MNKD Patents

[agedhippie]

Aug 20, 2018 21:05:38 GMT -5 sayhey24 said:

Is the new patent "Use of ultrarapid acting insulin" patents.justia.com/patent/10046031 enough to get Dr. Kendall some movement on getting changes to both the T1 and T2 standard of care?

I'll bite

No. It's just a patent and patents are not necessarily correct. A change would rest on the trial data supporting a patent and currently I believe that is all out there so there is nothing new.

[sayhey24]

What caught my eye was the word "ultrarapid".

My understanding as to why the FDA would not allow it on the label was because they do not create categories and no such category existed. However, if the U.S. Government has granted an "untrarapid" patent, I am thinking and maybe incorrectly, the FDA would have a tough argument in not granting a label for a patented product which the U.S. Government already calls "ultrarapid".

Did MNKD just backdoor the ADA?

[agedhippie]

Aug 21, 2018 18:55:35 GMT -5 sayhey24 said:

What caught my eye was the word "ultrarapid".

My understanding as to why the FDA would not allow it on the label was because they do not create categories and no such category existed. However, if the U.S. Government has granted an "untrarapid" patent, I am thinking and maybe incorrectly, the FDA would have a tough argument in not granting a label for a patented product which the U.S. Government already calls "ultrarapid".

Did MNKD just backdoor the ADA?

Incorrectly

US Government isn't calling it ultra-rapid, Mannkind is. A patent is (within limits) an assertion by the patentee and subject to challenge by third parties. Novo also have patents with ultra-rapid in them. That doesn't make them so with either the FDA or the ADA. I could describe an insulin as fluffy and get a patent, but that wouldn't give me an insulin I could market as fluffy.

[mango]

One New Granted MannKind Patent Published 8/21/2018 and Two New International MannKind Patent Applications Published 8/16/2018 (exciting times!)


Apparatus and method for cryogranulating a pharmaceutical composition

Abstract: Cryogranulation systems with improved dispenser assemblies are provided for use in manufacturing frozen pellets of pharmaceutical substances in a fluid medium. Methods of cryogranulating the pharmaceutical substance in the fluid medium are also provided. In particular embodiments, the dispenser assembly is used with suspensions or slurries of pharmaceutical compositions including biodegradable substances, such as proteins, peptides, and nucleic acids. In certain embodiments, the pharmaceutical substance can be adsorbed to any pharmaceutically acceptable carrier particles suitable for making pharmaceutical powders. In one embodiment, the pharmaceutical carrier can be, for example, diketopiperazine-based microparticles. The dispenser assembly improves the physical characteristics of the cryopellets formed and minimizes product loss during processing.

Type: Grant
Filed: January 17, 2017
Date of Patent: August 21, 2018
Assignee: MannKind Corporation
Inventors: Edwin Amoro, Karel Vanackere, Michael A. White


patents.justia.com/patent/10052285



Application Date: 16.04.2018

Publication Date: 16.08.2018

Applicants: MannKind Corporation

Inventors: John J. Freeman
Otto Phanstiel
William Elliot Bay
Kelly Sullivan Kraft

Title: (EN) FORMATION OF N-PROTECTED 3,6-BIS-(4-AMINOBUTYL)-2,5-DIKETOPIPERAZINE THROUGH A CYCLIC ALPHA-N-PROTECTED AMINO ESTER INTERMEDIATE

Abstract: (EN) A method for the synthesis of N-protected 3,6-aminoalkyl-2,5-diketopiperazines is provided. The method includes obtaining a cyclic α-N protected active amino ester and adding it to a mixture of an amine catalyst in an organic solvent.


patentscope.wipo.int/search/en/detail.jsf?docId=US224558909&recNum=2&office=&queryString=FP%3A%28MannKind%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=1117



Application Date: 16.04.2018

Publication Date: 16.08.2018

Applicants: MannKind Corporation

Inventors: Chad C. Smutney
P. Spencer Kinsey
Carl R. Sahi
Benoit Adamo
John M. Polidoro

Title: (EN) DRY POWDER INHALER AND SYSTEM FOR DRUG DELIVERY

Abstract: (EN) A breath-powered, dry powder inhaler, a cartridge, and a pulmonary drug delivery system are provided.


patentscope.wipo.int/search/en/detail.jsf?docId=US224557789&recNum=1&office=&queryString=FP%3A%28MannKind%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=1117

[mango]

New International MannKind Patent Published 8/30/2018 and the MannKind Cannabinoid Patent Enters National Phase


Application Date: 27.01.2017

Publication Date: 30.08.2018

Applicants: MANNKIND CORPORATION

Inventors: KINSEY, P. Spencer
LAURENZI, Brendan
SMUTNEY, Chad, C.
ADAMO, Benoit
GUARNERI, Joseph

