In re OxyContin Antitrust Litigation

    By Kevin E. Noonan --

In 2004, Purdue Pharma L.P. and its related companies were found to have obtained patents (U.S. Patent Nos. 5,656,295; 5,508,042; and 5,549,912) for their OxyContin® opioid pain relief formulations through inequitable conduct.  The basis for this determination was that Purdue had maintained before the Patent Office that its formulations were patentable because they were able to relieve pain in 90% of patients using a reduced dosage range compared with prior art opioid formulations.  The basis for these assertions was not clinical data but an "insight" by one of its scientists -- the District Court ruling that Purdue had misled the Patent Office into believing its assertions of patentability were based on clinical data.

The Federal Circuit initially affirmed, but on rehearing, vacated the judgment and remanded the case back to the District Court for reconsideration.  The Federal Circuit also affirmed the District Court's judgment that defendants Endo Pharmaceuticals, Inc., Teva Pharmaceuticals, Inc., Boehringer Ingelheim GmbH, and Impax Laboratories Inc. infringed Purdue's patents, and these defendants ultimately settled with Purdue.  In the meantime, several other generic drug manufacturers -- including Mallinckrodt, Inc., KV Pharmaceutical Co, and Actavis Totowa L.L.C. -- filed ANDA applications with the Food and Drug Administration, and Purdue brought suit pursuant to the provisions of the Hatch-Waxman Act (35 U.S.C. § 271(e)(2)).

The District Court decided to try the inequitable conduct case first, and last Monday issued its opinion.  The Court found that, while not entirely blameless, Purdue's conduct did not rise to the level of inequitable conduct.  The defendants' inequitable conduct assertions included the following eight bases; for each of which the Court assessed the materiality of the action and the evidence of an intent to deceive:

1.  Purdue lacked empirical evidence for claiming a reduced dosage range.

This basis had previously been successfully argued at the earlier trial and before the Federal Circuit.  Its basis was that Purdue "implied" to the patent Examiner that clinical studies supported the assertion that the claimed formulation was effective over a reduced dosage range, when in fact the formulation was based on an insight by one of the named inventors.

The Federal Circuit had agreed with the District Court that Purdue's misrepresentations in this regard were material to patentability, but had determined that the degree of its materiality "was not especially high" but was in fact "relatively low," based in part on its being merely an omission and not an affirmative representation.

The District Court next considered the evidence of an intent to deceive.  In the first trial, the Court had relied on statements and documents relating to Purdue's labeling claims to the Food and Drug Administration.  The Court also considered Purdue's reduced dosage range claims in the face of its inability to titrate the dosage to indicate an intent to deceive.  The Federal Circuit held this to be erroneous, in part because the "quantum" of proof required to satisfy patentability requirements and FDA regulatory requirements were different.

In view of the Federal Circuit's analysis, the District Court required the defendants to come forward with additional evidence of an intent to deceive.  The District Court found that the defendants failed to adduce such evidence, proffering "only vague allegations" that Purdue's business interests provided an incentive to obtain a patent on OxyContin®.  This, the Court said, was no more than "scant evidence" of an intent to deceive, and thus the Court refused to find inequitable conduct in this behavior.

2.  There was inadequate support for asserting that most other opioids had an eight-fold dosage range.

The defendants also asserted that Purdue had inadequate evidence for its assertions that, while other opioid analgesic formulations exhibited an eight-fold dosage range for controlling pain in 90% of patients, OxyContin® had a four-fold dosage range (thus requiring lower doses of drug and avoiding significant side-effects).  The defendants alleged that Purdue had no evidence for these assertions.

The District Court disagreed, finding that Purdue had adequate evidence for morphine, from a report prepared by its expert two years prior to filing the parent patent application.  The Court also credited an American Pain Society report that suggested opioid analgesics were effective over an eight-fold dosage range, and thus found that any misrepresentation on this basis was "vanishingly small."  In view of this conclusion, the Court did not even reach the question of evidence for an intent to deceive.

3.  Purdue failed to disclose clinical results that contradicted the dosage and titration claims.

The defendants also cited three scientific studies alleged to contain clinical results contradicting Purdue's assertions regarding its reduced dosage range and ease of titration.  The District Court found none of these reports to be material:  one described an experimental protocol that precluded titration, and the other two failed to test the dosage range asserted by Purdue in support of its patentability arguments (nor did either of these references study the ease of titrating other opioid analgesics).  In addition, the latter two reports had been asserted in the earlier litigation and the Court had not found them to be material.  Here, the Court said that the defendants had not provided "a sound basis to reconsider its prior determination."  Again, the Court did not reach the question of an intent to deceive in view of this determination on materiality.

