Us and European pharmaceutical patent litigation case study - the first part of the

  • Created:
  • / Author: Aaron Lewis
The State Intellectual Property Office of soft science research project
Project number: SS07-A-18

Study on us and European pharmaceutical patent litigation cases
Zhou Heping of China Medicine University
Completion: November 30, 2008

The first part us and European pharmaceutical patent litigation overview
Significance and role, US and European pharmaceutical patent case study
(a) the patent litigation case is the research and development of new drugs, patent application and examination indicator
Patent litigation case is the wind vane. In 2007 USA patent litigation in some famous cases, not only restrict American Court [future] other patent cases, and adjusted the benchmark patent office, has affected the enterprise patent strategy and new drug research and development strategy. Melaleuca waves stirred up a sentence.
Furthermore, although the independence of the judiciary, however, patent litigation there have been large country effect, American and big European patent cases on he produced significant influence.
For example: according to the Supreme Court case KSR v. Teleflex, American patent and Trademark Office announced obviously sex (similar to the patent law "of China's creative review guidelines"). Patent experts said the case has created a "-KSR" ("Post-KSR") age. America patent law "obviously" similar to the patent law "creativity in our country". Recognized industry: in 2007 America patent litigation big case, that is hard to obtain patent increase.
Similarly, the European Patent Office compared with the same period last year, authorization number fell by nearly 13%, than in 2006 to reduce the number of authorized 8100 pieces. EPO director Alison Brimelow talked about this trend said: "the patent is intended to support the economic benefits for the society of proliferation. However, a lot of patent number is not necessarily the R & D dynamic growth index. What we need is not only more patents, but better patent. In 2007 the European patent authorization ratio lower than usual, reflect the quality prior to the quantity, this is a step in the right direction." [Emma Barraclough, London, Managing Intellectual PropertyNewsweek - April 1, 2008]
(two) pharmaceutical enterprises is extreme case dependent patent
The dependent patent medicine enterprises. Compared with the electronic, mechanical field, effects of patent litigation cases on pharmaceutical and chemical enterprises is much more serious.
From the angle of economics to patent, patent imitation costs increase, thereby promoting innovation. The imitation cost increasing ratio of patent and patent creation effect is proportional to the. In the electronic and mechanical fields, patent only the imitation costs increased by 7%, but in the pharmaceutical field, the figure is 30%, is 4.3 times of electronic and mechanical field.
No one will be useless. Invested enterprises in patent protection and benefits is proportional to the. So, research method in Europe only 36% of the firm's R & D products, 25% of the patent application. The only exception to the extreme 79% pharmaceutical companies, pharmaceutical research and application for patent protection. [ James Bessen and Michael J. Meurer, "the patent failure" publishing: Princeton]
In 2007 the European Patent Office patent filings classification statistics prove the reliability of data. By 2007 the European Patent Office patent application, medicine is the most active field of application, accounted for 12% of total applications, followed by the electronic communication technology accounted for 10.2%, the computer 6.4%. [ Emma Barraclough, London, Managing Intellectual PropertyNewsweek - April 1, 2008]
(three) patent is leveraging large future drug market
Effective patent is the original drug research enterprise sharp spear; expired patent is the generic drug company shield. The initial signs of contradiction, show in court. Once the decision, reflected in the market.
By convention, the first year of patent protection period expires, sales of large branded medicine enterprises can be maintained at about 13% of the original, but has shrunk substantially in the next 6 months, rapidly reduced to about 1% of the original. According to the analysis, only American market, the next 10 inside patent medicine enterprises will be "blockbuster" patent losses of $140000000000.
The generic drug companies, the situation is just the opposite. From 2008 to 2012 "blockbuster" drug patent expiration, generic drug makers to nearly $46000000000 in sales market, the generic drug market scale is expected to increase from $44080000000 in 2008 to $54700000000 in 2012. [Lu Huisheng: "the next 5 years America patents expire drug nearly $77400000000" China intellectual property news 2008-3-28]
(four) "ism" and system
Others tell us something, others think that we need to know. We should select "make foreign things serve China" things according to their national conditions. Adopt a piecemeal approach research, easy to cause the "why" of the situation. Others put the blind leading to the trunk side, to feel the elephant nose, he would think that the elephant is like a rope; others put the blind leading to like legs, to feel the elephant leg, he thought that the elephant is like a pillar. This is Overgeneralization.
