he meaning of the word “of” when used in a patent? The Federal Circuit Court of Appeals that deal elusive question in a recent dispute between two pharmaceutical manufacturers and expert testimony of great help to find the answer.

But while the court has accepted the advice of experts on the meaning of “approximately” used in the patent, it appeared an about-face and rejected their testimony as to the ultimate question of infringement.

Ortho-McNeil Pharmaceutical brought the lawsuit against the manufacturer of generic drugs-Caraco Pharmaceutical Laboratories, alleging infringement of its U.S. Patent No. 5,336,691. Ortho patent covered a painkiller composed of two well-known analgesics, tramadol and acetaminophen.

The patent has shown that when combined in certain ratios the effects of both drugs were increased. Involved in this case was the claim of the patent No. 6, which involved a composition where the ratio of the material to acetaminophen is tramadol a weight of about 1:5. “

Ortho continued after Caraco filed an application for abbreviated new drug to disclose its plan to manufacture and sell his own composition containing tramadol and acetaminophen. Caraco said the medicine had an average ratio of tramadol to acetaminophen of 1:8.67 and no less than 1:7.5. Ortho Caraco argued that the drug would infringe its patent.

The district court granted the summary trial and Ortho appealed to the Federal Circuit. Both the district court and on appeal, the case focused on the construction of the term “about 1:5.” Ortho argued that covered a radius of at least 1:3.6 to 1:7.1, and that, under the doctrine of equivalents, the wording of Caraco infringed. Caraco argued for a restrictive interpretation.

The district court adopted the construction asserted by Ortho, the “about 1:5″ means “approximately 1:5, encompassing a range of ratios of no more than 1:3.6 to 1:7.1.” He came to this conclusion relying in part on the intrinsic evidence of the application and the specification and in part to the extrinsic evidence of Ortho experts, Dr. Donald R. Stanski and Dr. Eric Smith. The two experts gave the Notice that one of ordinary skill in the art to conclude that “about 1:5″ limitation include a series of reports that would extend to include and 1:7.1.

The Federal Circuit upheld that construction. As the district court, he found support for this construction as in the claim itself and the testimony of the expert Ortho, Dr. Stanski. “Dr. Stanski has estimated that” about 1:5 “means” about 1:5, which includes up to and including 1:7.1 “, noted the court.

Caraco Accepting this construction means that the product did not literally infringe Ortho patent. Ortho patent covered a maximum ratio of 1:7.1, while Caraco started 1:7.5. The question, therefore, became Caraco if the drug under the violation of the doctrine of equivalents.

Building on its experts, Ortho said it did. One expert, Dr. Stanski, said that the weight of 1:8.76 is substantially similar to a weight ratio of 1:5. Another expert, Dr. Smith said in its report that the “degree of synergy of a composition with a weight of tramadol to acetaminophen of 1:5 is identical to the measure of the synergy of a composition with a weight of tramadol to acetaminophen of 1:8.67.

But the district court agreed. It concluded that a finding of infringement by a formulation with an average weight of 1:8.67 would render meaningless “about 1:5″ limitation.

The Federal Circuit affirmed, finding that the 1:5 critical parameter for the invention. Stretching the limits of this parameter Caraco to cover the drug would be in direct conflict with the patent for the express both the claim of 1:1 and 1:5 ratios, the court said.

“In this case, if the ratio of 1:5 of the analgesic response is statistically different from that of other ratios any time,” the court said. “The intrinsic evidence points to the desirability and thus the criticality of the ratio of 1:5 compared to other ratios.”

“Ortho can not now claim that the parameter is sufficiently broad to encompass, through the doctrine of equivalents, the rate outside the confidence interval expressly identified in the patent,” continued the court. “We agree with the district court that eviscerate the limitation.”

For these reasons, the court said, he concluded that the drug Caraco does not infringe Ortho’s patent and that the district court properly granted a summary of non-infringement.

Ortho-McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd., Case No. 06-1102 (Fed. Cir. January 19, 2007).

Written by Robert Ambrogi for Bullseye, IMS Expert Services Publication

Robert Ambrogi is the editor of Bullseye, a monthly newsletter distributed by IMS Expert Services. IMS Expert Services is the first expert witness consulting and litigation research firm in the legal industry, focused exclusively on providing custom expert witness in search of lawyers.

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Headache is one of the most common ailments affecting thousands of people every day. Migraine alone directly affects about 12% of the population. The symptoms and pain associated with the various types of headache can be difficult for your doctor to recognize. This makes it hard to pin point exactly what type of headache is the problem and the best treatment for it.

Although research suggests that early treatment of migraine headache when the pain is mild results in better outcomes for patients, many patients delay taking their acute-migraine medication until their headaches are moderate or severe. Understanding when and why patients use their migraine medications is an important first step to improve migraine management.

