Wyeth v. Levine – Are we in for a world of ubiquitous black box warnings?

The Supreme Court’s recent decision in Wyeth v. Levine held that FDA approval of a drug’s labeling does not preempt a state law tort claim for inadequate labeling.  So what do you do if you’re counsel to a pharmaceutical company making physician-administered drugs?  Put the biggest, scariest black box warning you can on every prescription drug you sell.  There’s no downside!  Physicians frequently don’t read labeling, relying instead on prior experience with the drug, or what they learn from pharmaceutical reps and colleagues.  Patients rarely even see these labels, and instead hear only the doctor’s summary of risks.  This course of action would provide a complete defense for the drug manufacturer so that tort liability will stop with the administering physician.

This seems absurd and counterintuitive; shouldn’t drug warning labels communicate actual dangers and not just be a proxy for a tort defense?  FDA needs to step in and address this before physicians and patients have no way of knowing the actual dangers of these drugs.

Pfizer Buys Wyeth, Industry Consolidates, IP Lawyers Rejoice

Pfizer’s purchase of Wyeth is big news for the pharmaceutical industry, and for big business in general.  Because its blockbuster cholesterol drug Lipitor comes off patent in 2010, probably ceding much of its $12.6 billion market to generics, Pfizer went looking to boost its pipeline in search of the next blockbuster drug.

Despite the generally gloomy outlook on Pfizer’s own pipeline, it still has a number of blockbuster drugs that remain on patent (based on rough projected global sales for 2008): rheumatoid arthritis drug Celebrex ($2.5 billion, on patent until 2014), Xalatan for glaucoma ($1.8 billion, on patent until 2011), Detrol for overactive bladder ($1.2 billion, on patent until 2012), antibacterial drug Zyvox ($1.1 billion, on patent until 2021) and schizophrenia drug Geodon ($1.0 billion, on patent until 2012).  The company still makes money from off-patent drugs, such as erectile dysfunction treatment Viagra ($2 billion, off patent since 2000), but sales generally drop off dramatically as patents expire and exclusivity ends.  See high blood pressure medication Norvasc ($2.2 billion, but down from $4.9 billion in 2006 since it came off patent in 2007), antidepressant Zoloft ($142 million, but down from $3.3 billion in 2005, off patent since 2006) and antibacterial Zithromax ($121 million, but down from $2 billion in its patent expiration year of 2005).

Pfizer acquires a major player in Wyeth, with blockbuster drugs including antidepressant Effexor ($3.9 billion, off patent in 2010), children’s vaccine Prevnar ($2.7 billion , off patent in 2007 in the US, but extended to 2012 in Europe), arthritis drug Enbrel ($3.8 billion, off patent in 2009), antibiotic Zosyn ($1.3 billion, off patent in 2007) and sales from nutritionals, vitamins and Advil totaling $3.0 billion in 2008.

This represents a trend in the pharmaceutical industry towards consolidation, in the hope of producing the next Lipitor, a drug which can net a company tens of billions of dollars each year.  Of course, monopoly profits only come with exclusivity, so I’m guessing patent lawyers and IP litigators will continue to find themselves very busy, even in the down economy.

Patent Local Rules

Local rules for patent cases have become all the rage these days.  It all started with the Northern District of California, followed by the Southern District of California, Eastern District of Texas, and the Northern District of Georgia, amongst others.  Some judges in jurisdictions without local rules have even adopted very similar sets of rules for their own use. 

These rules all have common features.  They require early disclosures of Preliminary Infringement Contentions and Preliminary Invalidity Contentions, together with supporting documents.  They require parties to set out a schedule at the Rule 26 conference, deciding the course of claim construction.  Parties must exchange lists of terms to be construed, preliminary constructions, and then submit a joint claim construction statement.  Construction briefs must be written.  Finally, the claim construction hearing (or “Markman Hearing”) is held, where the judge hears both parties’ constructions and supporting evidence, and finally decides on the construction to be used for the rest of the litigation.