Title (EN) DRY POWDER INHALER

Abstract (EN) A dry powder inhaler including replaceable cartridges containing a dry powder for local or systemic delivery through the pulmonary tract and lungs is disclosed. The inhalers are used with inhalable dry powders, including medicament formulations comprising active agents for local or systemic delivery and for the treatment of diseases such as, pulmonary hypertension, cardiovascular disease, anaphylaxis, diabetes, obesity, cancer, and other diseases, or symptoms associated with these and other diseases, such as nausea, vomiting, pain and inflammation.


patentscope.wipo.int/search/en/detail.jsf?docId=SG225438026&recNum=1&office=&queryString=FP%3A%28MANNKIND%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=1116





Looks like these two here are related/same patent. This one below is the MannKind Cannabinoid patent that was just recently moved into the National Phase process. This means MannKind requested these entries into the national phase at each specific patent office of that country. 


International Filing Date: 27.01.2017

Publication Date: 03.08.2017

Applicants: MANNKIND CORPORATION

Inventors: KINSEY, P. Spencer; US
LAURENZI, Brendan; US
SMUTNEY, Chad, C.; US
ADAMO, Benoit; US
GUARNERI, Joseph; US

Title (EN) DRY POWDER INHALER
(FR) INHALATEUR À POUDRE SÈCHE


Abstract: (EN) A dry powder inhaler including replaceable cartridges containing a dry powder for local or systemic delivery through the pulmonary tract and lungs is disclosed. The inhalers are used with inhalable dry powders, including medicament formulations comprising active agents for local or systemic delivery and for the treatment of diseases such as, pulmonary hypertension, cardiovascular disease, anaphylaxis, diabetes, obesity, cancer, and other diseases, or symptoms associated with these and other diseases, such as nausea, vomiting, pain and inflammation.

(FR) L'invention concerne un inhalateur à poudre sèche comprenant des cartouches remplaçables contenant une poudre sèche pour une administration locale ou systémique à travers le tractus pulmonaire et les poumons. Les inhalateurs sont utilisés avec des poudres sèches pouvant être inhalées, comprenant des formulations de médicament contenant des agents actifs pour une administration locale ou systémique et pour le traitement de maladies telles que l'hypertension pulmonaire, une maladie cardiovasculaire, l'anaphylaxie, le diabète, l'obésité, le cancer et d'autres maladies, ou des symptômes associés à ces dernières et d'autres maladies, tels que la nausée, les vomissements, une douleur et une inflammation.


Claims

We claim:

1. A dry powder inhaler comprising:

a housing, and

a body comprising a mouthpiece integrally configured with the body,

wherein the body comprises a mounting area for a cartridge, and the body and the housing are movable relative to one another linearly and are operably configured to engage one another by insertion to effectuate the cartridge to be reconfigured to attain an airflow pathway for discharging a powder dose upon an inhalation.

2. The dry powder inhaler of claim 1 , wherein the mouthpiece has an air inlet for communicating with an interior compartment of the inhaler body.

3. The dry powder inhaler of claim 1 , wherein the housing reconfigures the cartridge installed in the inhaler by translation of the housing over the inhaler body from an open configuration to a closed configuration.

4. The dry powder inhaler of claim 1 , wherein the movement of the housing relative to the body is facilitated by guide rails structured along a longitudinal axis and extending from right side and/or left side of the inhaler body.

5. The dry powder inhaler of claim 1 , wherein the dry powder inhaler is configured to attain an open or loading position, and a closed or dosing position.

6. The dry powder inhaler of claim 1 , wherein the housing further comprises a protruding rigid element which pushes the cartridge to a dosing position from a containment configuration.

7. The dry powder inhaler of claim 1, wherein the inhaler is further configured to have rigid flow conduits.

8. The dry powder inhaler of claim 1 , wherein the housing comprises a cover which envelops a portion of the inhaler body.

9. The dry powder inhaler of claim 1, wherein the mouthpiece further has an internal volume extending from the first inlet port to the exit port, wherein the internal volume is greater than 0.2 cubic centimeters.

10. The dry powder inhaler of claim 1 , wherein the inhaler body comprises detents which prevent separation of the body from the housing in an assembled inhaler.

11. The dry powder inhaler of claim 1 , wherein the housing positions the cartridge to align with the mouthpiece by translation of the housing over the inhaler body from an open configuration to a closed configuration.

12. The dry powder inhaler of claim 1, further comprising a dry powder.

13. The dry powder inhaler of claim 12, wherein the dry powder is a pharmaceutical composition for inhalation.

14. The dry powder inhaler of claim 12, wherein the dry powder comprises 3,6-bis(N-fumaryl-4-aminobutyl)-2,5-diketopiperazine.

15. The dry powder inhaler of claim 14, wherein the dry powder comprises a cannabinoid in an amount from 1% to 40% (w/w).

