One of the most interesting aspects of working at AstraZeneca Canada was having a front row seat to the development of issues currently facing the pharmaceutical industry. In law school I found students were more accustomed to learning about something that had already happened - waiting for a decision to be released or legislation to be updated. However, at AstraZeneca I was able to work in areas where live debate was still taking place. While at AstraZeneca Canada I had the chance to see the AstraZeneca Legal Affairs team, in conjunction with external counsel, submit an application for to the Supreme Court of Canada in a case concerning the utility requirement in patent law. Additionally, I was able to work with the government affairs department in crafting policy statements concerning issues from the with the European Union such as patent term restoration, an innovator right of appeal in PM(NOC) proceedings and data protection as well as the implementation of a set of proposed for pharmaceutical patent litigation settlements.

As understanding the different facets of AstraZeneca's business was an important part of my internship, my placement supervisor arranged for me to go on several "field trips" and to meet with employees from different departments each week so I could learn about their role at the company. For example, one day we went on a tour of AstraZeneca Canada's distribution facility where all their pharmaceutical products are stored and shipped. The guide taught us about what happens when product is returned, when product expires and when, for whatever reason, the product is shipped or stored outside the ideal conditions. While at first glance this may seem far removed from intellectual property law, the next week we attended an examination for discovery where these types of questions came up. After spending time with employees from government affairs, regulatory, and marketing I began to see how all of the various departments came together to carry out the company's goals and to learn about the legal issues they might face on a day-to-day basis. In particular, one of the projects I worked on was updating and redesigning the internal AstraZeneca Canada Legal Affairs website. This gave me some insight into what issues AstraZeneca employees from other departments might seek out the advice of legal affairs for - including what to do if they received an access to information request or how to make sure they were compliant with Canadian Anti-Spam Legislation.

Overall, my experience at AstraZeneca Canada was a very positive one. While my internship was certainly instructive, I also had a lot of fun! I was able to attend a product launch for DUAKLIR GENUAIR, several turkey dinners and a clinic offering AstraZeneca's FluMist product, an intranasal flu vaccine. (While it might be a stretch classifying the latter as fun, it was certainly more enjoyable than the flu shot alternative!) The Legal Affairs team was very welcoming and I am grateful to them for taking the time to teach me about some of the work they are involved in. Participating in the Intellectual Property Law and Technology Intensive Program was one of the highlights of my law school experience. It was a rare chance to become involved in the practical, as opposed to the academic, aspect of intellectual property law and it provided a perspective that was different from both the classroom and working at a law firm as a summer student.

Corey McClary is a JD Candidate at Osgoode Hall Law School and was enrolled in Osgoode’s Intellectual Property Law and Technology Intensive Program. As part of the program requirements, students were asked to write a reflective blog on their internship experience.

The post IP Intensive: A Semester at AstraZeneca Canada appeared first on IPOsgoode.

The validity of a patent can be challenged on the basis of double patenting. In , the Supreme Court noted that there were two branches of this doctrine. "Same invention"-type double patenting [4] asks whether the claims of the later patent are "identical or co-terminus" to an earlier patent, while "obviousness"-type double patenting asks whether a person skilled in the art would find the claims "patentably distinct". Earlier this year, two different federal court judges addressed allegations that Eli Lilly's was invalid due to double patenting of the invention in the earlier . ( [5] and [6]). While both justices ruled in favor of Eli Lilly, they disagreed on the “appropriate date” at which the common general knowledge of a person skilled in the art should be assessed in order to undertake an obviousness-type double patenting analysis.

Both the '377 patent and the '784 patent relate to the compound tadalafil, which is now marketed by Eli Lilly under the brand name CIALIS and used in the treatment of erectile dysfunction (ED). However, it was not always known that tadalafil had such interesting uses, and the compound was initially developed as a treatment for disorders such as hypertension. Both Justice Gleason (Apotex-Tadalafil) and Justice de Montigny (Mylan-Tadalafil) agreed on the construction of the relevant claims in the '377 Patent (a claim for one compound, tadalafil, as a PDE V inhibitor) and in the '784 Patent (a claim for tadalafil as a PDE V inhibitor to treat ED). PDE V is an enzyme which catalyzes a chemical reaction that consumes a chemical that is responsible for, among other things, maintaining an erection. Tadalafil blocks this enzyme from functioning and thereby prevents the loss of an erection.

If, as of the "appropriate date", a person skilled in the art would have known that a PDE V inhibitor could be used to treat ED, then the two inventions would not be patently distinct and the '784 patent would be invalid for obviousness-type double patenting. The Court therefore needed to answer the question of what "appropriate date" should be used in the assessment.

