Given second US and European pharmaceutical patent litigation case study - part of patent litigation case inspiration and reference

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

Enlightenment and reference to the second US and European pharmaceutical patent litigation case study - part of patent litigation cases
Zhou Heping of China Medicine University

The second partEnlightenment and reference to the patent lawsuit case
The collection of beauty, the European Pharmaceutical litigation cases, American and the European Patent Office and the European countries, to determine the patent examination and tort, some basic consistent, some significantly different. These cases and benchmark our patent examination and judicial practice with infringement is different, however, on the whole, with many different.
In these cases, the facts and law application, especially the admissibility of evidence, fact focus, thinking and practices, not only highlight the features of different countries, but also the particularity of pharmaceutical and chemical fields, has the certain enlightenment, for reference. Due to my limited level, understanding or the summary may have limitations and improper and errors, therefore each case are listed American Federal Circuit Court of appeals the case file, can be used for tracing. The case of European case originated from the German law provides English abstract ("The Bardehle Pagenberg IP Report" 2007 No. I to V phase).
　　　　
In the case of a, "preempt" [give] to determine capital English enlightenment and reference
The "notice USA possession" (i.e.: pre-existing novelty), similar to the provisions of the patent law of our country.
(a) the distinguishing feature is the inherent property of [known technology and "nature" or "essence" which is more accurate? And the case statement part unified], the claim does not possess novelty
Compared with the prior art, if different technical characteristics in the claim is the inherent attributes of the technical scheme, namely the differences existing in the prior art, only at the technical level or other reasons, the field of common technical personnel do not recognize this feature, or don't feel the need to express the characteristics of. In this case, the claim does not possess novelty.
The preparation method of patent disputes in Prilosec business case, America Federal Circuit Court of Appeals has carried on the elaboration to the problem. In the determination of novel pharmaceutical compositions, compounds, compounds such as crystalline hydrate of patent application, may refer to the ruling idea.
See Appendix: America Federal Circuit Court of appeals No. 04-1562 judgment (Abstract).
(two) "preempt" must be the compound
"Compounds that pre possession", must be a compound can be obtained. If there is evidence that, unable to obtain the compound in the invention of fashion, the compound is not a sense of patent law previously held, even have disclosed that the chemical structure of the compounds, and certainly the compound exists.
In other words, even if the document discloses the structure of a compound, but there is evidence that, when the system is unable to the preparation of the compounds of fashion, this did not disclose the preparation method of the compound literature not previously held evidence. At the same time, still need to have evidence to prove that: in the invention was made, preparing the compound method or device, such as a chiral HPLC, was a relatively new unpredictable technology. In addition, many times the compound preparation record of failure is the compound did not "preempt" evidence.
In the "substantially pure (+) - citalopram compound" patent dispute case, America Federal Circuit Court of Appeals has carried on the elaboration to the problem.
See Appendix: America Federal Circuit Court of appeals No. 07-1059 judgment (Abstract).
(three) the sales or sales certificate "previously held promise"
Identified by the court, evidence is: the number of sales transactions, the oil shipped to the customer specific price and standard contract, including the FOB agreed in the contract (FAS) [FREE ON BOARD (FOB) translation of international trade terms as "when the goods across the ship's rail at the named port of shipment, the seller delivers." ], the allocation of risk and responsibility of buyers and sellers.
The trial of a case, the patentee and attempted to use "free samples" as there is no "preempt" excuse. The court concluded that "this kind of behavior is sales, rather than free samples". But in the judicial practice of our country, a "free sample" is a public use management behavior.
In "a non hydrogenated canola oil" patent dispute case, American Federal Circuit Court of Appeals has carried on the elaboration to the problem.
See Appendix: USA Federal Circuit Court of Appeals in chapter 06-1265, -1302 judgment (Abstract).
　　　
(four) the German Federal Patent Court Interpretation of novelty destroying broad literature
The German Federal Patent Court requirements: prior literature disclosed and refers not only to the wording, also includes the full text understanding deformation obviously reading of the field of common technical personnel carefully after. According to the Federal Patent Court on the case decision, to destroy the novelty of the document should be broad interpretation of the European Patent Office, much wider than.
