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.

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.

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.      

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.

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).

For example, a depressed patient must take a 20mg paxil pill per day to realize its beneficial effects that build up in the system. If the patient cuts the pill into halves or quarters, that dosage would be below the “therapeutic dosage”, and any positive effects are probably placebo effects, and not from the active substances in the pill. Further, notwithstanding how a patient gains such beneficial effects, it is arguable whether scientists and doctors have discovered how to “cure” depression (I’d say not), but surely they have found treatments (including electroconvulsive therapy) that are “therapeutically effective.”

Another interesting example occurs during surgery offered to Parksinsons patients, where stimulating electrodes are implanted into a patient’s subthalamic nucleus in the brain. First recording electrodes are lowered to determine location using firing characteristics (rhythm, speed) of neurons the electrode records along the way. This electrophysiological technique is used along with neuroimaging for correct placement of the stimulating electrode. However, sometimes these methods do not work, and the neurosurgeon must guess the proper location for the stimulating electrode, often by turning on the stimulating electrode and watching for therapeutic effects. They often watch the patient’s hand to watch for a lessening of the rolling tremble that is characteristic of Parkinsons patients. If they find such beneficial effects, they leave the electrode in its place. Thus, these neurosurgeons are by no means “curing” Parkinsons disease, but they have found a treatment that is “therapeutically effective.”

Two things bother me about the dissenter’s note. One is that he uses “healing” and “curing” as synonyms. To me, healing is much more of a process and does not necessarily end in being free from negative effects. A woman may emotionally “heal” from her husband’s death, but that does not mean that she ever is able completely separate herself from the life she once shared with him. The other is that he uses the term “pharmacological arts.” Anyone may correct me if I am wrong, as I am not a pharmacologist by training, but that sounds like an outdated term and makes me think about alchemists.

The dissenter raises an interesting point about patent specificity though. Should someone with a new product have to specify exactly what uses a product can be put to, and exactly who may benefit from its use? The majority seems to take a broad view, allowing more sweeping patents to come to light. But, the dissenter would require a list of diseases or classes of patients with such diseases that the drug may treat. It is well known in the patent field that one person may hold the patent to a compound, and another may hold the patent to a use or a function of the compound. To what extent should this be true? Construing it broadly would encourage R&D into the original compound, but narrow construction would enable people to brainstorm more uses for a compound, and allow compounds to be researched more thoroughly and brought to their full potential.

My last point: should judges trained only in law be allowed to make these types of decisions? Could either of these judges can think of such examples or counterexamples of what may be considered (or not) “therapeutically effective?” It must be quite frustrating for inventive scientists, scientifically-trained lawyers who help write the patents, and the scientifically-trained agents at the PTO to have these patents constructed by untrained judges.