4.  Whether Purdue's finding regarding "peak" plasma levels and duration of pain relief were "surprising."

Purdue had asserted during patent prosecution that its finding that OxyContin® achieved peak plasma levels at 2-4 hours after administration, and provided 12 hours of pain relief was "surprising."  The defendants argued that oxycodone was the fifth opioid to exhibit this behavior, and thus it could not be a "surprising" result since Purdue had devised formulations of morphine, dihydrocodeine, hydromorphone, and codeine that exhibited the same pattern.  In response, Purdue asserted that since every drug is different, finding this relationship between peak plasma concentration and pain relief for OxyContin® was indeed surprising and was not a misrepresentation.  These assertions were supported by expert testimony regarding the unpredictability of pharmacokinetics, and by the American Pain Society report discussed above, which stated that "different patients respond differently to different opioids."

The District Court said that the defendants had provided no scientific evidence contrary to Purdue's assertions and evidence, but instead relied upon the "common sense proposition" that a result cannot be surprising the fifth time it is obtained.  The Court characterized this as "facile reasoning" not supported by Purdue's "unchallenged evidence," and held that the defendants had not sustained their burden of showing that Purdue made a material misrepresentation to the Patent Office when it characterized its OxyContin® results as being "surprising."

5.  Purdue failed to disclose other controlled-release opioid formulations.

The defendants further maintained that Purdue committed inequitable conduct by not disclosing the existence of other controlled release opioid formulations to permit the Examiner to assess whether he agreed that the results asserted for OxyContin® were surprising.  Purdue had in fact disclosed controlled-release morphine and hydromorphine, but not codeine and dihydrocodeine.

The District Court found that this failure to disclose the other controlled-release opioid formulations was a material omission, being inconsistent with Purdue's representations that the results obtained with OxyContin® were surprising.  While stating that the level of materiality was low, the Court also found that the evidence of the other, undisclosed controlled-release opioids was not cumulative, since they doubled -- from 2 to 4 -- the number of other formulations the Examiner could have considered for comparison.

However, the District Court did not find Purdue's failure to disclose the existence of these additional controlled-release opioid formulations to be inequitable conduct, because it found no evidence of an intent to deceive.  The Court found credible Purdue's explanation for the failure to disclose:  that the two opioids it did disclose were more relevant to OxyContin® because they, like OxyContin® were used to control moderate to severe pain, while the undisclosed opioids were used for controlling mild to moderate pain.  The Court characterized Purdue's behavior in deciding whether to disclose the different opioid formulations as a "good faith" conclusion that morphine and hydromorphine were relevant to patentability of OxyContin®, and codeine and hydrocodeine were less relevant (and cumulative).  While disagreeing with this conclusion, the Court found that the defendants had provided no evidence of any intent to deceive.

6.  Failure to disclose that their expert witness was not an independent expert.

This allegation of inequitable conduct was based on Purdue's failure to expressly inform the Patent Office that its declarant, Dr. Kaiko, was not an independent expert but was an employee.  The District Court's determination that this was a material omission stemmed directly from the Federal Circuit's decision in Ferring A.V. v. Barr Labs, Inc.

However, the District Court found "overwhelming" evidence that the omission was made in good faith, based on Dr. Kaiko's status as a named inventor on each of the patents-in-suit.  The Court reasoned that had Purdue wished to conceal Dr. Kaiko's identity or interest, it would not have named him as an inventor.  The Court also considered the substance of Dr. Kaiko's declaration to indicate to the Examiner that he was involved in developing the invention, and distinguished this case from Nilssen v. Osram Sylvania Inc., where the patentee actively concealed the affiant's affiliation from the Examiner.

7.  Failure to disclose U.S. Patent No. 4,861,598.

The District Court agreed that Purdue failed to provide this patent reference to the Patent Office.  However, the omission was not material because the Examiner uncovered the reference and used it to reject certain claims during prosecution.  The Court noted that a reference cannot be found to have been withheld by the Examiner when the evidence is that the Examiner considered the reference, and thus that Purdue's nondisclosure was not a material omission.

