I was largely oblivious to the processes of prescription and generic substitution before my internship at Teva Pharmaceuticals. Little did I know that pharmacists had the discretion of substituting generics for brand name medicines, unless the prescriber had indicated ‘no substitution’ on the prescription, which might occur if a patient had experienced an adverse reaction to an alternative brand. Little did I know that the price of patented medicines is capped on a case-by-case basis by the federal Patented Medicine Prices Review Board. And little did I know that every provincial/territorial jurisdiction in Canada is party to a Tiered Pricing Framework that also places ceilings on generic drug prices relative to the reference brand price. I was fortunate to have a patient and knowledgeable supervisor in Ben Gray with whom to discuss a number of patent issues involving litigation strategy, biologics, skinny labeling, and means by which pharmaceutical companies seek to extend their commercial monopolies.

My internship at Teva afforded me the opportunity to connect with members of the inhouse legal team, including counsel and a law clerk, as well as external counsel to gain a clearer picture of the division of labour on legal matters. In-house counsel oversaw matters on the macro level, sometimes handling matters independently, but also procuring and providing instruction to external counsel and allocating resources across files. External counsel were assigned to individual files, but in-house counsel kept abreast of developments through regular updates to their litigation reports, which provide an overview of ongoing litigation from claims to timelines. The management of intellectual property, having its own dedicated counsel and litigation report separate from all other legal matters, is unsurprisingly a priority for Teva.

While I did encounter a trademark issue pertaining to licensing the use of Teva’s brand materials, the IP matters I was exposed to mostly concerned patents. Though I have completed a handful of undergraduate courses in chemistry, that information has since laid dormant in my brain—so it was to my relief when Ben assured me that a PhD in chemistry is not a prerequisite to the in-house work that he does. I don’t know that the same can be said for the work of external counsel having now reviewed a couple lengthy Notices of Application pursuant to the PM(NOC) Regulations. Admittedly, I took numerous detours while reading to refresh my memory on the meaning of various terms describing chemical groups and molecular structure.

As Teva markets both brand name and generic products, it also both defends and challenges the validity of patents. I found it valuable to be placed with an entity whose interests lie on both sides of the social bargain in patent law. Updating litigation reports on intellectual property and non-intellectual property matters with law clerk Lynn Chacra allowed me to survey a range of legal issues that can arise for a pharmaceutical company. The matters I engaged with in more depth, though, were IP-related. In the
course of my work, I became more familiar with the Patent Act, the Patented Medicines (Notice of Compliance) Regulations, and the Rules of Civil Procedure. But my takeaways were not limited to hard skills.

Future dealings with most corporate adversaries, co-plaintiffs and co-defendants is to be expected in an oligopolistic industry like pharmaceuticals. As I allude to in the title of this blog—it’s a small world in big pharma. Aside from a firm grasp of the relevant substantive law and procedural frameworks, the importance of soft skills cannot be overstated in building respectful working relationships with adversaries and colleagues alike. For instance, favourable procedural arrangements and even settlements can sometimes be reached on consent of the parties. Co-plaintiffs or co-defendants may also pursue joint litigation to pool resources. It was my pleasure to be placed with an office that exemplifies professionalism from the technical to the relational. Owing to my positive experience with the Teva team, I have arranged to virtually observe an appeal hearing after the formal conclusion of my internship, so I can say with complete sincerity that I would choose this internship again.

The post It’s a Small World in Big Pharma - My Internship at TEVA Canada Ltd. appeared first on IPOsgoode.

In , the and the , a patent can be valid up to 20 years after its filing, which means that the company which develops a COVID-19 vaccine can have a stranglehold on the production and pricing of the vaccine for two decades. This can have a significant impact on the ability for most populations to receive the vaccine. With over cases globally, any delay on the implementation of the vaccine will lead to disastrous loss of life.

In addition to the grave possibility of pharmaceutical companies placing a stranglehold on vaccine production through patent for profit (which they have been known to do in cases like ). The entire process of developing such a vaccine has been hampered by IP regimes. The for governments and pharmaceutical companies to pool their IP resources to allow for both the development phase to be faster as well as to ensure widespread and low-cost manufacturing. However, two of the largest powers in the pharmaceutical business, the and are leading the campaign against such a resolution. This is likely to mean, barring new legislation, that most countries’ patent regime will govern the dissemination of any new COVID-19 vaccine in their jurisdiction.

