Canadian drug company Biovail Corporation has agreed to pay $10 million to settle federal regulators’ charges of civil accounting fraud and deceiving investors and analysts, reported Marcy Gordon for Associated Press.  SEC charges remain pending against Biovail’s founder and former chairman and CEO, Eugene Melnyk; former Chief Financial Officer Brian Crombie; and two current executives: Chief Financial Officer Kenneth Howling and Controller John Miszuk. The Ontario Securities Commission also has charges pending against the four executives.

Gordon reported on the charges as follows:

Biovail and senior executives "engaged in a pattern of systemic, chronic fraud" that distorted its quarterly and annual reports filed over four years, Mark Schonfeld, director of the SEC’s New York regional office, said in a statement. To conceal the fraud, the executives "intentionally misled the company’s auditors and the investing public, showing their complete disregard for their responsibilities to shareholders," Schonfeld said.

In October 2003, the SEC alleged, Biovail and several executives deceived investors and analysts by falsely attributing nearly half of the company’s failure to meet its third-quarter earnings target to a truck accident involving a shipment of Biovail’s antidepressant Wellbutrin XL. The accident in fact had no effect on earnings for the quarter, the SEC said.

The agency also accused the company of three fraudulent accounting schemes between 2001 and 2003: Shifting around $47 million in expenses for drug research and development onto the books of a "special purpose entity," concocting a phony transaction to record $8 million in revenue, and intentionally misstating losses from foreign currency transactions to understate a quarterly loss by some $3.9 million.

As part of the settlement, Biovail has agreed to refrain from future securities violations and to hire an independent accounting firm to oversee its books.

Attached is the SEC Press Release issued following the settlement agreement and the Complaint filed by the SEC in this case.

Following up on our blog posting last week about the indictment of the former Intermune CEO on fraud charges related to allegedly marketing off-label uses of a drug, an unrelated class action suit has been filed in the state of Pennyslvania against Pfizer and Warner-Lambert alleging neglience and negligent and intentional misrepresentation for allegedly conducting a marketing campaign to promote off-label uses of its Neurontin drug and its generic equivalent, gabapentin, reported Amaris Elliott-Engel for Law.com.  These claims have survived a partial summary judgment ruling by Philadelphia Common Pleas Judge Mark I. Bernstein.

This case is reported to be the first case to hold that a brand name manufacturer can be held liable for money spent to promote a drug manufactured by a third party.

Elliot-Engel reported on the case as follows:

During the class certification hearing, the plaintiffs produced evidence that the defendants unlawfully promoted Neurontin to physicians for off-label use, despite the lack of scientific proof that the drug was effective in treating those conditions. . . . A $40 million promotional budget was devoted to those efforts, including the insertion of anecdotal articles in medical journals, paying physicians considered to be opinion leaders and sponsoring continuing medical education conferences that actually were paid promotional events, Bernstein said. At least 200,000 prescriptions for Neurontin were written in Pennsylvania, and the defendants earned between $53 million and $64 million on the drug per quarter in the state, Bernstein said. . . .

Neurontin was approved to treat epilepsy in 1993 and neuralgia in 2002. . . .Bernstein granted class certification last June. The class involves all people who purchased Neurontin and gabapentin between 1995 and the present for medical conditions other than adjunctive therapy for epilepsy and management of pain associated with herpes zoster rash outbreaks.

Each class member has damages worth less than $75,000; the class action members seek a refund for the amount they spent on Neurontin/gabapentin prescriptions given to treat off-label medical conditions not approved by the FDA, according to court papers.

This case and the recent indictment of Dr. W. Scott Harkonen raise some interesting public policy questions about off-label uses of medications and the promotion of such uses.  Have drug companies and the medical community been too quick to embrace off-label uses of drugs that are approved for other medical conditions?   Should there be greater regulation of off-label uses of drugs than what currently exists?   Do patients really understand when they take an approved drug for an off-label medical condition the full ramifications of what "off-label" really means? 

I am interested in hearing what the blog community thinks about this issue, so I welcome any comments on the topic.  We will continue to follow these two cases here at the California Biotech Law Blog as they unfold.

The Washington Post ran a column today by Jon Leibowitz of the Federal Trade Commission, which addresses a suit recently filed by the agency against Cephalon, Inc., which will test the legality of the practice of entering into “pay for delay” settlements.

Liebowitz describes the  “pay for delay” settlement controversy at the root of this case as follows:

When these troubling deals first came to light in the late 1990s, the FTC fought them — and stopped them cold. Between 2000 and 2004, no brand and generic companies entered pay-for-delay deals; in other words, companies resolved patent disputes without anticompetitive payoffs.

