API and IP Newsletter

 Contents

• DMFs filed in the month of September 2023

• General information

• Novartis Nabs FDA Nod for Rare Disease Drug Rival to AstraZeneca Meds

• Piramal Pharma has launched a high-throughput screening facility

• Intellectual Property

• Sorafenib tosylate (Nexavar) case in Germany

DMFs filed in the month of September 2023

In September 2023,  total 114, Type-II DMFs were filed, out of which about 63 DMFs were filed by Indian companies, MSN was at the top of list, filed 6 DMFs, Aurobindo filed 4 DMFs.

Some of our product specific observations are as below.

HOLDER	SUBJECT	COMMENTS
GLAND PHARMA LTD	FOSAPREPITANT DIMEGLUMINE	There are 16 other DMFs and over one dozen ANDA filers for 150 MG injection. It is used for the prevention of nausea and vomiting. This is low volume API high value API.
MSN LABORATORIES PRIVATE LTD	"LEVOTHYROXINE SODIUM USP"	This is very old compound, there are 10 DMFs filed, this is priced at USD 5000-10000/KG, and relatively small volume.
MSN LIFE SCIENCES PRIVATE LTD	ISTRADEFYLLINE	Istradefylline was approved in August 2019, it is very fast API development by MSN. It is an adenosine receptor antagonist indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease. There is one microcrystalline form patent listed in Organge Book but generics could file Para-III certificate for the same. MSN could be copying process disclosed in this microcrystalline form patent.
VALARY LAB LTD	LENALIDOMIDE HEMIHYDRATE (FORM-B)	In linalidomine there are many polymorph issues.  WO 2005/023192, US 7,465,800 B2, and U.S. 2009/0062343 A1, US 2009/0149499 A1, 2009/0149500 A1, US 2009/0176832 A1, and 2009/0187023 A1 disclose crystalline lenalidomide hemihydrate, unsolvated crystalline lenalidomide, solid form of lenalidomide comprising the unsolvated crystalline and amorphous lenalidomide, crystalline lenalidomide dihydrate, solid form of lenalidomide comprising dihydrate and amorphous lenalidomide, a solid form of lenalidomide comprising dihydrate and crystalline lenalidomide hemihydrate, solid form of lenalidomide comprising crystalline lenalidomide hemihydrate and amorphous lenalidomide, solid form of lenalidomide comprising crystalline Form F and amorphous lenalidomide and polymorphic forms designated as forms A, B, C, D, E, F, G, and H.  Many companies have filed DMFs for pre-mixes, amorphous API and different polymorphs. Form B patent would expire in 2024 and 2025.
GUJARAT THEMIS	RIFAMYCIN-S	This is only second DMF of Rifa-S after Lupin. Lupin had filed DMF in 1995. Rifa-S is converted to Rifampicin in one step.

General information

Novartis Nabs FDA Nod for Rare Disease Drug Rival to AstraZeneca Meds

FDA approval of Novartis’s Fabhalta makes the drug the first approved oral therapy for rare blood disorder paroxysmal nocturnal hemoglobinuria. With clinical data showing superiority versus two infused AstraZeneca drugs, Novartis’s pill is well-positioned to take market share from those blockbuster products.

News here.

Piramal Pharma has launched a high-throughput screening facility

Piramal Pharma has launched a high-throughput screening facility at its drug discovery services site in Ahmedabad, India.

News here

Intellectual Property 

Sorafenib tosylate (Nexavar) case in Germany 

This is a dispute about EP2305255 in Germany. This is very interesting. 

Bayer’s patent EP2305255, which had expired in December 2022. The patent protected sorafenib tosylate, brand name Nexavar, which is used to treat various types of cancers.

1. The Federal Patent Court declared the patent invalid in September 2021.

2. Several generic drug manufacturers launched their products on the German market.

3. Bayer filed suit for preliminary injunction against Zentiva, Ratiopharm (Teva), Hexal, Mylan, Betapharm, Stada and its subsidiary Aliud Pharma.

4. The Regional Court Munich granted Bayer a temporary preliminary injunction (PI) until the end of September 2021.

5. Germany has unique dual system, in which patent infringement proceedings and nullity suits are dealt with before different courts. The Federal Patent Court is in-charge of nullity suits, i.e. deciding upon challenges to the validity of German and European patents having effect in Germany.

6. On 29 September 2021, the Federal Patent Court handed down its ruling in a nullity suit brought by Ratiopharm and Stada. 

7. The Federal court said, four anions known to those skilled in the art as pharmacologically suitable and customary counterions/anions of strong acids with pKa values in the negative range are, namely hydrochloride, sulfate, tosylate and mesylate. 

8. This is a manageable number of anions, which is why patentee included all of them in salt screening program. 

9. Hence, The Federal Patent Court said the choice of tosylate for salt screening was therefore obvious to the expert.

10. When the judges invalidated EP 255 for lack of inventive step, preliminary injunction (PI) expired, and several generics companies launched their products.

11. Bayer applied for second PI. Generic companies also appealed against first PI. The appellate Judge declined to opine following German principle of separation. As explained German patent system is double-track system where patent infringement and patent validity proceedings are separated.

12. Bayer continued the litigation, Bayer argued at the Regional Court Munich that the Federal Patent Court’s judgment in the nullity suit was wrong. 

13. Bayer finally appealed the Federal Patent Court’s nullity ruling. In its judgment a few days ago, the Federal Court of Justice upheld the patent in a slightly amended form. Details of this case is not uploaded yet and we will update about Federal Patent Court’s findings. 

14. Case (ID: X ZR 83/21) will be updated here.

15. Very soon Bayer could file damage suit and would claim damage from respective generic launch date of generic companies till patent expiration date.  

Decision here and here