Patent Baristas

In Canada, linkage regulations similar to the Hatch-Waxman Act in the U.S. ensure that generics manufacturers have to address relevant patents listed on the Patent Register (the analog to the Orange Book) if they want to market their product prior to the expiry of listed patents.   Generics manufacturers can do so either by accepting the terms of the patents, or by filing a Notice of Allegation (NOA) alleging, amongst other things, that they will not infringe the patent or that the patent is invalid.

Three recent decisions litigated in this context contain important notes for pharma companies, biotech companies, generics companies and their patent attorneys and agents.

The Patent Act (post-1996) Imposes a Duty of Candour and Good Faith. In Lundbeck Canada Inc. et al  v. Ratiopharm Inc.,  Lundbeck’s patent was invalidated because the patent agents failed to “fully and fairly describe” the prior art in responding to an obviousness rejection raised by the patent examiner.  This decision may take on a broader impact, particularly if it is interpreted to require Canadian applicants to affirmatively inform examiners of aspects of the prior art that are both favorable and unfavorable.

Formulation Patents Must Claim All Medicinal Ingredients.  In Bayer Inc. v. Canada (Minister of Health) et. al., Bayer’s patent was held to be ineligible for listing on the Patent Register, despite reading on the product.  Where the approved product contains a formulation with more than one medicinal ingredient, only patents that claim formulations containing all of the approved medicinal ingredients may be listed on the Patent Register, regardless of whether the product is covered by the patent claims.

Disclaimers Can Be Validly Filed After Receipt of a NOA.  In sanofi-aventis Canada Inc. v. Hospira Healthcare Corporation, sanofi responded to Hospira’s NOA by filing a disclaimer in respect of a portion of one of sanofi’s listed patents.  Hospira argued that the Court should consider the sanofi patent as it read on the date the NOA was served and not as it read after the disclaimer was filed.  Although the court held (in favor of sanofi) that the patent should be read as of the date of the hearing, it also held that sanofi’s particular disclaimer was invalid because the patentee had not unequivocally testified that the disclaimer was a result of claiming too broadly in the patent as issued. Such an admission was necessary to the validity of the disclaimer.  The court also held that having attempted a disclaimer, sanofi could not subsequently assert against Hospira the portions of the patent it had attempted to disclaim.

Thanks to Kavita Ramamoorthy and the whole Life Sciences team.

Today’s post is reposted from The Cross-Border Biotech Blog by Guest Barista Jeremy Grushcow, a corporate lawyer at the Canadian law firm Ogilvy Renault LLP.

If you let go of trying to get more of what you don’t really need, it frees up oceans of energy to make a difference with what you have. When you make a difference with what you have, what you have expands.
~ Lynne Twist on the principle of sufficiency

As we go through a season of thanksgiving, it is a good time for reflection of being thankful for all that we have in life.  Part of that process requires that we appreciate what is sufficient for ourselves and what we can due to help others who lack sufficient necessities.  It is in that vein that I decided to deviate from reviewing a traditional intellectual property tome to looking at what it means to have enough.

In The Soul of Money: Transforming Your Relationship with Money and Life, Lynne Twist shows us that many of the “facts” we believe about money — more money is good, less money is bad; competition and scarcity are normal because due to the law of the jungle, etc. — come from attitudes towards money that are deeply ingrained in our culture.  These are a set of beliefs we use to guide our lives but they may not be completely accurate.

Twist asks us to turn away from a belief systems focused on scarcity (fear of not enough, push to always get more, resignation that it’s just the way it is) to belief systems focused on sufficiency (there is always enough; turn our attention and appreciation to what we already have).

“We live in a world that promotes a mindset of scarcity. That mindset eclipses our experience of our own wholeness and sufficiency and turns our attention to wanting what we don’t have. Consumer culture depends on people living in fear of scarcity, feeling inadequate, empty, and deficient so that we think we need to acquire and accumulate more to be okay. We’re told that there is no alternative, and that’s just the way it is. This mindset is invalid, destructive and disempowering. It is also untrue.”