Unfortunately, that success is under siege. Two federal appeals courts — in rulings that conflict with the analysis of a third appellate court — have found that a brand-name drug company facing a patent challenge is free to pay any amount to keep a generic producer from entering the market until the patent expires. These rulings depart from the spirit of Hatch-Waxman and our nation’s antitrust laws, and they harm consumers by subverting the competition at the heart of our free-market system.

Courts that have sided with pharmaceutical companies believe, in essence, that even an infirm patent gives its owner the right to pay competitors not to compete. . . .Not surprisingly, after two courts blessed such payoffs, the frequency of these settlements has increased sharply. In fiscal 2006, fully half of all pharmaceutical patent settlements (14 of 28) contained such payments. Brand-name manufacturers, seeing the potential to continue reaping monopoly profits, have taken advantage of this apparent judicial leniency. . . .

This dispute clearly puts Hatch-Waxman to the test: should a patent owner have the right to pay to keep a competitor out of the market until the patent expires?

Clearly, insurers and the public would say yes.  According to Liebowitz, Cephalon made an additional $4 billion dollars as a direct result form entering into this “pay for delay” settlement–this is money that came directly out of the pockets of insurers and patients.  As a member of the public who lost my health insurance following the collapse of my former law firm just over four years ago, when my former employer terminated COBRA at the six month mark, leaving me in the position of having to pay full price for prescription medications, I know all too well how expensive it can get to pay for prescription medications, when no generic is available.   There is definitely an impact on the public at large, insurers, and individuals when they have to foot the bill for a more expensive medication.

On the other hand, as an IP lawyer, I can’t help but scratch my head a bit over this case: the FTC is effectively taking issue over a patent owner trying to protect its exclusivity until the patent expires.  Isn’t that the patent owner’s right?

Not according to the FTC.  The FTC’s position is that patent owners do not have the right to enter into these types of settlements–that such deals violate the spirit of Hatch-Waxman and antitrust law.

It makes perfect sense to me why certain courts have sided against the FTC on this particular issue, and also why the FTC anticipates this case going to the Supreme Court.   According to Liebowitz, however, a bill is also making its way through Congress that would prohibit such agreements.  The FTC, of course, supports this legislation.

The California Biotech Law Blog will keep you posted as this battle unfolds.

The Supreme Court declined yesterday to review a ruling by the U.S. Court of Appeals for the Federal Circuit that there is no constitutional right to access experimental drugs, reported the Associated Press. 

The California Biotech Law Blog reported on this case back in August 2007:

My best guess without reading the decision is that the Court felt that this is a policy issue that should be decided by Congress, which seems to be what was reported. . . .

It will be interesting to see what the Supreme Court says on this case, if it is indeed heard by the Court.  As those of us who have studied Constitution Law know, the concept of "rights" has been liberally interpreted on occasion, according to Constitutional scholars, to reach a particular result that seems "just" from a policy perspective.  Could the current Court do the same? 

I somehow doubt it.  We have a "conservative" Court in place right now, so I doubt this Court will be reading new rights into the Constitution.  Granted, I am not a Constitutional Scholar, but that is my take on the current Court.

The California Biotech Law Blog accurately predicted that the Court would decline to read a new right into the Constitution.  While the Court did not provide any explanation of its decision not to hear the case, it can be assumed that the Court agreed with the Federal Circuit’s decision: that no right to experimental drugs exists, even when the patient is terminally ill.

So where does the Court’s decision leave this issue?

Clearly, a ruling on the issue in one federal appellate court does not preclude other appellate courts from hearing cases on similar facts and ruling differently on the same issue.   Thus, the possibility exists that another appellate court will revisit the issue down the road.

Having said this, in my opinion, a more likely scenario is that Congress decides to take up the issue at some point in the future.  This issue raises some valid public policy issues, and Congress is arguably the most appropriate forum to address them. 

I continue to take the position that there should be some mechanism by which the terminally ill can access experimental medications that offer a real promise to treating the terminal illness.  While I agree that perhaps the moral arguments in favor of making experimental medications available to the terminally ill do not rise to the level of a Constitutional right, I still think those arguments are compelling.  Doesn’t this issue merit some additional debate?

The recent opinion of the Federal Circuit in In re Seagate Technology (Fed. Cir. Docket No. 830; 8/20/07) imposed new limits on willful infringement by establishing a new standard: proof of willful infringement permitting enhanced damages now requires at least a showing of objective recklessness. 

This new standard overruled the prior standard set out in Underwater Devices Inc. v. Morrison-Knudsen, Co., 717 F.2d 1380 (Fed. Cir. 1983), which was that when a potential infringer has notice of another’s rights, he has an affirmative duty to exercise due care to determine whether or not he is infringing.

