AMGN v. Sanofi Ab Patent Case - What Biotech Investors Should Know
- BPIQ
- Mar 28, 2023
- 3 min read
Amgen v. Sanofi Sup Ct. oral arguments took place yesterday in the ongoing PCSK9* antibody (Ab) patent case. See the attached transcript and FIG. 1.
Who won the oral arguments? Verdict?
Although it's hard to predict the outcome of the case from the oral arguments, I give the advantage in the orals to Sanofi
Some of the Sup Ct justices don't like that AMGN's patent covers millions of antibodies (Abs) and only discloses 26 Abs
And the fact that there is no structure, only functional language in the AMGN patent claims, doesn't help**
Although some of the details of the lower appellate court panel's analysis was likely flawed, the basic law on "enablement", the issue on appeal now, probably still works well enough without the Supreme Ct stepping in here
And it didn't help AMGN that the U.S. govt argued in support of Sanofi
FIG.1 Front page of 1 of the patents in suit
Even if AMGN wins at the Sup Ct, it likely still loses this case
AMGN lost this case in the lower courts
And even if AMGN wins at the Sup Ct. on this "enablement" issue, the case goes back to lower courts and AMGN still needs to win on "enablement" after the facts are applied to a clarified enablement std
And then AMGN needs to have the district court's ruling on the related "written description" requirement overturned
If Sanofi wins, AMGN's patents in suit are dead and the case is over
Why should biotech investors care about this case, even if they don't invest in AMGN or Sanofi?
It affects the value of many biotech patents, and thus, many biotech companies
Does this case kill the value of most/all biotech companies?
I don't think so
The appeal relates to the enablement requirement
But we've been dealing with a similar issue for biotech patents for decades based on the related "written description" requirement
And although its been a tough few years for biotech stock values, that is not because of patent law
And many biotech companies still have a lot of value (e.g. multi-billion dollar valuations)
Some types of biotech companies are affected positively and some negatively depending on the outcome of this case
Either outcome might affect the value of your favorite biotech stock in a positive or negative way
That's why many biotech companies took a position on one side or the other as amici - "friends of the court"
As Justice Gorsuch commented "I've got so many friends, I can hardly stand it"
Which companies benefit from these cases? See even more info as a paid subscriber HERE.
*For helpful background on PCSK9 technology, see this Cleveland Clinic web page;
**Representative claim of 1 of the AMGN patents in suit:
1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.
This article is not legal, investment, or tax advice. No views in this article are relevant to the views of the clients of Double Helix Law
Article 1st published 3/28/23 EJV
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