Having just been strong-armed asked to give my “fair share” to a large, charity fund-raising aggregation conglomerate, I have been thinking a lot about the charities I support and how I can give more to where my efforts can make a real difference in the world.  We live in a culture where we are distanced from the devastating poverty in the world.  Consider the facts:

• Every six years six million child die before the age of five due to malnutrition
• More than half of the Africans suffer from diseases from poor water quality
• Every day 6,000 people die of AIDS and about 8,200 are infected
• Every half minute an African child die of malaria (more than one million per year)
• More than 800 million people go to bed hungry, 300 millions of them children

Now consider that only about 1 percent of the U.S. government’s budget goes to foreign aid and about 2 percent of U.S. charity dollars went to international affairs.  Charity is all too often over-simplified into notions that we should give money out of guilt for what we have or, conversely, that we’ve worked very hard to earn money and everyone one else should work hard and earn there’s, too.  The reality is not so simple.  Almost always, people are successful (or not) based on complex interactions and interconnectedness that is difficult to untangle.

In the book Outliers: The Story of Success, Malcolm Gladwell challenges the belief of the “self-made man” in making the case that superstars don’t arise out of nowhere, propelled by genius and talent: “they are invariably the beneficiaries of hidden advantages and extraordinary opportunities and cultural legacies that allow them to learn and work hard and make sense of the world in ways others cannot.” Examining the lives of outliers from Mozart to Bill Gates, he builds a convincing case for how successful people rise on a tide of advantages, “some deserved, some not, some earned, some just plain lucky.”

If one accepts that there are enough resources in the world for everyone, then solving problems such as hunger isn’t about just sending money to hungry populaces.  It’s about empowering people to figure out that despite perhaps being told all their lives that they must be dependent on outsiders, that they have the resources — enough resources — to participate in the global economy.

This is the concept of Kiva, who’s mission is to connect people through lending for the sake of alleviating poverty.  Kiva is a person-to-person micro-lending website, empowering individuals to lend to unique entrepreneurs around the globe.  Individual loans, which start at $25, help fund entrepreneurs ranging from a grocer in South Lebanon to a farmer in Tajikistan.  [*See Update below].

Today, I donated money to Kiva and made micro-loans to people in the Dominican Republic and Uganda.  Will it make a difference?  I’m not sure but I like to think so.  This bootstrap method relies on pro-market measures: microfinance, foreign direct investment, trade systems that encourages innovation and fosters self-reliance.  However, there are many well-deserving charities to choose from:

• CARE
• VillageReach
• Against Malaria Foundation
• Global Fund to Fight AIDS
• MicroPlace

Next, maybe I will take the Poverty Challenge.  What will you do?  Let me know in the comments.

About the Author

Lynne Twist is a global activist, fundraiser, and the author of The Soul of Money. She was an original staff member of The Hunger Project when it began in 1977, and was named the Humanitarian of the Year in 2005 by Youth at Risk. She argues that women are in a unique position to alter mindsets when it comes to economic sufficiency.

“The Soul of Money: Transforming Your Relationship with Money and Life,” by Lynne Twist” (224 pages; W. W. Norton & Company)  is available through Amazon.

Also see, What We’re Reading Now.

———

*Update:  It turns out that Kiva Is Not Quite What It Seems.

We’re back again this year with a list of the best gifts for patent geeks and entrepreneurs.  We thought that No. 1 on our list would be the Apple Mystery Tablet but it’s still a no-show.  And, no, we’re not going to recommend the $1800 UWCP Underwater Cellular Phone System from OceanReef (see the bizarre commercial here).  Here, we just want to provide a list that is versatile and that stimulates some ideas and discussion.  So, sit back over a cup o’ joe and take some time to look around to see what gifts you might like:

Klipsch IMAGE S4i Noise-Isolating Headset w/3-button Apple control $99 – It is impossible to overstate the value of a descent pair of in-ear headphones.  Not only do they sound better than your stock earbuds, they cut down on the cacophony of traffic sounds, load talking, crying from associates and complaints from staff.  Cheap alternative:  JBuds J3 Micro Atomic In-Ear Earphones with Travel Case.

