对话IP人 | FICPI主席:原研药和仿制药企业将迎变革

2018-04-12 13:57 · 作者:   阅读:2057


Editor's note:

本期“对话IP人”栏目邀请到国际知识产权律师联合会(International Federation of Intellectual Property Attorneys,FICPI)主席,加拿大迪纬律师事务所(Deeth Williams Wall LLP)创始合伙人Douglas N. Deeth先生。Doug Deeth拥有40余年知识产权诉讼经验,对于加拿大药品专利链接制度有着独到的见解。本期话题主要包括:加拿大药品专利链接制度变革、专利挑战诉讼策略以及影响加拿大专利药品价格的因素等。

In this edition of the "IP One on One" column, Mr. Douglas N. Deeth, President of the International Federation of Intellectual Property Attorneys (FICPI) and Founding Partner of Deeth Williams Wall LLP, Canada, will have a dialogue with IP Lead on such topics as changes to the pharmaceutical patent linkage system in Canada, litigation strategies for patent challenges, and factors influencing the approval and sale of patented medicines in Canada. Doug Deeth has nearly 40 years of experience in intellectual property litigation, and has unique insights into the Canadian patent linkage system. 





Doug Deeth




With your rich litigation experience in the field of chemistry and pharma and being a witness of the birth and development of the pharmaceutical patent linkage system of Canada, what big changes do you think the patent linkage system in Canada has experienced?



The linkage regulations came into force in Canada in 1993. Before that, there were two different systems that affected the sale of generic drugs in Canada, that I had experience with. When I started practicing, we had laws that allowed for compulsory licensing of patents. That system allowed Canada's generic industry to grow very quickly. With the assistance of these laws, two very large generic companies developed in Canada.


Then starting in the middle of the 1980s, that system of compulsory licensing disappeared. Generic companies that wanted to come on the market had to conduct their own patent searches, and had to decide whether or not the product they wanted to market was going to infringe any existing patents. If it thought to be safe to market a generic product it would do that. The brand name company did not know what the generic manufacturers were planning to do, and generic products would appear on the market, unannounced, resulting in some very big patent infringement litigation.


In 1993, our first linkage regulations came into force. One of the most significant changes was that the generic manufacturers had to give notice to the brand name companies, saying that they were seeking approval of a specific generic product and explain why the patents relating to that product that had been “listed” by the brand name company were not valid or not infringed. Initially, there was a period of about 30 months, where the generic and the brand would fight over whether or not there was any infringement of any valid patent. During that 30-month period, the generic product was kept off the market, even if it had been approved by the regulatory authorities. The 30 month period was later reduced to 24 months.


Canada’s system was intended to be different from the system that was already in place in the United States. The system in the United States was a system where a generic planning on entering the market would give notice to the brand name company saying "we're coming on the market". That notice was an act of infringement, and resulted in patent infringement litigation. In Canada, the system was not an infringement action, but a request by the brand name company to delay the regulatory approval of the generic.


The reason for this difference between the Canadian and US systems was that Canada intended to implement a very simple system, that would give a quick answer to the question of infringement. At first, this succeeded, and cases were quite simple. However, over the past 25 years, the litigation became much more complex and much more expensive, both for the brand and for the generic, and was no longer the simple proceeding that it was intended to be.

例如,1993年我接手的第一个专利链接的案子,客户花费了大约两万五千美元。这个客户感觉非常昂贵,因为这本该是一个非常简单的程序。但是到了2016年,同样的案子需花费50万到70 万美元。

As an example, the first case that I did under the NOC Regulations in 1993 cost my client about 25,000 US dollars. The client thought that was very expensive, because this was supposed to be a very simple process. But by 2016, the typical case was costing between 500,000 and 700,000 US dollars.


The linkage regulations were recently amended in September,2017 to convert the simple process to a full patent action based on quit timet infringement. The amendments bring the Canadian system closer to the US system.



As the litigation are becoming much more complex and much more expensive, is the protection awareness of brand name companies becoming stronger? Will the emergence of new drugs lead to greater difficulty in trials?



These are very good points. There are several reasons for this change in the litigation.


I think the most significant thing is the value of the market to the brands. For example, for a product like Omeprazole, the Canadian market was about one million dollars a day. So a brand trying to protect that market did not worry about spending five or ten thousand dollars a day on legal fees. That's the first thing.


The second thing I think is that there is more competition. In 25 years, some of the basic drugs have been genericized, and the generic drug companies are becoming a little bit more aggressive in their searches for new products, and they're going after drugs and attacking patents in more difficult cases, rather than waiting for these patents to expire as they might have done 20 years ago.


