Lilly Uses Horny Goat Weed to Fend Off Cialis Royalty Demands

Eli Lilly & Co. told a federal jury that a German company is trying to take credit for centuries-old Chinese medicine in seeking royalties on the use of its erectile-dysfunction drug Cialis to treat an enlarged prostate.

Erfindergemeinschaft UroPep GbR, a company founded by researchers from Hannover Medical School, claims it’s entitled to royalties from Lilly’s sale of Cialis based on a patent for prostate treatment. UroPep is seeking $84.3 million, or 12 percent of the $704 million in Cialis sales since 2011 that relate to its use in treating benign prostatic hyperplasia, also known as BPH.

“We offered to give Eli Lilly permission” to use the patented invention, UroPep lawyer John Hughes of Bartlit Beck in Denver told a federal jury in Marshall, Texas. “Their response: silence.”

Lilly said the patent didn’t cover anything new — and pointed to Chinese home remedies including one known as Horny Goat Weed, which it said is used both for erectile dysfunction and to treat BPH. It’s not the first time Lilly has brought up the herb — it was used to successfully invalidate part of a Pfizer Inc. patent for the rival impotence drug Viagra.

“UroPep filed a patent with nothing more than an idea,” Lilly lawyer Todd Vare of Barnes & Thornburg in Indianapolis told the jury. The idea “is well-known and obvious throughout the world.”

The drug, more commonly prescribed for erectile dysfunction, generated almost $2.5 billion last year, more than 11 percent of the Indianapolis-based company’s revenue. It’s Lilly’s second-biggest seller, behind the insulin Humalog, used to treat diabetes. Hughes told the jury that UroPep was not seeking royalties on any sales of Cialis for impotence.

The UroPep patent, issued in the U.S. in 2014, is for the use of a class of compounds to treat certain prostate diseases, including BPH. Lilly contends the patent doesn’t cover the specific active ingredient in Cialis, called tadalafil.

Cialis was approved by U.S. regulators to treat erectile dysfunction in 2008 and in December 2010 Lilly asked the U.S. Food and Drug Administration to also approve Cialis for treatment of the signs and symptoms of BPH.

After Lilly got approval, one of the UroPep inventors emailed Lilly to inform it of the then-pending patent application. Lilly didn’t respond to requests for licensing talks, UroPep contends.

This isn’t the only case in which Lilly is trying to fend off royalty demands from Cialis. The drugmaker is working to invalidate a patent owned by Los Angeles Biomedical Research Institute for a method of arresting penile fibrosis.

Presiding over the trial is Circuit Judge William Bryson, who occasionally handles district court cases but normally sits on the U.S. Court of Appeals for the Federal Circuit in Washington, which handles all patent appeals. While neither Lilly nor UroPep are based in Texas, the case was filed there because the court is the most popular for patent litigation.

The jury is expected to begin deliberations by Friday.

The case is Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., 15cv1202, U.S, District Court for the Eastern District of Texas (Marshall).

Read more: http://www.bloomberg.com/news/articles/2017-04-17/lilly-uses-horny-goat-weed-to-fend-off-cialis-royalty-demands

Lilly Uses Horny Goat Weed to Fend Off Cialis Royalty Demands

Eli Lilly & Co. told a federal jury that a German company is trying to take credit for centuries-old Chinese medicine in seeking royalties on the use of its erectile-dysfunction drug Cialis to treat an enlarged prostate.

Erfindergemeinschaft UroPep GbR, a company founded by researchers from Hannover Medical School, claims it’s entitled to royalties from Lilly’s sale of Cialis based on a patent for prostate treatment. UroPep is seeking $84.3 million, or 12 percent of the $704 million in Cialis sales since 2011 that relate to its use in treating benign prostatic hyperplasia, also known as BPH.

“We offered to give Eli Lilly permission” to use the patented invention, UroPep lawyer John Hughes of Bartlit Beck in Denver told a federal jury in Marshall, Texas. “Their response: silence.”

Lilly said the patent didn’t cover anything new — and pointed to Chinese home remedies including one known as Horny Goat Weed, which it said is used both for erectile dysfunction and to treat BPH. It’s not the first time Lilly has brought up the herb — it was used to successfully invalidate part of a Pfizer Inc. patent for the rival impotence drug Viagra.

“UroPep filed a patent with nothing more than an idea,” Lilly lawyer Todd Vare of Barnes & Thornburg in Indianapolis told the jury. The idea “is well-known and obvious throughout the world.”

The drug, more commonly prescribed for erectile dysfunction, generated almost $2.5 billion last year, more than 11 percent of the Indianapolis-based company’s revenue. It’s Lilly’s second-biggest seller, behind the insulin Humalog, used to treat diabetes. Hughes told the jury that UroPep was not seeking royalties on any sales of Cialis for impotence.

The UroPep patent, issued in the U.S. in 2014, is for the use of a class of compounds to treat certain prostate diseases, including BPH. Lilly contends the patent doesn’t cover the specific active ingredient in Cialis, called tadalafil.

Cialis was approved by U.S. regulators to treat erectile dysfunction in 2008 and in December 2010 Lilly asked the U.S. Food and Drug Administration to also approve Cialis for treatment of the signs and symptoms of BPH.

After Lilly got approval, one of the UroPep inventors emailed Lilly to inform it of the then-pending patent application. Lilly didn’t respond to requests for licensing talks, UroPep contends.

This isn’t the only case in which Lilly is trying to fend off royalty demands from Cialis. The drugmaker is working to invalidate a patent owned by Los Angeles Biomedical Research Institute for a method of arresting penile fibrosis.

