January 2, 2012

Property Rights

The importance of intellectual property ("IP") to a company (and its value, and valuation) can be both overstated and understated, often at the same time.

It is well understood that IP is an important component of a company's valuation (a contributor to sustaining competitive value). Often, the IP is the cornerstone. Other times, it merely is a key block or brick of the company's foundation.

The company's IP portfolio is robust. You should peruse it. In particular, management's near composition of matter patent is noteworthy and, I believe, and important contributor to enterprise value.

The recognition of that value might be made by the markets and investors in the near-term, or by the acquirer (or licensee) in the long-term.

Dr. Ross' discussion, towards the end of his presentation, about combination therapies got me to thinking about protecting one's IP related to one's drug (and active ingredient) and the patenting process related to combination therapies.

Company ABC files patents for combinations because it (a) prevents other companies from controlling the  marketing of ABC's drug in such combinations and (b) provides, in some cases, an opportunity for patent extension; for example, if ABC's drug A is combined with company XYZ's drug X as a new product. The primary value is (a) above, which allows a marketing push to expand application to other indications without relying on a third party to detail the market.

Thus, company ABC would (should) file a combination therapy patent for the combination of drug A with drugs (or classes of agents) B, C, D...n (i.e., math speak for all drugs). A good example of such a combination therapy patent is WO 2010/014784 A2, BMS' Combination of Anti-CTLA4 Antibody with Diverse Therapeutic Regimens for the Synergistic Treatment of Proliferative Diseases patent.

Now, what happens if ABC neglects to include drug {n+1}?

Nothing, because generic disclosure and claims should extend coverage to {n+1}, or at least prevent another the company that developed {n+1} from claiming the (A, {n+1}) combination due to obviousness. The {n+1} owner has trouble claiming (A, {n+1}) due to this obviousness, unless they can show a highly unanticipated advantage. So, it is generally possible for company ABC to add drug {n+1} later, as a continuation of the original patent application, while it is hard for the {n+1} owner to do this due to the obviousness issue.

Omitting drug {n+1} potentially is relevant if {n+1} is unrelated to B...n; for example, drug {n+1} belongs to a new class of agent or has a highly unanticipated advantage.

New class of agent? Yes: chemoablative immunotherapeutic. Here.

Highly unanticipated advantage? Yes: Craig's views on why combination therapies (e.g., PV-10 + radiotherapy, PV-10 + ipilimumab, PV-10 + dacarbazine) seem to work dramatically better, particularly on late stage patients with severe affliction, because of the addition of PV-10 and his hypothesis of its impact on the immune system in order to more effectively leverage the other therapy. Here.

Did BMS omit PV-10 from their combination patent for ipi? Yes.

Did other companies make the same omission? Yes. A sampling: Vical's Allovectin-7 and BioVex's (Amgen's) OncoVEX, among others.

Take a read of these patents, and you'll see.

Smart cookies, those Knoxville folks. What combination therapy patents have they filed?

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