Although the first wave of vaccine supply will likely be the largest bottleneck, supply has to be maintained, perhaps for years. This is because the COVID-19 vaccine , inoculating one for life, but closer to the seasonal flu vaccine, needing a new one each year for the new mutated strain. This opens up the chance that pharmaceutical companies will make minor improvements to keep updating the patent and keeping their stranglehold on the market similar to the in the US.

So, what does this mean for various jurisdictions around the world?

UK and US:

The UK and the US are against meddling in their traditional patent regimes, hoping to allow free market competition drive innovation and perhaps come up with a wide array of vaccines. This has been the standard approach of these two pharmaceutical giants for decades, but dangers do lurk in the shadows. With major institutional issues in these jurisdictions in the past such as the insulin and opioid crises, it leaves doubt in the ability for their traditional patent regimes to deliver a new vaccine to their hundreds of millions of citizens.

Canada:

In part 12 of Canada’s , a measure was added to allow the health minister to circumvent patent law and ensure enough would be produced locally. These measures could be used if the demand is too great for the patent holder to supply and adequate renumeration would be given. However, Canada’s main pharmaceutical lobby group, Innovative Medicines Canada, regarding how the government wouldn’t have to check with the manufacturer to determine how much they can actually supply. Since the legislation’s coming into force back in March, Canada has not used the bypass powers to supply some direly in need items such as ventilators, so the likelihood of this bypass being used remains to be seen.

New Zealand:

New Zealand’s patent regime has and measures built into it, paving the path for government intervention in circumstances where manufacturers can’t meet supply. Although, these measures are only after negotiating has failed or three years since the patent was granted. This leaves room for pharmaceutical companies to maneuver in a way which may be detrimental to access of the vaccine. As such, there have been to amend these laws for national emergency clauses which would ensure the government to step in.

Current IP regimes worldwide are steeped in many historical issues and aren’t flexible enough to deal with unprecedented cases such as the COVID-19 crisis. There are very few precedents for western countries to even use the measures made available by legislation and this may cause unaffordable hesitation. The loss of life that this will result in may be the wake-up call that heralds a revolution in how people view patents.

Jin Xu is a JD Candidate 2022 at Osgoode Hall Law School.

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Counterfeit goods are an age-old consequence of economic markets. These consequences are especially troubling when raising concerns about the delivery of prescription medicines that the public are presumed to trust. The (WHO) recognizes this. To improve the global supply chain's security, they have defined Pharmaceutical counterfeiting as medicine that is deliberately and fraudulently mislabeled concerning the identity and/or source. Counterfeiting is not limited to either branded or generic products. It occurs in different fashions, such as the inclusion of wrong ingredients, deficiencies of active ingredients, and false packaging.

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Problem with IP Regulations and the Supply Chain

A more technical consequence of pharmaceutical counterfeiting is that these medicines can often violate companies' patent rights offering legitimate medicines. In Canada, three pieces of legislation compose the legal framework surrounding intellectual property rights in the biopharmaceutical industry: (1) ; (2) the ; and (3) "Data Protection" found in ¹. Together, these regulations serve to protect innovations from being stolen or reproduced for consumer use and profit.

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Manufacturers of fake medicines are motivated by profits. They are likely to avoid the expense of precision measurement and formulation that directly infringes upon patent holders' rights. Unfortunately, many technicalities are involved in drafting biopharmaceutical patents, and because counterfeit manufacturers often cut corners in the production process, direct patent infringement may not always occur. Thus, patent holders and regulatory officials have two separate issues on their hands pertaining to supply chain security: counterfeit drugs that fail in effectiveness altogether and efficacious but patent-infringing generic drugs.

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Potential Solutions

Several recommendations to protect biopharmaceutical manufacturers may be offered. First, raising public awareness on the issues of pharmaceutical counterfeiting is essential¹. By pushing for campaigns that warn of pharmaceutical counterfeiting risks, we can limit the purchase and use of these fake medicines¹. Next, improving regulatory oversight could restrict the manufacturing of pharmaceutical counterfeits¹. Criminal sanctions and massive fines would likely deter companies from making counterfeit drugs while strengthening biopharmaceutical intellectual property rights¹. Finally, incentivizing domestic production of pharmaceuticals would limit the import penetration of counterfeits in the market. Nonetheless, a significant consideration for manufacturers is production cost, which is much cheaper in other countries.

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High taxes, high salaries, and, most importantly, inadequate intellectual property protections have discouraged Canadian manufacturing as well.��It is entirely possible that to fully secure the biopharmaceutical supply chain and eliminate counterfeits from the market, Canada will need to shift its focus to strengthening intellectual property rights.

