j*******1
发帖数: 266 | 1 我前不久在这里问过一个问题，得到了几位网友的帮助，在此表示感谢。
我很有一个类似的问题。我有一个想法：就是说美国FDA目前的批准药物方法有很大的缺陷，使本来应该上市的药不能上市。我想先得到专利后，在想方法说服FDA改变目前的批准药物标准。这样，就会有大量以前不能上市的药变成可以上市，对病人和药厂都有巨大的利益。
我不知这个想法有无可能得到专利局的批准？ | B*****t
发帖数: 3012 | 2 這個和專利局有啥關係....
能拿到專利常常(或者大多數情況下)得不到FDA批准...
的缺陷，使本来应该上市的药不能上市。我想先得到专利后，在想方法说服FDA改变目
前的批准药物标准。这样，就会有大量以前不能上市的药变成可以上市，对病人和药厂
都有巨大的利益。
【在 j*******1 的大作中提到】
: 我前不久在这里问过一个问题，得到了几位网友的帮助，在此表示感谢。
: 我很有一个类似的问题。我有一个想法：就是说美国FDA目前的批准药物方法有很大的缺陷，使本来应该上市的药不能上市。我想先得到专利后，在想方法说服FDA改变目前的批准药物标准。这样，就会有大量以前不能上市的药变成可以上市，对病人和药厂都有巨大的利益。
: 我不知这个想法有无可能得到专利局的批准？
| j*******1
发帖数: 266 | 3 这个药涉及到很多尚未得不到FDA批准的药物。如我这个idea 得到专利局的批准，那我
就会想方法让美国FDA修改它的一些批准程序，使那些得不到FDA批准的药物得到批准。
这就相当于变废为宝。而个宝贝并不是通过一个方法，而是说那些废物并不是废物，而本来就是宝贝，只不过FDA没有认识到。
【在 B*****t 的大作中提到】
: 這個和專利局有啥關係....
: 能拿到專利常常(或者大多數情況下)得不到FDA批准...
:
: 的缺陷，使本来应该上市的药不能上市。我想先得到专利后，在想方法说服FDA改变目
: 前的批准药物标准。这样，就会有大量以前不能上市的药变成可以上市，对病人和药厂
: 都有巨大的利益。
| c******n
发帖数: 16403 | 4 There is a reason or reasons why FDA adpoted their current protocols, it wou
ld be way much harder than you believe to change their well-establised proto
cols. Or I should say, you are over-confident.
而本来就是宝贝，只不过FDA没有认识到。
【在 j*******1 的大作中提到】
: 这个药涉及到很多尚未得不到FDA批准的药物。如我这个idea 得到专利局的批准，那我
: 就会想方法让美国FDA修改它的一些批准程序，使那些得不到FDA批准的药物得到批准。
: 这就相当于变废为宝。而个宝贝并不是通过一个方法，而是说那些废物并不是废物，而本来就是宝贝，只不过FDA没有认识到。
| j*******1
发帖数: 266 | 5 You might be right, however, I have a very good reason to argue with them.
They might not change their policy. I just like to know it possible to
patent the idea in US.
wou
proto
【在 c******n 的大作中提到】
: There is a reason or reasons why FDA adpoted their current protocols, it wou
: ld be way much harder than you believe to change their well-establised proto
: cols. Or I should say, you are over-confident.
:
: 而本来就是宝贝，只不过FDA没有认识到。
| I*****n
发帖数: 154 | 6 How do you show reduction to practice of your idea? You haven't reduced
your method to actual practice, since you have not practiced your method
with FDA yet. If you argue that you have reduced to practice conceptually,
it might fall into the category of abstract idea which is nonpatentable
subject matter. | B*****t
发帖数: 3012 | 7 你的專利是說服FDA的方法?
的缺陷，使本来应该上市的药不能上市。我想先得到专利后，在想方法说服FDA改变目
前的批准药物标准。这样，就会有大量以前不能上市的药变成可以上市，对病人和药厂
都有巨大的利益。
【在 j*******1 的大作中提到】
: 我前不久在这里问过一个问题，得到了几位网友的帮助，在此表示感谢。
: 我很有一个类似的问题。我有一个想法：就是说美国FDA目前的批准药物方法有很大的缺陷，使本来应该上市的药不能上市。我想先得到专利后，在想方法说服FDA改变目前的批准药物标准。这样，就会有大量以前不能上市的药变成可以上市，对病人和药厂都有巨大的利益。
: 我不知这个想法有无可能得到专利局的批准？
| j*******1
发帖数: 266 | 8 I can not to practice my idea, as it needs FDA realizes its problem with
current regulation, and modifies its regulation.
If FDA does not change their regulations, drug companies might still benefit
from the idea, as they can go other countries with different rule to
practice it.
Other way I think might work is that I file a provisional patent, and
publish it and try to convince drug companies or somebody to push FDA change
its regulation.
At time, they review my application, FDA might do something then.