Timbuk2 Commute 2.0 Laptop Messenger Bag $79 – For the road warrior, nothing makes things go better than having a descent travel bag.  It’s a solid gear bag, with more than enough space for a laptop, DSLR, various accessories and a phone or two, and it’s TSA compliant.  The laptop compartment unzips to lay flat so you don’t have to remove your laptop at airport security.  Plus, it’s waterproof.  For a wheeled alternative, try:  Delsey Helium Fusion Carry-On Expandable Suiter Trolley.

Kindle DX Wireless Reading Device (9.7″) $489 – With the latest incarnation of Amazon’s personal digital reader, the Kindle DX allows users to not only catch up on the latest novels while in transit, lawyers can use their Kindles to work more efficiently during the course of the business day.  Good for depositions as well as reading blogs (like Patent Baristas!).  Just don’t forget the accessories:  Amazon Kindle DX Leather Cover.

Giuseppe Zanotti Women’s Pumps $259 – Lawyers should dress well.  Actually, dressing well is an important function of a lawyer.  Many faux pas are forgiven the well-dressed lawyer.  Clients appreciate it and dressing well can be done simply without too much expense.  Made in Italy, these Giuseppe Zanotti sophisticated pumps adds a sleek heel and professional polish to suits and pencil skirts.  For the more practical patent attorney, you can always go with the Kenneth Cole New York Penny Loafer.

iRobot 560 Roomba Vacuuming Robot $379 – What lawyer wouldn’t like some obedient servant that slaves away for pennies and never complains?  For the compulsive cleaner in your life, the Roomba vacuum makes its way around furniture, cleans up the place and finds its way back to its charging base. The Roomba may not be the best cleaner but it can make a best friend for a lonely lawyer.  For those that would rather drink coffee than clean: Jura-Capresso Impressa F9 Fully Automatic Coffee and Espresso Center.

Western Digital My Book World Edition 2 TB Storage (White) $269 – Today, lawyers rely heavily on computers to help accomplish almost every task.  Do you have a disaster recovery plan? Practices and procedures for backup, storage, disaster recovery, and restoration are crucial to your law practice. Get a drive and then put backup procedures in place – don’t wait to “break glass in case of emergency”.  For a more portable option:  Toshiba 500 GB USB 2.0 Portable Hard Drive.

Scientific Explorer’s Disgusting Science – A Kit for Studying the Science of Revolting Things $19 – In general, chemistry sets have gone the way of the home x-ray machine due to tort lawyers — some of the first chemistry sets included such items as sodium cyanide, radioactive samples, and glass blowing kits.  But, you can still get some neat kits to satisfy the inner alchemist in you.  Alternative:  Scientific Explorer’s Spa Science Chemistry Kit.

SurfShelf Treadmill Desk and Laptop Holder $39 – If you must exercise, at least now you can still bill for your time.  The SurfShelf treadmill desk attaches any laptop or portable DVD player to most any exercise machine so you can get buff and still hit your billable goal.  We’re not sure if sweat voids your laptop warranty, though.  When you’re ready to ramp things up, try the Kettler Racer GT Indoor Cycle Trainer.

The iPhone 3Gs $199 – We have to include the Apple iPhone.   Yes, we know most geeks already have one and that it requires a 2-year agreement with the devil AT&T to use it but you can’t beat the functionality.  And, yeah, there’s an app for everything.  Non-Apple alternative:  Motorola Droid A855 Phone (Verizon Wireless).

iTunes Gift Card – Premium $100 – I’m against gift cards in general for the lack of ingenuity but if you’re going with an iPhone or iPod — or even if you’re not — you can’t go wrong with an iTunes card.  While I love all the great free podcasts, there are always items to purchase.  Good alternative:  Apple iPod shuffle 2 GB in Black.

Well, that’s the list.  It’s a good place to start and applies equally well to lawyers, inventors and business folks alike.   While I think any of the above gifts would be fine for assistants, too, the consensus seems to be that AmEx cards are best.  Please suggest your own preferences and gift ideas in the comments.

Also, check out last year’s list here.

Pfizer is continuing its fight with generic drug manufacturer United Laboratories, Inc. (Unilab)in the Philippines over the issue of the validity of the patent on Lipitor (atorvastatin) as Unilab tries to have the patent canceled. Unilab filed its petition for the cancellation of Philippine Patent No. 29149 for Atorvastatin, marketed under the brand name Lipitor, and Pfizer filed a complaint for patent infringement and damages against Unilab for selling its generic anticholesterol drug Avamax, which it priced 30 percent lower than Pfizer’s.

