Cheaper woodies

[Scooter]

Pharmaceutical companies haven't managed to make profits under the current rules? Can you name any industry that has consistently been more profitable?

[Sue U]

We have two concerns being expressed here. Fang’s’ is for a cheap erection mine is for the economic health of my country. I thick mine is a lot more desperate. If Scooter fails to obtain an erection would there be that much harm done? On the other hand if the economy of my country falls there will be a lot of pain, enough said.

You have got to be fucking kidding me. You think the US pharmaceutical industry is in such dire straits that it's in danger of collapsing -- and taking the US economy with it -- over one lousy patent case? Let me tell you, the US pharma industry is doing much better than fine. It has been so awash in cash that it actually doesn't know what to do with all the money it's piling up.

I am somsewhat conflicted we are need cheaper pharmaceuticals, but we also need financially healthy U.S. corporations to pay taxes and employ us citizens. When patent holders have to reveal all the details of their inventions it helps pirates steal their products. Why couldn’t this info be places in some type of secure escrow for the duration of the patent?

As has already been explained, the quid-pro-quo of getting patent protection and EXCLUSIVE rights to marketing a product for a set period is making the details of that product public, so that others can build on the ideas and thereby advance science and technology. Moreover, if you don't let anyone else see it, no one will be able to know whether your "new" patent is actually infringing on someone else's intellectual property rights. If someone illegally uses your patent during its period of exclusivity, you can seek legal recourse and enforcement of your rights.

Edited to insert dropped letters.

[Long Run]

Great, net result will be more spam selling us cheap Canadian drugs.

[rubato]

Great, net result will be more spam selling us cheap Canadian drugs.

Get a life.

The "cheap Canadian drugs" are the same drugs made in the same factories as the 5x more expensive versions that BushCo regulation requires you to pay for.

Moron.

BushCo = Fuck You, America.

yrs,
rubato

[Andrew D]

There are three basic reasons for requiring that a patent specification must "contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains...to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention."

Two have already been pointed out:

(1) It advances "the Progress of Science and useful Arts" (U.S. Const., Art. I, Sec. 8);
(2) "Moreover, if you don't let anyone else see it, no one will be able to know whether your 'new' patent is actually infringing on someone else's intellectual property rights.

The third is the converse of the second:

(3) If you don't let anyone else see it, no one will be able to know whether her or his "new" patent is actually infringing on your intellectual property rights. It would hardly be fair for you to be able to sue me for infringing on your patent rights, if you were the one who prevented me from ascertaining your patent rights in the first place. If you want me not to violate your rights, it is your duty to tell me what your rights are.

[Econoline]

I'm a complete layman with absolutely no law school education, and I somehow knew all that. I used to believe dgs when he said he was a lawyer but it's pretty hard for me to believe that anymore.

Let me tell you, the US pharma industry is doing much better than fine. It has been so awash in cash that it actually doesn't know what to do with all the money it's piling up.

I'd suggest the usual corporate investment--buy politicians!--but apparently they already own plenty of 'em and don't need any more...

[Andrew D]

I'm a complete layman with absolutely no law school education, and I somehow knew all that. I used to believe dgs when he said he was a lawyer but it's pretty hard for me to believe that anymore.

It is hubris, Econoline. There is a lamentably strong tendency among lawyers to believe that because they succeeded in law school, and because they passed the bar exam in some jurisdiction or other, they are qualified to opine competently about any area of law.

That is, of course, not true. I earned my JD at a top-tier law school, I passed the California bar almost effortlessly, and I am widely acknowledged as being exceptionally good at what I do. And what I do is fairly broad:

--> I am a property-insurance specialist, and the knowledge gained from that makes me more than competent at other forms of insurance.

--> I know how to write contracts -- retail contracts, trademark licensing agreements, etc. -- and I know how to rip apart the contracts written by my (my clients') opponents.

--> I know (for other reasons) a great deal about international human-rights law and the international law governing the relations among states and putative states.

I am also widely acknowledged as being a reliable opiner on the aspects of constitutional law on which I choose to opine. I can back up my opinions with the authorities which support them.

