Patent Baristas

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?

Ed.

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!

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.

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?

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

3.14159265358979323
846264338327950288
4197169399375105820
974944592307816406
28620899862803482
53421170679…

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

“I wanted to call this book A Dispeptic Introduction to Intellectual Property, but the publishers understandably said “Um, no.”  ~Dan Hunter

Sometimes, a book comes along that is just so cute you have to pick it up and read it.  Such it is in “The Oxford Introductions to U.S. Law: Intellectual Property,” a little guide to U.S. IP laws by intellectual property scholar Dan Hunter.

The Oxford guide provides a precise guide to the current laws of intellectual property and their history.  It follows the basic, straight-forward areas with chapters on Copyright, Patent, Trademark, Trade Secrets, and Related Rights.  Hunter first focuses on the central origins of intellectual property law.  He then explores the justifications for having an intellectual property system..

Hunter explains how intellectual property first came into modern form in the system of Venice during the fifteenth century..  With the rise of the modern state, European rulers came to issue letters patents, a term derived from the Latin litterae patentes or “open letters.”

These were letters from the sovereigns to everyone, stating that an individual or group now had the monopoly to ply a given trade within the realm of the sovereign.  Unlike today’s system, these were often issued to court favorites in order to control the production of gunpowder or certain types of clothing.

Laws need some reason for being, a very clear set of justifications.  Hunter examines the three basic normative justifications for the existence of various intellectual property laws.  These justifications are based (1) in economic or utilitarian theory, (2) on the labor-desert theory of John Locke, and (3) in the personality theory derived form Hegel and Kant.  Unfortunately, he didn’t mean Katherine Heigl.

This guide is a quick read and a great overview for someone who wants to get up-to-speed on the topic without getting bogged down in all the minutia of IP laws.  We recommend it.

“The Oxford Introductions to U.S. Law: Intellectual Property,” by Dan Hunter, Oxford University Press Inc, 242 pp, is available from Amazon.

About the Author

Dan Hunter is a Professor of Law at New York Law School. He is an expert in internet law, intellectual property, and artificial intelligence and cognitive science models of law. He holds a Ph.D. from Cambridge University on legal reasoning, computer science and law degrees from Monash University (Australia) and an LL.M. from the University of Melbourne. He regularly publishes on issues dealing with intellectual property law, including the regulation of virtual worlds, artificial intelligence, and high technology. He received a Fulbright Fellowship, an American Council of Learned Societies Research Fellowship, a Herchel Smith Research Fellowship in Intellectual Property Law, and a Science Commons Fellowship.

What:

American Conference Institute’s FDA Boot Camp.  Basic training in core regulatory concepts for life sciences lawyers, business executives and policy analysts

The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…exclusivity. — all are critical aspects in the commercialization process for drugs, biologics, and devices which are governed by FDA law and regulation.

Recent court cases, and high-profile trials concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated products — to have a familiarity with these concepts. The changing business dynamics of the life sciences industry have also made it critical for business executives, policy analysts and securities experts who work in this fi eld to have a clear understanding of the dynamics of the FDA.

ACI’s FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors, industry in-house counsel, and life sciences investment and securities experts, a strong working knowledge of core FDA competencies.

When:

Tuesday, March 20 to Wednesday, March 21, 2012

Where:

Doubletree Suites
Times Square,
New York, NY

But wait, that’s not all:

ACI is also offering informative and hands-on pre-conference workshop and post-conference master classes to get the background and/or the in-depth information you need to maximize your learning and networking experience at this event:

Workshop A: Fundamentals of FDA Regulatory Law will address topics to set the stage for the main conference by helping you thoroughly comprehend the structure of the FDA and the essentials of the pre-approval, approval, and post-approval process. Get the background you need to fl ow seamlessly into the conversations at FDA Boot Camp.

Master Class B: Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics will provide an in-depth overview of biosimilars as well as analyses of bioequivalency and exclusivities and their role in patent and product life cycle management.

Master Class C: Post-Approval Marketing Guidance and Preemption Protocols will address issues that arise post-approval, including advertising, promotion, and off -label promotion and enforcement, as well as preemption fundamentals.

Register today by calling 888-224-2480, faxing your form to 877-927-1563 or online at http://www.americanconference.com/fdabootcampnyc.

*Gunnery Sgt. R. Lee Ermey’s Official Site is here.

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.

If you have to participate in Valentine’s Day, at least make it legal when you hand the card to your significant other (hereinafter referred to as “My One True Love”).

Docracy, a website of online legal documents, has posted the “Be My Valentine – Lawyer Edition.” The Valentine form allows you to fill in a number of blanks Ã  la Mad Libs and voilà, you got yourself a genuine “romantic yet legally defensible Valentine’s Day card.”

