Cheaper woodies

[Scooter]

OTTAWA — The Supreme Court of Canada has invalidated the Viagra patent held by pharmaceutical giant Pfizer, opening the marketplace to cheaper versions of the popular erectile dysfunction drug.

In a 7-0 decision, the high court sided with Teva Canada’s challenge of the legitimacy of the patent. It annulled Pfizer’s patent, saying it tried to “game” the system.

The decision has big implications for users of erectile dysfunction drugs and the pharmaceutical industry because it allows companies to create generic versions that are usually cheaper for consumers.

The Teva victory means the company can begin selling its own version of the drug.

The ruling wipes out Pfizer’s market dominance with Viagra. Its patent was to have expired in 2014.

The case also has broad commercial implications for patent law.

The Patent Act gives a company a 16-year monopoly on a product if it can prove it is a new invention.

In return, the patent-holding company must show publicly in its application how it created its product, so others can copy it later.

“Pfizer gained a benefit from the act — exclusive monopoly rights — while withholding disclosure in spite of its disclosure obligations under the act,” Justice Louis LeBel wrote on behalf of the court. “As a matter of policy and sound statutory interpretation, patentees cannot be allowed to ’game’ the system in this way. This, in my view, is the key issue in this appeal.

“Pfizer had the information needed to disclose the useful compound and chose not to release it.”

This case turned on whether Pfizer deliberately thwarted Teva’s ability to copy the key chemical compound of the drug.

Teva challenged the validity of the Pfizer patent, claiming it did not meet the law’s disclosure requirements.

In its original patent application, Pfizer listed a massive number of chemical compounds, but didn’t specify which was the one that actually worked.

Pfizer obtained the patent in 1998 after applying four years earlier. It was first challenged by the generic drug maker in 2007.

Teva originally questioned Pfizer’s patent in Federal Court and the Federal Court of Appeal, but lost at both levels.

I should think that Viagra users have a massive class action suit. If the patent was invalid from the outset, then they have all been paying much more for the drug than they should have.

[Lord Jim]

The decision has big implications

Yes, that would seem to logically follow....

[dgs49]

If the law is described accurately in this article, then Canadian law is stupid. Patent claims have to disclose what is special about the invention, but should not require that the inventor disclose enough for someone else to reproduce it.

Why on earth would any pharma company fully disclose how to produce its patented products - particularly one which would feed so easily into "black markets"?

Stupid law. Stupid result.

[Scooter]

Patent law is essentially the same all over. Applicants must disclose how the product they are seeking to patent achieves what they claim it does. That didn't happen in this case.

[Gob]

It costs $20 a poke over here, how much over there?

[Scooter]

Somewhat less, about $15 I think.

[Big RR]

If the law is described accurately in this article, then Canadian law is stupid. Patent claims have to disclose what is special about the invention, but should not require that the inventor disclose enough for someone else to reproduce it.

Why on earth would any pharma company fully disclose how to produce its patented products - particularly one which would feed so easily into "black markets"?

Stupid law. Stupid result.

As Scooter said, that is exactly what is required for patent protection worldwide; if a company chooses not to get patent protection it can keep all details secret and market the drug/invention. Of course, if it can be reverse engineered, then anyone can practice the invention. The disclosure is the quid pro quo for the exclusivity for a term of years. Science inherently builds upon the work of others, so being able to eventually use the disclosed information meets the contstitutional mandate (in the US) of promoting science and the useful arts.

[Joe Guy]

What shocks me most is that viagra is so popular.

I didn't realize until viagra was marketed that so very many men required a drug in order to function sexually.

There are a lot more wet noodle dicks around than I ever would have believed.

They are lucky to live in an age where a man doesn't need to be naturally up for the occasion, I guess.

[Big RR]

Oh brave new world that has such people in it.

[liberty]

A Canadian judge rules in favor of a Canadian company; do I have that right? Surely that ruling does not apply in the US. Pharmaceutical is about the only industry we have left that brings money in to the country and now we are losing that.