"Further from the truth than ignorance and prejudice". In view of such an important patent litigation case is for pharmaceutical R & D, patent application, patent, infringement, as far as possible, avoid the "opinion", the system retrieved 2007 America Federal Circuit Court of Appeals Cases, selected and pharmaceutical patent case, translation among on substantive issues of fact and law application part, the first analysis of translation, extraction points, and then classified statistics, was that a patent dispute general trends in the data, finally the comprehensive cost issue three research achievements.
(five) the practical and prospective
Philosopher said: "feel things, we cannot understand it immediately. Understand the things, we can feel it more deeply."
1, study a patent case need to America Patent Law
The main part of this paper is studied systematically American Federal Circuit Court of appeals cases. The Federal Circuit Court of appeals is the court of final American most patent disputes, the trial scope involved in three categories: patent dispute case all patent dispute an appeal against the federal district court case, not American patent and Trademark Office review case, against the International Trade Commission ruled 337 terms.
As a case law country, the precedent is the law [ibid.]. Through the case analysis, we can understand the reference USA patent examination background, insight into the patent American pharmaceutical enterprise application strategy change, new drug R & D strategic trends, and to provide the reference for Chinese pharmaceutical export judging patent infringement.
There are 2 big field, patent litigation
There has been a big country effect field of patent litigation, USA and big European patent cases on he produced significant influence.
3, did not rain before going
Problems in the United States and Europe had, probably we are now experiencing, or will meet. By other's faults, wise men correct their own. A reasonable standard of the subject system of European Court of justice in the United States, the balance between patentee and the public interest, the reference to relevant facts and the application of law experience, widen our sight.
4, to prevent medical risks in international trade
In the field of trade international pharmaceutical, collection and collation of relevant national pharmaceutical patent litigation cases, is the foundation of foreign patent risk assessment. This patent risk assessment not only relates to pharmaceutical products import and export trade, China's enterprises to build factories abroad, M & A and so on, in American also relates to 337 in terms of risk prevention.
5, today he spear, tomorrow I shield
American Federal Circuit Court of appeals of patent right and infringement dispute case in the trial process, from time to time with the double standard signs. Today his spear, tomorrow maybe is my shield. Collection, these case studies, has the potential for future bilateral patent disputes, trade friction, do itself, to seize the initiative, to prepare.
Industry characteristics and trend of two, 2007 US and European pharmaceutical patent lawsuit revealed
2007, the European pharmaceutical patent litigation case studies show that, pharmaceutical patent field, industry characteristics and the main trends are as follows.
(a) contradiction branded and generic drugs is the main contradiction of patents in the field of Pharmaceutical Chemicals
Pharmaceutical patent field, the main contradiction is branded and generic drugs. The original research of medicine patent protection, so the original drug research is also known as patent medicine. Effective patent is the original drug research enterprise sharp spear; invalid patent is the generic drug company shield. The initial signs of contradiction, show in court. Once the decision, reflected in the market.
The original drug research enterprises generally have compound patent, and often and preparation method of patent, patent, patent agents use together constitute patent network. The main aspects of the contradiction is patented branded medicine enterprises. The original drug research enterprises to maintain their market dominance, filed a patent infringement lawsuit against generics firms. While generics firms to original research drug patent online open a gap, in order to compete for market. In the patent dispute case, "you" is "] told me [patent infringement of patent is invalid, I tell you". Your patent is [once] I declared invalid, sales will not tort. So, the contradiction branded and generic drugs is the main contradiction of patents in the field of pharmaceutical chemicals. The world is big big generics in patent litigation, such as column color [Israel] down.
(two) patent litigation cases concentrated in the "heavy bomb drugs"
In 2007 the Federal District Court USA drug patent infringement trial initial incomplete statistics, 126 drugs were involved, the more American annual sales of $1000000000 (including 1000000000) drug 31.
For example: Pfizer v. new patent infringement case, involving the cholesterol lowering drug Lipitor (atorvastatin calcium). Lipitor in America annual sales ranked first on the list, up to 8000000000. In 2006 and 2007 global sales of the top ten list: Lipitor also ranks first. Lipitor accounted for almost Pfizer Inc near 1/3 performance and profit.
