Meera Nair

Posts Tagged ‘Eli Lilly’

TPP – the untold story

In Posts on October 9, 2015 at 7:28 am

Since the agreement in principle of the TransPacific Partnership Agreement was announced this week, our media coverage has focused primarily upon its adverse impact to the dairy industry in Canada. The Federal Government was quick to respond with some reassuring details including an offer of $4.3 billion over fifteen years to ease the pain of greater competition.

But the government has yet to release the complete text of the agreement, content to indicate that it will provide more information in the next few days. Unless “more information” is comprehensive, Canadians will head to the polls on October 19, without a detailed understanding of the potential ramifications of the TPP.

At this stage, all we have is the technical summary provided by the government; among other details, the TPP apparently:

1. Includes protection from expropriation without prompt and adequate compensation.

2. Provides access to an independent international investor-state dispute settlement (ISDS) mechanism that is prompt, fair and transparent, and subject to appropriate safeguards.

3. Preserves the full rights of governments to legislate and regulate in the public interest, including for public health and environmental reasons.

The language appears intended to assure Canadian companies who invest abroad that their money and property will be safe – that statement (2) protects the integrity of (1). What the government fails to indicate is that this settlement mechanism has already seen use – directed at Canada. Brought to life through NAFTA, ISDS is a process by which foreign corporations can sue domestic governments for practices that might diminish expected profits. Moreover, these suits do not take place in a court of law, but in private tribunals.

Our government’s claim that the process by which disputes are to be settled is “prompt, fair and transparent, and subject to appropriate safeguards” is less than credible. As has already been written, ISDS disputes “are managed by a trio of corporate attorneys who rotate among the positions of advocate and judge. These tribunals are not answerable to any electorate and do not address public well-being as a court of law would do when confronted with the same dispute.”

Furthermore, our government’s claim that Canada’s right “to regulate … in public interest” is protected (said another way, we maintain our sovereignty) also strains credulity. As I noted here, in 1997 Canada retracted its own ban on a gasoline additive because of an ISDS dispute. Retracting the ban was not the only punishment meted out to Canada, the government also paid $13 million in damages, covered the opposing corporation’s legal costs, and publicly proclaimed that the additive was safe, even though our own environmental protection agency had said otherwise.

The one area where the TPP might be held at bay is in the area of tobacco law suits. It has been reported that the agreement includes a carve out against disputes from tobacco companies who object to policy measures that reduce smoking rates. (The disputes are very real; Uruguay is paying a heavy price for its worthy efforts to reduce smoking among its population.)  Sean Flynn (Washington College of Law), writes that such a carve-out “validates, rather than assuages, the concerns of those who have been criticizing ISDS systems for many years. Without express carve outs, ISDS provisions do threaten common health and safety regulations.”

The destructive nature of ISDS in existing agreements has prompted careful study and analysis. One such paper seems to have been designed expressly for the Canadian electorate; on 29 September 2015, co-authors Brook Baker (Northeastern University) and Katrina Geddes (Harvard University) posted Corporate Power Unbound: Investor-State Arbitration of IP Monopolies on Medicines – Eli Lilly v. Canada and the Trans-Pacific Partnership Agreement to the SSRN network.

Canada’s prominence is due to its dubious honour of being the first country to be targeted for patent dispute via ISDS, even though NAFTA ostensibly shielded domestic patent decisions from ISDS. Yet, we are embroiled in a $500 million challenge. This dispute began because our courts had the temerity to invalidate a patent that did not live up to expectation. Among the details provided by Baker and Geddes is that the research underpinning the patent consisted of a study of 21 patients over three weeks, with modest improvement detected in the condition of 11 patients (p.28). Baker and Geddes’ work is meticulous in its evaluation of ISDS and ought to have been compulsory reading for every member of Canada’s negotiating team.

