Sunday, May 04, 2008

IP without IP part 4

Session IV: At the Boundaries of IP (II): Between Tangible and Intangible Property

Cori Hayden & Alain Pottage

Pottage: Like software, norms need their own kind of maintenance.

In plant patents, courts initially required evidence that a cutting had come from a particular plant. Why was this problematic? It was a failure of normative production—an inability to incorporate a particular kind of industrial product within the patent scheme. There was a failure of description, highlighting the problems of the tangible/intangible divide and the ways in which IP doesn’t fit into either category. The plant right is in something that exists as a platonic ideal and that can be fixed in any number of instances without being used up.

Recent example: the automation of IP, in which the right is written into the genetic template. When you reproduce the thing you reproduce the right. Law is transcribed into new (old) media, in this case, biological media. This breaks down the distinctions on which patent law depends.

Hayden: She is also interested in how distinctions become materialized through law. Often we fetishize the notion of creativity or innovation as the goal of IP. We can also define what IP does by saying that IP, particularly patents, tells us what a copy is, and gives us the line between a proper copy and an improper copy.

There was a major Mexican initiative to increase the use among consumers and prescriptions by physicians of generic drugs. There are a number of copied drugs on the Mexican market that are all legal in that they don’t infringe. They’re defined against the original, but also in relation to each other: Generic; interchangeable generic; branded generic; similars. Generic and interchangeable generic are different in Mexico—different proofs of equivalence (chemically v. biologically equivalent). Branded generic has someone’s TM. Similars are a commercially popular category with no regulatory equivalent; what they are is hard to pin down—the generics sold by a popular pharmacy, Farmacias Similares. They popularized the notion that you can buy a cheaper substitute for a well-known drug.

But FS lost control of the semiotics of similarity and substitutability. The narrative: “It’s the same, but …” FS slogan: “the same, but cheaper.” A different slogan: “the same substance, but cheaper.” Another: “it is equal, but more economic.” Replicating the drug and the syntax. There is repeated use of “similares” as a term for the local pharmacy, whereas FS is “Simi.” What similarity means is highly contested, both commercially and by regulators. Side effect: FS declares there are only three types of drugs—innovators, interchangeable generics, and generics—it advertises that “similars” don’t exist. There is a battle to establish which is a “good” copy, not legally but in terms of quality.

The government is setting up as interchangeable generics as the only proper standard—bioequivalence, not just chemical equivalence. Similars always fall to the bottom of the contest for the best copy, even though similars don’t exist and even though they’re always one of the other kinds of copies as well as being similar.

(Comment: This is not a Mexican issue alone. There is a huge battle in the US over exactly the same debates for drugs where, for one reason or another, the generic versions didn’t follow the modern ANDA procedure.)

Debate in Europe and US over whether exact copies of biologics are possible when the biologics go off-patent. Thus we get a parade of terms to talk about the thing that is made after the patent expires: biosimilar, biogeneric, follow-on protein, follow-on biologic.

What does it mean to think about similarity as a mark of distinction—a mark you want to distance yourself from/a mark you want to achieve? Similarity is then not a mark of innovation, but of sameness. (Sweat of the brow? Reminds me of the skill debate over Bridgeman v. Corel.)

Generic is usually treated as a term that means lack of difference, but all sorts of differences are appearing at the moment a drug becomes “generic.”

Coombe: Hayden has shown that there is no such thing as the undifferentiated public sphere—there are major hierarchies of value. This is an opportunity for branding. The IP impetus is strong; this is not a place of freedom but of different constraints.

And then I had to leave. Thanks so much to the conference organizers!

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