Monthly Archives: May 2018

Moderna’s Futile Challenge against Arbutus ‘127 Patent

PTAB-trials-all

07.02.2018 Update: Preliminary response dated 06.14.2018 posted at Patexia. Strong and clear argument.

Response to Ground #1:

  1. Petitioner fails to demonstrate inherent disclosure of “…wherein at least about 95% of the particles in the plurality of particles have a non-lamellar morphology
  2. The petition materials lack any cogent analysis supporting its inherency theory and improperly attempt to shift the burden to Protiva
  3. The particle compositions and the formulation processes in the ’069 patent are NOT “the same” as those disclosed in the ’127 patent
  4. Petitioner’s alternate obviousness theory is improper under section 103(c)

Response to Ground #2:

fails to establish that the’817 PCT anticipates or, in the alternative, renders obvious claim any of the challenged claims.

Response to Ground #3:

  1. Claims 1-22 are not anticipated by the ’099 patent
  2. Petitioner’s alternate obviousness theory over the ’099 patent lacks motivation and is illogical.

Response to Ground #4:

fails to establish that the ’817 PCT, with any combination of additional reference(s), renders obvious claim any of the challenged claims.

 
05.03.2018 Original Post:

Moderna wants to use Arbutus superior LNP technology to deliver its mRNA therapeutics; but it doesn’t want to pay. So it recently filed two challenges against Arbutus’ patents (‘127 and ‘435).

It is disturbing that multiple Moderna executives (Bancel, Zaks) even lied to media repeatedly, saying that “I’m not aware of any IP that would be a concern”.

So a patent litigation is not a “concern”?

Here is my naive interpretation for the ‘127 case:

Patent litigation link

Moderna’s petition, original ‘127 patent, old ‘069 patent

Abstract:

The present invention provides novel, stable lipid particles having a non-lamellar structure and comprising one or more active agents or therapeutic agents, methods of making such lipid particles, and methods of delivering and/or administering such lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) that have a non-lamellar structure and that comprise a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.

Moderna argument #1: it’s the same old lipids (‘069)

‘127: no, it is a novel non-lamellar (non-lipid bilayer) particle, better delivery efficacy.

Moderna argument #2: non-lamellar structure is inherent to those old lipids prior art (‘069)

‘127: no, you have to find the right mix and manufacture it with the right method

Moderna argument #3: correlation between structure and delivery efficiency is obvious, so everyone will know to look at structure

Me: Meh … knowing is different than doing.

Moderna argument #4: prior art references Koltover (Ex. 1005) and/or Ewert (Ex. 1006) teach that there was a recognized potential benefit to using nucleic acid-lipid particles comprised entirely of particles with non-lamellar morphology.

Me: Meh … potential is NOT actual invention. And Moderna, you do agree that there is “benefit” in this invention.

Conclusion: ‘127 patent will stand.

Please feel free to educate me if my interpretation is wrong.

Further reading:

Are more than 90 percent of patents challenged at the PTAB defective?