I entered the program hoping for a chance to experience practicing intellectual property law as in-house counsel. I hoped to get an opportunity to see how a large company approaches intellectual property; how it views the patent regime, what aspects it considers helpful and harmful, and especially how a large corporate structure adjusts to changes and opportunities afforded by that regime. I was not disappointed.

Most of my time at Teva was directed towards writing reports on the validity of brand pharmaceutical patents. One of the main tasks of the Patent Strategy Group at Teva is to decide which patents might be successfully challenged in court. Successful challenges of current patents often allow Teva to bring generic products to market significantly earlier than would otherwise be possible. In addition to being allowed on the market earlier than otherwise would be possible, the way in which the operate means that Teva may also be able to enter the market as the sole generic pharmaceutical company. Being the first generic company on the market allows Teva to capture a large portion of the generic market, and to hold onto this market share even after other generic companies begin marketing.

In addition, I worked on several of the practical aspects of bringing together the required documentation in preparation for litigation, particularly litigation around damages claimed under section 8 of the Patented Medicines Regulations. Through the process of finding, bringing together, and summarizing documents I was able to get an idea of the amount of effort and cost involved in preparing for pharmaceutical litigation.

I was also able to spend some time working with the corporate law group. This experience allowed me to see the practical side of how a large company like Teva operates. In particular, this allowed me to see the many contracts, agreements, and corporate interactions that underpin the smooth operations of a large pharmaceutical company as it carries out its business operations and takes advantage of the opportunities afforded to it by intellectual property litigation.

I thoroughly enjoyed my time interning at Teva Canada; both the mentoring and the practical experience provided great insight into the operations of such a significant participant in Canada’s Intellectual Property system.

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Defining orphan drugs

Orphan drugs are medicines created to treat rare diseases; diseases that affect a relatively small number of patients.

Although the number of people affected by each disease is small, the combined effect of rare diseases is large. Combined, rare disease affect an estimated , though this number depends on .

Difficulties with the traditional approval process

The small affected population leads to two main impediments to drug availability. The first is the low expected profitability of the drug; due to a small potential market, and the second is difficulties in obtaining regulatory approval; due to difficulties in completing clinical testing with a small pool of potential test subjects.

The US ODA-style solution

To deal with these issues, have developed specialized orphan drug frameworks in addition to their regular drug frameworks. These orphan drug frameworks are designed to speed up and simplify orphan drug approvals. Typically, these frameworks involve incentives government funding for research and clinical trials, tax credits, and time-limited exclusive marketing rights. More recently, solutions like between countries have also been implemented.

The current Canadian approach to orphan drugs

Despite the popularity of these frameworks, up to this point “”. The lack of a process where incentives outweigh difficulties means many orphan drugs are not approved, and patients must apply for access on a case by case basis; a process which can be slow and inefficient.

Concerns with US ODA-style frameworks

This lack of an ODRF is about to change however, and as this framework is developed, policymakers will need to decide whether or not they wish to follow the US ODA. The US ODA, although as an example of an excellent regulatory innovation, and one that has been followed in several other jurisdictions, is not without criticism. Two criticisms in particular will be considered as examples.

The first is that as medicines become more specialized, they necessarily target smaller population groups. This leads to more and more drugs that qualify for ‘orphan drug’ incentives. For example, “”. This can lead to a system of rising healthcare costs due to marketing exclusivities and other extra protections.

The is that incentivizing orphan drugs leads to a situation where spending a large amount of taxpayer money results in only a very small number of patents eventually being granted. As governments pay for unsuccessful clinical trials, through grants or tax breaks, the ‘overhead’ costs of approved drugs becomes very high; which could contribute to rising health care costs?

Suggestions for a Canadian ODRF

These criticisms of a US ODA-style framework can be easily addressed, even ‘side-stepped’, in a Canadian ODRF. In many cases costs like those exemplified above stem from the two part purpose of the framework; to incentivize companies to seek drug approvals but also to into orphan drugs. However, this second goal is arguably of negligible importance in Canada due to the research and development work here. Therefore, the desired value of an orphan drug framework is limited to speeding up the Health Canada approval of drugs developed in other countries; and this does not require US ODA-style incentives – merely a matching of the Canadian system with the American and European systems; a combined approval process.

As policy makers continue to develop a Canadian orphan drug framework, they would do well to limit protection to that needed to secure the desired value; increased drug approval, not increased drug research.

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