The Federal Circuit’s opinion addressed three key issues:

1. Should a party’s assertion of the advice of counsel defense to willful infringement extend waiver of the attorney-client privilege to communications with that party’s trial counsel?  See In re EchoStar Commc’n Corp., 448 F.3d 1294 (Fed. Cir. 2006).
2. What is the effect of any such waiver on work-product immunity?
3. Given the impact of the statutory duty of care standard announced in Underwater Devices on the issue of waiver of attorney-client privilege, should this court reconsider the decision in Underwater Devices and the duty of care standard itself?

On the first issue, the Federal Circuit held that "as a general proposition, asserting the advice of counsel defense and disclosing opinions of opinion counsel do not constitute a waiver of the attorney-client privilege for communications with trial counsel."  However, the Federal Circuit declined to set out an absolute rule.

On the second issue, the Federal Circuit held that "an advice of counsel defense asserted to refute a charge of willful infringement" does not extend to trial counsel’s work product, absent exceptional circumstances.

On the third issue, the Federal Circuit overruled the standard announed in Underwater Devices, holding that "proof of willful infringement permitting enhanced damages requires at least a showing of objective recklessness."  The Court abandoned the affirmative duty of due care, and reemphasized that there is no affirmative duty to obtain an opinion of counsel.

 Peter Zura’s 271 Patent Blog provided a good summary of Federal Circuit opinion, as did the Patent Baristas, who also provided some additional background information on the issue, such as the Underwater Devices decision and the freedom-to-practice opinions.

So what is the significance of the opinion?

The Patent Baristas reported on the significance as follows:

The Federal Circuit has demonstrated once again that it is not afraid to effect a sea change in patent law jurisprudence in a big way. . . .

[I]t appears that Seagate signals a receding of the tide of willful infringement litigation. The decision appears to be intended by the court to make a willfulness case substantially more difficult to prove. In view of the complexity and high reversal rate on claim construction issues in patent infringement cases, how can it be argued in any but the simplest and clearest of cases (is there such a thing?) that an accused infringer knew or should have known of a strong case before litigation and adjudication? This would seem to require proof that the infringer was omniscient. Whether this logical conundrum was intended by the court or not, the effect will be to remove risk for accused infringers and shift some of the burden back to patent owners.

Clearly, the Federal Circuit used this case to impose new limits on the ability to obtain willful damages in patent infringement .  Is this a case of judicial legislating?  Or is it just  a case of the Federal Circuit correcting a prior misreading of the precedent?   

The fact that the Federal Circuit issued the opinion to coincide with the consideration of patent reform legislation in the House, which has also contemplated imposing limits on willful infringement damages, certainly is an indication that the Federal Circuit could have been influenced by the political debate going on in Congress. On the other hand, perhaps the Federal Circuit really did believe that the relevant precedent had been incorrectly decided, and that this alone prompted the Court to overturn the precedent. 

Somehow I am not quite convinced.  Are you? 

The U.S. Appeals Court in D.C. has ruled in an 8-2 decision that the terminally ill have no right to take unapproved drugs, even when their doctor says it is their best hope for survival.

The Mercury News reported on the decision as follows:

[T]he court said federal drug regulators are entrusted by law with deciding when new drugs are safe for wide use.

The families of terminally ill patients, several of whom died after they were denied promising drugs that were still in tests, filed the lawsuit. They said that dying patients were far more willing to take risks and argued that they should not be forced to wait for new treatments to win final approval from the Food and Drug Administration.

The judges said the families should take their pleas to Congress, not the courts.

However, the two dissenters said the ruling ignored the Constitution’s protection for individuals and their “right to life” and instead bowed to “a dangerous brand of paternalism” that put the government’s interests first.

According the The Mercury News, the next step is going to be to take this case to the Supreme Court.  It goes without saying that this is not likely to be the last we are hearing on this issue.

I have not seen a copy of the decision yet, so I’m interested to see how the majority reached the decision that they did.  My best guess without reading the decision is that the Court felt that this is a policy issue that should be decided by Congress, which seems to be what was reported above.

Clearly, from a pure policy perspective, the denial of access to potentially life-saving drugs to the terminally ill does not seem to be sound policy.   While the guinea pig argument (i.e. we want to protect the dying from being guinea pigs to be experimented on in their last days) may sound compelling to some, the reality is that most doctors are not going to do that to their patients.  They are only going to recommend possible treatments that hold some hope of working.  And why shouldn’t a patient who chooses to take a chance on an unapproved drug have that opportunity?  What is likelihood that any patient will really face a fate worse than what they are already going to face?

