, Mr. Ramesh Chand Juneja, adopted the trademark MANKIND as part of the trading style in 1986. 

It is asserted that 268 brands of Mankind are listed amongst the top five brands, in pharmaceutical products, with 85 brands at the first and 67 brands at the second place. 

Mankind  uses “KIND” as second part of the name of various pharmaceutical preparations which Mankind manufactures and sells. The marks of Mankind which use “KIND” as the second part thereof have been referred to, in the plaint, as the “KIND family of marks.

1. Mankind was aggrieved by the mark Novakind Bio Sciences Private Limited, used by Novakind (Defendant) for various pharmaceutical products manufactured and sold by it.  

2. A cease-and-desist notice was issued by Mankind to Novakind on 25 August 2020, calling upon Novakind to desist using the mark “NOVAKIND BIO SCIENCES PRIVATE LIMITED” as in the perception of Mankind, the said mark, by including “KIND” as the second part of the word “NOVAKIND” infringed Mankind’s registered trademark.

3. It is in these circumstances that Mankind has approached Delhi High Court by means of the present suit, seeking a permanent injunction restraining Novakind from using “KIND” as a part of the trade name/trademark under which Novakind’s manufactures and sells any of its medicinal and pharmaceutical preparations.

4. The plaint also sought an injunction against the use, by the defendant, of the mark “DEFZAKIND”, for Deflazacort tablets, packed and sold by it. The plaint provides a photographic representation of the “DEFZAKIND” strip.

5. While issuing summons in the present suit, this Court (ie Delhi HC), vide order dated 20 April 2021, granted an ex-parte ad interim injunction restraining Novakind from manufacturing, either on its own behalf or through any job worker, marketing or clearing, for sale in the market, any pharmaceutical product bearing the “KIND” suffix or which may, in any other manner, infringe the registered trademark of Mankind.

6. In further Court proceedings Hon. Judge C. Hari Shankar had heard learned Counsel for both sides.

7. The Hon. Judge opined when used for medicinal preparations, the Supreme Court, in Amritdhara Pharmacy v. Satya Deo Gupta , held the marks “AMRITDHARA” and “LAKSHMANDHARA” to be so structurally and phonetically similar as to confuse a customer of average intelligence and imperfect recollection. 

8. Mutatis mutandis, it has to be held that the marks “NOVAKIND” and “MANKIND”, when used for pharmaceutical preparations, are also confusing, especially as it is not in dispute that  Mankind uses, for all its products, the suffix “KIND” which has, therefore, become a source identifier of sorts for Mankind. 

9. Mankind has, in its favour, registration of the mark “MANKIND” in every class. Inasmuch as the marks “MANKIND” and “NOVAKIND”, even when compared as sole marks, are phonetically deceptively similar, their concluding “KIND” suffix/syllable being the same. 

10. The submission of Advocate of Novakind, Mr. Mahapatra that Mankind does not have any registration for the mark “KIND”, failed to impress the Court.

11. Moreover, Mankind is not pitching its case on infringement merely on the suffix “KIND”. The mark “NOVAKIND”, even seen as a whole, is phonetically deceptively similar to the mark “MANKIND”. The “KIND” suffix not being endemic to pharmaceutical preparations, there is every likelihood of a customer of average intelligence and imperfect recollection, who chances across “NOVAKIND” product, to believe it to be one of the KIND family of the marks belonging to Mankind. 

12. At the very least, therefore, the possibility of an impression of association between the Novakind’s mark and Mankind’s mark, in the mind of the customer of average intelligence and imperfect recollection would exist. 

13. Such likelihood of association is statutorily sufficient to constitute the infringement within the meaning of Section 29(2)(b)10 of the Trade Marks Act, inasmuch as the two marks are deceptively similar and they are used for identical goods. 

14. One more submission of Novakind’s advocate, Mr. Mahapatra that the pharmaceutical preparations are sold by brand names and not by the name of the company and that they are prescribed and disposed by persons who know their job, also could not impress the Hon. Judge.

15.  The Hon. Judge said, the test of deceptive similarity has to be viewed from the point of view of a customer of average intelligence and imperfect recollection. The drug that is dispensed is not merely prescribed by the doctor and dispensed by the chemist; the first person who comes up and asks for the drug is the person who has to consume the drug for being cured of the malady from which she, or he, suffers. The moment, there is possibility of confusion in the mind of such a consumer, the test of deceptive similarity stands satisfied. 

In view of the previously mentioned, the marks of Mankind and Novakind being deceptively similar, and the arguments of Mr. Mahapatra, to avoid an injunction, having failed to find favour with this Court, the ad interim injunction granted by this Court on 20 April 2021 is made absolute pending disposal of the present suit.

Decision here