And the third thing is that the technology and the patents protecting that technology are becoming much more complex. When we were litigating 25 years ago, the first case I had was whether a particular drug was made by a particular process. It was a fairly simple case. The most recent case I did involved a determination of whether a drug, when it ended up inside a tablet, had a particular particle size. It was very small particle size, and nobody had ever measured particles that small in a tablet before. So we had expert witnesses who developing new methods for measuring the size of the particles inside the formulated tablet. It was a much more complex case than those we had handled 25 years ago.



What is the balance between the brand name companies and generic companies in Canada? Could you introduce the pharmaceutical patent challenging strategies in Canada, based on your practices?


在加拿大有两个行业组织,一个代表大多数品牌药公司,加拿大创新药, 一个代表大多数仿制药公司,加拿大仿制药协会。这两个组织都会告诉你,这个制度是不平衡的,是偏向另一边的。

There are two industry organizations in Canada. There is one organization that represents most of the brand name companies, Innovative Medicines Canada, and there's another organization that represents most the generic companies, Canadian Generic Pharmaceutical Association. Both of those organizations will tell you that the system is not balanced but favors the other side.


So that probably means it's fairly equally balanced. I think from time to time there are decisions that are in favor of the brands, and then there are decisions that are in favor of the generics. Most of my work over the last 25 years has been for generic companies. But we do have brand clients as well, and I think the system is fairly well balanced. And I think it keeps the prices at a reasonable level, and the Canadian market is still a very attractive place for generic companies - we have many generic companies from not only Canada, but companies from the USA, from India, and from China, that want to come into the Canadian market.


The strategy for generics in Canada is not very different from the strategy that would be adopted in any other country. You obviously have to do your patent searches and get opinions on infringement and validity. You have to review the decisions of Courts in Canada and elsewhere about  the same patents.


The big difference is in the process that has been imposed by our linkage regulations. In a normal patent infringement action, the patentee has to explain why the generic infringes the patent. Litigation under the linkage regulations in Canada, the generic has to anticipate what the brand will say about what the patent means, and explain why the generic product does not infringe the patent, and why the patent is invalid, before the brand says anything about these issues. The generic really has to be a little bit more flexible about how it deals with these issues.



What do you think Canada could do to make the most of patent extension and patent challenge to realize the dynamic balance between generic and brand name drugs?



There are currently three systems that protect brand name products.


The first is the data protection system. That applies to data developed by a brand to get approval for a new drug with new molecule. And that gives the patentee eight years of exclusivity, whether or not there's any patent protection at all.


Then we have the patent protection which applies not only to new molecules but to new formulations, new processes, polymorphs, enantiomers, etc.

根据加拿大基于CETA(我们与欧洲的自由贸易协议)需要履行的义务,我们推出了专利期延长制度(Certificate of Supplementary Protection, CSP)制度,对专利到期后受合格专利保护的新药提供最多2年的保护。

Under Canada’s obligations to CETA, our free trade agreement with Europe, we have introduced a supplementary protection certificate, which provides a maximum of 2 years of protection for new pharmaceuticals that have been protected by eligible patents, after patent expiry. 、


So I think the uncertainty will be in learning how the supplementary protection certificates will be granted, because we have no experience with them in Canada, and we don't know whether Health Canada will be very generous in awarding these or whether it will be not generous. So it's very hard to say what the answer to that question will be because it's a brand new system that just came into force in Canada at the end of 2017.



It is reported that the Canadian government  released the proposed amended Patented Medicines Regulations on December 1st, 2017. Some analysists said this amendment will help Patent Medicine Prices Review Board (PMPRB) to keep consumers from paying excessively high prices. What do you think about it? What factors do you think influence price of the patented medicines?


加拿大专利药品价格审查委员会(PMPRB)已存在多年。PMPRB批准的药品价格用于品牌专利药,并且这个价格是在 PMPRB考察了美国及法国,德国,意大利,瑞典,瑞士和英国等六个欧洲国家的同类药品价格后设定的。

The PMPRB has been in existence for many years. Drug prices are approved by the PMPRB for patented brand name products, and the prices that are set after the PMPRB looks at the prices of the same drug in about seven different countries, including the United States and other six European countries - France, Germany, Italy, Sweden, Switzerland and the UK.


What the brands will do is to make sure that they have the price set in the United States first, (meaning the product has to enter the US market before it comes into the Canadian market) because Canadian drug prices are usually somewhere between the United States prices and European prices. If a brand puts the product on the market in Canada before the United States, there is no United States price that the PMPRB can look at to set the Canadian price, and so the brand will likely get a price in Canada that is lower than it would be if the product was marketed in the USA, because the PMPRB will be able to look at European prices only. If the US price is set before the Canadian price is set, the Canadian price will likely be higher because the US price is taken into account. The proposed amendments include removal of the US from the price comparison.


