API and IP Newsletter

 Contents

• ANDA approvals in March 2023

• General information

• Bird & Bird and Gilead invalidate two NuCana antiviral drug patents

• India needs to build antibiotic research ecosystem right away

• Intellectual Property

• Linagliptin: A Single Bench of the Delhi High Court has refused to grant interim injunction to Boehringer Ingelheim (BI) against generic manufacturers.

ANDA approvals in March 2023

We follow ANDA approvals every month. In march there are over 120 ANDA approvals and among then about 20 are tentative approvals.

Our brief comments are as below.

Drug Name	Company	Sidvim comments
MOXIFLOXACIN HYDROCHLORIDE ANDA  #204836	HETERO LABS	This approval is for 400 MG tablets. Other 5 Gxs are approved. This might not be very big market in US. We could not find out US market size information in public domain, but world-wide sale of moxi is about USD 118 mio. So, overall in US tablet market might not be very significant.
VIGABATRIN ANDA  #214671	ZYDUS	This approval is for 500 MG/Packet. This is for solution. Vigabatrin powder is used to control infantile spasms. Vigabatrin is about USD 140 mio product. Dr. Reddy's had earlier sought CGT approval and enjoyed 180 days exclusivity associated with the CGT. There are several approvals after 180 D exclusivity of DRL and there could be high competition in the market now. We covered earlier about CGT approvals. One could read about it here.
ROCURONIUM BROMIDE ANDA  #216234	CAPLIN	This ANDA approval is for 50 MG and 100 MG injectable. Rocuronium is a non-depolarizing neuromuscular blocker, it is widely used to produce muscle relaxation to help facilitate surgery and ventilation of the lungs. There are half dozen other ANDA holders and as per the IQVIA MAT December 2022, Rocuronium Bromide Injection had an annual sale of approximately $53 million in the US. Overall this is going to be very small product.
FLUOROURACIL. ANDA  #217295	ALEMBIC	This is an approval for 2.5GM/50ML (50MG/ML), injectable. Fluorouracil is used to treat cancer of the pancreas and stomach. Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Vial, has an estimated market size of $5 million for twelve months ending Dec 2022. This is small product and there are 3-4 other approved products in US market.
LENALIDOMIDE. ANDA  #213885	EUGIA PHARMA	There are several lenalidomide approvals in March. Launches were litigation driven and many generics had launched  5 MG, 10 MG, 15 MG, 20 MG and 25 MG capsules in US in March 2023. It is a blockbuster product and used to treat anaemia (low red blood cells) in patients with a certain type of myelodysplastic syndrome (MDS)

General information

Bird & Bird and Gilead invalidate two NuCana antiviral drug patents

In a trial concerning validity, US biopharmaceutical company Gilead has prevailed after the UK High Court revoked two NuCana patents. Parallel proceedings are ongoing in Germany and at the European Patent Office, where the Technical Board of Appeal has also recently revoked one of the patents at issue.

News here.

India needs to build antibiotic research ecosystem right away

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Bringing down the cost of antibiotic development will eventually lead to lower patient therapy cost. Developing the drug in high-income countries and selling it to underdeveloped countries like India does not make economic sense. Drug developers need to collaborate to improve access and split costs. They can reduce their expenses by conducting clinical trials in India, which has everything going for it to undertake them successfully in terms of the three Ps—population, patients and physicians. Considering that India has a population of 1.4 billion and a huge burden of infectious diseases, enrolling patients for trials is relatively easier and quicker. Says Saransh Chaudhary, President-Global Critical Care, Venus Remedies and CEO, Venus Medicine Research Centre

News here

Intellectual Property 

Linagliptin: A Single Bench of the Delhi High Court has refused to grant interim injunction to  Boehringer Ingelheim (BI) against generic manufacturers. 

1. BI had obtained two patents, i.e. Patent No. 227719 ( IN 719’) for the “Markush” formula being the ‘genus’ patent, which expired on 21st February, 2022 and subject patent IN 301 which would expire on 18 August 2023, which is called a ‘species’ patent.

2. This is the famous debate of coverage and disclosure addressed by Indian Courts since Novartis case. I will write a separate article for coverage vs disclosure discussions in various Indian Courts.

3. In simple terms, a patent granted with Markush claim would cover species but species patent would have enabling disclosure and could still qualify for a grant if all other conditions are satisfied for the grant. In many other competent jurisdictions it is popularly known as selection patent.  

4. This discussion of coverage and disclosure led to patent infringement litigation and Delhi HC  had issued the order on 29 March 2023 on six suits filed by BI against Alkem, Micro, Natco, Mankind, and Vee Excel Drugs and others.

5. The Justice Amit Bansal of Delhi HC observed that the facts are similar to the facts in AstraZeneca case for the drug dapagliflozin.

6. He noted that the company sought reliefs claiming that the drug is covered under the genus patent and the species patent till the time the genus patent was expired and only after the expiry of this patent, the company made the assertions that the drug is covered only in the species patent. 

7. The Judge stated, the company has also filed the sales details of linagliptin in its Form 27 submissions, which are periodic filings with the Patent Office regarding the working of the patent, for both the genus and species patents.

8. Hence he pointed that having obtained all these benefits based on the assertion that linagliptin is claimed and covered in genus patent, now it not appropriate for BI to take a stand to the contrary. 

9. BI cannot be allowed to approbate and reprobate, he said in the Order. 

10. The court observed that in prima facie view, the drug was disclosed, claimed and covered under the genus patent as well as the species patent.

11. Had linagliptin not been disclosed or claimed in the genus patent, BI could not have made a claim for infringement of the genus patent in two of the cases filed in 2019.

12. The court observed that prima facie the patent (IN'301) is vulnerable to revocation, and has said the company has "made an attempt towards evergreening the invention and re-monopolizing”.

Hence, Delhi HC refused interim injunction to Boehringer Ingelheim and permitted generic manufacturers to produce linagliptin.

Decision here.