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Post by dreamboatcruise on Apr 12, 2016 8:22:41 GMT -5
The patent for Afrezza is only good until 2020. I don't know how much that patent protects, whether that be just the binding of insulin to FDKP, the manufacturing process, etc. There are ways to extend patents to give us more time with it, but depending on how much the patent protects, it might be possible that Afrezza will be fairly worthless in just 4 years if a competing generic becomes available. I have no idea if a generic manufacturer will sink in the money necessary to figure out FDKP, but it's a possibility. Point is, Afrezza probably shouldn't be looked to as a long-term solution for money. I wouldn't mind selling it off at this point if it will help us develop the rest of our portfolio. It'd almost make sense to get what we can for it and move on, depending on how difficult it is to get market acceptance. Of course, no one will want it if 2 tries were made and still no uptake. Seems getting a biosimilar version of Afrezza to market would not be easy. Undoubtedly the dreamboat inhaler has patents with much longer expiration. It certainly isn't the typical "generic" play. |
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Post by slapshot on Apr 12, 2016 8:48:12 GMT -5
Agreed, and it looks to me that the later patents listed on the Mannkind website are directed to the inhaler and/or powder / packets and were filed (or based off filings) in 2009 so the life of the patent would extend until 2029.
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Post by nylefty on Apr 12, 2016 9:17:19 GMT -5
The patent for Afrezza is only good until 2020. I don't know how much that patent protects, whether that be just the binding of insulin to FDKP, the manufacturing process, etc. There are ways to extend patents to give us more time with it, but depending on how much the patent protects, it might be possible that Afrezza will be fairly worthless in just 4 years if a competing generic becomes available. I have no idea if a generic manufacturer will sink in the money necessary to figure out FDKP, but it's a possibility. Point is, Afrezza probably shouldn't be looked to as a long-term solution for money. I wouldn't mind selling it off at this point if it will help us develop the rest of our portfolio. It'd almost make sense to get what we can for it and move on, depending on how difficult it is to get market acceptance. Of course, no one will want it if 2 tries were made and still no uptake. Seems getting a biosimilar version of Afrezza to market would not be easy. Undoubtedly the dreamboat inhaler has patents with much longer expiration. It certainly isn't the typical "generic" play. If you read Stevil's later posts he admitted that he got the patent date wrong and that the patent he was referring to actually was good until 2023. |
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Post by dreamboatcruise on Apr 12, 2016 9:23:25 GMT -5
Seems getting a biosimilar version of Afrezza to market would not be easy. Undoubtedly the dreamboat inhaler has patents with much longer expiration. It certainly isn't the typical "generic" play. If you read Stevil's later posts he admitted that he got the patent date wrong and that the patent he was referring to actually was good until 2023. But I believe there are other patents that would still make it hard to copy Afrezza beyond that. At least I would certainly hope that is the case when they've spent the money to obtain hundreds of patents. |
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Post by agedhippie on Apr 12, 2016 13:38:00 GMT -5
Seems getting a biosimilar version of Afrezza to market would not be easy. Undoubtedly the dreamboat inhaler has patents with much longer expiration. It certainly isn't the typical "generic" play. If you read Stevil's later posts he admitted that he got the patent date wrong and that the patent he was referring to actually was good until 2023. I would be cautious with that. I started looking into this a while back and I thought some of the later patents are dependent on earlier pre-2000 patents. The work done on Technosphere goes back certainly as far as 1990 and the science predates that by a few decades. While Technosphere is undoubtedly protected by patents the science on which it is based is well known. |
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Post by lakon on Apr 12, 2016 15:17:33 GMT -5
If you read Stevil's later posts he admitted that he got the patent date wrong and that the patent he was referring to actually was good until 2023. I would be cautious with that. I started looking into this a while back and I thought some of the later patents are dependent on earlier pre-2000 patents. The work done on Technosphere goes back certainly as far as 1990 and the science predates that by a few decades. While Technosphere is undoubtedly protected by patents the science on which it is based is well known. Define science. Define well-known. One key aspect of Afrezza was debated at the ADCOM and continues to be a serious area of debate over decades. Does TIME matter? What is the action causing the seemingly unbelievable results? There is a lot UNKNOWN in with the WELL-KNOWN. I expect more patents will be forthcoming. I have serious doubts that all these really smart people are going to appear to solve this problem AGAIN. BTW, some may recall that Einstein made about a dozen or so predictions that took over 50 yrs and counting to prove... My position is that it is easy to say someone else knows and will solve a problem. It just often turns out to take a lot more time in practice. Therefore, I think the patents are great, but the trade secrets and know-how are PRICELESS. Anyway, if we are going to continue to beat this dead horse, perhaps, we should start a new relevant thread: MannKind Intellectual Property Defense. |
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Post by slapshot on Apr 12, 2016 15:30:43 GMT -5
It looks like the first inhaler patents (7305986, 7464706, 7648960, 8950397) all are based on 7-21-00 filing date which at first would make one think they expired in 2020, however they all get a patent term adjustment (PTA) which extends the life of the patents. 7305986 for example has a PTA of of 909 days. (The PTA likely being the source of the confusion)
The patents on the newer inhaler (that looks like its probably the dreamboat), such as 8912193, 8636001, 8499757 were filed 6-12-2009 so would expire in 2029 plus any PTA, '193 has 0 days, '001 has 1126 days.
i didnt check every patent that Mannkind has listed, as i couldnt tell you which is/are most valuable anyway, but i dint see any pre 2000 filing dates.
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Post by agedhippie on Apr 12, 2016 18:07:17 GMT -5
Look for patents by Steiner. He did the early work when Mannkind was still the Pharmaceutical Discovery Corporation. He left in 2003 and set up Biodel and then Perosphere.
