P 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.

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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.

The ruling goes back to this all-important concept a few times: without disclosure, there can be no patent. It's good to see the court making this a central point, because pharma companies are notorious for attempting to twist the patent system so they get virtually perpetual monopolies on their drugs, while still shrouding their research and manufacturing methods in as much secrecy as possible. In the US, Pfizer had a similar showdown with Teva over generic Viagra starting in 2010, in which Pfizer won using a second patent that didn't cover the active compound in Viagra itself, but rather the marketing of it as an erectile dysfunction drug. Thus, even though the core patent on the drug expired this year, Pfizer will likely retain a monopoly on it until 2019. This is in stark contrast to the UK, where the patent on using the drug to treat ED was invalidated for obviousness way back in 2000—but Pfizer still dominates the market there thanks to related patents on manufacturing methods.

Basically, Pfizer uses any method it can think of to prevent its patents from ever expiring and benefiting the public the way patents are supposed to, including writing disclosures that obscure the necessary facts. The Supreme Court was having none of it—rather than letting Pfizer retroactively fix the disclosure, or coming up with any kind of partial remedy that allowed them to retain the patent, the ruling correctly states that patents must be a deal between two sides to function, and thus the patent is (and always has been) invalid:

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.

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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.

This is a big victory for Teva and a major blow to Pfizer's Viagra empire, which is slowly crumbling around the globe. It's also likely to lead to even more illegal cross-border pharma sales, and even more of everyone's favorite email spam advertising online Canadian pharmacies—but that's another story.

1. the artificial extension of the Xalatan patent in Italy by means of: a) the application of a divisional patent; b) the validation of the divisional patent in Italy; c) the application for an SPC in Italy; d) the application for pediatric extension; and

2. the start of litigations aimed at discouraging or increasing the costs for the marketing of latanoprost generic products in Italy.

It is my view that if Congress does not continue to provide serious responses to online piracy, the U.S. copyright system will ultimately fail. The premise of copyright law is that the author of a creative work owns and can license to others certain exclusive rights – a premise that has served the nation well since 1790. Congress has repeatedly acted to improve enforcement provisions in copyright law over the years, including in the online environment. SOPA is the next step in ensuring that our law keeps pace with infringers....

[....]

The response provided by SOPA is serious and comprehensive. It requires all key members of the online ecosystem, including service providers, search engines, payment processors, and advertising networks, to play a role in protecting copyright interests – an approach I endorse. Combating online infringement requires focus and commitment. It should be obvious that we cannot have intermediaries working at cross-purposes.

SOPA is also measured. It appropriately provides much broader tools and flexibility to the Attorney General than it provides to copyright owners. This is a sound policy choice at this time. The Department of Justice has experience fighting online infringers, will use resources carefully, must exercise prosecutorial discretion in bringing actions, and must plead its case to the court and obtain a court-issued order before proceeding. Put another way, while the copyright industries are extremely important (and certainly a point of pride with respect to the U.S. economy), SOPA recognizes that many sectors rely on, invest in, and contribute to the success of the Internet.

It is for this reason that SOPA puts only limited tools in the hands of copyright owners, and provides the Attorney General with the sole authority to seek orders against search engines and Internet service providers. This is not to say that we should not continue to assess Internet piracy and the impact of SOPA or whether additional measures or adjustments may be needed. Indeed, SOPA assigns ongoing studies to the Copyright Office and the Intellectual Property Enforcement Coordinator for these very purposes. But I do think SOPA provides the right calibration at this time.

As with any legislation, SOPA deserves and can only benefit from a robust discussion. As the Committee works to further improve and refine the bill, I know it will fully consider a variety of perspectives and suggestions, including from my fellow witnesses. This said, I believe that Congress has a responsibility to protect the exclusive rights of copyright owners, and I urge the Committee to move forward with this in mind.

It also bears repeating that injunctions are not at odds with the First Amendment. As noted First Amendment scholar Floyd Abrams has observed, they are "a longstanding, constitutionally sanctioned way to remedy and prevent copyright violations."

"The Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS)" study was a so-called seeding trial, in which the stated objective was to assess the safety and efficacy of gabapentin, but the actual aim was to increase prescribing of the drug by duping the very physicians recruited to conduct the "trial," according to three medicolegal consultants involved in litigation against the drug's manufacturer.

In the STEPS trial, Parke-Davis recruited 772 physicians to prescribe Neurontin (gabapentin) and titrate the dose upward in patients whose partial seizures were not completely controlled by other drugs. The drug company purposefully recruited "site investigators with little or no clinical trial experience [and] provided insufficient training," and limited enrollment to about four patients per investigator.

The study design was uncontrolled and unblinded, and its rigid titration protocol led to the exclusion of 87% of the study subjects. One institutional review board that twice rejected the STEPS application to be conducted at their medical center stated that "the entry criteria and outcome measures are too vague to allow any scientific conclusions to be reach[ed]." Parke-Davis sales representatives collected and recorded individual subject data. In a clear example of data tampering, they not only attended epilepsy patients' office visits (under the guise of "shadowing" the clinician), but also actively promoted the use of Neurontin and blocked the use of competing medications, particularly lamotrigine (Lamictal), at those visits. They also rewarded participating investigators with free lunches and dinners.

"Mr. Krumholz and his coauthors clearly demonstrate that the true intent of seeding trials is to introduce a new product and induce clinicians to use it," according to Dr. G. Caleb Alexander. As others have noted, "Deception is not just an incidental part of a seeding trial, but rather the very success of the trial depends on such deception, since few institutional review boards, investigators, clinicians, or patients would willfully participate in a study with marketing objectives and little or no scientific value," Dr. Alexander wrote in commentary accompanying the report.

"Neurontin is an important FDA-approved medicine that physicians have prescribed to treat millions of patients safely and effectively. Neurontin has been widely studied for more than 2 decades and there is an extensive body of publicly available literature on its safety and its use."

The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain. Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA's judgment over which products are safe and effective. For that reason, "off-label" promotion is against the law.

But with billions of dollars of profits at stake, marketing and sales managers across the country nonetheless targeted anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. "Anyone that use[d] a scalpel for a living," one district manager advised in a document prosecutors would later cite.

A manager in Florida e-mailed his sales reps a scripted sales pitch that claimed -- falsely -- that the FDA had given Bextra "a clean bill of health" all the way up to a 40 mg dose, which is twice what the FDA actually said was safe....

Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.

Pfizer said in court that "the company's intent was pure": to foster a legal exchange of scientific information among doctors.... But an internal marketing plan called for training physicians "to serve as public relations spokespeople."

According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the great-great-grandson of the parent company.