In Mylan-Tadalafil the judge held that the "appropriate date" was the priority date of the earlier patent (January 21, 1994). At this point the evidence showed that the skilled person, although aware of the role of PDE V in cardiovascular disorders, would not have known about its role in erectile dysfunction. De Montigny rejected the priority date of the later patent (July 14, 1995) as the "appropriate date" for two reasons. First, such an analysis would simply become a question of whether the second patent was [7] without the patentee being able to rely on the one-year applicant disclosure grace period.[8] Second, when considering "obviousness"-type double patenting, the question is whether the later patent "disclose[s] novelty or ingenuity" over the earlier patent. If it does, then a second patent is justified.

However, in Apotex-Tadalafil justice Gleason found there was a "sound argument" for the selection of the priority date of the second patent (July 14, 1995) as the "appropriate date". Choosing the later date would guard against a patentee abusing the between filing a patent application and it becoming available to the public. If the common general knowledge were to develop in such a way as to suggest an additional use for the patented compound (in conjunction with the confidential information in the patent application) the patentee would have the advantage of filing a second patent that would have been obvious had the 18 month delay not been in place.

In the end, the issue became moot as the only piece of prior art published between the two dates (the '902 application above) turned out not to be relevant. However, if the issue were to be decided, I find the reasoning of Justice de Montigny more compelling. While the scenario described by Justice Gleason could occur, the patentee would run the risk of a competitor independently discovering the information in the first patent and filing an application for the new use themselves.

[1] Pioneer Hi-Bred Ltd v Canada (Commissioner of Patents), [1989] 1 SCR 1623.
[2] Patent Act, RSC, 1985, c P-4 s. 42.
[3] Whirlpool Corp v Camco Inc, 2000 SCC 67 at para 63. [Whirlpool]
[4] Whirlpool, at paras 64-65.
[5] Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC, 2015 FC 17. [Mylan-Tadalafil]
[6] Eli Lilly Canada Inc v Apotex Inc, 2015 FC 875. [Apotex-Tadalafil]��������������������������
[7] Patent Act, RSC, 1985, c P-4 s. 28.3. For the Supreme Court of Canada's approach to the non-obviousness requirement for a patent see Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61.
[8] Patent Act, RSC, 1985, c P-4 s. 28.3(a). For a summary of the one-year grace period for applicant disclosure see .

The post The Not-So-Obvious Aspects of an Obviousness-Type Double Patenting Analysis appeared first on IPOsgoode.

In previous cases, Monsanto's patents concerned a GM crop in which the plant's DNA had been modified using genetic engineering to introduce a novel trait not naturally expressed in the species. While it has been established that the extraneous genes��introduced into the plants are patentable, plants��themselves are generally not. Recently, with the aid of technology, Monsanto has been breeding "" naturally with properties almost as wondrous as the GM crops. If these plants are not��patentable, what intellectual property rights protect the investment the breeder has made in developing new plant varieties?

Monsanto is best known for changing the way the world grows food. The company is the leading producer of genetically engineered seeds of commodity crops such��as corn and soybeans. By inserting new DNA into an organism’s genome, plants can be endowed with characteristics not��typically observed in nature. Of particular note are Monsanto's crops which are resistant to the herbicide glycophosphate. In order to protect the research and development required to produce such GM organisms, farmers planting GM crops are required to enter into a contract with Monsanto agreeing that they will not save and replant seeds produced from the GM seeds purchased from Monsanto. Monsanto's patents grant the company the exclusive rights��for the��use of��their invention thereby preventing third-parties who have not signed a contract from acquiring GM seeds and planting them.�� ����

However, Monsanto's latest line of produce have been developed the old fashioned way... sort of. produces 2-3 times the phytonutrients of normal varieties, the contains fewer tear-inducing chemicals, and tastes sweeter and has improved nutritional content. However, despite their unusual properties, none of these products have been genetically engineered. Using the technique of (MAS), researchers were able to identify genes that led to desirable traits and then bred plants with these characteristics. By scanning the DNA of the resultant seeds, the technique allows for the determination of whether a seed will grow into a plant having the desired property without having to wait. This greatly increases the speed at which plants with the desirable traits can be bred and the number and variety of traits that can be introduced. What may have taken countless generations to occur in nature, if it were to ever occur at all, can be accomplished in a matter of years using MAS.