Mild Headache Causes

Headache is caused by irritation or injury to pain-sensing structures of the head. The structures that can sense pain include the scalp, the muscles of the neck and head, major arteries and veins in the head, the sinuses, and the tissues that surround the brain.

Headache may occur when these structures suffer compression, spasm, tension, inflammation, or irritation. The brain has no nerve endings so the brain itself cannot “hurt.”

Mild Headache Treatment

Treating a mild headache will usually involve over-the-counter pain medications. There are many different medications marketed for control of headache pain. The pharmaceutical companies spend millions of dollars each year to advertise their products. However, many “special” headache remedies are no better than simple acetaminophen, ibuprofen, or aspirin. In addition, stress reduction and rest may be helpful.

Mild Analgesics (pain relievers) – Aspirin, acetaminophen, and the nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naprosyn. Daily use of aspirin and/or acetaminophen may cause rebound headaches. Frequent use of aspirin and NSAIDs can lead to gastrointestinal bleeding and, in the case of aspirin, ?tinnitus (ear ringing).

1. Food: Give fruit juice or food if your child is hungry or hasn’t eaten in more than 4 hours (reason: skipping a meal can cause a headache in many children).

2. Rest: Lie down in a quiet place and relax until feeling better.

3. Local Cold: Apply a cold washcloth or ice pack to the forehead for 20 minutes.

Other preventive measures may include keeping warm if the headache is associated with cold, using a different pillow, or sleeping position or similar changes. Use good posture when reading, working, or doing other activities that may cause headache. Exercise the neck and shoulders frequently when typing, working on computers, or doing close work.

Effective acute treatment of headache begins with making an accurate diagnosis and ruling out secondary causes of headache. Once a primary headache is diagnosed, it is important to choose the right combination of behavioural therapy and acute care (abortive and symptomatic) therapy for each patient.



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Chest pain is merely a symptom, not a diagnosis. Many medical problems can cause chest

pain, and before the chest pain can be adequately treated, the actual underlying cause needs

to be identified. The following is a list of the more common causes of chest pain, roughly in

order of the frequency in which they are seen in the emergency room. Chest pain is one of

the most frightening symptoms you can have. It is sometimes difficult even for a doctor or

other medical professional to tell what is causing chest pain and whether it is life threatening.

Chest pain is one of the most common reasons people call for emergency medical help.

Every year emergency room doctors evaluate and treat millions of people for chest pain.

Chest pain isn’t just a problem for adults. It may occur in a child as well. Many of the causes

aren’t serious, but they may require a doctor’s attention. Follow this chart for more

information about chest pain in infants and children.

Physical activity that involves the chest muscles, especially when it is new or more strenuous

than usual, can cause muscles soreness. The pain is longer-lasting than most episodes of

ischemic pain and is often made better or worse by a particular position. Taking a deep

breath may make the pain worse, and it may only affect a specific area of the chest. Pressing

on this area of the chest usually causes the pain to become worse.

Angina: Angina is chest pain related to an imbalance between the oxygen demand of the

heart and the amount of oxygen delivered via the blood. It is caused by blockage or

narrowing of the blood vessels that supply blood to the heart. Angina is different from a heart

attack in that the arteries are not completely blocked. Also, angina causes little or no

permanent damage to the heart. Stable angina occurs while exercising and goes away with

rest. Unstable angina is not relieved by rest or actually occurs at rest.

Chest pain is a common symptom which can be caused by many different conditions. Some

causes of chest pain require prompt medical attention, such as angina, heart attack, or tearing

of the aorta. Other causes of chest pain can be evaluated electively, such as spasm of the

esophagus, gallbladder attack, or inflammation of the chest wall. Therefore, an accurate

diagnosis is important in providing proper treatment to patients with chest pain. The

diagnosis and treatment of angina is discussed below, as well as the diagnosis of other causes

of chest pain that can mimic angina.

Fortunately, chest pain doesn’t always signal a heart attack. Often chest pain is unrelated to

any heart problem. But even if the chest pain you experience has nothing to do with your

cardiovascular system, the problem may still be important — and worth the time spent in an

emergency room to have your chest pain evaluated.

Heart attack — A heart attack, or myocardial infarction (MI), occurs when a fatty plaque

ruptures. A blood clot (thrombus) can form on the plaque, which can partially or completely

block the artery. This blockage slows or blocks blood flow to the area of heart muscle fed by

that artery. If this continues for more than 15 minutes, the muscle can become damaged or

infarcted (that is, the tissue in that area dies). During a heart attack, the

patient may feel a discomfort that is similar to an episode of ischemia. A heart attack results

from a prolonged period of angina.

Sudden sharp chest pain mimicking the same symptoms of a myocardial infarction or

angina. The chest pain my be affected by breathing and may persist for several days and may

recur. Generally, pericarditis is presumed to have a viral cause and therefore show flu like

symptoms prior to the attack.