DrugWonks voiced a similar opinion today on the outcome of this case:

I believe the Abigail Alliance and others can make the case that they are not asking for wide use but targeted, tailored and scientifically responsible use that is consistent with their constitutional rights under the Fifth Amendment. This notion that somehow such rights are trumped by Padzur’s effort [to] take a wrecking ball to accelerated approval is a joke. The FDA is inconsistent on who gets what and when with respect to access to medicines and I don’t think the Supreme Court is going to let this “wide use” nonsense pass particularly since the Alliance is not asking for patients to determine when a product is safe but only to have the FDA create a regulatory pathway for allowing dying patients access.

It will be interesting to see what the Supreme Court says on this case, if it is indeed heard by the Court.  As those of us who have studied Constitution Law know, the concept of “rights” has been liberally interpreted on occasion, according to Constitutional scholars, to reach a particular result that seems “just” from a policy perspective.  Could the current Court do the same?

I somehow doubt it.  We have a “conservative” Court in place right now, so I doubt this Court will be reading new rights into the Constitution.  Granted, I am not a Constitutional Scholar, but that is my take on the current Court.

So, it’s quite possible that this will ultimately be placed in the lap of Congress, which will hopefully do the right thing and change the current policy.  There should be some way to legally access unapproved drugs in this country that might save your life when you are dying.  If someone wants to continue to fight to live until the bitter end and not throw in the towel, even if that person is grasping at straws, why should the FDA have the right to deny him or her that chance?  Who is the FDA really protecting in such a case?

A new biotech infringement decision as issued this week by the U.S. Court of Appeals for the Federal Circult, which ruled in favor of ViaCell against Pharmastem in PharmaStem Therapeutics, Inc. v. Viacell, Inc. (Fed. Circuit 2007).

The press release issued by ViaCell following the ruling stated as follows:

The Federal Circuit upheld an earlier decision by the U.S. District Court for the District of Delaware that ViaCell, through its marketing of ViaCord®, a product offering through which families can preserve their baby’s umbilical cord blood at the time of birth for possible future medical use, does not infringe PharmaStem’s U.S. Patent No. 5,192,553 (‘553) and U.S. Patent No. 5,004,681 (‘681), which relate to certain aspects of collection, cryopreservation, storage and use of hematopoietic stem cells from umbilical cord blood. The court also found the ‘553 and the ‘681 patents invalid based on prior art.

Peter Zura’s 271 Patent Blog discussed the infringement issues:

One of the sticking points in the litigation was language in the claims that required that the recited composition contained stem cells “in an amount sufficient to effect hematopoietic reconstitution of a human adult.”

Each of the defendants are in the business of servicing families with newborn infants in which blood from the infant’s umbilical cord is collected and cryopreserved for possible later use. The problem was that PharmaStem could not show enough evidence that the defendants’ cord blood contained a “sufficient” supply of stem cells to effect successful reconstitution of an adult. An expert provided testimony based on the defendants’ marketing materials, but did not consider any data regarding the composition of the cord blood units. Accordingly, the expert’s testimony was excluded.

In a more interesting move, the CAFC also determined that the method claims could not be infringed because all the steps were not performed by the same party – the defendants were responsible for collecting and cryopreserving cord blood samples, while transplant physicians unrelated to the defendants thawed the cord blood and used it for transplanting. Also, since the defendants never “owned” the blood, there was no contributory infringement. . .

Patent Docs further addressed the obviousness issues:

In finding there was not substantial evidence, the Federal Circuit stated that the obviousness standard required a “reason” the skilled worker would make the claimed device or carry out the claimed process, and have a reasonable expectation of success in doing so.  The Court found strong evidence in the prior art that the first prong of this test was satisfied.  As to the second prong, the Federal Circuit was not persuaded by evidence that it was unknown in the art that cord blood contained hematopoietic stem cells.  The Court cited portions (as characterized by Judge Newman’s dissent, by “simply reweigh[ing] selectively extracted evidence”) of the art to show that cord blood was known to contain such stem cells.  It appears that the Federal Circuit interpreted the art based on its understanding that the existence of progenitor cells in the blood was evidence for underlying stem cells, although elsewhere in the opinion the Court appears to conflate the two cell types.  The Federal Circuit’s explication of the biological underpinnings suggests that it believed that a production of such progenitor cells was accompanied by persistence (and thus the presence of) stem cells in the blood.  In discounting PharmaStem’s expert testimony, the Court relied upon what it considered contrary statements made by the inventors, and refused to credit the expert’s explanation that the cited art used the term “stem cell” inaccurately.