8.  That Purdue's conduct, taken as a whole, comprised a pattern that was evidence of an intent to deceive.

Having failed to persuade the District Court with clear and convincing evidence of inequitable conduct, the defendants asserted that, taken together, Purdue's actions were sufficient to comprise a pattern that evinced an intent to deceive.  The Court reviewed all of the defendants' allegations, and found that at best the defendants had shown Purdue to have committed a single misrepresentation of low materiality, a single immaterial omission, and two omissions made in good faith.  On this evidence, the Court declined the defendants' invitation to find a pattern of behavior consistent with an intent to deceive.

Having had the integrity of its patents (and reputation) restored, Purdue is now in a position to assert these patents against the defendant ANDA filers.  Provided that none of the defendants have modified the formulation in a non-infringing way, it is likely that Purdue will prevail, and consumers will need to wait for a successful challenge of these patents, or until their expiry, before generic OxyContin® will become available.

Comments

[Don L]

Let the billions start rolling in again!

[steve hayes]

I for one am not unhappy that we will not have a less expensive OxyContin. We will just see more victims of the prescription drug epidemic that is taking the lives of people of all ages and all economic classes. As the director of Novus Medical Detox, we daily see the ravages of prescription drugs. We need to wake up soon to the facts--some of these prescription drugs are just legal heroin and cocaine. They have the same molecular structure and create the same effects--except that they have the mantle of "legitimacy" because they can be obtained from a licensed pharmacy.

Steve Hayes
www.novusdetox.com

[Rachel Andrex]

Do not forget there are legitimate patients who need this drug. These patients rely on their medicine to manage serious pain and this decision has crippled the supply line that provides for them. The suppliers of medicine to the patient were depending on the generic pills to fill the prescriptions of patients and right now people are having difficulties getting their prescriptions filled. These people are already frail, tired and fighting there hardest to just stay alive. Oxycodone is a treatment to manage chronic pain, and managing that pain is necessary to keep these people alive. Shouldn’t consideration of the patients come first? Giants fighting battles in court rooms do not feel the pain this medicine was created to control or consider the ramifications on those who have the need in the first place. There should have been a plan of action when this decision was made to make sure the patients could receive there treatment with ease and that there was not is irresponsible. This whole battle was about money, and yes drug manufacturing is for profit business but is the bottom line really all that matters? This decision as it has played out has violated the principle of nonmalificence.

[Bob Weidman]

Wonderful! My prescriptions were already costing me over $350 per month. I will have to attempt to endure the agony of my autoimmune neuromuscular disease. I am on Social Security Disability which pays me less that $1,000 a month.
As for your comment Steve Hayes, you have no clue as to what you are talking about.

Dear Bob:

Many people directly impacted by the lack of generic oxycontin are unhappy with this decision. However, at least according to the Court, Purdue Pharma was not guilty of inequitable conduct, which was the basis for the patents to be held non-enforceable. Since the latest-expiring of the patents-in-suit will expire on August 27, 2013, generic versions will not be available until then (at least in the U.S.).

Thanks for the comment.

[Gregg D]

I am for one outraged. Today I had to get my monthly rx of oxycontin,which is very expensive in generic form to begin with. I currently do not have insurance at this time due to losing my job because of severe pain from a accident. My doctor wrote it for 90 tabs and due to the fact that there are no more generics after they clear the shelves I ended up with being able to get 47 to last a month. This ruling is killing the patients who really need this medication. All it is Purdue wanting to become a monopoly when it comes to this medication. I understand that there is a lot of illicit use in which I do not condone at all. I need this drug it actually helps quite a bit. Now I cannot afford it, People like Mr. Hayes appearently have not experienced extreme excrutiating pain that just does not go away,I pray he never does. When your 31 and had a normal life until a major accident and then your life gets turned upside down and without the medication it hurts to get out of bed or even to get yourself dressed or even work for 8 hours a day. Then theres a problem. We are living in one of the supposed best country in the world where your country is supposed to be dedicated to its people. Thats a big crock what ever benefits the leaders of the Us and the insurance and pharmacutical companies is what goes here. There will never be any kind of socialized healthcare here and we need it bad. They run ads to make us against it where we are scared that we are are going to become communists or that we will have to wait a year or two for by pass surgery or for any other major health problem. When infact its actually just a wonderful scheme to keep the drug companies and insurance companies filthy rich. The USA does not care about anybody except for people that can make them richer. I never thought in a million years that I would ever ever say this, But I hate my country, Im not gonna revolt or anything but as soon as I get enough money im going to move my family to canada or maybe France or a country who cares about there people. I cant afford to be an american anymore. If it was up to my country it would be probaly be cheaper and more profitable for me to just die then to get medical help from the government. For example I had menegitis last year and was in a coma for 3 days the hospital applied for assistance for medical help because we owned a car over the amount that was allowed on the application they would not approve it, They wanted my wife to transfer me to another facility. I was almost dead. When they finally decided to keep me. They wanted her to put a deposit down they wanted 1500.00 the county run hospital could care less if I was ok or if I was gonna live or die they wanted there money.