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Written by Khristoff Browning. Khristoff is a first year JD candidate at Osgoode Hall Law School. He is a contributing IPilogue editor and IP Innovation Clinic Fellow.

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Background

Teva Pharmaceuticals developed a medication for the treatment of multiple sclerosis called Copaxone. Sandoz Pharmaceuticals submitted to the Food and Drug Administration to develop generic versions of Copaxone. Teva launched a suit in 2012 claiming patent infringement under . “Average molecular weight” was a disputed term which Sandoz claimed to be ambiguous.

After hearing expert evidence, the district court found the term to not be ambiguous, and that Sandoz infringed Teva’s patent. Sandoz appealed to the Federal Circuit Court of Appeal, arguing that “average molecular weight” was “insolubly ambiguous”. The Federal Circuit heard the case de novo without giving deference to the district court’s factual determinations, and unanimously reversed the lower court’s decision. Teva for writ of certiorari to SCOTUS. The petition was granted and were heard on October 15, 2014, and the decision was published on January 20, 2015.

Arguments by Sandoz

In the oral arguments, counsel for Sandoz relied heavily on , a significant case where SCOTUS determined that the interpretation of patent claims are questions of law rather than questions of fact. Sandoz claimed that even fact-finding becomes a legal inquiry, since the district court has to make a legal inference of a fact to put it into context of the patents-in-suit. Being questions of law, Sandoz argued that the Federal Circuit need not give deference to district courts and was��correct in reviewing such claims de novo. Moreover, enforcing deference to the district court will create a “cottage industry of trial lawyers fighting with the judge about which bucket some particular evidence fits into”.

Arguments by Teva

Counsel for Teva pointed to the convention of the judicial system where district court judges find the facts and the Courts of Appeal review those fact-findings deferentially under Rule 52(a). They argued that patent construction claims are hybrids, containing a mix of questions of law and fact. Some cases, like this case, is one where factual findings by��themselves point to the correct outcome since the ultimate legal conclusion rests on fact-finding.

Decision

The majority of SCOTUS held that when reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, appellate courts must apply a “clear error”, not a de novo, standard of review. They distinguished between evidence intrinsic and extrinsic to the patent. In reviewing intrinsic evidence, a district court judge’s determination is solely a determination of law, which appellate courts can review de novo. When a district court requires��extrinsic evidence and consults experts to settle factual disputes, the judge’s determination is a factual finding that must be given deference unless a clear error has been made.

With regards to Sandoz’s argument that it may be difficult to separate “factual” or “legal” questions, SCOTUS stated that courts of appeals have long been able to separate factual from legal matters. As a result, SCOTUS determined that the Federal Circuit in this case erred in law in failing to review factual findings only for clear error.

Analysis

SCOTUS has settled the controversy in the applicability of Rule 52(a) in relation to patent construction claims that extends beyond the pharmaceutical industry. The decision promotes consistency in the law and judicial integrity of factual determinations at large. Moreover, with on appeal, reviewing patent construction claims de novo provides an incentive for��unnecessary litigation, increases trial costs, and arbitrariness of decisions.

Long-term implications from this ruling are less clear. It is to be expected that district court judgments on patent construction claims will not be appealed as often as before, and litigators will shift the focus of their claims on factual determinations to gain higher certainty on appeal. Since fact-finding often requires expert testimony, litigants will spend a greater amount of resources hiring experts, adding to the complexity for district court judges to explain their judgments in areas where they themselves may not have expertise.

Beyond the pharmaceutical industry, the emphasis of fact-finding in the district court and what constitutes a “clear error” on appeal may have shifted patent litigation in favour of those with deeper pockets to hire experts. It is unclear how this ruling will affect smaller players who claim to have their patent rights infringed by large companies.

Nonetheless, Teva v Sandoz provides greater clarity in litigation for patent construction claims and resolves the controversy of the applicability of Rule 52(a) towards appellate courts.

Jason Ho is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.

The post A Dose of Consistency: SCOTUS Settles the Controversy in Teva v Sandoz for Patent Litigation 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.

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How Do Intellectual Property Lawyers Interact Within a Larger Company?

During my time at Apotex, I had the opportunity to learn how the Global Intellectual Properties (GIP) group interfaced with some of Apotex’s other departments. Sometimes these interactions were in the form of regularly scheduled meetings, where a lawyer and representatives from other departments would meet to discuss the progress that is being made on Apotex products. Whether the interactions were more or less formal, scheduled or spontaneous, one thing was clear: in-house lawyers work hard to support every area of the company that requires their assistance.��

What is the Role of In-House Counsel?

