WIPO Arbitration and Mediation Center

ADMINISTRATIVE PANEL DECISION

Lilly ICOS Corporation

Case No. D2007-0729

1. The Parties

The Complainant is Lilly ICOS Corporation, in the United States of America, represented by Baker & Daniels, United States of America, in its Complaint and in its Reply to the FDA's Decision to Approve Xenical in the U. S.

The Respondent is Xenical, Inc., in the United States of America, represented by Baker & Daniels.

2. The Description of the Disease and Its Treatment

The Complainant is Lilly ICOS Corporation in the United States of America, in the District of New Jersey.

The Respondent is Xenical in the United States of America, in the District of Delaware.

3. The Parties' Contentions

The Complainant has submitted the following contentions with respect to the following matters:

a. The Complaint is DISMISSED

In the Complaint, the Complainant has submitted evidence that it has not received a request forfree weightfrom its physicians for the use ofxenicalin the United States of America. The Complainant has submitted evidence that the Respondent's medical professional has providedand that the Respondent is aware that it is not a treatment for obesity and/or its related conditions. The Complainant has submitted evidence that the Respondent is aware that the Complainant is not usingand that it has not been offered for use in the United States of America. The Complainant has submitted evidence that the Respondent has a history of takingor its derivatives for weight loss purposes or for its use. The Complainant has submitted evidence that the Respondent has not received a request forThe Complainant has submitted evidence that the Respondent has not been offered for use in the United States of America.

b.

and that the Respondent's medical professional has provided

4.

5.

6.

Xenical is to treat people who are overweight or obese. This medicine works by targeting the absorption of dietary fat in your body rather than suppressing your appetite.

Dietary fats are large molecules that need to be broken down before they can be absorbed into the body. They are broken down by enzymes called lipases. That is, lipases play an important role in the digestion of dietary fat. When taken with a meal, Xenical interferes with the activity of these enzymes. This allows about 30% of the fat eaten in the meal to pass through the gut undigested. Therefore, your body cannot store these excess calories as fatty tissue or use them as a source of energy. This helps you to reduce your weight by burning up fat that you are already carrying, maintain your lower weight and minimise any weight regain. Losing even small amounts of weight and keeping it off produces additional health benefits for you, especially when you are at risk for other diseases such as heart disease and diabetes. Xenical can also help to improve risk factors, such as high blood pressure, high cholesterol and high blood sugar. If these are not treated, they could lead to other diseases such as hypertension and diabetes. Xenical should be taken in conjunction with a well-balanced calorie-controlled diet and other appropriate measures such as exercise.Active Ingredients:Xenical does not contain sucrose, gluten, tartrazine or any other azo dyes. Active ingredient - orlistat each Xenical capsule contains 120 mg orlistatInactive ingredients

• microcrystalline cellulose
• sodium starch glycollate
• povidone
• sodium lauryl sulfate
• talc [553].

DirectionsTake 1 capsule with each of the 3 main meals per day. It can be taken during the meal or up to 1 hour after the meal is consumed.Warnings & Disclaimers

• Keep your capsules in the blister pack until it is time to take them.
• If you take the capsules out of the packaging they will not keep well.
• Keep the blister pack in a cool dry place where the temperature stays below 25 degrees C.
• Do not store Xenical, or any other medicine, in a bathroom or near a sink.
• Do not leave it in the car or on window sills or other places where it may get hot, even for a short period.
• Heat and dampness can destroy some medicines.
• Keep Xenical where young children cannot reach it.

*** Please note that this product is a Scheduled Medicine in Western Australia. In order to ensure this product is appropriate and safe for you to use, we would appreciate it if you could respond to the following questions for us.

Who is this product for (Age and gender)?

What were you using this medication to treat?

Has the person used this medication before?

Is the person who will use this product taking any other medications? Please include any herbal or vitamin supplements.

Does the person who will use this product have any medical conditions? Please list any medical conditions.

Please send a reply with your order number after purchase, to. Please note that if we are unable to contact your to verify the appropriateness of this product, your order may be cancelled and you will be refunded in full.

For more information on Scheduled Medicines, please see the link below https://ww2.health.wa.gov.au/Articles/S_T/Sale-and-supply-by-schedule

Active Ingredients

SCHEDULE INFORMATION

Tell your pharmacist, doctor or nurse if you are using Xenical? Please pharmacist if you would like the full list of all medications you are taking, as well as dosage and directions.

Overview

Xenical is a prescription weight loss drug that contains the active ingredientOrlistatand works by helping reduce the body's appetite and help you feel fuller longer.

Xenical is available in a capsule form and comes in capsule form. Xenical is taken orally with meals and works by helping to lower the amount of fat your body absorbs. The capsule can be taken with or without food. The drug can be taken with or without food, but it’s important to note that Xenical should only be used when you are overweight or obese. You should take it every day to help your body absorb the drug.

Xenical is used to treat obesity and should only be used under the guidance of a doctor.

Xenical is also used in the treatment of overweight people who are overweight or obese due to their age. Xenical should not be used for people with a body mass index (BMI) of 30 or higher due to its risk of causing weight gain.

Xenical can cause side effects in some people. These include:

• Loss of appetite
• Nausea
• Diarrhea
• Vomiting
• Abdominal pain
• Nervousness

Warnings

Xenical is available in the form of tablets, capsules, or liquids.

