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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Chronic pain can prove to be bad experience for those who are enduring it. However, one doesn’t require to live with this condition any more. Fortunately, there are medicines for beating chronic pain.

These medicines may have certain side effects. However, if you get in touch with an experienced health care practitioner, you can get the best possible medicines that would suit your medical or health condition.

Listen to your doctor pharmacist carefully prior to deciding on a particular medication. This will help you in staying away from any serious side effects that result from taking these medicines

Here are certain effective medicines usually prescribed for treating chronic pain:

a) Acetaminophen

The medicine treats chronic pain. The brand name for this medication is Tylenol. You should remember that most over-the-counter and prescription pain medicines contain good amount of acetaminophen in them.

Hence, you need to be extra careful when taking pain relief medicines for chronic pain. Overdose of acetaminophen can result in liver damage. In case, you are taking more than 2 acetaminophen pills a day, you need to tell your doctor.

b) Non steroidal anti-inflammatory drugs

These drugs are said to be really effective in treating chronic pain. These medicines can be taken as soon as you feel the need to. When taken regularly these medicines tend to build up into blood and then combat the pain caused due to inflammation or swelling.

Certain medicines are also available in low-dose and can be taken without any prescription. If your doctor prescribes you to take non-steroidal anti-inflammatory drug, make sure that you take these with milk or food. This will curb the side effects related to stomach.

Taking other pain relief medicines in conjunction with NSAIDs is an absolute no-no. In case, you want to take a different pain killer, you should consult your doctor.

c) Narcotics

These relieve chronic pain. However, these can be addictive. Hence, you must consult your family doctor prior to taking them. Narcotics are the best option for people who are suffering from severe chronic pain.

These drugs need to be an integral part of their treatment. Make sure that you tell your doctor about any kind of inconvenience you experience when taking this medicine. These doctors also cause constipation or difficulty in having bowel movements.

In case, you are on narcotics you must drink at least six to eight glasses of water on a daily basis. Also eat 3 to 5 serving of vegetables and 2 to 4 serving of fresh fruits on a daily basis. Inform your doctor about constipation. He or she may provide you with some laxatives to treat it.

d) Anti-depressants

e) Tricyclic anti-depressants or Duluxetine can be used to treat chronic pain.

f) Capsaicin

It is a naturally occupy substance found in chilli pepper. It is used to make certain topical analgesic creams. This drug changes the pain signals in the skin. It blocks pain without blocking other sensation. This medicine will also cause a burning sensation when first applied. You need to wear gloves when applying this medicine.



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What is the 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.



Buy Tamiflu

Colds with or without cough usually are caused by a virus. Antibiotics are not effective against viruses. Colds cannot be cured, but cold symptoms can be treated with over-the-counter medications.

Colds are most contagious during the first 2 to 4 days after symptoms appear, and may be contagious for up to 3 weeks. Your can catch a cold from person-to-person contact or by breathing in virus particles that are spread through the air by sneezing or coughing. Touching the mouth or nose after touching skin or another surface contaminated with a rhinovirus can also spread a cold.

Acetaminophen is less likely to upset your stomach than other non-steroidal anti-inflammatory drugs such as ibuprofen which are used to relieve aches and pains. However, studies have shown that acetaminophen, aspirin or any other NSAID may worsen asthma and/or peptic ulcers. Aspirin should not be used in children under eighteen years old because it may play a role in causing Reye Syndrome, a rare but severe liver and central nervous system condition. Be sure to discuss all medication choices with your doctor.

A person who is going to cough first draws a deep breath in. This action causes his glottis to close and his muscles to contract, thus building up pressure in the chest. Then suddenly, the glottis opens, an explosive discharge of air sweeps through the air passages and carries with it the excess secretions or, in some cases, foreign matter, which has irritated the larynx, trachea, or bronchi.

Improper use of this medication (abuse) may result in serious harm (e.g., brain damage, seizure, death). Do not increase your dose or take this medication more often than recommended by your doctor or the package instructions without your doctor’s approval.