Another example: Bristol Myers Squibb and Sanofi Aventis v. Apotex pharmaceuticals, Teva pharmaceuticals and Cobalt pharmaceuticals patent infringement case, relates to stroke prevention drug Plavix (clopidogrel sulfate tablets). Plavix in second in America annual sales rankings, 5800000000. In 2007 global sales of the top ten list: Plavix is still second, sales of $7300000000.
(three) the focus of pharmaceutical patent litigation
Patent protection of pharmaceutical and chemical fields theme: compound and preparation method and application thereof, composition and its preparation method and application thereof. Compound patent protection is the chemical structures of the new compounds. The composition of patent, including the old compound new formula, new preparation etc.. Use patent may be included in the class. Generic company, challenge, original research drug counterattack patent disputes focus, often focused on the composition of patent, patent known compounds and preparation method of patent. For example: sustained release preparation of patent, patent new crystal known compounds and synthetic method of patent.
(four) patent litigation big also the world pharmaceutical major
This simple new drug application most enterprises to America FDA, which challenges the original research enterprise patent medicine enterprises the highest number of litigation patent dispute case, is the largest enterprises, the top six are: Teva pharmaceutical company of Israel American; Barr Laboratories Inc; MYLAN pharmaceutical company America; APOTEX pharmaceutical company Novartis Canada; the Sandoz pharmaceutical company; Ruan pharmaceutical company in India.
Novartis of Switzerland is one of the pioneers of transformation of large pharmaceutical companies to the field of generic drugs, the acquisition of Sandoz, strong performance the generics business to make up for its brand prescription drug business weakness. India pharmaceutical enterprises generic R & D capability of global first, Nguyen pharmaceutical company in India is the third largest pharmaceutical company.
(five) between the two sides advantages can be transformed
The original drug research and generics firms is the contradiction between the two sides, the respective advantages, can be transformed by their own patent and its legal status change. For example: passive, active, or take the initiative and passive, end. Generics firms during imitation once acquired its own patent, prior generics firms immediately into weapons to patent, V. after generics firms or the original drug research of patent infringement. Between the enterprise first copy a patent medicine business and then a generic version of the drug, patent litigation gradually increased.
(six) a patent infringement case, the defendant, often involving a number of patents
In 2007 American Federal District Court 155 drug patent infringement case in the first, involving 126 kinds of drugs, litigation patent of 255. Number of patent infringement litigation, the defendant has two or more than two, litigation patent two or two above.
For example: Fosamax treatment of osteoporosis developed by Merck Co (Alendronate Sodium Tablets), which is the main chemical compositions of alendronate sodium. Merck Co sued Teva pharmaceuticals, Barr, Watson, Ivax, Apotex, Cobalt and Mylan seven companies violated its Fosamax patent. The USA 9 patents: US 5358941, US 5681590, US 5849726, US 6008207, US 6090410, US 6194004, US 5994329, US 6015801, US 6225294.
(seven) and pharmaceutical enterprises litigation pretrial lower proportion
Reconciliation is not but the end result many patent litigation, in many cases, is the most important one of the solutions. It is reported American only less than 5% of the patent litigation to trial ended [ Lin Yisi: "in the America how to use patent 'China' and 'shield'", China intellectual property news, 2008-5-28]. However, pharmaceutical enterprises is an exception, although the data indicated the patent patent litigation cost increased significantly, but pharmaceutical companies court litigation reconciliation before proportion is low.
The patentee and the infringer pre-trial reconciliation often signed a patent license agreement. However, because the development of new pharmaceutical enterprises with high risk, high profit industry characteristics, and imitation cost is very low, so the pharmaceutical patent right people are usually reluctant to sign a patent licensing agreement, make the market, but to have fought well, try to monopolize.
Although the appellate court of Appeals for the federal circuit, about half of the cases before the judgment of Circuit Chief [ Federal Judge Michel presented his "State of the Court" (Draft) On May 2008, 15,], but the drug patent infringement case before the judgment is less settled. According to incomplete statistics, in 2007 American Federal District Court on drug patent infringement cases in which 155 early, before the court and only 15 (including the plaintiff and defendant reconciliation).
(eight) the features and the pharmaceutical enterprises litigation pretrial
In recent years, a remarkable characteristic of pharmaceutical enterprises of lawsuit reconciliation is signed a "comprehensive agreement". That is: the two sides in the agreement, often more than one patent dispute cases, more than one patent, a drug production, sales, as well as the rights and interests involving more than one country or region, to comprehensively "licensing", mutual compromise, mutual use, achieve a win-win objective. This also proves that: the strong weak, the weak variable is strong, the key lies in whether has the independent intellectual property rights.