The generated text explains to your beloved that he or she is being granted the title of “Valentine” and expected to give you the same in turn. There are a couple of clauses specifying that the title can’t be granted to another individual for the duration of the agreement, that there will be some displays of public affection.

Or, you might want to check out the Anti-Valentine’s Day Playlist.

The Hague rendered a judgment in the patent case between Taste of Nature (Koppert Cress) and Cresco on the patentability of a plant (Raphanus sativa) obtained by an unpatentable biological process. Court of the Hague, 408315 / KG ZA 11-1414.

Taste of Nature started the summary proceedings in early December 2011. They were of the opinion that Cresco, by selling their Red Radish Cress (purple Radish sprouts), was infringing the patent of Taste of Nature.

Taste of Nature developed a seedling of radish (Raphanus sativa) that is characterized by a high anthocyanin level. Anthocyanin is an antioxidant that gives the plant a red, purple or black color, and is regarded as a favorable substance from a health perspective.

Taste of Nature holds European patent EP 1 290 938 (the “Raphanus Patent” or “EP 938”),” which relates to a plant and a sprout of a plant of the radish species Raphanus sativa with an increased anthocyanin level, and to methods for its production.

Claim 1 reads as follows.

1. A Raphanus sativa plant, obtainable by screening Raphanus sativa plan far [this should probably be: “plants for”; Summary Proceedings Judge] their ability to produce sprouts with at least some purple coloring, selfing and/or crossing said plants for several generations and selecting progeny having sprouts with purple coloring, characterized in that the sprout of said plant comprises anthocyanins at a level of at least 800 nmol per gram fresh weight of sprout.

The description of EP 938 includes the following sections:

[0012] The Raphanus plant of the invention preferably is a plant of the species Raphanus sativa, more preferably the plant is obtained through breeding and selection from the Raphanus sativa lines CGN 6924, CGN 7240, or both. Most preferably, the Raphanus plants of the invention are obtained through breeding and selection from the Raphanus sativa line V33, (i.e. ATCC No. PTA-3630).

In respect of the patentability of essentially biological processes within the meaning of Article 53, opening lines and (b), of the European Patent Convention (the “EPC”), the Enlarged Board of Appeal (the “EBA”) of the European Patent Agency ruled as follows:

 Hence, in more general terms, the conclusion to be drawn is that a process for the production of plants, which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention, including the provision of a technical means, serves to enable or assist the performance of the process steps, remains excluded from patentability as being essentially biological within the meaning of Article 53(b) EPC.

However, if a process of sexual crossing and selection includes within it an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then that process leaves the realm of the plant breeding, which the legislator wanted to exclude from patentability. Therefore, such a process is not excluded from patentability under Article 53(b) EPC but qualifies as a potentially patentable teaching.

The above applies only where such additional step is performed within the steps of sexually crossing and selection, independently from their number of repetitions. Otherwise the exclusion of sexual crossing and selection processes from patentability under Article 53(b) EPC could be circumvented simply by adding steps which do not properly pertain to the crossing and selection process, being either upstream steps dealing with the interpretation of the plant(s) to be crossed or downstream steps dealing with the further treatment of the plant resulting from such crossing and selection process.

Taste of Nature argued that a patentable invention is involved because EP 938 relates to products (a plant, a sprout, a holder with sprouts or plants and material of a plant) obtained by using a certain method, rather than that method itself.

The Summary Proceedings Judge disagreed:

In its provisional opinion it is plausible that under Article 53, opening lines and (b), of the EPC, not only an essentially biological method is unpatentable, such as the “classical breeding” in this case, but also a product directly obtained by using that method, because a method claim also protects the product directly obtained using that method (see Article 64(2) of the EPC). If it were to be ruled that a product-by-process claim is admissible for the directly obtained product of an unpatentable essentially biological method, that would render the exclusion in Article 53, opening lines and (b), of the EPC as interpreted by the EBA in G1/08 pointless, because in that case the same situation would be involved as if the EBA had considered the process claims admissible, which is not the case. The view proposed by Taste of Nature – which, when requested, it was unable to substantiate otherwise than arguing that that the EBA did not expressly state its opinion on a product-by-process claim – is not a useful interpretation of, and does not do justice to, what must be regarded according to the EBA, as stated in its judgment substantiated in detail, as the purpose and scope of Article 53, opening lines and (b), of the European Patent Convention, and is dismissed.

Cresco can now start nullity proceedings, in which the Court is asked to nullify the patent of Taste of Nature in The Netherlands.