Think the European Patent Office: in just finished all the clinical experiment, can be found in second medical use is open; in other words, even if the prior literature suggests active use claim, second medical use is still a novelty, as long as the experiment did not complete.
However, the Federal Patent Court decided that, a few simple experiment it is enough to make patent novelty.
Lilly compound patent claims due to lack of novelty and inventive step, by the German Federal Patent court. The judgment and the European Patent Office in the olanzapine (case 3 Ni 21/04 [EU] case "Olanzapine") in the conflict set new standard of review. The Federal Patent Court did not comply with the European Patent Office decision (T158/96 and T 715/03). In the relevant patent application priority recently, Eli Lilly and company not all clinical trials open their completed, to the invention and experimental incomplete prior literature comparison, is different, can draw a line. However, the German Federal Patent Court think, prove therapeutic indications have been made public, does not need the clinical experiment. (Dr. Wolfgang Bublak provides English translation)
(five) the German Federal Patent Court sentenced shows no therapeutic literature also destroys novelty
German Federal Patent Court for revocation of the patent Merz of memantine (Case 3 Ni 59/05 [EU] - Memantine).
Memantine is the first drug novel compounds for the treatment of Alzheimer's disease. By Merz pharmaceutical sales, brand is Axura, Ebixa, Namenda and Memox. Memantine good sales momentum, in recent years, more than $one billion a year. The compound was invented in 1968, for the treatment of Alzheimer's disease and Parkinson's disease.
Merz won the European Patent 392059, the patent protection of new medical uses of memantine. Then, Merz and supplementary protection certificate (SPC, in Germany: 102 99 048), until 2014 the protection provided by. Barr pharmaceuticals subsidiary Pliva, according to the basic patent memantine and supplementary protection certificates corresponding invalid request. The German Federal Patent Court for revocation of the patent. The reason is the lack of revocation of patent novelty. The patent lack of novelty is a public document, which describes the clinical experiment of memantine against Alzheimer's disease. However, the experimental results suggest that the diamond compared with placebo, showed no therapeutic effect. This means that: as long as the aim is to cure the disease, regardless of whether the treatment is successful, will destroy the novelty of patent related purposes. This is consistent with the provisions of German case law, no (such as through clinical trials) proved that the therapeutic effect of drugs. Effect of its novelty and a document, is a comparative study of memantine and another drug for the treatment of dementia. The literature literally no explicit mention of Alzheimer's disease. But the reference textbook that Alzheimer's disease is a leading cause of dementia. (Dr. Wolfgang Bublak provides English translation)
(six) the German Federal Patent Court racemic compound effects of pure enantiomers of novelty
The German Federal Patent Court decision: racemic compound effects of pure enantiomers of novelty, and ordinary technical personnel in this field, it is easy to think of calcium salt instead of sodium salt. Therefore, revoke the pharmaceutical company Pfizer of atorvastatin patent (Case 3 Ni 36/05 [EU]). Atorvastatin is cholesterol lowering drugs, the world's best-selling, 2006 sales of $12900000000, a brand name is Lipitor and Sortis. Atorvastatin has several patents. The most important patent is the foundation of patent EP 247 Pfizer has 633. Later the European Patent EP 409 281, protection of calcium salts with pharmaceutically active enantiomers. The calcium salt is now listed product specific components. American, Spain and the Guaduoerwei hold therapeutic effects of atorvastatin specific enantiomer patent. However, Australia, Austria, Canada and Holland and the United Kingdom announced invalid. Germany now has also announced its invalid. The German Federal Patent Court confirmed the verdict; racemic compounds (two enantiomeric mixtures) effects of pure enantiomers of novelty. Therefore, the earliest atorvastatin patent are destroyed after the enantiomers of patent. Again, the court in the judgment of novelty clearly a more flexible approach with Germany, the European Patent Office "photo" novelty judgment method [explain "photo" the basic meaning of] the opposite. Although in the prior art only atorvastatin sodium salt, no atorvastatin calcium salt, but the court held that: ordinary technical personnel in this field it is easy to think of calcium salt instead of sodium salt, so that calcium salts have been disclosed. Pfizer has appealed to the Supreme Court, the final judgment may be 5 years later. (Dr. Wolfgang Bublak provides English translation)
Two, in the case of "non obviously" enlightenment and reference for decision
America "non obviously", similar to the patent law of our country creativity. Although USA, Australia, Britain and the European Patent Convention four laws are using "obviously" a word, but only America law did not "creative" statement.