[Henry Massingale]

I have been so out of touch with this world and the issues within, and because of this system failure brought on by this 9/11 , War and the Scams that brought the American People to their knees. I am a little bit angry, because some one said to me why, why Mr. Massingale do you persist? Because I choose to. I do not belong in this world of a Matrix, that most hold in the hearts as if it is all that.
Now people do not feel that addicts need help within this Health Care Bill. Let me show you how wrong you are and I did give warning that I would write words in to this Matrix that would shake the
Foundation of this Government Institution. So put on your seat belt because its the Law.
Who are the investors of the pharmaceutical Company Purdue that makes Oxycontin and how are you above the Law ?
A short story,
Prescription Drugs Match Heroin, Cocaine in Overdoses in U.S.
June 17, 2010, 1:06 PM EDT
By Tom Randall
June 17 (Bloomberg) -- Emergency-room visits from abuse of prescription and over-the-counter medicines doubled in the U.S. in four years, matching for the first time the number of overdoses of illegal drugs such as cocaine and heroin.
Regulator-approved treatments were implicated in a record 1 million patients who sought help at hospital emergency departments in 2008, twice the number as in 2004, according to a study released today by the Centers for Disease Control and Prevention, in Atlanta. Overdoses from illicit drugs were unchanged, at 1 million emergency visits.
The most hospitalizations were caused by painkillers, with visits more than doubling, and tranquilizers, with an 89 percent increase. King Pharmaceuticals Inc., in Bristol Tennessee, and Purdue Pharma LP, in Stamford, Connecticut, won approval in the last year for drugs to prevent misuse. A half-dozen drugmakers are developing pain pills that resist abuse methods such as crushing, dissolving in alcohol, and taking more than needed.
“Additional measures are needed urgently,” researchers wrote in the CDC’s Morbidity & Mortality Weekly Report. “Recent public health and law enforcement measures intended to prevent nonmedical use of such drugs have not prevented rate increases.”
The biggest increase in emergency visits was from adults in their 20s, according to the study. The researchers analyzed reports from 220 emergency departments across the U.S. to estimate the nation’s tally.
--Editors: Bruce Rule, Jeffrey Tannenbaum
To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net.
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
1.Oxycontin : a media-made drug scare
"The 'poor man's heroin,'" U.S. News described the drug. ... In general, the population is older, Fisher says, and many suffer from chronic illnesses and .... isn't nearly as bad as it's made out to be, why has it received so much media attention? .... Oxycontin lawsuit : Purdue Pharma Sued by Consumer Groups ...
opioids.com/oxycodone/oxycon.html - Cached

