Contents
Sun Pharma Patent applications Part IV
These are mainly applications published in 2017. SCO-120 as an NCE seems to be very interesting from Sun’s perspective. It is in Phase I. About 50% of the inventions are being prosecuted.
Publication Number | Publication Date | API | Application relates to | Comments |
WO2017066270A1 | 2017-04-20 | Diagostics, not particular to any API | Diagnostic | Application filed by Dusa Pharmaceuticals, Inc.. Must be very interesting for Sun as this application is being prosecuted in Europe and US. |
WO2017072699A1 | 2017-05-04 | dimethyl fumarate | Composition | Validated in Canada, Mexico and South Africa |
WO2017072792A1 | 2017-05-04 | SCO-120 | NCE | Patent is validated in many countries. This molecule could be SCO-120. As per Sun's website, SPARC has initiated a Phase 1 study in the US to assess the PK and Safety of SCO-120 in healthy volunteers. |
WO2017081590A1 | 2017-05-18 | omarigliptin | Process | Abandoned, Merck has announced that the company will not submit marketing application in the US and Europe. Sun abandoned the family. |
WO2017081702A2 | 2017-05-18 | enzalutamide | Process | Abandoned. |
WO2017083167A1 | 2017-05-18 |
| Composition | Application by Ocular Technologies Sarl, must be market in US and JP where application is being prosecuted. |
WO2017083410A1 | 2017-05-18 |
| Composition | Abandoned. |
WO2017093973A1 | 2017-06-08 | sofosbuvir | Process | Abandoned. |
WO2017094029A2 | 2017-06-08 | diltiazem | Composition | Specific composition for US and JP market? Patent is validated in only two jurisdictions. |
WO2017094031A2 | 2017-06-08 | apremilast | Process | Abandoned. Sun is not using this process in their DMF. |
WO2017094204A1 | 2017-06-08 | Luliconazole | Crystalline form | Application is active in JP and US. Sun has not filed DMF. Looking the prosecution of luliconazole applications, Sun must be active in Japan and might be using this grade of API for JP. |
WO2017098533A2 | 2017-06-15 | lisdexamphetamine | Process | lisdexamphetamine is only being marketed in Canada by Sun? Application abandoned in other jurisdiction. |
WO2017099210A1 | 2017-06-15 |
|
| Only JP equivalent |
WO2017103688A1 | 2017-06-22 | extract of Cissampelos pareira | Natural product | Natural product extract, and patent application is active in few south Asian countries and Brazil. |
WO2017122011A1 | 2017-07-20 |
| Papaver plant species | Seems to be interesting invention, Papaver plant species wherein the plant is modified. This is being prosecuted in many key jurisdictions. |
WO2017130221A1 | 2017-08-03 | Idelalisib | Process | Sun has not filed DMF yet. This process patent is abandoned. Sun is not using this process. |
WO2017134606A1 | 2017-08-10 | Ertugliflozin. | Crystalline form | Abandoned. Ertu is reasonably new approval. December 2017. Sun must have started to work very early and must be facing stability/quality problems with this crystalline form. |
WO2017134685A2 | 2017-08-10 |
| NCE | Btk inhibitors, might not be interesting, application abandoned. |
WO2017138023A1 | 2017-08-17 |
|
| Perfusion system. This seems to be very interesting application for Sun and being |
WO2017141193A1 | 2017-08-24 | sacubitril | Process | Abandoned |
WO2017141271A1 | 2017-08-24 | afatinib | Composition | Abandoned, Sun had filed DMF, but maybe this process is not being used? |
WO2017141275A1 | 2017-08-24 |
| Diagnostic | Being prosecuted in US and JP and perhaps device could be marketed in these countries. |
WO2017145089A1 | 2017-08-31 | Bosutinib | Crystalline form | Abandoned. Must be difficult to make API, after so many years of approval only MSN and Alembic have filed DMFs. Sun also seems to have dropped the project. |
WO2017149552A1 | 2017-09-08 | amiodarone | Composition | Application being prosecuted only in US. Must be Taro's ANDA is covered by this invention. |
WO2017151657A1 | 2017-09-08 |
| Composition | Application filed by Ocular Technologies Sarl and being prosecuted in many countries, this invention must have commercial value. |
WO2017152129A2 | 2017-09-08 |
| Composition | Application filed by Ocular Technologies Sarl and abandoned, must be uninteresting composition. |
WO2017158625A1 | 2017-09-21 | nilotinib | Composition | This application is being prosecuted in many countries including US. Sun would be definitely working on Gx version. As per news article Sun had planned to launch in local market which was not successful. |
WO2017163170A1 | 2017-09-28 | apixaban | Composition | Abandoned |
WO2017163267A1 | 2017-09-28 | divalproex | Composition | Sun had dossier in US market. This invention might not be worked by Sun and hence this application is abandoned. |
WO2017163268A2 | 2017-09-28 | divalproex | Composition | Abandoned |
WO2017168435A1 | 2017-10-05 | liraglutide | Composition | Patent is being prosecuted in Russia, China, Japan, Canada and Mexico. Subcutaneous gel market is being explored in these countries by Sun? |
WO2017168454A2 | 2017-10-05 |
| NCE | Btk inhibitors, might not be interesting, application abandoned. |
General information:
AHIP Blasts Pharmaceutical Industry as Drug Prices Increase
A little more than 15 percent of all of the drugs studied (722 drugs) would be increasing in prices at the beginning of 2021. Prices would rise approximately 4.5 percent on average.
(News here)
Google to use quantum computing to develop new medicines
Through the collaboration, Boehringer Ingelheim and Google plan to focus on implementing quantum computing in pharmaceutical R & D including molecular dynamic simulations.
News here.
Intellectual Property:
Copaxone and Teva
FDA published list of Approved NDAs for Biological Products that were deemed to be BLAs on 23 March 2020.
The list is here.
FDA issued draft guideline and FDA interpreted the terms protein and chemically synthesized polypeptide.
1. “protein” to mean “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.”
2. “chemically synthesized polypeptide” to mean any alpha amino acid polymer that “(1) is made entirely by chemical synthesis and (2) is greater than 40 amino acids, but less than 100 amino acids in size.”
Teva is the innovator of multiple sclerosis drug Copaxone (glatiramer acetate). As part of its efforts to restrict the Gx competition (that already exists as generics since 2015), Teva wanted FDA to include Copaxone in the list as “biological product” so that subsequent filers to follow BLA (The Biologics License Application) path for the approval.
On 31 December 2020, District Court of Columbia denied summary judgment motion filed by Teva for inclusion of Glatiramer as “biological product”.
The Court upheld FDA’s view that Copaxone is not “Analogous” to a protein because Copaxone lacks “specific, defined sequence” which is an absolute criteria for defining protein. The Court said Teva's bid to reclassify Copaxone is anticompetitive
Some more details here.
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