But there are things about which I know fuck-all. The merits of the New York vs. New Jersey dispute over the ownership of Ellis Island? I haven't a clue. (When the dispute first came to my attention, my first thought was that the US owns the whole thing, so how could the dispute even matter? That shows you how much I knew about it.) Whether the primary responsibility for the failure of levees in California lies with the State of California or with the US Army Corps of Engineers? I haven't the vaguest notion. Etc., etc., etc.

And I am not afraid to say so.

And that, I think, is how it ought to be. Yes, I am a lawyer. Yes, that means that I know a great deal more about the law than do people who are not lawyers. (Just as nuclear physicists know a great deal more about nuclear physics than do I, Sino-Soviet historians know a great deal more about Sino-Soviet relations than do I, etc.)

But that does not mean that I am an expert in everything about the law. And it would be wrong of me to say that I am.

[Big RR]

You have one other charcteristic of lawyers, andrew (at least the good ones), when you don't know something you research (or remain silent) it rather than speaking out of your ass. It's what makes your comments particularly valuable; a little research goes a long way.

[dgs49]

As anyone who has ever actually gone to law school knows, patent law is a separate and esoteric area of the law. It requires that you pass a separate bar exam (in addition to the state bar), and, like tax law, it is an area of law that "normal" lawyers steer very clear of unless they absolutely know the specifics of the particular question.

When I wrote that "I am not en expert on the subject," my intention was to call attention to the fact that I am not an expert in patent law. Apparently this is too subtle for some of you.

But what I do know is that I have worked for several companies during the process of preparing patent applications, and there was in these many brainstorming sessions a conspicuous and not subtle effort to articulate the "claims" in a way that made it difficult for anyone else to duplicate the invention without a considerable investment in time and expertise. For those who care, consider the requirement for a "synergistic" aspect of the invention, meaning basically that the invention provides benefits that are not obvious or entirely predictable, even for a subject-matter expert. That's what makes the invention patentable.

Oddly enough, I would be curious to read rubato's musings on this thread, since I believe he is the only one here who regularly goes through a process that is analogous to what Pfizer does with the patenting of a new drug. Does the inventor disclose enough IN THE PATENT APPLICATION to enable a competitor to duplcate the invention?

[Gob]

You actually believe that?

Of all the weird and wonderful things you've said here Dave, that takes the biscuit!!

[Scooter]

As anyone who has ever actually gone to law school knows, patent law is a separate and esoteric area of the law. It requires that you pass a separate bar exam (in addition to the state bar), and, like tax law, it is an area of law that "normal" lawyers steer very clear of unless they absolutely know the specifics of the particular question.

And you had a patent lawyer (BigRR) tell you that you "interpretation" of the law was completely out to lunch.

But what would he know?

[Big RR]

Dave--I think you're confusing the issue; certainly any patentable invention must be nonobvious to those skilled in the art. And claims are often drawn quite broadly in an effort to cover as much as possible--while the most desirable/useful embodiments are sometimes claimed in specific claims, they often are not (indeed, if the most useful embodiments are developed after the filing of the application, these need not be disclosed specifically under the "best mode" requirements, the best mode known to the inventors at the time of filing is all that needs to be disclosed). So if you're saying that claims are often drafted to avoid drawing attention to the precise embodiments you plan to commercialize, then you are correct.

However, the law is quite clear that any patent application must teach those skilled in the art how to make and use the invention or it will be unpatentable; this is and always has been a requirement of US patent law (as well as the laws of the jurisdictions I am familiar with) for the reasons discussed above. Yes, is a range of compositions are claimed, and it is found (after filing) that 37% active ingredient is by far the best formulation, it need not be specifically disclosed (of course if this is known at the time of filing it must be), but one must teach what the active ingredient is, how to make or obtain it, how to compound the formulations, and any other information needed to make or practice the invention or face either not getting a patent or have it subsequently declared invalid. I have not seen the opinion of the Canadian court, so I don't know what the basis of the invalidation was, but I'd bet this is exactly what happened.