Presiding over the trial is Circuit Judge William Bryson, who occasionally handles district court cases but normally sits on the U.S. Court of Appeals for the Federal Circuit in Washington, which handles all patent appeals. While neither Lilly nor UroPep are based in Texas, the case was filed there because the court is the most popular for patent litigation.

The jury is expected to begin deliberations by Friday.

The case is Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., 15cv1202, U.S, District Court for the Eastern District of Texas (Marshall).

Read more: http://www.bloomberg.com/news/articles/2017-04-17/lilly-uses-horny-goat-weed-to-fend-off-cialis-royalty-demands

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So, just what is an enlarged prostate gland? Well, it is important to stress that an enlarged prostate does not necessarily scream prostate cancer. But boy can the whole ordeal by uncomfortable. Benign prostatic hyperplasia, or an enlarged prostate gland, is an condition that usually manifest itself in man over the age of forty and just might be the most common medical problem facing men over sixty.

Symptoms of An Enlarged Prostate

The actual cause of enlarged prostate joins the cure for the common cold as one of medicine's greatest mystery, but if you've got one, chances are you don't have to be Jessica Fletcher to figure it out. A normal prostate gland is about the size of those walnuts that the fancy airlines like to substitute in place of the traditionally cliche plane peanut, as the prostate grows it will generally begin to squeeze the urethra-it then in turn narrows. The bladder then feels compelled to push urine through the newly slimmed down urethra more forcefully-this will result in the urge to make more frequent trips to the Little Boy's Room. As the problem progresses, the bladder may get just a little perturbed at having to do extra credit and ultimately may not be able to completely empty itself. And when the bladder get really peeved, prostate patients may find themselves with acute urinary retention, a complete shutdown of urination. It is a serious condition which should be followed by an immediate trip to the nearest healthcare facility.

Some of the enlarged prostate symptoms to keep your eyes peeled for include:

· Leaking of urine

· The inability to empty the bladder

· Frequent trips to the bathroom-especially at bedtime

· Difficulty starting urination

What is an enlarged prostate sign of danger? It's time to head to a doctor if you lose the ability to urinate, begin to experience nausea, fever, and chills, or if lower back pain becomes accompanied by blood in the urine-none of which are good signs.

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Self-care steps are often enough to make you feel better.
• Holy basil leaves serve as an effective enlarged prostrate natural remedy. Crush some holy basil leaves and mix the juice extract with yogurt. Consume this mixture once everyday. This is particularly useful when the weather is hot. In cold conditions holy basil juice coupled with honey is an excellent alternative.

• Another effective enlarged prostate remedy is to sit in a warm water tub for half an hour. The heat helps to reduce the swelling, easing the pain.
• Palmetto is also extremely useful as an enlarged prostrate remedy. It aids in dealing with problems such as urination at night, swelling and inflammation and pain.
• Yoga and meditation help to relax and maintain a correct position while sitting.
• It is also important that you increase your intake of water. This will aid the treatment and hasten your recovery.

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The prostate is a male sex gland located beneath the bladder. According to "Prescription for Nutritional Healing" by Dr. James A. Balch, M.D. and Phyllis A. Balch, prostatitis, which is inflammation of the prostate gland, and prostatic hypertrophy, or enlarged prostate, are the most common prostrate problems experienced by men. There are several herbs used in alternative medicine that are believed to be beneficial in cleansing the prostate. Consult with a physician before using an herbal remedy to cleanse the prostate.
Red Clover

Red clover is reputed for its ability to cleanse the liver and the blood, promoting prostate health. According to "The Healing Herbs" by Michael Castleman, red clover is also used as a cancer treatment, worldwide, by approximately 33 different cultures.
Castleman states that red clover should not be used by those with a history of stroke, heart disease, thromboembolism and thrombophlebitis. Possible side effects include diarrhea and stomach upset. Check with your physician before taking red clover to avoid any possible interactions with prescription medications.
Uva Ursi

Uva ursi is a popular diuretic that is thought to be beneficial in cleansing the urinary tract, dissolving sediment and promoting colon health. According to "The Healing Herbs," uva ursi has been used for its antiseptic and diuretic properties for more than 1,000 years by the American Indians and the Chinese. In addition to cleansing the urine, it is sometimes used to treat high blood pressure, congestive heart failure and diarrhea. It is also used topically to treat wounds.
The safety of uva ursi has not yet been determined. Possible side effects include stomach upset, dark green urine, ringing in the ears, convulsions and vomiting. Uva ursi contains very high levels of tannins, which may play a role in causing cancer. Do not use uva ursi without first consulting a health care professional.
Saw Palmetto

According to "Prescription for Nutritional Healing," saw palmetto is sometimes used to treat prostate inflammation and enlargement, and eases the hormonal stimulation of the prostate gland. It is also used to aid in the treatment of enuresis, which is the inability to control urination, difficulty urinating and painful ejaculation.
The safety of saw palmetto has not yet been determined and it has not been approved by the Food and Drug Administration. Do not take saw palmetto if you have a hemophilia or any other blood disorder. Saw palmetto should not be taken if you are currently on blood thinning medications, as it may increase the risk of bleeding. Talk to your doctor if you have a history of respiratory disorders, stomach ulcer or heart disease.

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It is known that 50% of men over the age of 50 have prostate problems and don't even know it. Insufficient water intake, poor diet and being overweight are considered to be grand contributors. Have you ever considered that hormonal imbalances and constipation may be at the root of the problem?

Constipation causes swelling in the colon and therefore creates pressure on the prostate gland which sits in close proximity. Because of the location, constipation allows bacteria to migrate from the colon to the prostate. In turn, this inflammation and swelling is called prostatitis.

The causes of constipation are many. Poor nutrition, holding back, lack of physical exercise, emotional and mental stress, medications, lack of enough good quality water and the myriad of poisons that infiltrate us on a daily basis.
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