In 2008, Pfizer and Ranbaxy laboratories Ltd. India, on a global scale all involve the Lipitor patent litigation, is a typical "a comprehensive agreement", an agreement, the two sides to resolve the dispute of patent in 12 countries. According to the agreement, Pfizer permit south, in November 30, 2011 the America patent expires, sales Lipitor and Caduet generics. Caduet is a drug containing atorvastatin and amlodipine two active ingredients, the treatment of hypertension and hyperlipidemia. The agreement also identified new sales generics in the seven other countries in time. The seven countries are: Holland, Belgium, Canada, Germany, Sweden, Italy and australia. Through this agreement, both sides also solves the country in a few Malaysia, Brunei, Peru and Vietnam's Lipitor disputes. Tort litigation Pfizer is Lipitor and Caduet mentioned in these countries will be withdrawn. While the new commitment, no longer challenged the validity of Pfizer's patent. The agreement also solves the Pfizer and Ranbaxy in American of quinapril patent litigation, as well as in the Viagra patent litigation in Ecuador.
A patent relating to the agreement: the most basic compounds in USA Lipitor patent, due date is 2010; enantiomer patent, in USA due date is 2011; and various preparation methods and crystalline patent, maturity of 2016 to 2017. Pharmaceutical compositions of Caduet patent expiration date is 2018.
Both sides believe that this comprehensive agreement is a win-win: beneficial to patients, conducive to competition, conducive to the protection of intellectual property rights.
(nine) patent litigation to the patentee to protect the patent and patent imitation challenge significantly increased the cost of
Patent cases belong to the complex case, which relates to pharmaceutical patents, more belonging to the complex case, so the lawyer fees are high. A patent infringement case, often involving multiple defendants. A patent infringement case, often involving patents. But reconciliation pharmaceutical enterprises litigation pretrial ratio is low, the end of the first instance, may appeal again, take years. All these factors together, resulting in patent infringement litigation costs remain high, so that the patentee to protect the patent and patent imitation challenge the sharp rise of the cost of.
(ten case), differentiated
American Federal Circuit Court of appeals of patent rights and infringement dispute case trial, sometimes with a double standard signs. The so-called case, differentiated.
For example: in the Amgen v. ITC and Roche Diagnostics (Fed. Cir. 2008) of a case, Amgen will import of Roche's lawsuit, think about the violation of provisions of imported production by the patent method in terms of prohibited products 337. Roche is the import of recombinant human erythropoietin (EPO) behavior, seek the sued tortious immunity, think that 271 (E) (1) required by the DNA, RNA and reorganization of biotechnology in the production of pharmaceuticals for human use of the "safe harbor" should explain the "safe harbor" meaning: people of protection against network the design of the copyright under the environment of the network service provider liability limitation system, the so-called "safe harbor" (safe harbor) system. Typical is the 1998 USA through "Digital Millennium Copyright Law" (Digital Millennium Copyright Act). The main content:
First, prerequisite, the network service provider to enjoy the limitation of liability for the treatment of specific: (1) the network service provider to refuse to provide services for repeated infringement of the user; (2) measures the network service provider shall not intervention taken by the copyright holders to protect their copyright works logo or. Second, the provisions of the two kinds of limitation of liability for Internet service providers, so as to determine the applicable to the specific circumstances of the system of limitation of liability, namely the system or network storage network service providers of the infringing material circumstances and the Internet service provider information search tool. In the two case, the network service provider when certain conditions are satisfied, shall not bear the liability to pay damages, but only assume limited stop tort liability. After the "safe harbor" explanation of expanding into other areas. ] ", applicable to the case.
Amgen argued: 271 (E) (1) exemption should not apply to import business method patent products prepared. That the "safe harbor" should be applied only to "because of the America manufacturing, using, offering for sale or sold or imported into the American the patented invention" alleged infringers. But, as an extension, this exception does not apply to not included tort Infringement -- here is imported into product patent method.
The Federal Circuit Court of appeals that: should applicable statutory exceptions, and extending explanation. In view of the fact that the Supreme Court has judged: 271 (E) (1) provides exceptions should be extended to explain. The Merck v. Eli Lilly's case, the court also stressed: Congress reduced the patent barrier the purpose is to let the federal regulations approved pharmaceutical products. The Federal Circuit Court of appeals to maintain the committee decided: when the imported products is for use with the 271 (E) (1) exemption under the purpose, "the patent method of Safe Port Act applies to 337" under the terms of the.