[Scooter]

The ruling:

Teva Canada Ltd v. Pfizer Canada Inc.

P[fizer] holds Patent 2,163,446 for the use of a “compound of formula (I)” or a “salt thereof” as a medicament for the treatment of erectile dysfunction (“ED”). The patent’s specification ends with seven cascading claims for successively smaller ranges of compounds, with Claims 6 and 7 relating to a single compound each. Only sildenafil, the subject of Claim 7 and the active compound in Viagra, had been shown to be effective in treating ED at the time of the patent application. Although the patent includes the statement that “one of the especially preferred compounds induces penile erection in impotent males”, the patent application does not disclose that the compound that works is sildenafil, that it is found in Claim 7, or that the remaining compounds had not been found to be effective in treating ED.

T[eva] applied for a notice of compliance in order to produce a generic version of Viagra. The Federal Court prohibited the Minister from issuing the requested notice of compliance. The Federal Court of Appeal dismissed the appeal.

Held: The appeal should be allowed. Patent 2,163,446 is void.

The patent application did not satisfy the disclosure requirements set out in the Patent Act, R.S.C. 1985, c. P‑4 (“Act”). The patent system is based on a “bargain”: the inventor is granted exclusive rights in a new and useful invention for a limited period in exchange for disclosure of the invention so that society can benefit from this knowledge. Sufficiency of disclosure lies at the very heart of the patent system, so adequate disclosure in the specification is a precondition for the granting of a patent.

Although s. 58 of the Act allows courts to consider valid claims separately from those that are not valid, and although valid claims survive in the face of one or more invalid claims, s. 58 is engaged only after the validity analysis is carried out. It does not allow a court to consider the validity of a single claim independently of the rest of the specification, even if the claim in question is the only one that may be valid. The lower courts held that each claim in the patent is a separate invention. As a result, they considered the disclosure requirements with respect to each individual claim, not to the specification as a whole. This confused the principle that the claims define the scope of the exclusive right being sought with the principle that the content of the specification determines whether the disclosure requirements have been met. The Act requires that the court consider the specification as a whole, which includes the claims and the disclosure, from the perspective of a person skilled in the art to determine whether the patent meets the disclosure requirements. Only where the specification as a whole shows that each claim in a patent application concerns a separate invention will the consideration of the disclosure requirements be limited to a single claim.

In this case, the disclosure in the specification would not have enabled the public “to make the same successful use of the invention as the inventor could at the time of his application” because it does not indicate that sildenafil is the effective compound. Considering the specification as a whole, the use of sildenafil and the other compounds for the treatment of ED comprise one inventive concept. Even though a skilled reader will know that, when a patent contains cascading claims, the useful claim will usually be at the end concerning an individual compound, the claims in the patent ended with two individually claimed compounds. There was no basis for a skilled person to determine which of Claim 6 and Claim 7 contained the useful compound, further testing would have been required to determine which of those two compounds was actually effective in treating ED.

Although s. 27 does not specify a remedy for insufficient disclosure, the quid pro quo underpinning the Act leads to the conclusion that deeming the patent invalid is the logical consequence of a failure to properly disclose the invention and how it works. If there is no quid — proper disclosure — then there can be no quo — exclusive monopoly rights. Even if s. 53 was not raised and its requirements were not met, this does not mean that the disclosure was adequate for the purposes of s. 27(3). These provisions can be independent of each other.

There is no question that sildenafil’s utility had been demonstrated as of the time of filing of the patent application. This takes the invention out of the realm of sound prediction. As to the delay of 13 years between the filing of the patent and the challenge, the relevant question is whether the disclosure was sufficient as of the date of filing, so the delay is inconsequential.

[Big RR]

thanks Scooter--it makes much more sense. Apparently the court here is saying that Pfizer did not disclose that sildenafil was the compound found to be effective, and that the patentees were disingenuous in trying to obscure this by suggesting other compounds were likewise effective; note that the court specifically states that the utility of sildenafil was known (to the applicants) at the time of the filing of the application, and the finding that the disclosure was insufficient as of this date.