Please allow me to share a concept with the People Of America, that will build for tomorrow. The Great Wall Of China in America. A 10 year project, and within the respect of why China built that wall and even as of today China makes money form that wall. This project will build towns and cities on both sides of the border and will bring peace.
Another concepts is,
To find a way into the hearts of children, first you must allow a truth to be shared and then let this share build within their hearts and you will see children open their minds to things not known.
Permission is given to copy this and put it in every school in the United States, to build on so that it will all ways be known that we do care.....we have been down that road and the glory for that dollar is lost by things done....
Welcome to FASC Concepts
The Day The World Stood Still
We are at War with a Drug Empire
We have been joined by so many people , from the blog site of Eminem to Chuck Norris to Jay Z and thousands of other people who wish to bring a new life to all.
When I wrote my first " Boycott" I just wanted to see the trickle effect it would have, with out stepping into a forth dimension and having my in site lost.
The Arabic Drug Empire is the only one in the world that seeks to kill every last man woman and child in the world in order for their chosen few can repopulate the world....
Our goal is for our words to go around the world, to be heard in the streets to the country until it reaches the White House and shakes the very foundation of this Government Institution. It is not what we say that counts in as much as, it is what we do not say that builds words of truth.
Some say that a Boycott is a waist of time, but it would depend on what is said , to understand we wish to live and we fight with words of truth to in force our right, because we face inhalation through the miss use of a faith.
It is not our goal to change a way a people think, but it is a goal to show only a truth, my goal is simple, to bring the destruction and down fall of this empire...
The following is also linked to drugs and Drug Empires that date back around 1000 years BC and a World and things not spoken of because of a intent for it to disappear from the knowledge of Mankind. A world so old that time its self had all most for got.
A true story, also documented in history.
That because of malevolent acts that is also ancient and is also documented history before Christ, the sacrilege committed against God in order to gain great wealth and to enslave nations through drugs, to build children into that they wish.... All of this is true and a fact of documentation of history.
This sacrilege spoken of is in fact the sacrifice of life to spiritual evil. Even now documentation in Mexico and the United States , 1979 to 2000 reports filed and some cover ups now proved to be true.
I read these things and I see where the Arabic Drug Empire is involved with the Mexican Drug Lords. What lost of understanding is that according to the faith of Ben Laden it is forbidden by God to walk among the infidels. That all infidels are to be vanquished from this world in order that the chosen ones will repopulate the world.
It is a well known fact that the Arabic Drug Empire seek biological war tactics and it has been heard that a chemical balance is sought of how to implement Biological with Drugs, in order for it to be undetectable.
The betraying of the Mexican Drug Lords by The Arabic Drug Empire will bring death to Mexico and the United States.
Why should the Mexican Drug Empire take faith in my words, first If you and I stood before God I say to you that this is true it is the words of the streets that hold credit, and nothing is offered to them, The Mexican Drug Lords, dealing drugs is illegal. It is time to step away sit back and see what this drug dealing is doing and see those who have begun to lose their soul to this money making drug and the true and ancient evil bound to it.
You do not have to take faith in my words for now, let your soul and mind speak to you.
Some people seek proof of God, will, let me show you the essence of evil first and ah, will enjoy the ride, because it is said by thousands of people who do drugs that some how a door was opened to them a what came through to them, is only felt / sensed, and it stays in a darkness unseen to eyes, as it twist their soul into the thing of which they are not.
Some say that the one of few will step forward and a balance will once again be in place, while others disrupt by the telling of of the end within the Book, Revelations . As for me I read and I see that the fate of men is within their hands.
Will I have shown you the links and a truth that you did not know, a world that should have been lost in knowledge of things so old and built within Empires, so help to pay this forward.
So join Us International Boycott Of The Arabic Drug Empire Phase 2
Henry Massingale
FASC Concepts in and for Pay It Forward covers the web with over 219,000 post on google
Drop by and see why we built a anti crime / war form in a Health Care Reform Concept. To strategically Rebuild America
www.fascmovement.mysite.com on google look for page 1 american dream official site

[Henry Massingale]

This is my Little War against the Arabic Drug Empire...... and Purdue , you are now in my way.....
As it would seem, the Social Grace of the Rich is above the Law as long as the dollar support is at the back door.
Do you wish to end this War, then stage a protest march that will awaken the American People, then take this War issue against Purdue Pharmaceutical Company.... I am tired of seeing our Men and Women of the United States Military die as the America Dollar supports our enemy.
For nine years we have been at war and I still ask the big why ? Why is there a hands off policy that prevent the destruction of these poppy plants ? Did you know that American Dollars supported the Terrorist Attack on 9/11/2001, and thousands of lives have been lost. Who are the investors of the Pharmaceutical Company Purdue that makes Oxycontin and how are they above the Law ? Oxycontin is Heroin made from the opium / poppy plants. It is Illegal by Law to buy and resale Heroin. Purdue is responsible for the deaths on 9/11 and the on going addiction here in America. If it was Purdue who wished to be known as the largest heroin dealer in the USA, well congratulations and for showing the people who you do business with.
This drug from the poppy plant and the fight against its use goes back around 4000 to 6000 years and man seeks to control that which has shown that the poppy plant is as nature selected, uncontrollable. This is like a old saying as the Scorpion stung the Frog as he swim across the water and the Frog said why did you do this , now both of us will die ? And the Scorpion said it is my nature....
Boy oh boy , I wounder how much in Tax dollars this is going to cost Us to clean up. Purdue you just dont get it, but this you will, The American People look like a bunch of idots to this Arabic Empire, we look stupid so thank you again Purdue.
So join Us International Boycott Of The Arabic Drug Empire Phase 2
Henry Massingale / FASC Concepts in and for Pay It Forward covers the web post on google Drop by and see why we built a anti crime / war form in a Health Care Reform Concept. To strategically Rebuild America www.fascmovement.mysite.com on google look for page 1 american dream official site