On the non other factors obviously decision, such as "commercial success". The British court called "indirect evidence", and that is "secondary evidence". USA, Australia and Holland court called "business background evidence", in addition to "commercial success", including "long-term needs, and not be others found" etc..
(a) to determine a new salt compounds known creative
In the field of medicine, whether the new salt compounds known to creative, want to consider the following factors:
1, ordinary technicians in this field will according to the existing technology to produce a known compound salt motivation, depending on the nature is to solve the problem or the problem itself.
The scope and number 2, can choose the anions. Although theoretically be salt formation with a known compound anion infinite, but if you want to find a "suitable for the pharmaceutical industry" anion, must to [Cancel] "to the Pharmacopoeia and manual to check", to find a drug trial before the approval of salt. The number of the choice of anion has been reduced to 53. However, in the amlodipine besylate patent dispute case, do not have to value a pharmaceutically acceptable anion quantity. Because the clear and convincing evidence that: ordinary technicians in this field will give priority to benzene sulfonate, because of its known acid strength, stability and other known chemical properties has been reported in the existing data.
3, many experiments to support non obviously? According to the specific facts to determine. The new salt of known compounds, "without test several parameters", as long as a parameter test. The only parameter to test is the formation of new salt anion. This is a fundamental limit the number of experiments. In other words, if the parameters to change in more than one times, need to experiment, will with geometric gradient increasing.
4, not only because it is the "conventional experiment", to deny patent. To deny the patent is: in the prior art teaching or revelation of people to do this "conventional experiment". 103 the provisions the last sentence that "should not be negated method according to the invention patent made". Using existing techniques taught in "conventional experiment" to deny patent, whether the requirements to determine the appellant experimental motivation comes from the existing technology to teach, and the next experiment is "normal" does not affect the results.
5, the reasonable expectation of success, not the absolute guarantee of success.
6, the parties before (other relevant cases) fact action is directly adopted.
7, when the unexpected effect of non obviously as evidence, the unexpected effect must be have the effect compared with the closest prior art. Namely: comparison of the object must be the closest prior art.
8, about the non other factors obviously decision, such as "commercial success". The analysis of this commercial success is known compounds caused by itself, or the formation of new salt anion generated.
USA Federal Circuit Court of Appeals in amlodipine besylate patent dispute case, the above problems were discussed in detail. Draw ["found preferred value not invented by routine test, unless there is a There's no telling effect" conclusion. ].
See Appendix: America Federal Circuit Court of appeals No. 06-1261 judgment (Abstract).
　　　
(two) non obviously decision structure similar compounds
In the structure of similar compounds not obviously in the judgment, should be based on the prior art to determine all obviously. Some of the information teaching away from the invention: as in the prior art [reveal prior] tens of thousands of compounds selected three of the best compounds, which does not include the lead compound invention discloses the invention creation; prior art lead compounds toxicity or other side effects etc.. The prior art is a whole. If there are far from the invention of teaching, its essence is that has non obviously of evidence.
1, in the similar structure compounds not obviously in the judgment, is divided into two steps: the first is to analyze whether obviously according to the closest prior art to determine the lead compounds, lead compounds structure modification direction to consider.
2, according to the number of screening compounds and the effect and toxicity data, as a lead compound is selected Is it right? Obviously evidence.
3, analysis of structure modification direction is obviously, that is: in the prior art is revealed the structure-activity relationship.
4, benzene homologues with similar effect, and not expect the pyridine ring homologues have the same effect.