Unilab claims that according to the IP Code, as amended by the Cheaper Medicines Act, the patent should not have been granted since it failed to meet the requirements for patentability. Unilab claims the patent is merely an attempt at evergreening, an abuse of the patent system by patent holders that seek to perpetuate their monopoly over a product beyond the period allowed by law. Opponents claim that before the expiration of the original patent, new applications over the same product with minor modifications are filed so that a new 20-year period of monopoly is obtained through the grant of another patent.

Unilab contends that there is nothing inventive about the Atorvastatin covered by Patent No. 29149 since it is nothing but an isomer of the Atrovastatin compound already disclosed in US Patent No. 4,681,893 (which discloses NCE atorvastatin) and Philippine Patent Nos. 24661 and 26330. Unilab claims that the IP Code, as amended by the Cheaper Medicines Act, explicitly states that an isomer of a known substance shall be considered to be the same substance and is not entitled patentable.

It is true that pharmaceutical companies often file additional patents, including those covering crystalline forms, those in combination with other known compounds, and those for other medical uses.  However, there is a public need for continued innovations around an initial discovery.  Opponents don’t want any further changes to be patentable and that could shut down innovating in these areas.

Pfizer argues that the patent in question was issued by the IPO after having gone through a thorough examination and was deemed to meet all the criteria for patentability based on Philippine laws.

Republic Act no 9052 entitled Universally Accessible Cheaper and Quality Medicine Act of 2008

The Quality Medicine Act amends the IP Code to state that the mere discovery of a new form of a new property of a known substance which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or the mere use of a known process unless such known process results in a new product that employs at least one new reactant is non-patentable.  In addition, a patent owner has no right to prevent third parties from using a patent without his authorization after a drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent holder or by any party authorized to use the invention. The Act also grants the right to import drugs and medicines to any government agency or any private third party.

In the case of drugs and medicines, the patent owner has no right to prevent the testing, using, making or selling of the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory organizations required under any law of the Philippines, or of another country that regulates the manufacture, construction, use or sale of any product.

Upon recommendation of the secretary of the Department of Health, the director-general of the Intellectual Property Office can grant compulsory license for the importation of patented drugs and medicines, with reasonable compensation to the patent owner.

The president of the Philippines also has the power to impose maximum retail prices over any or all drugs and medicines listed in Section 23 of the Act, which include: those indicated for treatment of chronic illnesses and life threatening conditions such as but not limited to endocrine disorders, cardiovascular diseases, skin diseases, pulmonary diseases, neuro-psychiatric disorders, other infectious diseases; those indicated for prevention of pregnancy; and anesthetic agents.

Expect this fight to continue.  The stakes are high.  According to reports, Lipitor was the largest-selling drug in the world in 2006, earning its producers $12.9 billion in sales the same year alone.  In 2008,  Lipitor sales internationally were at $13 billion.

gray market n. a market employing irregular but not illegal methods; especially : a market that legally circumvents authorized channels of distribution to sell goods at prices lower than those intended by the manufacturer.

~Merriam-Webster’s Dictionary of Law

A gray market (or grey market) is the trade of a commodity through distribution channels which, while legal, are unofficial, unauthorized, or unintended by the original manufacturer. Unlike black market goods, grey-market goods are not usually illegal. Instead, they are sold outside normal distribution channels by companies which may have no relationship with the producer of the goods. Frequently this form of parallel import occurs when the price of an item is significantly higher in one country than another. Only physically and materially different parallel imports are banned.

In the gray market, diverters buy the products from the low-end market and re-import them back to the high-end market. With foreign products, such diversion results in cheaper unauthorized imports from the low-end market competing with more expensive authorized imports in the high-end market. Thus, gray market goods are also known as parallel imports. The big price difference between the two markets enables the diverters to sell the product at a price that is lower than the market price in the high-end market and still make a big profit.  Gray markets thus reduce the profitability of price discrimination by leveling price difference in different market segments.

