6th Annual
Paragraph IV Disputes
Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics

April 24-25, 2012
Workshops: April 23 and 26, 2012
Marriott New York Downtown
New York City

Each spring, leading pharmaceutical patent litigators for brand name and generic drug companies gather in New York City at American Conference Institute’s (ACI’s) Paragraph IV Disputes conference to discuss, debate, and analyze the latest trends, judicial rulings and legislative developments affecting Hatch-Waxman litigation.  Come and be part of this industry-leading think tank:  meet with the leading legal minds in this area and access the information which will help you master the critical competencies needed for the new era of Hatch-Waxman litigation.

An experienced faculty comprised of respected and renowned counsel for brand name and generic pharmaceutical companies will help you develop your new plan of attack for 2012 and beyond.  They will provide insights on all facets of Paragraph IV litigation: pre-litigation concerns – the commencement of suit – final adjudication – and every step in between.  Sessions will address the key elements of Paragraph IV litigation in addition to some of the most pressing and recent controversies surrounding Paragraph IV cases, including:

  • The impact of the AIA on Hatch –Waxman litigation
  • Carve-outs, use codes and labeling
  • Claim construction conundrums
  • Prior art obviousness and obvious-type double patenting
  • Inducement of infringement and divided infringement
  • Inequitable conduct
  • Damages

This conference will also bring you the opportunity to hear from renowned federal jurists and a key official from the Federal Trade Commission. Learn firsthand how the bench analyzes the theories of your case and what the FTC deems as “fair and foul” in the settlement of pharmaceutical patent disputes.

Informative and hands-on workshops will complete your conference and networking experience:

  • Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals will provide you with the patent and regulatory backdrop for the more in-depth Hatch-Waxman litigation controversies discussed in the main conference;
  • A Working Group Session on Assessing The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation will address how new pre- and post issuance procedures may alter certain components of Paragraph IV litigation and parallel proceedings between the Federal Courts and PTO; and
  • The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Name and Generics will give you practical and hands-on strategies for drafting and negotiating settlement agreements that will pass muster with the FTC.

Seats at ACI’s Paragraph IV Disputes 2011 sold out. Reserve your place now before it is too late.

Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563 or logging on to www.AmericanConference.com/Paragraph IV.  Special group rates are also available. A $200 discount is available to Patent Baristas readers.

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The only event where the industry leaders driving the business of biosimilars come together to set the standards shaping the rapidly evolving legal and regulatory landscape.

Whether you are on the branded or generic side, you cannot afford to miss this opportunity because you will:

  • Hear directly from the FDA on how they will implement the abbreviated pathway
  • Benchmark your strategy against market leaders such as Amgen, Dr. Reddy’s,
  • Eli Lilly, Merck, Momenta, Pfizer, Sandoz and many more
  • Gain priceless knowledge from the actual scientists, economists, in-house
  • and outside counsel thought leaders blazing the FDA’s biosimilar pathway
  • Network with peers facing the same regulatory, research and development cost, and patent management challenges in an true knowledge sharing environment

With an estimated $150 billion in potential biologics revenue at stake annually and a wave of patent expirations starting in 2014, there will be a hard-fought battle to protect and increase market share.


Tuesday, May 22 to Wednesday, May 23, 2012


New York Marriott
East Side
New York, NY


Register for ACI’s Biosimilars Conference  by calling 888-224-2480, faxing your form to 877-927-1563, or registering online at www.AmericanConference.com/Biosimilars.

PatentBaristas.com is a Media Sponsor of this event.  Readers of Patent Baristas are entitled to $200 off the current conference price tier.   The discount code you will need for this is: PB 200.

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Legal IQ has  launched a new white paper on Intellectual Property (IP) Portfolio Management Trends and Success Factors 2012, which reviews the recent challenges and changes in IP.  It draws upon the insight of leading legal professionals from across the world, and across Patents and Trademarks. They share how they view the future and plan to tackle the legal challenges and changes in IP.

To see the full survey result of 600 legal professionals, more key trends for 2012, and to read case studies from leading experts in the field, download the complete white paper at Legal IQ’s 2nd Annual Global Patent Congress website here.

All trends indicate an underlying drive to realign and grow in the face of changing technological, economic, and industry conditions. Portfolio management strategy is a cornerstone of success and a driver for growth. An openness to embrace the growing availability of new technology is also key to enable greater efficiency.