【在 I*****n 的大作中提到】
: How do you show reduction to practice of your idea? You haven't reduced
: your method to actual practice, since you have not practiced your method
: with FDA yet. If you argue that you have reduced to practice conceptually,
: it might fall into the category of abstract idea which is nonpatentable
: subject matter.
| j*******1
发帖数: 266 | 9 当然不是。專利是保护我的IDEA。 有没有專利，FDA都可能改变或不改变它的政策。
但如果本来能得到專利，而我又没去做，就可惜了。
【在 B*****t 的大作中提到】
: 你的專利是說服FDA的方法?
:
: 的缺陷，使本来应该上市的药不能上市。我想先得到专利后，在想方法说服FDA改变目
: 前的批准药物标准。这样，就会有大量以前不能上市的药变成可以上市，对病人和药厂
: 都有巨大的利益。
| z******n
发帖数: 336 | 10 关键是fda和uspto根本就是不同的政府部门，审查不同的东西，之间没有从属关系
你的发明符合不符合颁发专利的要求决定于uspto，和fda没关系
你的发明安全不安全有没有药效决定于fda，和uspto没关系
benefit
change
【在 j*******1 的大作中提到】
: I can not to practice my idea, as it needs FDA realizes its problem with
: current regulation, and modifies its regulation.
: If FDA does not change their regulations, drug companies might still benefit
: from the idea, as they can go other countries with different rule to
: practice it.
: Other way I think might work is that I file a provisional patent, and
: publish it and try to convince drug companies or somebody to push FDA change
: its regulation.
: At time, they review my application, FDA might do something then.
| | | j*******1
发帖数: 266 | 11 我的问题是发明符合不符合uspto颁发专利的要求，和US FDA是否同意更改政策无关。
即使US FDA不同意更改政策，其它国家也可能同意更改。
【在 z******n 的大作中提到】
: 关键是fda和uspto根本就是不同的政府部门，审查不同的东西，之间没有从属关系
: 你的发明符合不符合颁发专利的要求决定于uspto，和fda没关系
: 你的发明安全不安全有没有药效决定于fda，和uspto没关系
:
: benefit
: change
| B*****t
发帖数: 3012 | 12 這種涉及101的問題,最高法院不研究都不清楚
你這裡就想問個結果嘛?起碼也得更詳細的說一下到底是怎樣的idea
【在 j*******1 的大作中提到】
: 我的问题是发明符合不符合uspto颁发专利的要求，和US FDA是否同意更改政策无关。
: 即使US FDA不同意更改政策，其它国家也可能同意更改。
| s*******1
发帖数: 135 | 13 申请专利不能引起FDA的注意。你发表你的想法，引起关注后才会引起注意。 | j*******1
发帖数: 266 | 14 谢谢几位的回答。一周前，我已FILE 了provisional application to USPTO,
我把它放在下边，请大家看看：
Treating Patients with Potential Therapeutic Drugs
Major development of the Western medicine is from discovery of new medications, the United States is the country with biggest pharmaceutical companies in the world, and the companies follow the U.S. FDA guidelines. However, the guidelines have significant limitations.
Conceptually, according to the drug treatment, disease may be divided into three types.
1. Disease can be treated with a single drug effectively
some diseases can be cured with a single drug. For example, E. coli causes urinary tract infections, and Staphylococcus aureus cause lobar pneumonia. Antibiotics are the cure for the diseases.
2. Diseases can be treated effectively by different drugs separately
the second type of diseases is that different drugs may have therapeutic effects on them. There are many drugs which either cure or control its symptoms, examples are hypertension, diabetes, AIDS, asthma, gastric ulcer, and so on. Treatment of hypertension alpha blockers, beta blockers, calcium channel blockers, ACE against the agent and so on. These drugs can alone produce antihypertensive effects, and taking several drugs together can produce a stronger antihypertensive effect. Cocktail recipes for dealing with AIDS, as well as formulations treatment of gastric ulcer drug are each individually have a role, and together with the better.
3. Diseases can be only effectively treated with different drugs together
the third type is that the disease can be treated effectively only with several relevant simultaneously to achieve desired therapeutic effects.
Even patients with the same disease, Some of them respond well to drugs, while other do not, such as rheumatoid arthritis, schizophrenia, depression, drug dependency, and so on. Some of them may have the second type of disease, while some have the third, although their disease have same name.
New drug development is a very costly and time-consuming process. It will take around 15 years and more than a billion dollars for a new drug to be approved and go into market. A new drug is almost all one compound. FDA does not exclude the possibility to have multi-components in drugs. However, high cost of the test would make it impossible.
Drugs to treat type 1 & 2 diseases can proved to be safe and effective in the FDA guidelines, as it only requires to test one compound. The type 3 diseases need several compounds in the trials at same time, which cannot be done due to unbearable costs.
We do not know what disease falls into the third type, what we know is that there is no effective ways to treat or cure cancer, autoimmune diseases, and developmental disorders. Some or many of them may belong to the type of disease.