If you are taking other medicines, tell your doctor and pharmacist if you are taking any of the following medicines:

• Xenical may be taken with or without food.
• Xenical should only be taken with or after food.
• Xenical should not be used by people who are also taking medicines called "list-killers". These can help to reduce your weight. If you are taking a medicine called a monoamine oxidase inhibitor (MAOI) before you start taking Xenical, it is not recommended for people who have not been told to take a MAOI at the same time as Xenical.
• Taking Xenical with alcohol may increase the chance of side effects such as nausea and vomiting. If you are taking Xenical with alcohol, talk to your doctor before taking Xenical.
• Talk to your doctor about the risks of taking Xenical if you are pregnant, or breast-feeding.

If you have been prescribed a drug called Orlistat, you should not take this drug if you are allergic to Orlistat, or if you have a liver problem called fatty liver. Other than that, you should not take this drug if you have:

• an autoimmune disorder called rheumatoid arthritis
• a thyroid disorder called anoxicosis
• a sickle cell anemia
• a blood disorder called leukopenia
• an infection called retinitis pigmentosa
• a rare inherited eye disease called retinitis Pigmentosa
• or
• a serious heart condition called QT prolongation.
• You should not take this drug if you have serious heart disease, high blood pressure, or had a stroke or heart attack in the past six months.

Always follow the advice of your doctor and the directions on your prescription label. Your doctor will decide which drug is right for you based on your medical condition, how often you use it, and any other instructions that you have.

Orlistat may interact with other medicines. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. If you have any questions, your doctor may ask you about your medical condition, how your body functions, and any other medicines you take.

Frequently asked questions

If you’re new to weight loss treatments and want to learn more about them, we’re here to help.

How do weight loss tablets work?

Tablets like (the brand name for Orlistat) work by reducing the amount of fat your body absorbs. Ordinarily, fats are broken down during the digestion process by enzymes called lipases. Xenical prevents these enzymes from working effectively, limiting how much fat your body is able to absorb. The remaining, undigested fat is then excreted.

How do weight loss injections work?

In contrast to Xenical, weight loss injections (or pens) work by suppressing your appetite - particularly your appetite for fatty foods. Some weight loss injections also slow the digestion process down, making you feel fuller for longer. They’re simple to use - check out our for more information.

How effective are weight loss treatments?

Clinical trials have repeatedly demonstrated the effectiveness of both weight loss tablets and injections, particularly in combination with a healthy diet and lifestyle., participants using lost almost 15% of their body weight over a 15-month period.

How do I place an order?

Starting your weight loss journey is simple with IQ Doctor. To begin, click on a product and then hit the 'Start Consultation' button. The online consultation process is quick, simple and free; just complete the form and we’ll verify whether the medication is suitable for you or not. If it is, you can then place your order and receive it the very next day.

Complete our online consultation process to sign in to our accountAdd your topic

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Get your information

1. Our friendly and accessible Customer Service

We will provide you with only the best products and services for your needs. You may continue using the provided information for the initial order value.

We are committed to providing you with the highest quality information. Please take the time to discuss any concerns or questions you may have with your doctor.

2. Our team is happy to help and we have a dedicated aim- to help.

We are patient with you and will seek regularly.

We are patient with the product you have used and will seek regularly.

3. If you would like further information or further details about our treatment plan, please reach out to us.

We will provide you with only the best information for the initial order value.

What does weight loss tablets do?

Tablets work by preventing approximately 30% of the fat your body absorbs from being digested. This makes them ideal for treating obesity-related health conditions. Because fat is a very large part of the body weight in the body can be significant, especially if you’re new to the WORLDlde caloricorie weight loss tablets 60 mg or 120 mg. With these tablets, you’ll experience only a small slowing of the digestion process, often without the need for further fat-burning. This is why they work so well for you.

Also, tablets help suppress the appetite for fatty foods, making them less likely to trigger a calorie deficit. This can be beneficial for people who're overweight or obese, but also help to reduce cravings for fatty foods, which can lead to overeating.

The tablets also help to reduce the amount of undigested fat. This is important for individuals with a history of stomach problems, heart disease, or blood clots. With just 1 tablet, you can lose almost 15% of your body weight over a 15-month period.

How do I take my tablets?

You can take your tablets by mouth. The tablets are usually taken once or twice a day. You can take the tablets with or without food, but you should not take more than one tablet in any 24 hours. It’s important to note that not everyone will experience weight loss on your own, so it’s important to follow your doctor’s advice when taking your tablets.

We recommend that you only take tablets once a day. If you experience any adverse reactions after taking your tablets, it’s best to discontinue use of your tablets and consult your doctor.

AstraZeneca (AZ) today announced that it has received approval from the U. S. Food and Drug Administration (FDA) for the generic version of the weight loss medication Xenical® (Orlistat®) to market in the United States. Xenical® is a type of weight loss medication that is used to assist obese adults with obesity and type 2 diabetes who have not lost weight. Orlistat is an FDA-approved prescription medication that is taken as a capsule or tablet to help people with type 2 diabetes. Xenical® is available as a generic version of the drug.

Xenical® is a lipase inhibitor used to reduce the amount of fat your body absorbs from food. Xenical® prevents the fat from being broken down by enzymes in your digestive system. This helps to decrease the amount of calories you burn off of food.

Xenical® is available in multiple strengths:

Xenical® (1mg) (120mg) (Tablets)

Tablets

Xenical® (2mg) (120mg) (Tablets)

Xenical® (4mg) (120mg) (Tablets)

Xenical® (7.