Some of the key findings of the white paper include:

  • Cost Control is of Importance to 93.6% of Trademark professionals and 96.4% in Patents
  • Most Business-Critical Activities: Alignment of Trademark/Patent Assets with Business Strategy
  • Key Future Investment for Trademarks will be Consultancy, and for Patents, Software.

To find out about Legal IQ’s 2nd Annual Global Patent Congress www.patentcongress.com/news, taking place 25 – 26 September in Copenhagen, simply call+44 207 036 1300 or email enquire@iqpc.co.uk.

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More commentary on the compulsory license granted by the Indian Patent Office for Bayer’s drug Sorafenib Tosylate (Nexavar):

I read your follow-up post on compulsory licensing.  In it, you state that average income in India is $8000.  I have no idea what your source is, but you are regrettably wrong.  Average gross salary in India in 2010 (per Wikipedia) was $1,330.  Nominal GDP per capita was $1,527 in 2011.  You can’t use purchasing power parity numbers for this analysis (and even then you would be off by about $5000) because the whole issue is that Indians can’t buy Nexavar in rupees at locally-sensible prices in the same way that milk in India is priced locally and is probably a lot cheaper than the approx. 40 rupees per liter that we pay in the U.S.

Also consider that $1,330 per year is the average, gross salary.  Because of income equality, something like 80% of the population in India lives on less than $400 per year per family.  This is a gross salary, and does not reflect disposable income after income taxes, payroll deductions and local sales taxes.  Also consider that the in the vast majority of households only men work, so the $1330 earned by the average male head of household is the total income.  Finally, family sizes are much larger than in the West, and there is no safety net so people need to save for their own medical care and retirement.

In light of this income disparity and poverty, it makes sense for India to have a compulsory licensing regime.  Nothing says that Indian values or laws have to mirror American ones — whether it relates to IP, freedom of speech, or speed limits.

Your point that the government is not helping is not helpful — India has something like $3 per person per year to spend on healthcare.  Treating one patient with Nexavar would mean leaving almost 2,000 people with absolutely no healthcare at all.

While Bayer may have faced some difficulties dealing with the local market, by pricing the drug where they did they made it clear that they intended to capture the few thousand upper class cancer patients in India who have wealth comparable to U.S. upper-income households, and leave the rest of the country without access to Nexavar during Bayer’s patent exclusivity period.

The compulsory licensing scheme does not really hurt Bayer except for the few million dollars they may have earned from the wealthy cancer patients in India.  Bayer is free to charge very high prices to recoup its investment and earn its ROI in the part of the world that can afford Nexavar.

What Bayer should have done is manufacture Nexavar in India through a local joint venture, sell it at a locally-affordable price, and use its control of the JV to prevent export.

Sachin Jay Darji
Certified Specialist in Real Property Law

Not sure what to say other than I agree with the points in this letter. I couldn’t fine the original document that listed salaries but gapminder.org lists the Indian income per person (GDP/capita) as $2,972.  Regardless, my point wasn’t that many in India cannot afford expensive drugs.  That’s a given.

I want people to have access to drugs  and I’m not suggesting people with the inability to pay should be denied healthcare.  My issue is why must Bayer pay the full brunt?  Why only Nexavar?  Once you make the argument that people without means should gain access to drugs based on income regardless of property rights, why isn’t every drug subject to the same license?

I agree Bayer did not do themselves any favors in not making the drug more widely available.  I just am uncomfortable that no one else has to pay.  Not the wealthy.  Not governments.  No sharing of economic burden.  Oh, well, I think this horse has been beaten enough.

It is a conundrum.

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Well, I’ve certainly heard from a number of people regarding my earlier post on  the compulsory license granted by the Controller-General of Patents, Designs and Trade Marks to Natco Pharma for manufacture of Bayer’s drug Sorafenib Tosylate (Nexavar), a drug used to treat liver and kidney cancer.

The gist of the complaints are that I’m a/an [insert expletive] for not caring about Indian citizens who cannot afford to pay for the drugs.  Despite the fact that when you dig yourself into a hole it’s best to stop digging, I will try to say a tiny bit more.

Let me just say that despite how things tend to come out when they go from my head to written form, I do get it.  The average annual income in India is around US$8,000, according to 2011/2012 salary survey.  That doesn’t leave a lot of money for paying for cancer medications.  In India, Bayer Corp. markets sorefinib as Nexavar for about $5,600 a month under a patent in force until 2021.

My problem with the decision is that it comes across as having a pre-determined outcome and then a reasoning was crafted around the desired outcome.

