pfg, the patent is worthless if the fda does not approve Afrezza. That is why you're not hearing anything about it.
One last attempt to explain - the combination is done through a series of steps. The drugs are not physically combined. The drugs are combined in a 'treatment'.
I will nit try to convince you further. The patent is therefor everyone to read and decide for themselves.
ceda, you hit on a very good point. Why indeed? Perhaps that is why they agreed to pay such usurious rates of 19% - because they knew they'd be paying off the loan early anyway and such interest will never materialize. Perhaps Deerfield knew this that is why they asked for the $90M milestone payments in addition to the 19% interest rate. It was a strange loan that even a Mann lover like me feels a bit ripped off. Off course if it were paid off upon partnership it will all make sense.
From an operational perspective what the patent does is prevent others from buying Afrezza products and packaging them with their bed time or long lasting drug. On the other hand, MNKD can negotiate with any of the other drug manufacturers to market a pack (with its own NDC (national drug Code) that has both products in a single package. If the combination product is priced such that it is cheaper than buying individual products, then no one will buy them as separate products. At the same time doctors will find it convenient to issue one prescription instead of multiple prescriptions. In addition, insurance companies will prefer to reimburse the cheaper treatment.
pfg, you said 'if anyone can identify a CLAIM that supports the protection that Bbarra or others may be claiming, I will be happy to concede that my interpretation is incorrect.'
Here are the claims:
17. The method of claim 1 wherein said ultrarapid acting insulin preparation is administered at a dosage sufficient to maximally reduce hepatic glucose output within 60 minutes of administration.
19. The method of claim 1 wherein the ultrarapid acting insulin preparation comprises an insulin analog.
20. The method of claim 19 wherein the insulin analog is insulin aspart, insulin glulisine, or insulin lispro.
To explain the claims: #17 is to use Afrezza, and #20 is to use Lantus, Novo's or other drugs that may be combined with Afrezza.
Maybe this Afrezza patent is hard to understand. Let me use another product for analogy. Merck has an interferon drug, that by itself is ineffective in treating Hepatitis C. Vertex has a Hep C drug that by itself is better but not good enough to be a cure. The two products combined became the first "cure" for a viral infection and had a cure rate of 80%. The patent was granted for a treatment with the combined products. Again, these products may be sold separately but Vertex owns the right to provide a treatment with the two products combined. [Of course, Gilead (Pharmasset) has now developed a product that has a 95% cure rate and doesn't use interferon]
Apparently MNKD convinced the USPTO that Afrezza combined with another product produces much greater result than Afrezza alone or the other product alone. Thus the patent..
sandra, the way the patent is written is to cover a method of treatment that combines Afrezza with another drug to produce an optimal and superior outcome. Ordinary outcome will not result in approval. An invention has to be unique and if the products by themselves are not unique (which is the case here) the combination must produce unique and unexpected outcome.
This patent combines Afrezza with another drug (and the possible combinations are enumerated) to produce surprising and superior outcome. I think it's as simple as that.
The patent protection is for the business process the leads to the use of the combination drug. The combination of the two drugs by itself is not patentable since each already exists and available by themselves and can in the ordinary usage be combined.
'I definitely have to stop starting out with other people's numbers' - those weren't my numbers I posted. Those were numbers presented by Al yesterday.
When Al presented in November, the first question raised (by JPM analyst) was: Are you expecting an Adcom. This was not a coincidence. This was Al plating the question.
When Al presented yesterday and flashed a page on Cash Position - which showed clearly they will be out of cash by April (and Deerfield financing agreement prevents them from going below $25M which means they will be in technical bankruptcy by early March 2014), this was intentional. His message is: It's coming soon.
Business process and method patents are hard to comprehend. The patent is designed to protect the steps toward the combination of the products (each of which would be patented separately). The patent is for the steps. That's how business methods are patented. I should know, I managed to find the loophole in a Supreme Court ruling that opened the door to business process patents. I take pride in being the patent owner of the first business process ever approved by the USPTO. The end result of MNKD's patent is to prevent anyone from combining Afrezza with any other product.
The jist of the product is to obtain a 20-year protection for a combination of Afrezza and a bedtime diabetes medication. The specific mention of Novo and Sanofi's product gives it airtight protection.
The benefit for Sanofi is that its Lantus patent is expiring 2015. By doing a combination patent, it extends exclusivity by another 20 years. Therefore a generic version cannot be combined with Afrezza without obtaining a license from MNKD. If Sanofi bought MNKD...you can finish the sentence.
pfg, I disagree. I am a lawyer and wrote my own patent that was the very first business process patent that is now the basis for patents by Microsoft, Google, Ebay, etc. I sold it to IV Ventures. Look up IV Ventures. It was set up by the founder of Microsoft labs and owns the majority of U.S. patents. Give me your email address and I will send you a link to my patent.
A patent is always worded as broadly as possible to prevent others from copying it using alternative ways or reverse engineering it. That is why it is hard to understand and isn't focused on one method or process. The direct mention of Sanofi's product and Nov's product is a direct hit.
Just adding that Lantus patent expires 2015. By combining Afrezza to Lantus, Sanofi gets a 20 year extension to its Lantus product. They will manage to overcome generic versions of Lantus if the combo pack takes over..
Just to recap:
#1. Avis and Marlin posted that both Sanofi and Novo issued 500M shares to the U.S. Stock registry in 4Q 2013; - see the link to the SEC filing posted by Marlin.
#2. Jan 7, 2014, MNKD is awarded a patent for combination Afrezza/Lantus and Afrezza/Novo's product - 20 years exclusive patent - See the thread on U.S. Patent this week.
#3. MNKD authorized shares is 500M.
#4. MNKD started a clinical trials for a new vendor supplier for raw insulin for Afrezza
$5 No word on EU filing
#6 Sanofi partnered with Pfizer to acquire Exubera. Sanofi sold its share to Pfizer for $3.2B after disagreement on how to market the product; Sanofi bought the Exubera plant in Germany from Pfizer.
#7 A stock swap.of 1 MNKD for 1 SNY + 1 NVO = $89; A price good enough for Al, don't you think? And it will cost Sanofi and Novo what? Temporary dilution?
#8 Sanofi owns Europe/Asia market; Novo U.S. Market?
combination packs are very common. Only fda approved products can be combined or fda and non-fda regulated products (e.g. drug and medical supplies/syringes).. Yes, they will have to submit for an NDC for the pack but that is just paperwork and automatically approved.
They could be geographic partition of the market. One in the U.S., the other for the rest of the world. If this happens there will be no MNKD. The plant will be owned by whoever owns the U.S. market and the Europe/Asia will build its own plant.
It also explains the new Clinical Trial for another vendor supplier of the insulin - either Novo or Sanofi (whoever is owning Europe/Asia). The U.S. has $10B worth of sales so there is a long time available to test another insulin source for the U.S. market.
Does this also explain why we haven't heard about EU filing? Because that would expose the partnership/buyout agreement?
Looks like its all adding up.
For the newbies, Sanofi partnered with Pfizer to acquire Exubera. Sanofi sold its share to Pfizer for $3.2B after they couldn't agree on the marketing strategy. So it makes sense that there are believers of inhaled insulin within Sanofi. Novo is probably doing it to protect its market share. Folks - this is all speculation so far.
No, Letsroll. MNKD was granted a patent last week for a combination of Afrezza and Lantus and Afrezza and Novo's product. The products are combined as a treatment. Potentially, there can be a pack with one NDC (national drug code) that has Afrezza for after meals and Lantus for bedtime. Doctors will prescribe the pack and drugstores will carry them as packs.