Michael Geist

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Laboratory by Derek Bruff (CC BY-NC 2.0) https://flic.kr/p/ieiWeh

Access Copyright Demands Higher Royalties Due to Education Investment in Technology

When the Supreme Court of Canada issued its SODRAC v. CBC decision last fall, critics warned that the decision may be anti-technology. The majority of the court ruling included a paragraph in which it suggested that users that invest in new technologies may be required to share some of the benefits with copyright holders:

Where the user of one technology derives greater value from the use of reproductions of copyright protected work than another user using reproductions of the copyright protected work in a different technology, technological neutrality will imply that the copyright holder should be entitled to a larger royalty from the user who obtains such greater value. Simply put, it would not be technologically neutral to treat these two technologies as if they were deriving the same value from the reproductions.

The danger with the decision should be immediately obvious as it creates disincentives to invest in new technologies. I argued in a post on the decision:

January 19, 2016 — 1 comment — News

Please! By Josh Hallett (CC-BY 2.0) https://flic.kr/p/yALRk

The Trouble with the TPP, Day 11: Weak Privacy Standards

The Trouble with the TPP continues this week with a series of posts on the TPP and privacy (prior posts include Day 1: US Blocks Balancing Provisions, Day 2: Locking in Digital Locks, Day 3: Copyright Term Extension, Day 4: Copyright Notice and Takedown Rules, Day 5: Rights Holders “Shall” vs. Users “May”, Day 6: Price of Entry, Day 7: Patent Term Extensions, Day 8: Locking in Biologics Protection, Day 9: Limits on Medical Devices and Pharma Data Collection, Day 10: Criminalization of Trade Secret Law). The inclusion of privacy within the TPP has been touted by governments as one of the benefits of the agreement, but the privacy provisions are so weak as to move global privacy backwards, weakening emerging international standards and locking countries into rules that restrict their ability to establish additional privacy safeguards.

While some have questioned the concerns associated with privacy and the TPP by arguing that it is it a trade agreement, not a privacy treaty, the reality is that the commercial importance of big data has never been greater. Indeed, it is odd to see some emphasize the importance of increased, harmonized intellectual property protections but simultaneously express satisfaction with bare minimum privacy protections that provide companies with a patchwork of rules and consumers without standardized protections. Personal information is a critical part of e-commerce and the need for public confidence in privacy protections alongside corporate certainty about their rights and obligations with the personal information they collect should be beyond debate.

January 18, 2016 — 3 comments — News

"SECRET" stamp by Alex Wellerstein (CC BY 2.0) https://flic.kr/p/aCJZrf

The Trouble with the TPP, Day 10: Criminalization of Trade Secret Law

The Trouble with the TPP series continues with a surprising and troubling aspect of the intellectual property chapter: the criminalization of trade secret law (prior posts include Day 1: US Blocks Balancing Provisions, Day 2: Locking in Digital Locks, Day 3: Copyright Term Extension, Day 4: Copyright Notice and Takedown Rules, Day 5: Rights Holders “Shall” vs. Users “May”, Day 6: Price of Entry, Day 7: Patent Term Extensions, Day 8: Locking in Biologics Protection, Day 9: Limits on Medical Devices and Pharma Data Collection). The trade secret issue was flagged by Professor Dan Breznitz of the Munk School of Global Affairs in a column in the Globe and Mail late last year. While some have tried to downplay the issue, the reality is that the TPP represents a radical shift on trade secrets law for most participating countries, who can expect years of pressure to gradually expand the scope of criminal penalties for trade secret violations.

January 15, 2016 — 4 comments — News

Stethescope by Dan Wiedbrauk (CC BY-ND 2.0) https://flic.kr/p/mTmYTX

The Trouble with the TPP, Day 9: Limits on Medical Devices and Pharma Data Collection

The link between health care and the TPP’s intellectual property chapter is easy to spot, but there are other chapters with implications for the issue. The Trouble with the TPP series today considers Chapter 8, which covers Technical Barriers to Trade (TBT). The chapter contains some surprising restrictions on the ability for national regulators to require the disclosure of certain information as part of the regulatory review process for pharmaceutical products and medical devices (prior posts include Day 1: US Blocks Balancing Provisions, Day 2: Locking in Digital Locks, Day 3: Copyright Term Extension, Day 4: Copyright Notice and Takedown Rules, Day 5: Rights Holders “Shall” vs. Users “May”, Day 6: Price of Entry, Day 7: Patent Term Extensions, Day 8: Locking in Biologics Protection).

The Canadian government summary of the TBT chapter does not disclose that there are data collection restrictions. In fact, the only reference to the issue states that the chapter “improves regulatory transparency in the areas of cosmetics, medical devices, and pharmaceutical products.” Yet the chapter does far more than address regulatory transparency. For example, Annex 8-C 7bis requires each party to makes its determination on whether to grant marketing authorization for a specific pharmaceutical product on the basis on factors such as clinical data, manufacturing quality, and labelling information. However, it also states that:

January 14, 2016 — 4 comments — News

Enbrel by Nicole Mays (CC BY-NC 2.0) https://flic.kr/p/FDzpx

The Trouble with the TPP, Day 8: Locking In Biologics Protection

As the TPP negotiations reached their conclusion in Atlanta last October, one outstanding issue stood above all others: protection for biologics. While not well understood by the public, at issue was billions of dollars and access to cutting edge medicines. The Trouble with the TPP series examines the outcome of the biologics issue and argues that even with less protection than the U.S. advocated, the TPP’s requirements still represent a significant problem for global health (prior posts include Day 1: US Blocks Balancing Provisions, Day 2: Locking in Digital Locks, Day 3: Copyright Term Extension, Day 4: Copyright Notice and Takedown Rules, Day 5: Rights Holders “Shall” vs. Users “May”, Day 6: Price of Entry, Day 7: Patent Term Extensions).

Biological drugs are pharmaceuticals involving complex molecules or mixtures of molecules that are made of biological sources manufactured within a living system. They differ from conventional drugs that are manufactured by combining chemical ingredients. Building on greater knowledge of genetics and cell processes, the area represents a major growth area for the pharmaceutical industry. With the complexity comes cost, however, with biological drugs far more expensive than conventional ones. Much like the generic pharmaceutical industry creates cheaper, generic versions of chemical drugs, companies have begun to create “biosimilars” as cheaper versions of biological drugs, relying on data from clinical trials to formulate the alternative. Pharmaceutical companies have therefore sought protection for the clinical data.

January 13, 2016 — 3 comments — News