Patently O described the rationale for the decision:

Invention is Obvious: When asserting obviousness based on a combination of prior art references, the patent challenger must show that a PHOSITA “[1] would have had reason to attempt to … carry out the claimed process, and [2] would have had a reasonable expectation of success in doing so.”

Reason to attempt: In view of the prior art references, the first part of that test is plainly satisfied here. The idea of using cryopreserved cord blood to effect hematopoietic reconstitution was not new at the time [of filing]. Two of the prior art references…suggest using cord blood for that purpose. Two others…suggest cryopreservation and storage of the cord blood until needed. Accordingly, this is not a case in which there is any serious question whether there was a suggestion or motivation to devise the patented composition or process.

Expectation of Success: The inventors appear to have conclusively proven that umbilical cord blood is capable of hematopoietic reconstitution.  Unfortunately for them, completing a proof is not necessarily inventive. Rather, prior scientists strong suspicion of the capability creates an expectation of success so strong that “no reasonable jury” could find the patent valid.

While the inventors may have proved conclusively what was strongly suspected before—that umbilical cord blood is capable of hematopoietic reconstitution—and while their work may have significantly advanced the state of the science of hematopoietic transplantations by eliminating any doubt as to the presence of stem cells in cord blood, the mouse experiments and the conclusions drawn from them were not inventive in nature. Instead, the inventors merely used routine research methods to prove what was already believed to be the case. Scientific confirmation of what was already believed to be true may be a valuable contribution, but it does not give rise to a patentable invention.

The Medimmune v. Genentech case has received extensive media coverage since the Supreme Court decision earlier this year, but if you still have questions about the case and its anticipated impact, you should check out the recap published on IP Frontline by attorney Dennis Fernandez and college student Brian Bensch.

In their article "The Impact of MedImmune v. Genentech," the authors describe the potential implications of MedImmune as follows:

The major implication of MedImmune is that potential and current licensees will find it incredibly easier to file a declaratory judgment action. . . . After MedImmune, licensees will be able to recklessly challenge contracts knowing that the worst possible consequence is that the contract is upheld. . . .

[T]he implications of MedImmune are already taking shape. Since the MedImmune ruling only four months ago, the Federal Circuit Court of Appeals has begun to clarify the impact of MedImmune by dropping the "reasonable apprehension" clause of its subject matter jurisdiction test in its decision in SanDisk Corporation v. STMicroelectronics, Inc. . . .

 [I]n its decision on March 26 of this year, the CAFC established a new test that "holds that "where a patentee asserts rights under a patent based on certain identified ongoing or planned activity of another party, and where that party contends that it has the right to engage in the accused activity without license," the party may bring a declaratory judgment action."

In the end, the authors conclude that the impact of the ruling will be as follows:

[T]he Supreme Court’s MedImmune decision weakened the stability of both future and current licensing agreements. While the federal circuit’s precedent had been rather unambiguous, the Supreme Court accepted the circularly reasoning and exaggerated risk claimed by MedImmune and allowed it to file for declaratory judgment relief against its licensor without first ending their licensing agreement. The decision gives a blank check to licensees to challenge their licensor on patent invalidity charges if they feel they have any chance at success.

As a licensing attorney looking at this case and the subsequent San Disk ruling, I can’t help but wonder if the impact of these decisions is really going to be as severe as legal commentators are predicting.  While certainly this line of cases enables licensees to challenge licenses more easily, I question whether this will really happen with the kind of frequency you might expect from the commentary.  Is it possible that they are looking at these cases from litigator’s perspective rather than considering the business realities that would often caution against souring an otherwise cordial business relationship?

The vast majority of licensing negotiations are not done at the end of a big stick, and that there are generally sound business reasons to maintain a good relationship with the other side of the negotiating table.  While it is true that these cases make it easier for licensees to challenge a licensing relationship, I question whether it will make good business sense for licensees to do so as frequently as it has been suggested they will do.  Will licensors really want to do deals with licensees who have challenged other licensing agreements with third parties?  Will licensors really want to develop relationships with licensees who have challenged  other licensing arrangements with prior licensors? 

In the end, I suspect that the application of these cases will depend largely on the realities of the business world.  I find it hard to believe that regularly challenging license agreements will ultimately prove to be a good business strategy as the dust settles on these decisions.  I anticipate that in the end declaratory judgments will be used a little more judiciously to challenge relationships that have already soured, in much the same way that litigation and the threat of litigation have been used prior to the MedImmune ruling.  When a relationship can be managed outside of the courtroom, I continue to believe that, despite the hype to the contrary, the average licensee is going to stick with negotiation and stay away from the courts.