Judge Linn in opposition in that: it was clear, Congress is likely to be consciously make safe harbor provisions including ITC, although the "safe harbor" itself, the terms are not so. But in fact has been extended to.
Notable is, that court decision: 271 (E) (1) of all "safe harbor" does not exempt the defendant seeking FDA approval behavior, need to undertake a case.
The home has commented: Congress does not want to be 271 (E) (1) the provisions of interest, as to the domestic pharmaceutical companies, extending to a foreign pharmaceutical company, or it may be consciously stop the FDA has not approved the import of medicines. Obviously, this is a typical differentiated.
Three, the Federal District Court in 2007 USA pharmaceutical patent infringement cases statistics at
American each year about 2000 to 3000 patent lawsuits [ Lin Yisi: "in the American how to use patent 'China' and 'shield'", China intellectual property news, 2008-5-28], and according to not complete the preliminary statistics, in 2007 USA drug patent infringement cases at the beginning of 155.
(a) the drug
The original drug research company v. generics firms patent infringement case 155 (including several defendant and plaintiff prosecution in a court). 155 cases of infringement lawsuit, involving 126 kinds of drugs, there are 29 kinds of medicine, patent prosecution in two or more than two district court. The above USA included in annual sales of 1000000000 (including 1000000000) 31 kind of drug, the drug accounted for 24.6% of the total number of. In 2007 global sales of the top ten list: Lipitor, are still the first, with sales of $13500000000 or second; Plavix, sales of $7300000000; Nexium followed, ranked third, with $7200000000 in sales. Lilly's Zyprexa global sales of 5000000000, accounting for sixth [ double Crane Pharmaceutical Market Intelligence Center compilation: "America" pharmaceutical management "magazine 2007 annual global pharmaceutical enterprise 50 strong" "China Pharmaceutical News" in June 5, 2008].
(two) the patent number
The original drug research company v. generics firms 155 patent infringement litigation, 255 patents.
Pharmaceutical patent infringement lawsuit defendant often have two or more than two. 17 kinds of drug patent infringement lawsuit defendant has two or more than two. Even the defendant reached 14 enterprises many patent infringement lawsuit.
(three) the more generic, more the number of the defendant
The number of generic drugs and become the defendant is proportional to the number of infringement, imitation is more, the more. This simple new drug application most enterprises to America FDA, is the most challenging research generics, patent up to the enterprise, but also the litigation patent dispute case most enterprises, including: Israel's Teva pharmaceutical experience 49; American Barr pharmaceuticals in 20; America MYLAN experience 19; Canada APOTEX involving 17; Novartis mountain Taoist experience 16; India's laboratory in 13.
Among them, the original drug research first imitation, which is the first challenge original research drug patent pharmaceutical enterprises, America law can enjoy 180 day exclusive period. The first challenger, often have a strong R & D strength and use the law. Israel's Teva pharmaceutical topped the list, followed by America Barr pharmaceuticals, APOTEX MYLAN , India America Ranbaxy, canada.
In 2007 four, USA Federal Circuit Court of appeals pharmaceutical patent dispute appeal statistics
American Federal Circuit Court of appeals to accept American all patent appeals, including violation of the 337 terms of the patent infringement case, the vast majority of patent cases to the court of final appeal. These cases are the main contents of the case law [forest Yisi: "in USA how to use patent 'China' and 'shield'", Chinese intellectual property news, 2008-5-28].
(a) the number of cases and the number of patents
In 2007 USA Federal Circuit Court of appeals trial drug patent appeal cases 26, involving 39 American patent.
(two) according to the professional classification of case number
Appeal, according to professional classification: 8 cases involving patent agents; 6 cases involving medical patents; 5 cases involving chemical drug patents; 3 cases involving biological pharmaceutical patent; otherwise legal procedures and other case 4.
(three) according to the classification of legal issues in the case number
A court case, often involving several legal issues. The appeal case, according to the legal classification: relates to previously held case 4 cases; 9 obviously involves; relates to claim interpretation and case infringement involving 9 pieces; specification does not support the claim case 2; involved in wrongdoing, 2 pieces of unenforceable.