America Federal Circuit Court of Appeals in "thiazolidine two ketone derivatives" patent dispute case of structurally similar compounds not obviously judgment are described.
See Appendix: America Federal Circuit Court of appeals No. 6-1329 judgment (Abstract).
　　　
(three) the nature of unexpected make patent material creative
From the patent law perspective, a compound and all of its properties are inseparable, they are one. In comparison with the existing technology, ignoring any properties are no legal basis. New use of known objects cannot make known the thing itself to obtain patent protection. However, nature related to use and expects that not to.
1, to determine the composition of the creative, "reduce the mortality, nature also can reduce the side reaction of human immune," uses and unexpected is extremely important, ignoring the use and nature of such not expected to be wrong.
2, "in the prior art is taught from claims present any specific facts", this is the invention of creative evidence.
In the "anti snake venom composition" patent dispute case, American Federal Circuit Court of Appeals has carried on the elaboration to the problem.
See Appendix: America Federal Circuit Court of appeals No. 06-1507 judgment (Abstract).
　　　
(four) enantiomer separation or preparation is difficult and unexpected properties show that the non obviously
Enantiomeric compounds have not obviously, difficulties and expected and separation or preparation of less than about the nature of the. The compound forecasting enantiomeric nature of error, the enantiomers with non obviously.
In the "substantially pure (+) - citalopram compound" patent dispute case, America Federal Circuit Court of Appeals has carried on the elaboration to the problem.
See Appendix: America Federal Circuit Court of appeals No. 07-1059 judgment (Abstract).
(five) the pure compounds isolated from the mixture of the obviously judgment
The existing technology is a mixture, separated from the mixture of pure compounds. The applicant can not only because of the purity of the product can be patented as. But if the following three conditions, the pure compounds may have not obviously:
1, people do not know the existence of compound purified; or
2, in the prior art, do not know its active ingredients of the mixture; or
3, the purity of the compounds which are different from the nature and characteristics of known product, and is not only a difference in degree.
In addition, how to purify itself may be a patented invention.
If some of the best known properties of a mixture, in whole or in part from one specific components, or if the prior technology may allow ordinary technical personnel in the field of reasonably believe that is indeed the case, even if the existing technology has not concentrated or purification of the components of the purified compounds were taught, with respect to the mixture is obviously.
In the "ramipril stereoisomers" patent dispute case, America Federal Circuit Court of Appeals has carried on the elaboration to the problem.
See Appendix: America Federal Circuit Court of appeals No. 06-1530 judgment (Abstract).
(six) of ordinary skill in the art level and obviously recognized
"With ofloxacin and pharmaceutically effective therapeutic amount of acceptable carrier after mixing, the ear surface sites of infection administration". Non obviously affirmation of this invention, ordinary technical personnel in this field should be a family doctor or pediatrician or engaged in R & D, including pharmaceutical preparations and disease treatment, or after drug treatment of ear training expert? If it is a family doctor or pediatrician, has not obviously. If the latter, the invention is obviously.
In the "antibiotic ofloxacin ear surface local administration" patent dispute case, America Federal Circuit Court of Appeals has carried on the elaboration to the problem.
See Appendix: America Federal Circuit Court of appeals No. 06-1564 judgment (Abstract).
Enlightenment and reference three, the case of "full disclosure" decision to give
(a) instructions adequate public correlated with the unpredictability and claims
American patent law in the empowerment (enablement), or translated as "enable", refers to the ordinary technicians in this field to see published technology prospectus, without super conventional experiment, it can be repeated a claimed invention. This concept and the Chinese patent law required "disclosure fully" and / or "claim to be the most close to the description".
To note is: unenablement is a concept different from unenforceable, although the two terms in the patent is often translated as "not implemented". "Unenablement" is due to technical problems so that the public could not reproduce the claimed invention, its reason is the specification does not support the claim or the disclosure degree and scope. "Unenforceable" refers to the patent applicant in the application process of honesty and credit, such as the existence of "inappropriate behavior" (inequitable conduct), so that the patent "unenforceable". The concept of the patent law in China to "unenforceable" has no corresponding expression.