Prior to beginning my Apotex internship, I was a bit unclear on what work was performed by in-house lawyers, rather than by external counsel. Throughout my internship, I was able to learn how various legal tasks were delegated.

The in-house legal team is tasked with advising the company, helping to make decisions about the best way to proceed in certain situations, and managing the tasks assigned to external counsel. In-house lawyers are also involved with drafting documents and revising external lawyers’ work. As in-house lawyers understand the specific nature and quality of work that is required and the needs of their company, they are best-equipped to critically review incoming work and act as a liaison between the organization and the external law firm.

What Did I Do?

At Apotex, I completed tasks for a number of lawyers and experienced a wide range of work as a result. My largest project was to draft a Notice of Allegation; the originating document for proceedings under the . I completed various research tasks, including determining the litigation status of relevant cases. I learned how to critically review a patent, its file-wrapper, and prior art documents to determine what invalidity and/or non-infringement arguments might plausibly be made. This type of assignment provides an opportunity for in-house counsel to assist in drafting legal documents and to critically review work done by external firms.

My work was not limited to patents.�� I also gained exposure to trade-mark matters and corporate/commercial work. For the latter, one of my tasks was to draft a corporate policy from existing documents and memorandum. I then reviewed the current documents to determine whether they were compliant with the draft policy, and to note any ways in which their compliance could be enhanced.

What About the Employees?

I have left the best for last – everyone with whom I interacted at Apotex was great. My supervisor was very helpful, glad to answer all of my questions, and ensured I was exposed to as much of the company and its work as possible. Our daily meetings provided an opportunity to discuss my progress, and his door was always open for any unscheduled meetings, as well. Everyone else who worked in the department was friendly, and happy to help in my learning experience. I was grateful for the experience, and, at the same time, felt I was able to contribute to the department.

Would I Recommend the IP Intensive Generally, and Working at Apotex in Particular?

Absolutely! The IP Intensive is a great way to become exposed to the IP community, and begin to learn some of the tasks that IP lawyers seek to accomplish. Working in an in-house environment will certainly provide a different perspective from working in a firm, as each has different responsibilities and focuses.

For anyone interested in completing an internship at Apotex, my experience was fantastic and I was able to learn a lot in my short time with the company. If you are interested in patent (and perhaps some trade-mark and corporate) law, this might be the right experience for you!

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

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The Pharmaceutical Patent Regime

Several changes to Canada’s pharmaceutical patent regime were desired by Europe, and . Canada has agreed to allow a patent term extension (PTE) of up to two years. Additionally, the dual proceedings for patents – prohibition applications under the Patented Medicine (Notice Of Compliance) Regulations 1993 (as amended) for regulatory matters, followed by a court determination of patent validity or infringement – will likely be reformed. This second change is coupled with the newly acquired ability of brand companies to appeal an adverse PM(NOC) decision. However, the Canadian data and marketing exclusivity periods will , respectively, rather than move to the European period of 10 years. (To see past IPilogue coverage on this topic, click .)

These changes have predictably elicited polarized viewpoints. The Canadian Generic Pharmaceutical Association (CGPA) commended , but voiced their disappointment of others, including the PTE. The CGPA is pleased with the expected discontinuation of the dual litigation practice, the recognition of the generic pharmaceutical industry’s importance in Canada, and the limitations placed on the use of the PTE. Notably, a suggests that the PTE’s annual increased cost, even with the two year maximum, will range from $850 million to $1.65 billion.

By contrast, it was alleged in January 2013 that in Canada. Opinions nonetheless differ on whether brand companies have met previous promises to increase R&D in Canada in exchange for improved patent protection.

Whether these two changes are good for Canadians or not remains to be seen. Can the predicted annual cost of the PTE to Canadians be offset? The federal government’s will not help those paying for prescriptions out of their own pocket, and lacked any assurance that reimbursement will continue in the long term. Pharmaceutical companies may perhaps decrease their product costs in response to lower litigation costs, or may conduct more research in Canada – but probably not sufficient to offset the high PTE cost.

Geographical Indications

Protecting Geographical Indications (GIs) was another important aspect of CETA. Until now, the only GI protection in Canada has been for . Otherwise, GIs are protected under or as certification marks under the . These laws have not always protected European GI producers against prior Canadian users, as occurred with the Parma ham GI in . In Europe, GI protection is largely and is potentially available for any foodstuff or beverage, although some countries such as the UK have also long had a scheme like Canada’s and have also protected GIs under the law of unfair competition or false marketing.