When the brand makes a request for an approved price, it has to give the PMPRB some information on how much it cost to develop the drug. One complaint that the brands have is that the full cost of developing the drug is not taken into account, but I think that, in general, Canadian prices for brand name drugs are realistic when compared to the prices in the United States.


When a generic comes on the market, the price is set as a percentage of the brand price. The first generic to enter the market typically gets between 50% and 75% of the brand price. By the time the third generic comes on the market the price is down to 25% of the brand price. That's a reduction from prices of five years ago when the third generic would typically sell for about 50% of the brand price.


The best way to keep drug prices low in Canada is to make it easier for the second and third generics to come on to the market, because as soon as they come on the market, the prices of the first generic drug will come down.


This was accomplished under the old linkage regulations. It was a very practical system. If there were several generics that wanted to get on the market, there would often be one fight between the brand and the one of the generics, and if the patent was held invalid in that first fight, the brand often gave up against everybody else and those five or six generics would enter the market all at the same time; that kept the prices quite low.


We don't know yet how that will work under the new system. I think the PMPRB is a realistic way of setting the price for the brand. The generic prices will be kept low because the second and third generics will come on the market at a much lower price than the brand and the first generic will have to lower its prices to compete. But some people say that we still have higher generic drug prices in Canada than in the United States.


Of course, the initial pricing for the brand depends on the cost of developing the drug and the market for it. There are drugs that have several different potential uses. Drug companies will decide on which use to get approval for by considering the cost of development and the likely selling price for the drug. Drugs useful for indications for which there are no approved competitive products may sell for higher prices than the same drug would get if sold for a different indication.


The pricing of a drug is a reflection, perhaps, of the cost of research, but it's also a reflection of how much people are willing to pay for it. If you have a life-saving drug that is going to keep somebody alive for several months, it's going to sell for much higher price than a drug that treats a headache. So it's really supply and demand that affects the market price for the drug. If you have a new blood pressure drug, you will have competition from many drugs on the market that will control blood pressure so you can't make your product much more expensive than those.



Unlike the situations in the United States and South Korea, Canada doesn't provide for market exclusivity for first generic drugs. What is the significance of exclusivity of first generic drugs?



The market exclusivity in the United States is designed to encourage generic companies to challenge the validity of patents listed in the Orange Book, thus encouraging the entry of generic drugs into the US market.


There are two problems that I see with the US system. One is, because there is a big reward if you get your ANDA filed first, that ANDA may not be as well prepared as it should be, and that may result in a delay in the approval and launch of the first generic product. That also means that there is a delay in the launch of every other generic, because those generics cannot start selling their product until after the first generic has been on the market for 6 months.


The other problem is that the exclusivity given to the first generic to file in the United States can be subject to abuse. The first generic is entitled to this period of exclusivity, that is tied to the date it launches its product in the US market. Sometimes a generic will agree to delay the launch of its product in a settlement agreement with the brand; this can result in a delay of the launch of other generics who have to wait until the exclusivity period expires or is terminated.

在加拿大, 成为第一个仿制药公司的优势是进入市场的第一个仿制药,而不是提出了新药申请的第一个仿制药公司,将获得更高的价格,。有时候第一个仿制药公司也会通过与品牌药的诉讼和解上市,和解协议要求品牌药继续与其他试图进入市场的仿制药进行诉讼。

In Canada, the reward for being the first generic is to get the higher price awarded to the first generic to enter the market, not the first generic file its application for approval. Sometimes the first generic will get on the market by settling litigation with the brand, under an agreement that requires the brand to continue the fight against other generics who are trying to enter the market.


We have had a couple of cases in which had three or four generics have had their cases all heard together by the Court, and the first generic to file has argued that the judge should delay his decisions on the other generics to give the “first” generic a chance to enter the market first. So far, our courts have rejected that argument



For the past several years, many Chinese pharmaceutical companies are actively expanding their overseas business. How should they prevent the risk of intellectual property infringement when they enter the Canadian market?



I think there are two or three things that have to be done.


First of all, Canada has to be looked at as a separate market from the United States and from Europe, with different rules. Often the claims of Canadian patents are different from those in other countries. You would normally do a freedom to operate searches and opinions in the USA and in Europe, and I think you have to do that again in Canada.


However, we often suggest that our clients give us the opinions that they have from the United States or from Europe, and we can review those and say whether or not that opinion would be the same in Canada, which it will be for many US and Canadian patents, or we can say it will be different for reasons that are unique to Canadian law. This can result in significant savings of time and cost.