[Scooter]

A Canadian judge rules in favor of a Canadian company; do I have that right?

Pfizer and Teva are both multinational companies that have operations in Canada.

Go back to sleep.

[liberty]

Pfizer, Inc. (/ˈfaɪzər/) (NYSE: PFE) is an American multinational pharmaceutical corporation headquartered in New York City,[2] and with its research headquarters in Groton, Connecticut, United States. It is the world's largest pharmaceutical company by revenues.[3]
Pfizer develops and produces medicines and vaccines for a wide range of conditions including in the areas of immunology and inflammation, oncology, cardiovascular and metabolic diseases, neuroscience and pain. Pfizer's products include Lipitor (atorvastatin, used to lower blood cholesterol); the neuropathic pain/fibromyalgia drug Lyrica (pregabalin); the oral antifungal medication Diflucan (fluconazole), the antibiotic Zithromax (azithromycin), Viagra (sildenafil, for erectile dysfunction), and the anti-inflammatory Celebrex (celecoxib) (also known as Celebra in some countries).

The Teva organization's rich history dates back to 1901 when the company was founded in Israel as a small business distributing imported medications. By 1945, operations in the United States were formed as Lemmon Pharmacal Company, which was acquired by Teva in the 1980s. More recently, the company, renamed Teva Pharmaceuticals USA, became a wholly owned subsidiary of Israeli-based Teva PharmaceuticalsIndustries Ltd., the world leader in generic pharmaceutical products.1

[Scooter]

What a moron.

Pfizer Canada Inc. is the Canadian operation of New York-based Pfizer Inc., one of the world's leading biopharmaceutical companies.

While Canadian headquarters of Pfizer Bio-Pharmaceuticals and Animal Health are in Kirkland, Quebec, our Consumer Healthcare business is based in Mississauga, Ontario and our Vaccines Research Unit is located in Ottawa, Ontario. We also operate distribution facilities in Mississauga, Ontario and Calgary, Alberta, and Global Supply and Distribution Centres in Montreal, Quebec and Brandon, Manitoba.

Once again, the Canadian subsidiary of a multinational company was suing the Canadian subsidiary of another multinational company. I understand that this is too complex of a concept for you to wrap your head around, so why don't you shut up now, stop demonstrating more stupidity than everyone already knows you possess, and leave the adults to their conversation.

[dgs49]

While I am not an expert on the subject, if this article accurately describes Canadian patent law, the it is not "the same all over."

The essence of a U.S. patent is the "claims." The claims describe what is unique and beneficial about the invention, e.g., "A mousetrap that employs a unique combination of electrical stimuli and chemical agents to euthanise the offending rodent."

They DO NOT provide enough information to reproduce the patented product. When the patent expires, competitors are permitted to "reverse engineer" the product, and they do so with reckless abandon if the product is any good.

A successful challenge to a patent based on the inventor not fully disclosing what it is and how to make it is a stupid decision based on a stupid law.

[Scooter]

You are an idiot.

Patent Law 101:

The enablement requirement is directly related to the specification, or disclosure, which must be included as part of every patent application. "The specification shall 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." See 35 U.S.C. § 112. At the end of the specification, the applicant lists "one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention." See 35 U.S.C. § 112. Enablement is understood as encompassing three distinct requirements: the enablement requirement, the written description requirement, and the best mode requirement.

Every patent application must include a specification describing the workings of the invention, and one or more claims at the end of the specification stating the precise legal definition of the invention. To satisfy the enablement requirement, the specification must describe the invention with sufficient particularity that a person having ordinary skill in the art would be able to make and use the claimed invention without "undue experimentation." See In re Wands, 858 F.2d 731 (Fed Cir. 1988). In In re Wands, the Federal Circuit Court of Appeals listed eight factors to be considered in determining whether a disclosure would require undue experimentation. The Patent and Trademark Office has incorporated these factors in the Manual of Patent Examining Procedure. See MPEP 2164.01(a).