Here’s what the Patent Court said:

1. The reasonable requirements of the public not being met.  Basically, the court said that only 2% of the total number of kidney and liver cancer patients were able to access the drug.  But, Bayer offered to offer more patient assistance in a program where a patient would buy one month of drug and get it free for the remaining 3 months.  However, the Controller rejected this outright saying:

“In the present proceedings, we are not concerned with philanthropy, which no doubt is appreciable. Such actions cannot be construed as steps to work the invention on a commercial scale to an adequate extent.”

Huh?  The Controller wouldn’t let Bayer expand availability and then said it wasn’t making the drug available.  Also, is it only Bayer’s responsibility?

2. The Controller found that the price of the drug was not “reasonably affordable” to the public.  Despite all that was written, the Controller said this was the real issue at hand:

“It stands to common logic that a patented article like the drug in this case was not brought by the public due to only one reason, i.e. its price was not reasonably affordable to them.”

As I tried to say in the original post, this is all about money.

3. The Controller found that the importation of Bayer’s drug into India did not amount to “working” the patent in India and held that ‘worked in the territory of India’ means manufactured to a reasonable extent in India.  But almost 90% of all pharmaceutical patents are also only imported into India.

So, where does that leave me?  I’m an ardent supporter of providing access to drugs to those in need.   I’m not a blind supporter of unlimited profits by drug companies.  I’m also not foolish enough to believe that we can provide all level of care to all persons on the planet.

What makes me feel uneasy is that only the patent holder is deemed to be responsible for providing access to care. A situation where only 2% of the total number of kidney and liver cancer patients were able to access the drug is appalling.  But, where did anyone step up and offer to provide better access?  Where did anyone offer payment assistance (other than Bayer, which was rejected)?

Don’t get me wrong, I agree that big pharma needs to be kept in balance and unlimited profits can’t further society either.  All I’m asking is why isn’t there a broader discussion on how to share the burden of medical care costs?


A good review of the decision and many thought-provoking comments are available at Spicy IP here:  Breaking News: India’s First Compulsory License Granted!

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WIPO Looking at Global Access to Safe Drinking Water

The World Intellectual Property Organization has waded into the global debates over access to safe drinking water, with an upcoming workshop on patents and water purification technologies.  The workshop on 22 March will be called, “The Role of Patent Information in Supporting Sustainable Access to Safe Drinking Water – Presentation of Patent Landscape Reports on ‘Water Desalination Technologies and the Use of Alternative Energies for Desalination’ and on ‘Water Treatment/Purification Technologies’.”  It will be held in conjunction with World Water Day 2012, in cooperation with the International Renewable Energy Agency (IRENA) and the Global Institute for Water Environment and Health (GIWEH).  The program is available here. Information about WIPO’s work on patent landscapes is here.  (via Intellectual Property Watch)

What About Human Trafficking in our own Backyards?

Did you know that the average age of child sex trafficking victims is 12 years of age? By age 16 or 17, they are considered old, used and unwanted. By age 18 they are told they better find another job, but by then they don’t have any options. The hardest piece of dealing with these girls that fall “victim” to domestic minor sex trafficking is that they don’t see themselves as victims. What exactly is Domestic Minor Sex Trafficking (DMST) and how does it differ from Human Trafficking? DMST is the prostitution of minors that occurs within the US borders. It involves American citizens participating in modern-day slavery, on US soil. What can you do?  Get aware and get involved.  See Shared Hope Intl.  (via Intent Blog)

Munch Cards with this App

LinkedIn offers a phone app called CardMunch that allows you to enter business card info using your LinkedIn login. Basically, you take a picture of a business card from within the app and the information is transcribed by CardMunch and entered as a contact on the app. You can then add the contact to your iPhone address book or click on another icon to connect on LinkedIn. With another click, you can email the contact directly or forward her contact information elsewhere.  This is a free app for managing business card clutter. (via Legal Productivity)

ABC World Diaper News

The final story on ABC World News with Diane Sawyer on March 14, 2012 involved the diaper patents of Marion O’Brien Donovan, although Donovan was not explicitly named. Donovan revolutionized the infant care industry by inventing the prototype of the disposable diaper. Donovan’s first breakthrough, in 1946, was to design a waterproof diaper cover made from shower curtains. The final product, available in 1949, was made of nylon parachute cloth, and featured  metal and plastic snaps instead of safety pins..Donovan called her diaper the “Boater”. After much experimentation, Donovan later designed a composition of sturdy, absorbent paper that did the job just as well.  (via IPBiz)

IPBiz For Sale

Speaking of IPBiz, their website (ipbiz.com) is reportedly up for sale.  The website is run by Lawrence Ebert, a patent lawyer located in central New Jersey. The minimum offer is listed as $250.00 with a Buy It Now option for $35,000.00.  See more at the web site afternic.com.