Flu symptoms are quite similar to cold symptoms; it’s often hard to tell the difference. But there is one clue about flu that can help you know. When you have the flu, you feel flu symptoms sooner than you would cold symptoms, and they come on with much greater intensity. You may feel very weak and fatigued for up to 2 or 3 weeks. You’ll have muscle aches and periods of chills and sweats as fever comes and goes. You may also have a stuffy or runny nose, headache, and sore throat.

Cold or say common cold happens for three to four days and goes back with time. But allergic cold comes more often say every three to four weeks with same time period and symptoms and stay for longer. Better will be ask your health care provider about whether you are suffering from just common cold or allergic cold and cure for the same.

In fact many medical specialists now say that children in particular shouldn’t be given cough medicines, especially with cough suppressants, because they can have potentially dangerous side effects such as drowsiness, balance problems and chest infections in asthmatics. Other ingredients such as antihistamines can cause coughs and decongestants such as pseudoephedrine might cause irritability, sleeplessness and problems with muscle tone.

If your symptoms are bearable, you’re probably better off saving your money and treating your cold or flu the old-fashioned way — by drinking plenty of fluids, resting if possible, and seeing your doctor if your symptoms don’t go away after a few days, or if they get worse.



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Finding the Best Hemorrhoids Relief when your in a big rush.

When you find you have a serious problem with hemorrhoids, you need to find the best relief fast. What the best relief is, however, can seriously depend on your circumstances.

If you have no warning, then what you have in your house becomes the best there is, simply because it’s available. However, there are several other home treatments that are good to keep on hand if you know that hemorrhoids tend to be an ongoing problem that provide significant amounts of relief fast.

Some of the best relief for hemorrhoids are widely available in most homes.

The first line of defense is generally a combination of a hot sitz-bath and ibuprofen or acetaminophen.

To take a hot sitz-bath, draw two to three inches of the hottest water you can stand into a bathtub, and sit in it for about twenty minutes, up to three times per day. If you are going to take frequent sitz-baths, it may be beneficial to invest in a special attachment that allows you to take a sitz-bath while sitting on your toilet, but in an emergency your bathtub works fine.

After the hot bath, immediately wrap ice or an ice pack in a towel and sit on it. The quick alternation of heat and cold can significantly help with circulation and pain reduction.

Ibuprofen is better to take than acetaminophen, as ibuprofen acts as an anti-inflammatory in addition to helping with pain, but either will do in a pinch.

If you can find a footstool around the house to elevate your feet while you sit on the toilet, this will help with hemorrhoids by reducing the strain on the area. Moistening plain, white, soft toilet paper with water for cleaning also tends to be very soothing for hemorrhoids, and far better than scratching at the area or subjecting yourself to potentially irritating dyes or chemicals.

Once you get to your local pharmacy, a wide range of good relief options opens up to you.

The two physical items you’ll probably find to be of greatest benefit are the aforementioned sitz-bath attachment, and a doughnut shaped cushion to sit on which will also remove as much stress as possible.

There are a plethora of creams and ointments on the market, but the best ones for immediate relief generally include the active ingredient lidocaine, a topical anesthetic, which may appear by itself or in combination with other medications.

Hydrocortisone is also a good quick-acting ingredient, although it should not be used for long periods of time as it can lead to tissue thinning in the area which will only make hemorrhoids worse in the long run. As long as you keep this in mind, it’s a good salve for relief.

The last item which will be of interest to anyone seeking relief from hemorrhoids is witch hazel pads. These moistened, medicated pads soothe itchy, burning, swollen hemorrhoids wonderfully, and do a good job of cleaning the area besides.

Hopefully, this list of options for quick, effective hemorrhoid relief has given you enough information to get immediate freedom from pain. Now that you can think, it pays to research ways to permanently treat your hemorrhoids.

Final Words

The vast majority of all hemorrhoids are best treated at home, so the chances of a quick and final resolution to your problem are extremely good. All of these methods of relief can and should be used throughout your treatment, because there is no reason to suffer from hemorrhoids at all.

For your own safety, always discuss the information you find here and elsewhere with your health professional, before acting on it.



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