Contents
Sun Pharma: Patent portfolio analysis Part II
Below table contains information about Sun Pharma R&D activity from mid-2014 to mid-2015.
Sun was very active in phase III, pre-registration and just launched molecules. Their patent portfolio seems to be very judiciously maintained and all applications which are not being worked on are abandoned in subsequent years.
Sidvim comments would highlight which molecules Sun would be focusing on in the coming years. Broadly, inventions marked in green are still very interesting for Sun after 5-6 years of development and must be part of their various dossiers. Roughly, about 50 patent families were filed during the analysed period and out of them, about 20 families seem to be very useful for Sun.
Publication Number | Publication Date | API | Invention relates to | SIDVIM Comments |
WO2016005934A1 | 2016-01-14 | Metoprolol succinate | Composition | Metoprolol is difficult to formulate. There are several inventions around ER Metoprolol, this is one among them. |
WO2016013031A1 | 2016-01-28 | Platform Technology | Composition | Sun application, withdrawn. This technology might not be interesting. |
WO2016016742A1 | 2016-02-04 | Isotretinoin | Composition | Roche decided to discontinue manufacturing due to diminishing market share due to the availability of the many generic versions and the settling of multiple lawsuits over side effects. It continues to be manufactured as of 2019 by Absorica, Amnesteem, Claravis, Myorisan, Sotret, and Zenatane. |
WO2016016769A1 | 2016-02-04 | Palbociclib | Process | February 2015 FDA approval and July 2015 is the priority. Sun must have started working much before approval, but finally dropped the application. Sun might not be interested in Palbociclib? |
WO2016016774A1 | 2016-02-04 | Canagliflozin | Crystalline form | Sun application, withdrawn. |
WO2016016852A1 | 2016-02-04 | Canagliflozin | Process | Sun application, withdrawn. Sun either not using in-house API or these processes are not commercially viable. |
WO2016016853A1 | 2016-02-04 | Dabigatran etexilate | General purpose | Sun application, withdrawn. |
WO2016016908A1 | 2016-02-04 | Optha drugs | General purpose | Sun application being prosecuted in EU and US, must be interesting invention |
WO2016024224A1 | 2016-02-18 | Trelagliptin | Process | Sun application, withdrawn. |
WO2016024225A1 | 2016-02-18 | Ticagrelor | Crystalline form | Being prosecuted in US, Sun ANDA must be using amorphous Ticagrelor |
WO2016024249A1 | 2016-02-18 | Palbociclib | Crystalline form | Sun application, withdrawn. This is second family withdrawn for this molecule. Maybe crystalline forms are not stable. |
WO2016024289A2 | 2016-02-18 | Nilotinib | New salts | Pending in US. preparing for 2023 launch. There are some issues with Nilotinib and launch dates to be rechecked. |
WO2016024291A1 | 2016-02-18 | Linaclotide | Composition | Granted in US. Teva settled, launch dates would be governed by settlement date. This formulation could be in ANDA filing of Sun. |
WO2016035014A1 | 2016-03-10 | Ruxolitinib | Process | Sun application, withdrawn, launch is difficult before 2026. |
WO2016038520A1 | 2016-03-17 | Ticagrelor | Process | Withdrawn, this process might not be used by Sun. |
WO2016038521A1 | 2016-03-17 | Liraglutide | Composition | Withdrawn, this composition does not seem to part of Sun's dossier. Launch also looks difficult before 2023. |
WO2016051288A1 | 2016-04-07 | Isotretinoin | Composition |
|
WO2016051380A1 | 2016-04-07 | Afatinib | Crystalline form | Approval in July 2013, patent granted in US and Sun must be using this crystalline form in their dossier. |
WO2016063246A1 | 2016-04-28 | Tedizolid | Crystalline form | Application withdrawn, Gx launch possible not before 2028! |
WO2016067194A1 | 2016-05-06 | Anacetrapib | Process | Application abandoned, Merck too abandoned plans for approval! |
WO2016075588A1 | 2016-05-19 | Daclatasvir | crystalline form | Application withdrawn, this form must not be stable and Gx launch is not possible before 2027. Sun must be lying low in development of Daclatasvir. |