However, as the plants have been bred "naturally" and have not been genetically engineered, they��are not patentable in the same way as GM crops could be.��In Pioneer Hi-Bred Ltd v Commissioner of Patents^[1],��Marceau J. held that the terms "manufacture" and "composition of matter" as�� used in the definition of "invention" in s. 2 of the "would be distorted if a unique but simple variety of soybean were to be included within their��scope"��and as such "the soybean variety developed by the appellant cannot be the subject-matter of a patent of invention."��A contract with a farmer may prevent that farmer from planting subsequent generations of seeds, but what is to stop a third-party from acquiring a seed and taking advantage of Monsanto's extensive investment in research?

Member countries of the World Trade Organization are required to provide a minimum standard of intellectual property protection as outlined in the (TRIPs). Article 27(3)(b) allows a member to exclude from patentability plants and biological processes for the production of plants. However, the same provision requires members to provide protection for plant varieties either through patents or a sui generis rights system. In addition, the (UPOV) requires members to provide an intellectual property right specifically for plant varieties. Collectively these rights are referred to as Plant Breeders Rights (PBR). In the United States the grants exclusive control over sexually reproduced plant varieties and the legal protection of PBR in Canada are set out by the and .


In order to qualify for protection under the Plant Breeders' Rights Act, a plant must be new, identifiable and distinguishable from other varieties (distinct), stable after repeated propagation and have homogenous features after sexual reproduction. These rights provide the holder the exclusive right to sell and propagate the plant variety in Canada for a period of up to eighteen years.����While Plant Breeders' Rights offer a method to protect the intellectual property of plant varieties in Canada, they��come with some exemptions. For example, of the Plant Breeder's Rights Act stipulates that a compulsory licence for the use of a plant variety can be granted to persons that��apply. Article��15(2) of the 1991 ��convention provides an (optional) exception to Breeder's rights where a farmer may��collect seeds of the protected plant variety from a harvest and use them to plant future crops.����


While indiviudal plant varieties may not be patentable, there is still some debate whether plants or plant material other than plant varieties are patentable. Plant Bioscience Ltd. was granted a patent for a "" but the MAS��method was later found to be an "" which is excluded from patentability.��Currently, the is deciding whether the of such processes are patentable.��Although I would argue that Monsanto's "supperveggies" are certainly innovative and represent a significant investment in research, its seems that for now they won't be afforded the same protection as their GM counterparts.

Corey McClary is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.

^[1]��Pioneer Hi-Bred Ltd v Commissioner of Patents, [1987] 3 FC 8 at paras 9-11 (FCA).

The post Intellectual Property Rights in Non-Genetically Engineered Plant Species appeared first on IPOsgoode.

Telmisartan is a pharmaceutical used in the management of hypertension. It is marketed under the trade name Micardis, but several generic versions are also available. In an effort to obtain a Notice of Compliance and market its generic version of Micardis, Apo-Telmisartan, Apotex submitted an Abbreviated New Drug Submission (ANDS) on December 16, 2010. The main requirement of an ANDS is that the manufacturer of the drug demonstrate that the new drug is the "pharmaceutical equivalent" of a Canadian Reference Product (CRP) which is usually a brand-name drug, in this case Micardis (). "Pharmaceutical equivalent" is defined as a new drug that, in comparison with another drug, contains identical amounts of the "identical medicinal ingredients", in comparable dosage forms, but does not necessarily contain the same non-medicinal ingredients ().

However, over a series of correspondences and meetings between Apotex and the TPD, a decision to reject the ANDS was finalized on April 12, 2012. The reasoning of the TPD was that Micardis and Apo-Telmisartan did not contain "identical medicinal ingredients" and were therefore not "pharmaceutically equivalent".

The only medical input ingredient in Micardis is telmisartan, a carboxylic acid. However, Micardis also contains the non-medical ingredient sodium hydroxide. During the wet granulation process employed during manufacturing, an acid-base reaction occurs between telmisartan and sodium hydroxide. As a result, the form found in the final drug product is, in fact, the salt telmisartan-sodium.

Similar to Micardis, Apo-Telmisartan contains telmisartan as the sole medical input ingredient and makes use of a wet granulation process during manufacturing. However, Apo-Telmisartan employs potassium hydroxide as an excipient (non-medical ingredient). Apotex claimed that no acid-base reaction occurs between telmisartan and potassium hydroxide and the form found in the final drug product is telmisartan and not the salt telmisartan-potassium. The TPD concluded it was unclear from the data whether the final product contained the free acid form of telmisartan or a mixture of the potassium salt and the free carboxylic acid.

Although the Health Canada Policy on "" clearly provides that different complexes, esters, or salts of the same active moiety are considered non-identical, it does not indicate at what time (input or final product) the issue of identicalness should be addressed.

The TPD took the position that "identical medicinal ingredient" refers to the active substances as they appear in the final product and not the input ingredients. Therefore, the finished product in Apo-Telmisartan is either telmisartan or telmisartan-potassium, neither of which is identical to the CRP Micardis (telmisartan-sodium).