The lone media coverage of ISDS this past week came via the Winnipeg Free Press. In an op/ed penned by Ronald Labonté and Arne Ruckert (University of Ottawa), they write: “Canada is already the most sued country in the world. It has so far lost $170 million in NAFTA cases with hundreds of millions more still pending.”

What has been most perplexing about the mania for the TPP is the insistence that Canada could not be left out. Given our experience, can Canada afford to be left in?

That the TPP might have actual trade benefit could well be true. But will the gains be large enough to compensate for the losses we will endure by throwing away our capacity to make sound policy decisions, in keeping with our own aspirations with respect to clean air, clean water, public health and safety, labour laws, or allocation of intellectual property rights?

ISDS was originally deemed a necessary measure for situations where the country involved did not have a robust, functioning system of law. Canada does not fit that bill.

So far, Canadians have been presented with a take it or leave it conceptual view of the TPP. There remains a third approach: hold out for a trade agreement that is only about trade, with the expected give and take in tariffs that is required for fruitful growth across all parties. As Labonté and Ruckert noted, Europeans are pushing back on similarly flawed agreements.

International corporations do not need to be given absolute freedom to seek unbridled profit to the detriment of public interest. Canadians have an opportunity to express their concerns to our government. And when the dust settles on October 19, if the opposition parties hold the balance of power, we can only hope that they will set aside partisan sniping and work together. Canadians deserve nothing less.

the $500 million tip of the TPP iceberg

In Posts on July 13, 2014 at 8:19 pm

Last week, international negotiators met in Ottawa to further discuss the Trans-Pacific Partnership (TPP) agreement. With the usual shroud of secrecy, few details regarding agenda and outcomes were released for public consumption. Nevertheless, based on a leaked copy of the chapter relating to intellectual property, there is sufficient reason for concern with respect to copyright. As reported last week (see Electronic Frontier Foundation here, Michael Geist here, Public Knowledge here, and VICE here) Canada’s copyright regime is likely to be challenged on at least two fronts:

  • the role of internet service providers (will they remain as neutral providers or become key figures in policing the internet?)
  • copyright duration (will Canada’s life-plus-fifty term give way to life-plus-seventy?)

Geist reminds us that the TPP will touch more than copyright; Canada’s privacy and patenting regimes are also implicated. Indeed, the question of Canadian sovereignty with respect to patenting is already at risk, via Eli Lilly’s $500 million challenge to the Canadian government regarding the loss of two secondary-use patents. The means by which Eli Lilly has launched its claim is a consequence of the Investor-State Dispute (ISD) mechanism of NAFTA.

Courtesy of Dennis Lowe and National Geographic

Courtesy of Dennis Lowe and National Geographic

Our made-in-Canada copyright regime has been painstakingly crafted over ten years of deliberative thought; to watch it cast aside will be difficult. But more deleterious will be further entrenchment of the ISD mechanism through the TPP. Yet this issue has received little attention in Canada. Perhaps in part because the topic is not sexy; Investor-State Dispute sounds painfully dull. The phrase cannot be summarily equated to freedom of expression, invasion of privacy, or even the dubious claim that a hit television series could not have been made under the TPP. ISDs are constructed with arcane language that seemingly has little to do with everyday life, but they are potentially lethal as is being demonstrated by Eli Lilly.

Eli Lilly provides the bizarre spectacle of a corporation suing a government because a court decision did not favour the corporation. It has vehemently insisted that the decision of Canadian courts not to uphold two secondary-use patents is a violation of investor safeguards provided through NAFTA; specifically, those relating to minimum standard of treatment, non-discrimination, and expropriation. That the courts rejected the patents because the drugs concerned did not live up to the standard of utility set by Canadian law, was not reasonable according to Eli Lilly. To take action against Canada required contorting the ISD chapter of NAFTA, despite the fact that the chapter in question does not apply to intellectual property. The entire event would read like a lurid novel, if novels were written about intellectual property and national sovereignty.