WO2016079693A1 | 2016-05-26 | Ibrutinib | Process | Active in US and EU, Sun must be using this process at commercial scale! |
WO2016079697A1 | 2016-05-26 | Daclatasvir dihydrochloride | Process | Approval in 2016, Patent application filed much before FDA approval! But abandoned, this process might not be interesting for Sun |
WO2016079699A1 | 2016-05-26 | Teneligliptin | Process | Teneligliptin is neither approved in the USA or in Europe. In P I since 2007! Sun withdrew application and rightly so. |
WO2016087952A1 | 2016-06-09 | General purpose | Composition | This ER composition seems to have market in JP and Mexico! Application is prosecuted in only these two countries!! |
WO2016088041A1 | 2016-06-09 | Cefpodoxime proxetil | Composition | This composition must be sold in Romania and Mexico as patent is active in only these two jurisdiction along with India. |
WO2016088081A1 | 2016-06-09 | Ertugliflozin | Process | Ertugliflozin FDA approval in 2017! Application filed much before 2017, but process might not be interesting and hence Sun must have discontinued. |
WO2016088094A1 | 2016-06-09 | Baricitinib | Process | API in Sun’s US dossier must be using this process, this application is being prosecuted in USA. |
WO2016088100A1 | 2016-06-09 | Tedizolid | Process | 2014 FDA approval, this patent family is abandoned, Sun is not using this process? |
WO2016088101A1 | 2016-06-09 | Tedizolid | Process | This intermediate process is not used. Family abandoned. |
WO2016088102A1 | 2016-06-09 | Tedizolid | process | This intermediate process is not used. Family abandoned. |
WO2016088103A1 | 2016-06-09 | Tedizolid | process | This family is also abandoned, there is high likelihood that Sun dropped Tedizolid product development. This molecule did not do well too, peak sales estimated $ 300 mio |
WO2016092442A1 | 2016-06-16 | Palbociclib | Crystalline form | Family abandoned. Sun is not using this crystalline form in their dossier? |
WO2016092527A1 | 2016-06-16 | Dolutegravir | Process | This application is withdrawn, Sun is not using this process for sure. |
WO2016108130A1 | 2016-07-07 | Nebivolol | composition | Sun might not be using this composition, application abandoned. |
WO2016120892A1 | 2016-08-04 |
| Composition | This general composition might not be interesting for Sun. Abandoned. |
WO2016120894A1 | 2016-08-04 | Fluticasone | Crystalline form | Sun is using this protected Fluticasone crystalline form. |
WO2016125080A2 | 2016-08-11 | Baricitinib | Process | This process is used by Sun in Baricitinib API. Application is being prosecuted in US. |
WO2016129000A1 | 2016-08-18 |
|
| This application is being prosecuted in key countries. |
WO2016132341A1 | 2016-08-25 | Tofacitinib | Process | This process is not being worked by Sun, family abandoned. |
WO2016151438A1 | 2016-09-29 | Ibrutinib | Process | Abandoned |
WO2016178881A1 | 2016-11-10 | Optha Drug |
| Ocular Technologies Sarl application. This is being prosecuted in US. |
WO2016185490A1 | 2016-11-24 |
| NCE | Application is being prosecuted in many countries. Could be very interesting. |
WO2016189463A1 | 2016-12-01 | Ertugliflozin | Process | FDA approval 2017. Sun must have started very early development. This process must be used by Sun in their API, this is being prosecuted in US. |
WO2016189481A1 | 2016-12-01 | Isotretinoin | Composition | This invention must be worked by Sun, being prosecuted in many countries. |
WO2016193779A1 | 2016-12-08 | Isotretinoin | Composition | This invention must be worked by Sun, being prosecuted in many countries. |
WO2016194000A1 | 2016-12-08 | Iron sucrose | Composition | Sun must be using this composition in US dossier. Sun is prosecuting this application in US. |
WO2016194004A1 | 2016-12-08 | Dimethyl fumarate | Composition | Sun is prosecuting only in US, this composition must be used in US dossier. |
WO2016194024A1 | 2016-12-08 | Luliconazole | Composition | Pola Pharma application, only prosecuted in JP. Very Japan centric invention. |
WO2016199169A1 | 2016-12-15 |
|
| This invention is worked by Sun, application is being prosecuted by Sun in JP, EP and US. |