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Post by slapshot on Apr 13, 2016 6:01:07 GMT -5
You are correct, Phamaceutical Discovery Corp has some technoshpehere / microparticle patents that were filed in the 90's, such as 5352461 (Feldstein & Steiner) patented in 1994 (filed 1992) and 6071497 (Steiner & Feldstein et al.) patented 2000, filed in 1997.
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Post by lakon on Apr 13, 2016 14:17:14 GMT -5
Look for patents by Steiner. He did the early work when Mannkind was still the Pharmaceutical Discovery Corporation. He left in 2003 and set up Biodel and then Perosphere. Spot on and my point exactly. Look at Biodel. They are "restructuring" as we post and still undelivered. Don't get me wrong. BIOD has some interesting stuff, but I don't think it ever gets anywhere without Capital, Capital, Capital, and all the rest. Patents are only part of the picture. There are plenty of patent farms, but what do they actually produce? Look at the Universities. investor.biodel.com/releasedetail.cfm?ReleaseID=952374Perosphere might make a great partner. They definitely have candidates for seriously unmet medical needs. Mr. Kresa might even be able to bring the DoD to the table for interest in battlefield triage. Just thinking outside the box. Yet, I do wonder how Steiner and Mann got along. Unfortunately, it matters. Ciraparantag (PER977): Broad-Spectrum Anticoagulant Reversal Agent Ciraparantag is an intravenously administered synthetic molecule designed by Perosphere as a broad-spectrum reversal agent for anticoagulants. perosphere.com/content/research/per977.htmPER1080 is a rapid-acting formulation of a therapeutic drug candidate that seeks to prevent allergic reactions to peanuts and other allergens. perosphere.com/content/research/per1080.htmFelbamate for Traumatic Brain Injury PER726 is an intravenous therapeutic drug candidate that seeks to reduce brain cell damage, which typically occurs after cardiac arrest, stroke, or traumatic brain injury ("TBI"). This program is based on an IV drug delivery formulation of felbamate created by Perosphere. Felbamate is an approved, orally administered drug marketed as an anti-epileptic in the United States. Perosphere intends to pursue clinical development of felbamate for neuroprotection. Felbamate is highly insoluble in aqueous media and as a result cannot currently be administered intravenously, as is necessary for a neuroprotective indication. ... I'm not sure that the word " necessary" is necessary in the above, taken from their web site. Particles, like Technosphere, behave like a gas under the right conditions. If a patient is breathing and/or ventilated, it might be possible to treat a Technosphere application like administering a gas... I've never heard of this concept discussed in this context. I saw pictures of rats forced to inhale; however, they have been known to claim not to have -- inhaled that is. (Cheap shot, I know.)  I'm pretty sure CBD has similar neuroprotective properties, perhaps with less side-effects, besides increased appetite.  |
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Post by peppy on Apr 13, 2016 14:28:25 GMT -5
In reply to the post above; seems to me technosphere could be delivered to intubated patients.
(I picture the lab animals intubated. a made up problem solving picture, who knows.)
en.wikipedia.org/wiki/Tracheal_intubation
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Post by 4allthemarbles on Apr 14, 2016 13:35:58 GMT -5
Well well well. I hope you are all proud of yourselves. Do you remember that movie, Revenge of the nerds? Hmm. Remember the end of the movie when Skolnik gave that speech? That's right, you guys are the Alpha Betas. Que the music... Talk about false assumptions. No, I never saw Revenge of the Nerds. Are you trying to suggest that Stevil is a nerd who will get his revenge if MannKind goes bankrupt? In any case, I've never belonged to a fraternity and have been a nerd throughout my long life. Seriously lefty? I recommend you check out that movie. Revenge of the Nerds, 1984. Robert Carradine, Anthony Edwards, John Goodman, Timothy Busfield, the great Donald Gibb (Ogre) and Ted McGinley. Special appearance by Jamie (James) Cromwell. It is an 80's movie masterpiece. And no lefty, no false assumptions. It was the "outgoing" speech I was referencing. I know, off topic. |
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Post by nylefty on Apr 14, 2016 13:42:50 GMT -5
Talk about false assumptions. No, I never saw Revenge of the Nerds. Are you trying to suggest that Stevil is a nerd who will get his revenge if MannKind goes bankrupt? In any case, I've never belonged to a fraternity and have been a nerd throughout my long life. Seriously lefty? I recommend you check out that movie. Revenge of the Nerds, 1984. Robert Carradine, Anthony Edwards, John Goodman, Timothy Busfield, the great Donald Gibb (Ogre) and Ted McGinley. Special appearance by Jamie (James) Cromwell. It is an 80's movie masterpiece. And no lefty, no false assumptions. It was the "outgoing" speech I was referencing. I know, off topic. The false assumption was that everybody had seen this movie. I suspect that if I asked ten friends, maybe two would say they've seen it |
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Post by brotherm1 on Jun 25, 2016 8:36:37 GMT -5
Are you sure that is right about 2020? That doesn't seem right , but I can't remember for sure. Also, to be honest, you don't seem too sure?  ? United States Patent 7,648,960 Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles Filed: November 21, 2003. So 20 years from Filing date would be 2023, not 2020. Good catch. Regarding Afrezza patent expiration, I had just listened to a portion of the Medical Matters show on the radio. They were discussing the significant price increases for prescription drugs over the very recent years. They were discussing how drug companies are frequently extending their patents which in turn bolsters the prices of their products. They cited the HIV drug from Abbvie for example, stating Abbvie has 108 patents on it. They cited another company, for example, they said was a popular drug with 4 patents on it (I did not catch the name or drug). Anyway, I just thought this was interesting and perhaps MNKD with their significant patent expertise is also working of a patent extension for Afrezza. How it's done I've no idea, but the talk show hosts were saying the extensions can be decades long. |
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