Under CETA, Canada has agreed to increase the scope of GI protection to include . Areas that will remain unchanged in Canada include: words commonly used to describe items (Black Forest ham), generic plant names (kalamata olives), and components of longer terms, which can all still be used in association with wares. For other items, such as Asiago cheese, current users can continue to use the term, but future users are prohibited. It has not been indicated whether Canadian GIs can be protected in Europe. However, even if this protection is reciprocal, the limited use of GIs by Canadian producers suggests from the additional protection.

While existing Canadian trade-marks will , it seems that previously blocked European GIs, even if potentially confusing with Canadian trade-marks, may now be used in Canada. Thus, the European Commission has claimed that Prosciutto di Parma can in Canada. The possibility of harm to existing Canadian trade-mark owners and consumer confusion over the source of the two products becomes quite real. Consumer impact can of course be viewed as either a benefit (increased choice) or a detriment (confusion) but the potential harm to Canadian producers with valid trade-marks, coupled with the limited GI use by Canadian producers, suggests a clear victory for Europe in this sector.

Conclusion

In light of CETA’s impact on patent law and GIs, Canada appears to have lost the IP game to Europe. Whether this preliminary assessment holds true once the full text of CETA is released, and is applied in Canada, remains to be seen.

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Biologics play an important role in the Canadian health care system through their use in treating numerous diseases and medical conditions. of biologic drugs include antibodies and growth factors.

Patents and data protection covering biologic drugs in Canada are beginning to expire thereby creating opportunities to bring more affordable SEB versions to the market. It is important to distinguish between traditional generic pharmaceutical products and SEBs. The term SEB was specifically chosen by the Canadian government to clearly distinguish between the regulatory process and product characteristics for SEBs and traditional generic drug products.

A is a drug that enters the market subsequent to a version previously authorized in Canada and with demonstrated similarity to a reference biologic drug. A SEB relies in part on prior information regarding safety and efficacy that is deemed relevant due to the demonstration of similarity to the reference biologic drug and which influences the amount of and type of original data required.

Because of the significant differences between SEBs and traditional generic drug products Canadian health authorities created new guidelines to govern the approval of new SEBs. Guidance from Health Canada is particularly prudent since the do not contain specific regulatory mechanisms for approval of SEBs. In March 2010, Health Canada released its framework for the approval of SEBs in a document entitled “”. These guidelines indicate that manufacturers seeking approval of a SEB must file a new drug submission as opposed to an abbreviated new drug submission as is the case with traditional generic drug products. While SEBs require a new drug submission they may still rely in part on data from the reference product but may not state that the SEB and the reference product are bioequivalent or are clinically equivalent. The also include SEBs within their scope thus linking patent protection to the approval process and opening the door to patent litigation.

The Canadian pharmaceutical industry is no stranger to patent litigation under the Patented Medicine (Notice of Compliance) Regulations and it appears SEBs will be no different. In early 2012 Teva Pharmaceutical Industries Ltd. (Teva) applied for a Notice of Compliance in order to market a SEB consisting of the protein filgrastim. In their application, Teva made reference to a reference biologic product owned by Amgen Inc. (Amgen).�� Amgen commenced a proceeding () under the against Teva seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance for Teva’s filgrastim product prior to the expiry of (the “537 Patent). The 537 Patent is listed on the patent register against Amgen’s biologic filgrastim product. The 537 Patent will expire on July 31, 2024. According to Amgen’s Notice of Application, Teva has made a number of allegations against the 537 Patent including:

• Invalidity of certain claims due to (1) double patenting (2) invalid selection (3) material misrepresentation (4) anticipation (5) obviousness (6) missed conflicts and (7) lack of utility and lack of sound prediction;
• The 537 Patent is not entitled to claim priority from a United States application;
• Claim 43 is the only relevant claim; and
• Claims 12, 16-24, 26, 27, 29-42 and 48-82 will not be infringed.

This proceeding represents the first SEB litigation in Canada. While this litigation will only determine the issue of whether the Court should prohibit the Minister of Health from granting Teva a Notice of Compliance, it will be interesting to see if any novel legal issues arise regarding SEBs. Given that Canadian SEB litigation is in its infancy, this proceeding may have important implications for the future of SEBs in Canada. For an interesting article on Canada’s SEB market the reader is directed to the following .

Sean Jackson is a JD candidate at Osgoode Hall Law School and is currently enrolled in Osgoode’s Intellectual Property Law and Technology Intensive Program.�� As part of the program requirements, students are asked to write a blog on a topic of their choice.

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