Under the current FDA rules, a compound must pass the safety and efficacy testing to get approval for clinical use. I call compounds or drug Safety Passed & Efficacy Approved Drug (SPEAD). Another class of compound might passes the safety test, but did not pass efficacy test, or the test is not complete or the test not done. I call the compound Potential Therapeutic Drug (PTD), as they must be a part of required compound to treat the third types of disease, and fails efficacy test due to lack of other relevant compounds in the trials. The FDA guidelines filter out all of the PTD which leads to lack of proper treatment of the third class of diseases.
Essence of this invention is to use PTD in clinical practice.
Safety of PTD is comparable with SPEAD. Patients who take PTD would not bear more risks compared with ones who take SPEAD. Using one or a few PTD, combining with one or a few SPEAD might have four possible clinical outcomes:
1) Combination is not safe & ineffective. That people do not apply this combination.
2) Combination is not safe, but effective. If so, treating physician should evaluate nature of side effects, and benefits it brings. If side effects are nausea and vomiting, or limb weakness, but it prolongs the life, people should continue to use this combination. If the patients have fibrillation, and that combination should be disbanded.
3) Combination is safe, but ineffective. That is to say with this combination has no effect on the condition, it is not useful.
4) Combination is safe and effective. This is what people aim to.
At the moment, doctors cannot use PTD, so there is no data to tell patients what combination, at what circumstances any combination would benefit patients. With the PTD application, the doctor will soon find out what combination would benefit what kinds of the patient at what circumstances
This invention states that PTD might be and should be used to treat many medical conditions and major targets of PTD treatment would be patients with serious medical conditions such as advanced cancer, Alzheimer's disease, etc., adverse reactions may be limited and put under control, the PTD may significantly improve the medical conditions, or even give a new life to patients. | L**P
发帖数: 3792 | 15 这就是专利的全部内容么？uspto不会对provisional application做任何审查的，就是
个文件备份而已，期待你在一年内(超过一年文件备份功能失效）再把这pro转正成
utility application进入审查，然后大家再拭目以待进展
medications, the United States is the country with biggest pharmaceutical
companies in the world, and the companies follow the U.S. FDA guidelines.
However, the guidelines have significant limitations.
three types.
urinary tract infections, and Staphylococcus aureus cause lobar pneumonia.
Antibiotics are the cure for the diseases.
effects on them. There are many drugs which either cure or control its
symptoms, examples are hypertension, diabetes, AIDS, asthma, gastric ulcer,
and so on. Treatment of hypertension alpha blockers, beta blockers, calcium
channel blockers, ACE against the agent and so on. These drugs can alone
produce antihypertensive effects, and taking several drugs together can
produce a stronger antihypertensive effect. Cocktail recip: es for dealing
with AIDS, as well as formulations treatment of gastric ulcer drug are each
individually have a role, and together with the better.
【在 j*******1 的大作中提到】
: 谢谢几位的回答。一周前，我已FILE 了provisional application to USPTO,
: 我把它放在下边，请大家看看：
: Treating Patients with Potential Therapeutic Drugs
: Major development of the Western medicine is from discovery of new medications, the United States is the country with biggest pharmaceutical companies in the world, and the companies follow the U.S. FDA guidelines. However, the guidelines have significant limitations.
: Conceptually, according to the drug treatment, disease may be divided into three types.
: 1. Disease can be treated with a single drug effectively
: some diseases can be cured with a single drug. For example, E. coli causes urinary tract infections, and Staphylococcus aureus cause lobar pneumonia. Antibiotics are the cure for the diseases.
: 2. Diseases can be treated effectively by different drugs separately
: the second type of diseases is that different drugs may have therapeutic effects on them. There are many drugs which either cure or control its symptoms, examples are hypertension, diabetes, AIDS, asthma, gastric ulcer, and so on. Treatment of hypertension alpha blockers, beta blockers, calcium channel blockers, ACE against the agent and so on. These drugs can alone produce antihypertensive effects, and taking several drugs together can produce a stronger antihypertensive effect. Cocktail recipes for dealing with AIDS, as well as formulations treatment of gastric ulcer drug are each individually have a role, and together with the better.
: 3. Diseases can be only effectively treated with different drugs together
| k*********h
发帖数: 1841 | 16 "With the PTD application, the doctor will soon find out what combination
would benefit what kinds of the patient at what circumstances."
这不是说直接在人体上做PTD的试验吗？而且你写NPA的时候,spec.是不能建立在假设的
结果上面的。 | j*******1
发帖数: 266 | 17 PTD是已经经过至少是II 期试验，证明安全的化合物，因为在只能试一个化合物的情况
下 (费用太高），无法证明它们有效。既然是安全，而又没有别的可行的办法，为什么
不让病人试一试？
【在 k*********h 的大作中提到】
: "With the PTD application, the doctor will soon find out what combination
: would benefit what kinds of the patient at what circumstances."
: 这不是说直接在人体上做PTD的试验吗？而且你写NPA的时候,spec.是不能建立在假设的
: 结果上面的。
|
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