WO2016203495A1 | 2016-12-22 | Liraglutide | Composition | Application is being prosecuted in JP, Mexico, and Canada. Surprisingly abandoned in US. Has shelved US project? |
General information
Court Issues Notice to Serum Institute of India On Suit Against Use of Name 'COVISHIELD' For Proposed Vaccine
The civil suit was filed by a Nanded-based pharmaceutical company "Cutis Biotech" which claimed to be the "lawful and prior user" of the tradename "COVI SHIELD”. (Read more)
Piramal will expand former Ash Stevens site in Michigan
The project will add 2,300 m2 of space, including 790 m2 of production space, at the former Ash Stevens plant, which the Indian contract manufacturer purchased in 2016. Plans include a 4,000 L reactor for large-scale production, two kilo labs for process development and clinical-scale production, and a 3,000 L Hastelloy reactor to handle potent compounds. The expansion is expected to add 20 jobs when completed in 2022. (Read more)
Intellectual Property
Mylan Vs Teva (T 1025/18 Pharmaceutical compositions containing Formoterol)
This case is Mylan (Patent proprietor and Appellant) Vs Teva (Opponent and now respondent) EP1381346.
Opposition board earlier had revoked the patent. Mylan appealed.
There are several claims,
Claim 1 is as follows
“A pharmaceutical composition, comprising Formoterol free base at a concentration of 5 mg/ml to 50 mg/ml, or a derivative thereof, in a pharmacologically suitable fluid, wherein the composition is stable during long term storage, the fluid comprises water, and the composition is suitable for direct administration to a subject in need thereof."
In EPO, oppositions are very typical and methodical. In any opposition proceedings, EPO,
1. determines the closest prior art.
2. defines objective technical problem. Then, Board decides whether technical problem is solved in view of the closest prior art.
3. applies problem solution approach in solving the objective technical problem.
Document D1: US 6.040,344 was the closest prior art agreed by Mylan and Teva.
Objective technical problem: According to Mylan, the objective technical problem is the provision of an improved aqueous formulation of Formoterol for direct administration to a subject, whereas according to Teva the problem to be solved is to provide an alternative aqueous formulation of Formoterol.
Further EPO applied problem solution approach and investigated whether there is sufficient evidence supporting the alleged effect.
Mylan argued that the technical effect observed is an improvement about the long-term stability and the suitability for administration to a subject. The improvement in long term storage of the claimed formulation is linked to the pH and the buffer concentration.
According to Teva, there is no evidence in the patent that might render credible the allegation of an improvement in long term storage stability for the claimed formulations.
In the Board's view, in the present case, the adaptation of common variables such as the amount or nature of a buffer of a liquid formulation, belongs to the field of the routine tasks for the person skilled in the art.
It is confirmed by textbook teaching cited in opposition proceedings. A textbook on pharmaceutical dosage forms and drug delivery systems and the relevant extracts from there are evidence of the common general knowledge of the person skilled in the art. The board came to conclusion that it is one of the most important activities of pre-formulation work is the evaluation of the physical and chemical stability of the drug substance.
The Board said, the person skilled in the art, knowing teaching of D1, of the satisfactory short-term stability, would inevitably test the long-term stability of the disclosed formulation.
The Board opined, there is no distinguishing technical feature between the subject-matter of claim 1 and the formulation disclosed by D1, hence, the invention is obvious and cannot confer an inventive step on the claimed subject-matter.
The appeal was dismissed.
There are many auxiliary requests and many other cited documents. A detailed decision could be read here.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