The written description requirement compares the description of the invention set out in the specification with the particular attributes of the invention identified for protection in the claims. It is possible for a specification to meet the test for enablement, but fail the written description test. The basic standard for the written description test is that the applicant must show he or she was "in possession" of the invention as later claimed at the time the application was filed. Any claim asserted by the inventor must be supported by the written description contained in the specification. The goal when drafting patent claims is to make them as broad as the PTO will allow. THe writing requirement imposes two important limitations: the applicant may not seek protection for a claim that is broader than the supporting specification; and, if the applicant intends to focus on a particular attribute of the invention in the claims, that attribute must be clearly indicated in the specification.

In addition to disclosing sufficient information to enable others to practice the claimed invention, the patent applicant is required to disclose the best mode of practicing the invention. See 35 U.S.C. § 112. The best mode requirement is violated where the inventor fails to disclose a preferred embodiment, or fails to disclose a preference that materially affects making or using the invention. See Bayer AG v. Schein Pharmaceuticals, Inc., 301 F.3d 1306 (Fed. Cir. 2002). A violation of the best mode requirement involves two essential elements: first, it must be determined whether the inventor actually had a preferred mode of practicing the invention at the time the application was filed; if it is established that the inventor did contemplate a best mode for practicing the invention, the question becomes whether sufficient information was disclosed to enable a person of ordinary skill in the art to practice the best mode of the invention.

Try moving you lips while reading, if that will help you understand.

What a moron.

[Big RR]

Well I am an expert in patent law DGS, and you are absolutely wrong; US patent law (35 USC 112 and other sections) requires not only that the a patent applicant describe in the text (or specification of the application) the invention completely and in sufficient in detail to to permit those skilled in the art to make and use the invention, but also to describe the best mode of practicing the invention (an additional detail not required in a number of other jurisdictions), failure to do so can result in a patent not being issued and/or invalidation of any patent which might have been allowed. Many patents have been invalidated in the US for failure to provide this information, and every patent practitioner knows and understands this when drafting applications. Indeed, it is a basic tent of patent law that one receives the "exclusive right for a limited term" a patent provides in exchange for this disclosure. In the US (as well as many other countries) one need not use or sell the patented invention to keep the patent in effect (except for a very narrow, rarely used public interest exception), the benefit the nation receives is this disclosure.

Yes, the claims define the metes and bounds of the invention covered by the patent, but the specification is equally important, and I have personally been part of cases where the patents were invalidated for failure to provide an enabling specification and/or the best mode.

If the law is stupid, so be it, but that is the way it has been since our first patent stutes were enacted. If you think you can do better writing one which achieves the constitutional mandate of advancing science and the useful arts, be my guest.

Spot on Scooter.

[liberty]

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.

[Big RR]

And are you saying the current patent law (which has been the same in this regard in every patent statute enacted since the late 18th century) will cause or contribute to the failure of the US economy? If so, I don't agree; the patent system encourages investment in R&D by giving the innovators a period of exclusivity for the marketing of a patentable invention, while contributing to the knowledge of the scientific community. Pretty good deal for the innovators and the country. Everyone wants to pay less (s9n't this simple ecopnomics), but we as a nation are willing to pay more to innovators who comply with the requirements of the patent staute.

[Scooter]

mine is for the economic health of my country

If the economic health of your country depends on the sale of Viagra, there must be a lot more flaccid American penises than anyone ever thought.

A pity it didn't work on flaccid brains, you might stand a chance of coming up with something intelligent to say.

[liberty]

And are you saying the current patent law (which has been the same in this regard in every patent statute enacted since the late 18th century) will cause or contribute to the failure of the US economy? If so, I don't agree; the patent system encourages investment in R&D by giving the innovators a period of exclusivity for the marketing of a patentable invention, while contributing to the knowledge of the scientific community. Pretty good deal for the innovators and the country. Everyone wants to pay less (s9n't this simple ecopnomics), but we as a nation are willing to pay more to innovators who comply with the requirements of the patent staute.

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?