In a report dated to March 2013, Public Citizen provides a meticulously researched account of Eli Lilly’s actions and the operation of ISDs within trade agreements. At that time, Canada was only facing a $100 million challenge (Eli Lilly has since upped the ante); even so, Public Citizen did not miss the irony at hand:

… while Canada faces an investor-state challenge from Eli Lilly, the country has joined negotiations to establish the TPP, which would expand the investor-state system further. To date, Canada alone has paid more than $155 million to foreign investors after NAFTA investor-state attacks on energy, timber, land use and toxics policies. Underlying Eli Lilly’s claim against Canada is the notion that government patent policies and actions are subject to the investor privileges provisions of the agreement.

Public Citizen observes that Eli Lilly’s actions marks the first occasion of an intellectual property challenge occurring under the auspices of NAFTA’s ISD provisions. Our previous “first”, the first challenge of any kind, does not offer much comfort, resulting as it did in a loss both monetarily and for public health. Briefly, in 1997 a ban on the gasoline additive MMT was repealed by the Canadian government in response to opposition by Ethyl Corporation, the American producer of the additive. At the time, Public Citizen wrote:

The Canadian government settled the NAFTA suit yesterday agreeing to pay Ethyl $13 million in damages and to cover the company’s legal costs. It will also proclaim publicly that MMT is “safe” in direct contradiction of the view of its national environmental protection agency.

With respect to Eli Lilly’s present action, Michael Geist and E. Richard Gold (Professor, Faculty of Law, McGill University) have both indicated that the corporation’s chances of winning are slim. Notably, in a briefing session recently held in Washington DC, Gold indicates that “… no competent tribunal could rule in Eli Lilly’s favor”. We can only hope that both Geist and Gold are correct. But competence might prove a relative term; so far, arbitration tribunals have not distinguished themselves in weighing public interest (as a domestic court of law would) into the decision-making process. (Public Citizen has thoroughly documented past arbitration decisions, with added detail for some of the more egregious outcomes.) Moreover, even if Canada secures a win, that does not necessarily exclude involvement in costs.

The Washington DC briefing session was hosted by the firm of Stern, Kessler, Goldstein and Fox on 5 June 2014, with all the presentations posted online. I am hard pressed to choose a favorite but Simon Lester (Trade Policy Analyst, Cato Institute) raises the issue of Canada’s increasing involvement with ISDs. Despite some indication from the Canadian government that CETA (the impending trade deal with the European Union) will mitigate the ISD risks, Lester notes that Canada is simply trying to “tweak the language” to ensure that court decisions cannot be challenged. “…  what I have seen written is that the only changes are that no claims can be made under expropriation, but there are more avenues [of claim]… the slight tweaks that Canada wants to make are probably not enough.”

If the Canadian government is not decisively protecting sovereignty within a bilateral trade negotiation, it is unlikely that we will do better in the multi-national forum of the TPP.

There is much more that could and should be written about ISDs but, for now, Lester shall have the last word. In his presentation, he asks an important question: “Normally, the Supreme Court gets the final word. But apparently, there’s an international court system above the domestic Supreme Court system.  … Is everybody okay with that?”

 

 

 

 

 

the bad, the good and the expensive

In Posts on February 5, 2013 at 2:29 pm

A persistent cold has sidelined me for a few days; reading is the silver lining.

the bad

InfoJustice’s latest bulletin provides details of Eli Lilly’s challenge to Canada’s patenting system. Eli Lilly’s patent for Strattera, a drug used to treat ADHD, was invalidated by Canadian courts on the grounds that the drug did not live up to expectations. Eli Lilly is pressing their claim via NAFTA, which allows multinational corporations to seek compensation from Canadian taxpayers.

“Invention” is defined as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.”  Eli Lilly complains  that:

In a series of decisions issued since 2005, the Federal Court of Canada and the Federal Court of Appeal have created a new judicial doctrine whereby utility is assessed not by reference to the requirement in the Patent Act that an invention be “useful”, but rather against the “promise” that the courts derive from the patent specification. This nonstatutory “promise doctrine” is not applied in any other jurisdiction in the world.