The Federal Circuit Court of appeals court [USA] think, "in a highly unpredictable domains, seek to protect broad rights, on its own patent disclosure must be in accordance with the patent law Fu can have high requirements, the burden of proof". For example: the claim can "choose any surface active agent" any concentration of the substance, including hundreds of surfactant. And, this field is highly unpredictable, the need for experiments, however defined in only three examples, are rarely taught. The claim is invalid because of the lack of the public and repeat the present teachings.
In the "megestrol acetate oral suspension" patent dispute case, American Federal Circuit Court of Appeals has carried on the elaboration to the problem.
See Appendix: America Federal Circuit Court of appeals No. 07-1093 judgment (Abstract).
(two) features to support
Functional characteristics in the claim, in the specification should have adequate support structure, otherwise the claim is not clear.
1, to a method and function defining the claim, it has two steps: A) must first identify qualified function; then, B) must read the instructions to find the corresponding structure function. If in the manual without a corresponding structure and functions defined in claim, the claim will be unclear and is found to be invalid. Because people don't know what is the method claims.
2, ordinary skill in the art of testimony and cannot replace the open structure should be defined in.
3, even if the detailed structure of the patentee has not publicly is well known in the art, the instructions must also discloses some structure.
4, just say to using known techniques or methods, this is not the open structure.
America Federal Circuit Court of Appeals for US 6602502 (502 patents) features "of functional claims control method" did not support the corresponding structure in the specification, determine the claims 13 and 40 invalid.
See Appendix: America Federal Circuit Court of appeals No. 06-1307 judgment (Abstract).
To determine the right and tort requires four, case
(a) the right to request the term meaning clear, need not resort to manual interpretation
The right to request the terms, if its meaning is clear, you don't have to resort to manual context interpretation. Only the claim itself does not explicitly expressed, only from the specification for definition or explanation context. Namely: first certainly "claim itself provides substantive guidance" on specific terms, then "defined in context is the dispute the best guide to lexical meaning".
In "containing a pharmaceutically acceptable polymer composition" patent dispute case, America Federal Circuit Court of Appeals has carried on the elaboration to the problem.
See Appendix: America Federal Circuit Court of appeals No. 06-1101 judgment (Abstract).
(two) specification "Markush" [give English and explains the basic meaning (see related comments on the 65 page section "718 patents on" a pharmaceutically acceptable polymer "with a closed word. The right to request the commonly used terms"...... A group of "( " group of ") to represent the Markush type, which is a series of choices listed in the claim. Markush type, by its nature, is closed. 718 patent describes "the pharmaceutically acceptable polymer" to "choose free PVP, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, ethylene vinyl acetate copolymer / crotonic acid, methacrylic acid copolymer, maleic anhydride / methyl vinyl ether copolymer and its derivatives and mixtures of water soluble hydrophilic polymers". The term language excludes other forms of polymers, such as hydrophobic or water insoluble substance (such as wax) ") ] expressions, does not limit the claim.
In the claim "Markush" form closed claim. But in the patent specification, "Markush" form does not have any meaning.
If a certain technical content, such as "the pharmaceutically acceptable polymer", in the specification with "Markush" form "the pharmaceutically acceptable polymer selected...... A group of hydrophilic polymer composed of "; while in the claim, the corresponding content is not" Markush "form, but with the" open "said" the polymer comprises......". This kind of situation, not because the specification "Markush" form, and the related claim is defined as "closed". As for the claims are manual support, is another question.
In "containing a pharmaceutically acceptable polymer composition" patent dispute case, America Federal Circuit Court of Appeals has carried on the elaboration to the problem.
See Appendix: America Federal Circuit Court of appeals No. 06-1101 judgment (Abstract).
(three) "mean." and "is the difference."
"Mean." (the original "means.") and "is" (the original "is.. .") difference.
In the specification "means." he gives the inventor is defined. On the contrary, "is.. ." does not explicitly considered the inventor is defined.