Another thing that has to be carefully considered: you should not always believe what your supplier or client tells you about the product or the ingredients in it.


We’ve had cases where the product that is delivered to the client is not what was specified and includes ingredients that should not be there or that have properties or characteristics that are different from those specified. It is very difficult to deal with that when these differences show up in litigation testing.


So it's not only a matter of looking at the legal landscape and looking at the patents, but it's also a matter of looking at your product very carefully to make sure that the product is what is supposed to be.



There are lots of differences in pharmaceutical patent systems between Canada and the United States. Will Canada approach the United States or maintains its own characteristics in the future?



When I started my practice, there were two big Canadian generic companies, and the Canadian generic market was limited to those two companies, Novopharm and Apotex. Novopharm was acquired by Teva several years ago.


Then we developed a system under the linkage regulations who was very unique to Canada, and for a short period of time we had a very unique Canadian system and a unique Canadian market.


In the last 20 years we have seen several American and Asian generic companies coming to Canada.


We have also had a change in our linkage regulations to make them more like the American system. That just happened last year.


The other change that's happened which I think will continue is a change in the industry. 25 or 30 years ago you had exclusively generic companies and exclusively brand name companies.  Law firms were the same; a law firm would not act for both (if your firm represented a brand name company you would not act for any generic company).


What we've seen in the last 20 years is that the brand name companies are either buying generic companies or having their own generic divisions, and generic companies are developing their own unique products and seeking patent protection for them.


When a brand name product is losing its patent protection, we often see the brand name companies making its own “authorized” generic versions of the product, or licensing a generic company, sometimes its own subsidiary, to do that. So there will be a continuing convergence of brand names and generics and often one company will have a brand name division and a generic division.


A third thing may change is the brand name pharmaceutical market itself. It is in several ways a very strange market, because in most cases when patents expire, and competition enters the market, the brands do not reduce their prices to compete with the generics - the prices stay the same - and they try to sell the brand name products at the same high prices even though they have competition and no patent protection.


In some cases these brand name products (often referred to as “legacy products” were sold to smaller companies who continued to sell them at the original high prices, or even increasing the price, maintaining only a small market share but making very good rates of return on their investments.


This may have started to change three or four years ago, when the patents on Viagra were held either invalid or expired. Pfizer lost patent protection for Viagra and was, I think, the first company in Canada that reduced its price on the branded product to match the generic pricing. I think we'll see more of that in the future. In addition, as patents are expiring, brands appear to be willing to enter into long term supply agreements with hospitals, governments and other buying groups at lower prices than they offered before in order to keep their market share.


In the last couple of years the market for legacy products has become less attractive, as the ability to raise the prices has been affected by greater government scrutiny of drug prices and public concern over high drug prices.


As a result of these changes, ie the decisions to reduce the prices of brand name drugs when generics enter the market, the reduced attractiveness of legacy products, and greater awareness of drug prices in the US market, we will see changes the marketplace for both branded and generic drugs.


I think that in the next ten years, you'll see a lot more price reductions on brand name drugs when the patents expire, and we will have a market, at least in North America in which drug companies become fully integrated, selling both brand name drugs with full marketing support and then generic versions of the same drugs when the protections granted by data protection, patents and CPSs expire.


It is much easier for a brand to enter the market with a generic version of its own drug than it is for a generic to get approval of its generic version of the brand. This will make it harder for generics to enter the market unless they have a large portfolio of products to offer to the market. It will be increasingly difficult for a generic with only a small number of products to compete in the marketplace.

Douglas N. Deeth

Douglas N. Deeth先生为加拿大安大略省注册执业律师, 加拿大专利和商标代理人,并有美国专利及商标局 (USPTO) 的代理资格。Doug 是加拿大Deeth Williams Wall律师事务所的创建人之一。Doug拥有三十多年的诉讼处理经验,特别是在化学和制药方面。

Douglas Deeth was admitted to the Bar of Ontario in 1976.  He is also a Registered Canadian Patent and Trademark Agent and Registered U.S. Patent and Trademark Agent.  Doug is a founding member of Deeth Williams Wall LLP.  Doug has more than thirty years of litigation experience.  and has particular expertise in chemical and pharmaceutical products and processes.

Doug 在国际评论中被公认为加拿大知名的知识产权律师之一,, 目前担任国际工业产权律师联合会(FICPI)的主席。

Doug has been recognized in several international reviews as one of Canada’s leading intellectual property lawyers.Doug is currently the president of FICPI (the International Federation of Intellectual Property Attorneys).

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