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Oh Lord, won’t you buy me a Mercedes Benz?
My friends all drive Porsches, I must make amends.
Worked hard all my lifetime, no help from my friends,
So Lord, won’t you buy me a Mercedes Benz?
~ Janis Joplin

Under Section 84 of the Indian Patents Act, 1970, any person can make an application to the Controller for a compulsory licence after the expiry of three years from the date of sealing of the patent, on the following grounds:  (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not worked in the territory of India.

The Trade-Related Aspects of Intellectual Property Rights and the Doha Declaration provide for compulsory licensing in specified circumstances, including concerns on public health or public interest.

In India, Bayer Corp. markets sorefinib as Nexavar for about $5,600 a month under a patent in force until 2021.  The Indian Patent Office has now issued an order that the high price of Nexavar makes it “not available to the public at a reasonably affordable price.”

The full order stated that the suit met all three requirements, that is:

  1. that since Bayer supplied the drug to only 2% of the patient population, the reasonable requirements of the public with respect to the patented drug (Nexavar) were not met;
  2. that Bayers pricing of the drug was excessive and did not constitute a “reasonably affordable” price; and
  3. that Bayer did not sufficiently “work” the patent in India.

The grant of the license by the Controller-General of Patents, Designs and Trade Marks to Natco Pharma for manufacture of the drug Sorafenib Tosylate (Nexavar) to treat liver and kidney cancer is a landmark event.

Natco said its version would cost Indian patients $175 a month. It was the first case of compulsory licensing under India’s unique patent laws passed in 2005. Under the license Natco must pay 6 percent in royalties to Bayer. Aid groups counter that Indian generics are a lifesaving resource for patients in poor countries who cannot afford Western prices to treat diseases like cancer, malaria and HIV.

“This is a rare instance where a general compulsory license has been issued, not bound by government use provisions or those requiring to show ‘extreme urgency’ or ‘emergency,” said Dr. Amit Sengupta of the People’s Health Movement.

G. Ananthakrishnan wrote an Op-Ed piece in the Indian newspaper The Hindu stating:

The government’s decision to grant a compulsory license for the manufacture of an important anti-cancer drug should be the first step towards making available essential drugs at little or no direct cost.

Producing drugs is, no doubt, an expensive business, and significant funds are invested in research and rigorous testing. The drugs developed through this process have great impact on the well being of people. Yet, patents can also produce monopolies, and thus immense power for corporations. It is important to remember that patents deal with intellectual property, which, unlike other property, produces no conflict over use. Use by one person does not cause any rivalry with another and thus has no marginal costs.

What is revealing is that the price gap between government procurement of drugs and retail sale can be staggeringly wide — between 100 per cent and 5,000 per cent. Moreover, the price index for medicines has parted from the index for all commodities and moved steadily upward, since 1997-98. This is clear evidence of unethical pricing of many medicines for rising profit, using patents as a cover, as well as lack of regulation.

If you disagree with Mr. Ananthakrishnan  logic, you may provide feedback at:  anant@thehindu.co.in

As we’ve discussed before, nothing in life is free. Drug companies won’t develop drugs unless they can charge for the drugs. Here, the drugs are available. This is a case of (usually) governments not wanting to pay the cost of healthcare for their own citizens. And what government wouldn’t want to pay less?

I’m all for furthering discussions on how to share the burden of medical care costs but saying that the burden should fall solely on the patent holder is short-sighted and unfair.

Oh Lord, won’t you buy me a Mercedes Benz?

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Well. as you know, March 14 (3/14) is the day that people around the world celebrate that ridiculously long number known as pi (π), which is:


And that’s just the first hundred digits!

Do numbers matter?  Most think so:

“Numbers are really just abstract symbols, and we have to bring meaning to them somehow,” Peters says. Think of all the very different ideas that can go with the number nine: 9°F, $9 billion, and a 9 percent chance of a tsunami. “In general, people who are numerate are better able to bring consistent meaning to numbers and to make better decisions,” Peters says. “It suggests that courses in math and statistics may be the educational gift that keeps on giving.”

See Numeracy: The Educational Gift That Keeps on Giving?

Less mature folks may want to check out:  ‘Can I Pi You A Drink?’ & More Pi Day Pickup Lines

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