In short, what is the definition of the inventor's own expression are defined, which statement is not the inventor's own, according to the instructions on the overall problem description language similar to.
See Appendix: America Federal Circuit Court of appeals No. 06-1101 judgment (Abstract).
(four) "about"
US 4988515 patent claim the term "about" ("about"), avoid strictly defined values for certain parameters. The range must be based on technology and context to interpret. Consideration should be given to the "about" in the patent specification, review the history and other claims of how the application, should also consider changing the parameters related to the purpose of the invention can produce effect. The meaning and use of external evidence to help determine the parameters of the critical degree.
See Appendix: America Federal Circuit Court of appeals No. 06-1307 judgment (Abstract).
(five) "near" and "about"
The patent claim is to inform the public of its limits, namely the scope of protection. Whether to consider from two aspects: one is whether the distinction with existing technology; two is whether the infringer.
1, whether the claim of the terms in the clear, depending on whether the technical personnel in the field to understand the claim protected content. If the terms are inconsistent, or is ready to accept either course, even can not be explained, the claim is not clear.
2, these terms should be able to give a reasonable definition. is given "reasonable meaning" depends on the specific description. The following case, "near" describes the animal a part on the body, the animal body size difference caused by the difference of skin, courts that do not use accurate numerical measurement is not bad.
3, these terms should not only can be isolated from the existing technology closest to the invention, but also between the known technology and patent related many numerical constitute infringement, give clear information, otherwise the claim is not clear.
In the "removal of claw end long epithelial tissue laser excision of nail" patent dispute case ["near the front edge of the toenail" said close to or at the far edge of the epidermis, is clearly effective. ], America Federal Circuit Court of Appeals has carried on the elaboration to the problem.
See Appendix: America Federal Circuit Court of appeals No. 06-1455 judgment (Abstract).
(six) "the content of inorganic acid anion" and "accessories"
1, the right to request a specific value, in determining the protection scope, according to the method of the specific test data, extended to the allowed range of error.
2, how will the quantitative data in the claim compared with the allegedly infringing products? The right to request the quantitative value, in comparison with the allegedly infringing products, available relative comparison method, as long as to be able to determine the existence of the infringing products in technical characteristics in the claim, can prove tort. But, can only infer there was correlation between both sides, but cannot determine whether the infringement object has the right technology characteristics, does not apply to prove infringement.
3, "accessories" include coating tablet and capsule shell or the ingredients? This will take the document in the manual interpretation and review process, especially with the purpose of the invention to determine.
4, claim to "accessories" given the limited functionality, the scope of protection does not include the removed auxiliary materials associated with the functional specification.
In the "pharmaceutical compositions containing gabapentin" patent dispute case, America Federal Circuit Court of Appeals has carried on the elaboration to the above question.
See Appendix: America Federal Circuit Court of appeals No. 06-1572 judgment (Abstract).
(seven) "glycerin monostearate" is "equivalent replacement polymer"
According to the test function method, determination of glycerin monostearate is polymer equivalent. Glycerin monostearate is a hydrophilic, non polymeric material. However, when the product contains opposite characteristics and claim, with equivalent substitution theory may be legally [may not be fully] not sufficient in law.
See Appendix: America Federal Circuit Court of appeals No. 06-1101 judgment (Abstract).
(eight) estoppel prevents "Magnesium Oxide" equivalent "instead of an alkali metal or alkaline earth metal carbonate"
The original claim 1 in "a stabilized metal", in the review process, reduced to "alkaline earth metal carbonate". Clearly, which the applicant for a waiver of the [up] part narrow modification, including "Magnesium Oxide".
In "Moshe Pury and Magnesium Oxide hydrochloride containing stable composition" patent dispute case, American Federal Circuit Court of appeals are described [content of the problem...... ]: in the patent review process, the applicant to narrow the modification has to give up the part, no review of estoppel is based on, can not be used as the equivalent features in a tort action and then going back to.
See Appendix: America Federal Circuit Court of appeals No. 07-1074 judgment (Abstract).