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  • Shelly Albaum

Another Cliff Hanger: IPR Delay


Following last week's expansion of the Inter Partes Review trial on the '086 Patent to include Claim 2 after all, the parties agreed yesterday to extend by a month the deadlines for their response and reply briefs. You can read about it here:

Second Joint Notice of Stipulation to

Revised Schedule Regarding Due Dates 1 and 2

So now Dartmouth/ChromaDex's RESPONSE to Elysium's petition is due June 4, instead of May 4, and Elysium's REPLY to that response is now due August 22, instead of July 23.

That really burns, because we were expecting to read ChromaDex's response the day after tomorrow, and now we have to wait another month.

While We're Waiting...

So while we're waiting, let's take a closer look at what we are waiting for:

In the PTAB's order instituting trial, the PTAB explained exactly what its concerns were with the claims at issue. Those expressed concerns are the roadmap for Steptoe's attack on Elysium's petition.

There are two reasons why I was expecting Steptoe to just simply CRUSH it this Friday.

First, Steptoe is going to spend a lot more time thinking about this and analyzing this than the PTAB has or will.

Second, I think Elysium is coming from a very weak position in asserting that the existence of buttermilk prevents a party from patenting anything derived from the buttermilk and prepared for a specific purpose.

It just can't be so.

I get it that the existence of apples and sticks might prevent one from patenting apple-on-a-stick, But the existence of hazelnuts and jars did not prevent Ferrero from patenting Nutella. Indeed, the concoction we know as Smucker's Goober -- peanut butter and jelly swirled together in the same jar -- was originally patented by Proctor and Gamble in 1961. Did you decide to put a layer of peanut butter in between two layers of jelly? Here's your patent.

The world is full of patents for specific ways of preparing things made from known ingredients.

Patent law anticipates an entire class -- Class 426 -- of patented edible compositions. The foods still have to be novel, non-obvious, and adequately disclosed, like any other patent.

But simply saying that something is a combination of pre-existing, known substances by no means checkmates a patent. Here are the kinds of patents that are anticipated by Class 426:

A. EDIBLE PRODUCTS OR COMPOSITIONS

1. Products or compositions which historically have been considered to be a food, and products or compositions which contain a naturally occurring material (i.e., plant or animal tissue) which has been historically regarded as a food; e.g., milk, cheese, apples, bread, dough, bacon, whiskey, etc.

2. Products or compositions which are known to have or are disclosed as having nutritional effect.

3. Products or compositions which are closed or claimed as being edible or which; perfect, modify, treat, or are used in conjunction with an edible such as (1) or (2) above or with another edible, so as to become part of the edible composition or product, or which converts a nonedible to an edible form.

4. Plural inorganic elements or minerals for fortification.

5. Mixtures of enzymes which are edible, per se, or which are used in preparing a product or composition proper for this class.

6. Products or compositions proper for this class which contain a live micro-organism which enhances or perfects the digestive action of the intestinal tract, e.g., Bacillus acidophilus milk, etc.

7. Edible bait.

8. Edible products or compositions which have structural characteristics.

So About That 8,383,086 Patent...

I think a charitable interpretation of Elysium's argument is that the '086 patent covers NR in a form that you can ingest, and the NR in milk is already in a form that you can ingest, so there is nothing new in the patent.

For that to become the law, Elysium needs to show that buttermilk containing NR is just like Niagen in that the buttermilk ALSO contains:

1. Isolated NR molecules in a

2. Pharmaceutical composition

3. In admixture with a pharmaceutically acceptable carrier

4. Formulated for oral consumption

4. That increases NAD+ biosynthesis

That is a tall order, because buttermilk doesn't sound like a pharmaceutical composition in admixture with a pharmaceutically acceptable carrier.

I'm not even sure that buttermilk is "formulated" at all.

Here is how the PTAB handled it:

Isolated

The PTAB conceded that the NR in buttermilk isn't "isolated," which I think means that claim 2 of the '086 patent (like all of the '807 patent) is valid and enforceable against Basis, which also contains isolated NR in concentrations greater than 25%.

Can we can just go home now? Yes.

But for fun, let's look at the other claims.

Pharmaceutical Composition

The PTAB was not convinced that the '086 patent could permissibly make any of the other claims.

Is food, like buttermilk, a "pharmaceutical composition?"

I would have thought not, simply because the grocery store and the pharmacy are different places and everyone knows that.

Here's what the PTAB said in its preliminary assessment:

"Patent Owner offers no construction for the term 'pharmaceutical composition' other than to argue that milk is not a pharmaceutical composition...We agree with Petitioner that the term...''pharmaceutical composition' should include food products' because the specification says that Niagen can be 'used in the form of...capsules, elixirs, suspensions, syrups, wafers, chewing gums, food, and the like.'"

Now it doesn't take a JD or a PhD to understand that if the pharmaceutical composition can be included IN food, that doesn't mean that the food itself BECOMES a pharmaceutical composition.

For example, I sometimes pill my dog by putting the pill in some peanut butter. The peanut butter does not become a pharmaceutical just because I put the pill inside it.

Something tells me that Steptoe will be able to make this argument in a compelling way.

But if Steptoe wants me to bring my dog to the trial to demonstrate just what nasty, you-did-not-think-were-even-potentially-edible substances could be "pharmaceuticals" based on the PTAB's reasoning, we'll be happy to visit DC (just hold your nose).

Carrier

The PTAB doesn't do itself any favors with its expressed reasoning on whether the '086 Patent can claim NR in a carrier.

The definition of "carrier" that the PTAB accepted is:

A liquid or solid filler, diluent, excipient, or solvent encapsulating material, [that] is involved in carrying or transporting the subject compound from one organ, or portion of the body, to another organ, or portion of the body. Each carrier must be acceptable in the sense of being compatible with the other ingredients of the formulation and not injurious to the patient. (emphasis added)

The PTAB then reasons thus:

Sugars such as lactose can be a carrier;

Milk contains lactose;

Therefore, the NR in milk is admixed with a carrier.

That's just crazy-talk that would get the PTAB panel a poor grade in any freshman critical thinking class.

If the PTAB reasoned logically, their argument would go like this:

Sugars can be a carrier;

The NR in milk is in fact encapsulated by the sugars in the milk which in fact transports the NR between organs after ingestion;

Therefore, the NR in milk is admixed with a carrier.

I get it that lactose could be a carrier that encapsulated the NR in milk and transported it between organs -- if only it had learned.

But in fact the lactose in milk does not do those things, so by the PTAB's own definition it is not a carrier.

A simple analogy: I own a car. I could sign up with Uber and transport people for a fee. However, the fact that my car COULD serve that purpose does not make my car an Uber, or me an Uber driver, because I did not sign up and it is not in fact used for that purpose.

That's why although lactose could be a carrier, the lactose in milk is not in fact a carrier.

Again, I think there is a real opportunity for Steptoe to hit this one out of the park.

The Remaining Claims

The PTAB makes the same kind of arguments with respect to all the terms other than isolated: a pharmaceutical composition is just anything; a carrier is just anything; formulated for oral consumption means just anything; admixture means nothing; and increases to NAD+ biosynthesis don't require any minimum.

Will the PTAB stick to those positions in the face of serious argument, which they admit that they have not yet encountered? Will Foley on behalf of Elysium be so cowed by Steptoe that they spontaneously abandon their case and withdraw from representing Elysium?

Stay tuned...

#ChromaDex #CDXC #ElysiumHealth #Litigation #NicotinamideRiboside

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