The advantage of these patent local rules is that they set deadlines for the completion of claim construction discovery and the hearing, thus pushing the cases along the court docket.  Parties can focus early on what terms they need to research and construe, and what interpretations will work best for their arguments.  Early disclosure ensures cooperation in these endeavors.  Jurisdictions with these patent local rules are thus popular with plaintiffs who want resolution quickly.

However, patent local rules have been criticized because they may focus the issues too early, before the parties ( and the judge) really know what is at stake.  Rules that do not allow changes in construction after preliminary exchanges may be too rigid as parties realize later in the case that they missed important issues.  Further, many of these procedural events occur before the judge is able to comprehend technology involved.  For this, many have recommended neutral tutorial sessions for the judge, or assistance of Special Masters to help the judge learn the technology or science involved in the case.

The Boston Globe recently ran an article by Sacha Pfeiffer regarding the possibility of drafting patent local rules for D. Mass..  Judge Stearns gave positive comments, and a few other judges have responded positively.  The current President of the BPLA, Lee Bromberg, said that applying patent local rules in D. Mass. would make the jurisdiction more attractive for plaintiffs, lowering costs of litigation for local businesses (particularly some of the smaller biotech companies), and also boost business for local hotels, restaurants, law firms, and support as more people come to litigate.  Just look what making patent litigation more attractive did for E.D. Tex.!  It will be an interesting story to follow as rules are drafted and tried out by the D. Mass. judges.      

Aborigines win Australian land claim

Aborigines win Australian land claim – Yahoo! News

OK, so here’s another one of my posting that seems to have *nothing* to do with IP or technology and law… But I know that Australia has a history of entertaining claims about indigenous rights–the ones off the top of my head being about copyright and indigenous art and patents and indigenous medicines.

In the Federal court decision, the Noongar people were given a limited land title claim to the city of Perth, the capital of the Western Australia state. It grants native title to lands not usurped by freehold or leashold titles. At issue are the national parks and reserves and what rights this land title claim gives over these areas.

Part of the case hinges on whether the Noongar people had maintained their culture and customs since European settlement in 1829. Since this was decided, this may also provide them–and other similarly situation indigenous peoples–the grounding to make other claims over indigenous rights.

Perhaps such a claim may help with copyright battles over indigenous art–symbols and styles–or with claims over indigenous plants or medicinal traditions. Regardless, it shows the court’s willingness to accept that indigenous cultures have title over things they possessed centuries before European settling.

The Bartlett Diaries has a run-down on the many biases in reporting on this issue.

BennetonTalk provides a more sympathetic interpretation of the aboriginal plight.

Judges decide meaning of “Therapeutically Effective”

I found this recently on Bill Heinze’s IP Updates Weekly:

In Amgen, Inc. v. Hoechst Marion Roussel, Inc. (August 8, 2006) the Federal Circuit disagreed with the district court’s construction of “therapeutically effective amount” in claim 1 of the patent …

According to Circuit Judge Schall:

Based on a reading of the claims in light of the specification, it appears that the patentee used the words “therapeutically effective” in order to broadly claim a pharmaceutical composition with a wide range of effects. Those effects do not necessarily include curing disease in humans. … the patentee noted that recombinant EPO, like that found in the claimed invention, “is the first therapeutic product which can be used to effectively treat hundreds of thousands of patients who suffer from anemia and other disorders involving low red blood cell counts.” In our view, this statement merely lists some of the uses of the invention, without restricting the scope of the invention. . . .

The dissenter wrote:

Significantly, I note that the words “therapeutically effective” are conventionally employed in the pharmaceutical arts to indicate that the claimed pharmaceutical product has utility in the treatment of a human disease where such treatment tends to cause the “healing” or “curing” of the disease.

He went on to say that the patent should reference the particular classes of patients for whom the drug would be “therapeutically effective.”

I agree with the majority here, to the extent that they define “therapeutically effective” as not necessarily including “curing.” In my experience in basic science research and its involvement in medicine, “therapeutically effective” generally describes an effect that can be contrasted with treatment with placebo – ie, the amount of the drug that has beneficial effects that proves to be significantly different from effects in patients treated with placebo (an inactive substance).

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