2009 BIOL503 Class 5 Intellectual Property I, Part 8: Globalization Issues

Intellectual Property I: Globalization Issues CSUCI2009 BIOL503 K. Pessin

Intellectual Property I: Globalization Issues

Patent law and process harmonization

Issues: Developing or non-developed nations

India pharmaceutical patent laws

Issues: Off-shoring

Extraterritoriality of US patents

Using information ex-US for practice of US patented process

Issues: Off-shoring

Industrialized nations: Pool and standardize patent office resources to be more efficient

No harmonization yet

Patentable subject matter: life forms, medicines

Enforcement, e.g., countries which split validity from infringement

Patent office administrative proceedings to invalidate patents

Absolute novelty vs. one year grace period, U.S.

First-to-file vs. first-to-invent (U.S.)

Intellectual Property I: Globalization Issues http://www.trilateral.net/projects/biotechnology/ Trilateral Co-operation JPO, USPTO and EPO Standardize electronic information Specific projects

Intellectual Property I: Globalization Issues http://www.trilateral.net/tsr/tsr_2005/trilateral_activity.pdf Post-grant challenge instead of litigating in court

Issues: Off-shoring

Developing nations

Case study: India- are you an innovator or not?

Fish or cut bait

Intellectual Property I: Globalization Issues Field Trip

Intellectual Property I: Globalization Issues http://www.patentoffice.nic.in/ipr/patent/ipti/ipr_workshop_chennai_sep2006.pdf

India: Only new drug is patentable, not formulations

Effect: Generic improvement drugs to market sooner

http://www.patentoffice.nic.in/ipr/patent/patent_2005.pdf India sez: "We're all in for patents, except not prodrugs, derivatives, etc."

Intellectual Property I: Globalization Issues http://www.patentoffice.nic.in/ipr/patent/pat_inaug.htm Report: Law prohibiting patenting derivatives violates treaty.

Developing countries

Lack innovation infrastructure

Need innovative medical care

Compulsory licenses

Traditionally, “working requirements”

“ Work the patent” or else compulsory license

Newer - drugs

Institutional issues in developing countries

IP = low priority

Requires self-supporting IP offices, expensive

Issues: Off-shoring

Offshore manufacture

International Trade Commission

Intellectual Property I: Globalization Issues Extraterritorial weasels?

Basic rule: US Patents only enforceable in US

Law: No practicing patented process off-shore and shipping product back into US

But what about practicing patented process off shore and not shipping resulting product back into US?

Law: Can’t send all components off shore to manufacture patented product

Law: Can’t send specially adapted component off shore to practice patented process

But, what about if components aren’t tangible?

“ Component” must be tangible: ATT v. Microsoft , software isn’t a “component”

New: What about if components are only to practice a patented process?

Laitram v. Deepsouth Packing (1972)

Shrimp deveiner

Avoided infringement by splitting machine into 3 sub-assembly components, sending off-shore for foreign buyers to put together themselves

http://caselaw.lp.findlaw.com/scripts/getcase.pl?court=us&vol=406&invol=518

Response 1984:

35 USC 271(f) “closes a loophole in existing law which permitted copiers to export jobs and avoid liability by arranging for final assembly of patented machines to occur offshore . . .”

35 U.S.C. 271 Infringement of patent.

(f) (1) Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

(2) Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_271.htm

35 U.S.C. 271 Infringement of patent.

(g) Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after -

(1) it is materially changed by subsequent processes; or

(2) it becomes a trivial and nonessential component of another product.

http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_271.htm

ATT: You infringe under 35 USC 271(f)!

Microsoft: No we don’t -

( I ) Software code is an intangible string of information not a “component” as required by the statute.

( II ) Because copies of the code were used to create the infringing software/hardware combination, no physical particle that Microsoft exported actually became part of the finished product.

Object code Final computer assembled and sold overseas

Intellectual Property I: Globalization Issues http://www.supremecourtus.gov/opinions/06pdf/05-1056.pdf

Intellectual Property I: Globalization Issues http://www.computerworld.com/action/article.do?command=viewArticleBasic&articleId=9018258&source=NLT_PM&nlid=8

Exporting scientific knowledge is not an infringing act

“ -omics” Type Patents

Patent claim: Method for screening molecules

Accused activity: Method for screening practiced in Singapore, selected molecules (unpatented) shipped into U.S.

Held: Not infringement pursuant to 35 USC 271(g)

“ Thus, the process must be used directly in the manufacture of the product, and not merely as a predicate process to identify the product to be manufactured. A drug product, the characteristics of which were studied using the claimed research processes, therefore, is not a product “made by” those claimed processes. Accordingly, Housey did not state a claim of infringement by a Bayer drug product based on its asserted method claims.”

Bayer AG, et al. v. Housey Pharmaceuticals, Inc

http://www.ll.georgetown.edu/federal/judicial/fed/opinions/02opinions/02-1598.html

Intellectual Property I: Globalization Issues QUIZ

You have a patent on a specific DNA. If you E-mail the DNA sequence information off-shore, and the DNA is synthesized or isolated off shore, is that infringement?

DNA sequence DNA made