Apotex asserted that "identical medicinal ingredient" should assess whether the input ingredients were the same. Under this interpretation, as the input ingredient is telmisartan in both cases, Micardis and Apo-Telmisartan would be "pharmaceutically equivalent".

Ruling in favour of Apotex's position, Justice Kane relied on several fundamental principles of statutory interpretation to resolve the issue. Looking at the ordinary interpretation of the word "ingredients", the original ingredients remain ingredients and are not referred to as the possible mixtures they might become. The judge uses a baking analogy where egg whites and sugar are used to create a meringue for a pie. If someone was asked what the ingredients were in the pie, the answer would not be meringue, but would be sugar and egg whites. In addition, of the FDR requires the manufacturer to provide samples of the ingredients of the new drug and samples of the new drug in dosage form. This suggests that "ingredients" refers to something other than the final dosage form as they are listed separately.

Although I agree that there is a lack of clarity in the definition of the term "identical medicinal ingredients", I was at first concerned that interpreting "identical medicinal ingredient" as the input ingredient and not the final dosage form could lead to some safety issues. As the neutral form and salt form of a compound can often have different properties, finding an input ingredient "pharmaceutically equivalent" to a CRP only to have that ingredient converted to a different compound during manufacturing could lead to a compound for which the safety and efficacy has not yet been verified. However, in this case Apotex supplied evidence that there was no safety concern involving the use of potassium hydroxide as an excipient and furthermore, the Director General of the TPD��could assess the safety and effectiveness of the final product��during the next stages of approval. After Justice Kane's judicial review of the matter, it appears as though "identical medicinal ingredient" refers to the input ingredient and not the final product. For now, that's how this cookie has crumbled.

Corey McClary is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.

The post "Meringue" is not an Ingredient in Lemon Meringue Pie: Defining "Identical Medicinal Ingredient" appeared first on IPOsgoode.

The suspension of US intellectual property rights stems from a dispute between Antigua and Barbuda and the United States concerning online gambling sites. In 1994, Antigua and Barbuda had passed the ��allowing licenses to be granted to��organizations applying to��open online��casinos. The industry became quite lucrative��and the online gambling industry became the in Antigua reporting peak revenues of ��(although other sources a much lower value).

The trouble started in the early 2000s when the United States Department of Justice began on internet gambling sites based in foreign jurisdictions. Several��pieces of federal legislation, including the , the and the , prohibit (or were proposed to prohibit at the time) financing, managing, supervising, directing, or owning a gambling business. This had a on��Antigua and Barbuda's online gambling industry.��The profitable sector, once accounting for in 2001, shrunk to less than 7% of global online gambling market��in 2007 with revenues of less than one billion.

Antigua and Barbuda the United States' prohibition on cross-border online gambling services in 2003, alleging these constraints were against the��United States'��obligations under the (GATS). In November 2004, the panel established by the Dispute Settlement Body (DSB) determined that the United States failed to "accord services and service suppliers of any other Member treatment no less favorable than that provide for under the terms, limitations and conditions specified in the US Schedule" contrary to Articles XVI:1 and��XVI:2 of the GATS. The US appealed the decision but the Appellate Body .

In May 2005, the United States said it intended to implement the DSB's recommendations��concerning changing the laws��and it was given 11 months and 2 weeks to do so. However, they never really seemed to get around to it as in June 2006, Antigua and Barbuda requested a panel be established under Article 21.5 of the (DSU). The DSU applies when there is a "disagreement as to the existence or��consistency with a covered agreement of measures taken to comply with the recommendations and rulings".

In March 2007, the panel confirmed that the United States had failed to properly address the rulings of the DSB. Article 22.2 of the DSU provides��that in��situations where a member "fails to bring the measure found to be inconsistent with a covered agreement into compliance" within a reasonable period of time the innocent member may "request authorization from the DSB to suspend the application to the Member concerned of concessions or other obligations under the covered agreements." In this case the agreements include both those under the GATS and intellectual property rights covered under the agreement on (TRIPS). In December 2007, the Arbitrator assessed Antigua's annual losses due to US��restrictions��on online gambling websites to be US$21 million. On January 28, 2013, the DSB authorized the suspension of concessions and obligations Antigua owed��to the United States in respect to their intellectual property rights.