16. The dry powder inhaler of claim 15, wherein the cannabinoid is tetrahydrocannabinol or cannabidiol.

17. The dry powder inhaler of claim 14, wherein the dry powder further comprises a phospholipid selected from l,2-dipalmitoyl-OT-glycero-3-phosphocholine and 1,2-distearoyl-OT-glycero-3-phosphocholine.

18. A dry powder inhaler comprising a body, a housing, a cartridge and a mouthpiece, said body having a mounting area for said cartridge and said cartridge comprising a dry powder composition comprising microcrystalline particles of fumaryl diketopiperazine and a drug, and wherein said housing translationally glides over said body in a proximal to distal direction to open the inhaler, or from distal to proximal direction to close the inhaler, wherein when the inhaler is closed the inhaler has one or more rigid air conduits for dispensing the dry powder.

19. The dry powder inhaler of claim 18, wherein the drug is tetrahydrocannabinol or cannabidiol.

20. The dry powder inhaler of claim 18, wherein the dry powder further comprises a phospholipid selected from l,2-dipalmitoyl-OT-glycero-3-phosphocholine and 1,2-distearoyl-OT-glycero-3-phosphocholine.


patentscope.wipo.int/search/en/detail.jsf?docId=WO2017132601&recNum=&maxRec=1000&office=&prevFilter=&sortOption=&queryString=&tab=PCTBiblio

patentscope.wipo.int/search/en/detail.jsf?docId=WO2017132601&recNum=&tab=PCTClaims&maxRec=1000&office=&prevFilter=&sortOption=&queryString=



National Phase Enteries

1. European Patent Office (EPO) on 29.08.2018

register.epo.org/application?number=EP17745037


2. Israel on 29.07.2018

www.ilpatsearch.justice.gov.il/UI/RequestDetails.aspx?ReqId=260823




patentscope.wipo.int/search/en/detail.jsf?docId=WO2017132601&recNum=&tab=NationalPhase&maxRec=1000&office=&prevFilter=&sortOption=&queryString=

[mnholdem]

This international patent protects MannKind's inhalation device in nearly every country around the globe:

Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). with international search report (Art. 21⁽³⁾) ^{(84) (71)}

For a list of international patent country codes see: patft.uspto.gov/netahtml/PTO/help/helpctry.htm

[peppy]

Sept 6, 2018 9:34:24 GMT -5 mnholdem said:

This international patent protects MannKind's inhalation device in nearly every country around the globe:

Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). with international search report (Art. 21⁽³⁾) ^{(84) (71)}

For a list of international patent country codes see: patft.uspto.gov/netahtml/PTO/help/helpctry.htm

[mango]

Sept 6, 2018 9:38:24 GMT -5 peppy said:

Sept 6, 2018 9:34:24 GMT -5 mnholdem said:

This international patent protects MannKind's inhalation device in nearly every country around the globe:

Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). with international search report (Art. 21⁽³⁾) ^{(84) (71)}

For a list of international patent country codes see: patft.uspto.gov/netahtml/PTO/help/helpctry.htm

Those are some sexy inhalers

I'm curious about that top middle one looks like it could be for specific purpose/population/maybenot?

[mnholdem]

It looks like it has a barrel/sleeve that slides over the cartridge, rather than a flip-top like the Afrezza device. Interesting.

[mytakeonit]

Could that be a nose inhaler ... in case you couldn't inhale thru the mouth for any reason?

[madog365]

nasal passage delivery for drugs targeted to the brain. take a look at the SNIFF study. 

[mytakeonit]

So no diabetes in my brain? Not sure why the barrel is so round.

[oceanmotion]

Looks to me like an easy-to-grip variant for pediatric use

[mango]

Sept 11, 2018 11:48:35 GMT -5 oceanmotion said:

Looks to me like an easy-to-grip variant for pediatric use

I can definitely see that! I bet that's what it is for, good thinking 🤓

The patent also coincides; says it is for easy gripping 

[mango]

New MannKind Granted Patent 9/11/2018


Methods for the synthesis of activated ethylfumarates and their use as intermediates

Abstract: Disclosed embodiments relate to improved methods for the synthesis of activated fumarate intermediates and their use in chemical synthesis. Disclosed embodiments describe the synthesis of activated fumarate esters including those derived from activating groups including: 4-nitrophenyl, diphenylphophoryl azide, pivaloyl chloride, chlorosulfonyl isocyanate, p-nitrophenol, MEF, trifluoroacetyl and chlorine, for example, ethyl fumaroyl chloride and the subsequent use of the activated ester in situ. Further embodiments describe the improved synthesis of substituted aminoalkyl-diketopiperazines from unisolated and unpurified intermediates allowing for improved yields and reactor throughput.

Type: Grant

Filed: November 23, 2015

Date of Patent: September 11, 2018

Assignee: MannKind Corporation

Inventors: Kelly Sullivan Kraft, John J. Freeman, Paul Serwinski, Vincent Pavia, Otto Phanstiel, Navneet Kaur


patents.justia.com/patent/10071969