If the Federal Courts do not construe a promise from the patent, the statutory requirement for utility that historically required only a “scintilla of utility” applies. However, if the Federal Courts derive a “promise” from the patent specification (for example, to treat a human disease with fewer side effects) then utility is measured against that promise, and the patentee is required to prove that it had demonstrated or soundly predicted the promised result as of the date the patent was filed (paras 37-38).

Eli Lilly insists that such a standard violates Canada’s international obligations and creates a climate of “uncertainty and unpredictability”:

A patentee cannot know how the promise will be construed by the Federal Courts. Some Justices have looked only to the claims to derive the promise, other Justices have derived a promise from statements made within the patent disclosure, while others have “implied” a promise from the nature of the disease treated by the invention (para 43).

While the company laments the seeming capriciousness of our Judges, readers are likely to understand that different drugs in different circumstances may very well entail different perspectives. The timing (beginning in 2005) is interesting, coming as it does after 2004 when our Supreme Court emphasized the importance of a case by case analysis of  questions of fair dealing v. infringement. “Uncertainty and unpredictability” are the better byproducts of an information society, far better than the certainty of poor consumer satisfaction that comes when international corporations are able to monopolize market places.

InfoJustice’s bulletin draws from Public Citizen’s Global Trade Watch which gives the full story of Eli Lilly’s “inventive interpretation” of our trade agreements and makes plain how dangerous these proceedings are in matters of overall access to medicines. Public Citizen concludes with:

The outcome of Eli Lilly’s investor-state attack under NAFTA is critical for those seeking to safeguard countries’ ability to determine the patent standards they believe serve the public interest in access to affordable medicines. It is critical not just to protect Canada’s prerogative to end patents found to not deliver promised results, but to avoid instilling other governments with fear of investor-state reprisal for similar policies to rein in medicine costs. It is critical not just so that Canadian taxpayers can ensure that the demanded $100 million goes to more worthy ends than enhancing Eli Lilly’s profit margin, but to avoid emboldening other pharmaceutical firms contemplating the launch of similar investor-state demands against other governments seeking to balance the rights of consumers and pharmaceutical firms. As the Eli Lilly case gets under way, negotiations for the TPP and its proposed expansion of the investor-state system continue. Stopping the NAFTA expansion deal presents health advocates with today’s biggest opportunity to halt the advance of the system that empowered Eli Lilly’s audacious threat.

the good

Writing for the New Yorker, Columbia law professor Tim Wu describes a fascinating story about an indie film “surreptiously shot inside of Disney World.”  Wu refutes assertions that the filming violated intellectual property rights; fair use and social commentary feature prominently in his explanation. Spoiler alert: the full plot of the story is given so if you are inclined to see a movie where “Disney World is not as simple window dressing [but transformed] into something gruesome and disturbing,” then you may not wish to read Wu’s article.

the expensive

Writing for the Globe and Mail, Frances Bula reports that TED is coming to Vancouver for 2014-2015. The Tourism Commission of British Columbia hopes that the presence of TED will further position Vancouver as an internationally recognized site of creative thinking. Tickets to TED events run at $7,500.00; I hope that some effort is made to include Vancouver’s high-school teachers in the audience — they are among the first to encourage future creators.

Update: February 7, 2013.  More on TED in Vancouver; by Mike Chisholm writing for the Vancouver Observer.

Update July 23, 2013. Glenn Moody, writing for Techdirt, gives the news that Eli Lilly is now claiming $500 million in damages from Canada.  “What’s troubling is that similar [investor-state dispute settlement] schemes are being negotiated for both TPP  and TAFTA/TTIP.  That will give corporations even more opportunities to sue nations for supposed “expropriation”, and to challenge perfectly legitimate local laws that dare to stand in the way of bigger profits.”