While Antigua and Barbuda are not the only country to demand compensation for the United States' refusal to lift restrictions on Internet gambling (for example, a was reached with the EU), they are the only��country to pursue the somewhat uncommon remedy of a suspension of intellectual property rights.��Perhaps they are insisting on this remedy in the hopes of��negotiating a better deal.��The US$21 million annually��awarded by the DSB��is much less than the billions the online gambling industry was claimed to be��worth. In this sense it may not seem as though the punishment is sufficient for the US's transgression. However, (suspension of concessions in a sector of trade different than the sector in which the trade injury was suffered) is proposed to offer members with less economic power a meaningful mode of redress against more-developed WTO members. The threat of the suspension of IP rights could result in rights-holders pushing the government to settle the matter in an alternate manner. At this point it is not exactly clear what US intellectual property might be sold by Antigua and Barbuda or if there will be any rules concerning bundling and minimum prices. Theoretically, this could pose major problems to US IP rights-holders as their intellectual property could be sold for a mere pittance. While government authorized piracy may��be anathema to some, it is certainly a valuable bargaining chip for future negotiations.��With the government in the final stages of developing a platform to monetize the suspension of IP rights,��it looks likes intellectual property rights are poised to take the plunge.

Corey McClary is an IPilogue Editor and a JD candidate at Osgoode Hall Law School.

The post Pirates of the Caribbean: US Intellectual Property Rights to Walk the Plank? appeared first on IPOsgoode.

The purpose of the present revisions��are to bring the TPD in line with current market, scientific and policy developments and with the (FTCT). On December 12, 2012, the EU Commision published��a for the revision of the TPD requiring that health warnings��cover 75 % of the package area (Article 9) and providing an option for Member States to "maintain or introduce provisions providing standardization of packaging of tobacco products". Standardized or plain packaging would require the removal of all branding from the packaging including, colours, imagery, corporate logos and trade-marks. The appearance of packages, including the health warnings, colour and size, and font and placement of the brand name, would be standardized. Although it is generally accepted that offer some health benefits��by deterring people from smoking, introducing such measures poses a problem from an intellectual property point of view. Is it an invasion of a company's intellectual property rights to prevent the use of a trade-mark to promote and identify their products if such a ban could provide some health benefit to the public?

The�� suggested the aforementioned provisions in the Commission's proposal did not conform with fundamental rights outlined in the ��(CFREU)��concerning intellectual property (Article 17). An increase in��the size of��health warnings would severely limit the space available for companies to display trade-marks, leaving less than 25 % of the package available as national law requires additional features such as tax stamps and security features. Similarly, the committee says that��these proposals��are contrary to the (TRIPs)��which states that "The use of a trademark in the course of trade shall not be unjustifiably encumbered by special requirements such as��use in a special form or use in a manner detrimental to its capability to distinguish the goods or services of one undertaking from those of other undertakings". However, both the CFREU (Article 52)��and TRIPs (Article 8) impose limits on intellectual property rights if they "meet objectives of general interst" or "protect public health and nutrition", respectively.

The by the European Parliament for the revision of the TPD have not introduced mandatory plain packaging stating that the regulation of other aspects of the packet, besides the size and content of the health warnings, fall outside the scope of the TPD.��Article 9(c) imposes that the combined health warnings shall cover only��65 % of the external areas of both the front and back surface of the unit packet and any outside packaging. While these��consessions may seem like a victory for intellectual property rights, the TPD has left room for member states��to maintain or introduce provisions providing standardization of packaging��of tobacco products (Recital 41).

As Australia is currently the only jurisdiction to have��introduced plain packaging requirements through the (TPP), many European countries are monitoring the legal implications of such an initiative. Both Japan Tobacco International SA and��British American Tobacco Austalasia Limited��challenged the validity of the TPP saying it was against s 51(xxxi) of the ��which allows the parliament to make laws with respect to “the acquisition of property on just terms from any State or person for any purpose in respect of which the Parliament has power to make laws”. The High Court of Australia there was no violation (for more on this decision see IPilogue post ). Even though the companies were deprived of their property, there was no��"accrual of a benefit of a proprietary character to the Commonwealth which would constitute an acquisition".��The TPP is currently subject��to ��before the World Trade Organization.��

Although the ruling in Australia would not guarantee or even speak favourably for the introduction of plain packaging under EU law��(Article 17 of the CFREU has no��"acquisition" requirement), the Scottish government is��pressing ahead with and become the second country in the world to adopt such measures. As there are already�� heavy restrictions on how tobacco products can be ,��tobacco packaging is one of the last bastions towards this end. Tobacco companies appear to be slowly losing ground��in this area��as well, as��considerations for intellectual property rights appear to be taking a backseat to increased health concerns.

Corey McClary is an IPilogue Editor and a JD candidate at Osgoode Hall Law School.

The post Plain Packaging for Tobacco Products in the EU Up in Smoke? appeared first on IPOsgoode.