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Nearly everyone has had a headache. But, there are some people that have learned how to eliminate them and during the year they might have one or two. Most of these headaches are usually related to stress, depression or anxiety. The most common type of headache is a tension headache. Tension headaches are due to tightening of muscles in your shoulders, neck, scalp and jaw. You are most likely to get tension headaches if you work too much, don’t get enough sleep, miss meals or use of alcohol.

Very few headaches have serious underlying causes, but those that do require urgent medical attention. For example, a severe headache may be a sign of meningitis. Then there are the most common headaches in women – the migraine headaches. Migraines can originate from some brain disorder, from neck vertebrae shifting, or from anxiety. In elderly people, a headache with tenderness of the scalp or temple may be due to temporal arthritis, in which blood vessels in the head become inflamed.

Now, why is it that headaches become a common problem among people? They become a common problem since they affect our daily routine. A mild or severe headache is a nuisance, which takes the joy out of life. Once you have a headache, you became agitated and irritable it becomes hard for you to focus on what you’re doing. Headaches decrease your awareness and give you tunnel vision – vision where you are concentrating your pain and not what is happening around you.

According to a recent survey, seven out of ten people have at least one headache a year. The majority of headaches last for only a few hours, but some can persist for weeks. Migraine headaches are the most severe headaches, which can last all day and can occur everyday. Nearly forty-five million Americans suffers from chronic headaches and most of these headaches cost billions of dollars in lost productivity every year and plenty of misery.

A majority of headaches come from anxiety and neurosis. I know many people will deny that they are neurotic, but this does not change that fact that they are. Denial is the first signs of neurosis. People don’t know how neurotic or how much stress or anxiety they have. They go day by day stressing over their day job, their children, their school, and the relationships they have. Stress causes neck and shoulder muscle tension causing imbalances in the muscles holding the neck vertebras in place. This can lead to simple or severe headaches.

If you have re-occurring headaches, take time to get a shoulder and neck massages every once in a while. Compliment this with getting a chiropractic neck adjustment to release the muscle imbalances that can cause your headaches.

Headaches can have many causes, but serious causes of headaches are rare. Sometimes headaches warn of a more serious disorder. But, if you have a sudden or severe headache, it is best to seek medical help right away to see if it is related to a serious disorder or just related to your unhealthy lifestyle.



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The evaluation of abdominal pain requires an understanding of the possible mechanisms responsible for pain, a broad differential of common causes, and recognition of typical patterns and clinical presentations. All patients do not have classic presentations. Thus, unusual causes of abdominal pain must also be considered, especially in elderly and immuno compromised patients.

The differential diagnosis of generalized abdominal pain in adults is entirely different from that in children, with the caveat that children gradually progress from infancy to adulthood and so an adolescent is more an adult than a child. A colicky pain comes and goes or at least fluctuates in intensity. The patient may writhe about during the pain, seeking a comfortable position. The pain of peritonitis is constant and the patient lies still as movement aggravates the pain.

Acute abdominal pain can represent a spectrum of conditions from benign and self-limited disease to surgical emergencies. Evaluating abdominal pain requires an approach that relies on the likelihood of disease, patient history, physical examination, laboratory tests, and imaging studies. The location of pain is a useful starting point and will guide further evaluation. For example, right lower quadrant pain strongly suggests appendicitis.

Abdominal Pain in Adults Causes

1. Diseases people worry about most are appendicitis, gallbladder disease, ulcers, infections, and pregnancy associated problems.

2. Doctors also worry about the following conditions: ruptured blood vessels, heart attack, liver and pancreas inflammation, kidney stones, problems with the blood circulation to the intestine, diverticulitis, and other diseases.

Symptoms

The type of pain can vary greatly. When abdominal pain occurs, it can:

*Be sharp, dull, stabbing, cramp-like, twisting or fit many other descriptions

*Be brief, come and go in waves, or it can be constant

*Make you throw up (vomit)

The pain may take the form of cramps that come and go or it may be constant. It may feel like stabbing, aching, or burning in your abdomen. Pain may also spread to your back or chest. Sometimes the pain may be accompanied by nausea, vomiting, diarrhea, or fever.

Abdominal Pain in Adults Treatment

Abdominal pain without fever, vomiting, vaginal bleeding, passing out, chest pain, or other serious symptoms often gets better without special treatment.

If the pain persists or if the patient believes the pain may represent a serious problem, they should see their healthcare provider.

A heating pad or soaking in a tub of warm water may ease the patient’s pain.

Over-the-counter antacids, such as Tums, Maalox, or Pepto-Bismol, also can reduce some types of abdominal pain. Activated charcoal capsules also may help.

Pain relief – your pain may not go away fully with painkillers but it should ease.

Fluids – you may have fluids given into a vein to correct fluid loss and rest your bowel.

Medicines – for example, you may be given something to stop you vomiting.

 



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