The Ninth Circuit looked at gray markets as a question of trademark infringement or unfair competition under the Lanham Act, which generally require a showing of likelihood of consumer confusion.  Thus, when the goods are identical but merely imported from another market, the likelihood of confusion cannot be established because the consumers received exactly what they expected and were not confused.

In the new book “Gray Markets: Prevention, Detection and Litigation” by David Sugden, the author claims that such a market causes  estimated losses of $40 billion in annual sales for technology manufacturers alone. Sugden provides a comprehensive analysis of the gray market as well as a road map for handling gray market cases.

Divided into four sections, the book provides an introduction to gray markets with examples of its effect on a variety of industries.  One example shows the case of Fagan v Amerisourcebergen Corp. et al.  Fagan suffered personal injuries as a result of repeated injection of counterfeit Epogen used to treat anemia.  Fagan continued to receive and inject counterfeit Epogen even after the counterfeits were discovered.  He brought proceedings for personal injuries against the manufacturer (Amgen), the wholesale distributor (Amerisourcebergen), and the retailers (CVS Corporation and ProCare Pharmacy).  Fagan claimed that all the defendants were aware of the problem of diversion of drugs and had failed to take appropriate steps to secure the distribution chain.

The US District Court found that the wholesale distributor was in the best position to control movement of drugs and therefore in the best position to protect the trade from counterfeit drugs entering the market. It was foreseeable that in purchasing products on the gray market, counterfeit drugs might enter the distribution chain. The wholesale distributor was therefore required to take steps to protect the distribution chain. Similarly, the retailer had failed to exercise “the highest practicable degree of prudence, thoughtfulness and vigilance and the most exact and reliable safeguard to the system with reasonable conduct of the business”.

The fact that pharmaceutical prices can vary significantly between countries, particularly as a result of government intervention in prices, continues to make gray market drugs a very substantial segment.

The second section of the book deals with ways of reducing the potential gray market, particularly through what is called Gray Market Abstinence.  In words that apply to many situations, Sugden notes:

As an initial matter, it is better to be proactive than reactive.  Preventing a problem is invariably preferable to responding to a problem.  In the context of brand abuse, this self-evident principle is especially fitting.  In today’s global marketplace, an unmonitored gray market can devastate a brand’s esteem.  Waiting for the problem to surface may be too late.

Sugden then details methods for monitoring the supply chain and the legal strategies for countering gray market goods after discovery.  There is lots to gain from how to apply theories of copyright and trademark liability to state laws and international approaches.  It is a cat-and-mouse game that can pit brand name manufacturers against teenagers, grandmothers and mobsters.  In an ever-flattening world of Globalization 3.0, this chase will only intensify.

About the Author

David R. Sugden is a partner at Call, Jensen & Ferrell, where he specializes in intellectual property, trade secret, copyright, technology, business torts, and brand protection. In addition to serving as lead counsel in any number of legal enforcement actions, he has successfully executed numerous surprise search and seizures in which he, with the assistance and protection of law enforcement, has entered the premises of defendants suspected of piracy, black market or illegal gray-market activity.

“Gray Markets: Prevention, Detection and Litigation” by David Sugden (Oxford U. Press, 2009 | 360 pages | 9780195371291) is available through Amazon.

Also see, What We’re Reading Now.

“I really don’t think they have thought this through. A world without intellectual property rights would be a pretty horrible place to live. There would be no investment in new technologies.”
~Michael Taylor of CIED

The European Patent Office (EPO) is studying the growth in eco-innovation since the introduction of the Kyoto Protocol on climate change.  Although the current economic climate has caused a decline in the number of patent applications, the study will look at how the green patent landscape has evolved since the 1997 Kyoto Protocol and examine how companies have responded to incentives and policy signals.  The report was originally planned to coincide with next month’s UN climate summit in Copenhagen but it is now expected to be out in time for a 2010 conference.

Raw data from the EPO shows that patent applications for environmental technologies indicate rapid growth. In the ten years from 1998, patent applications for new energy innovations grew by an average of 6% per year. Wind power, fuel cells, solar thermal and photovoltaic energy technologies have shown the strongest growth since the late 1990s. The US, Germany, Japan and the Netherlands have the highest number of applications in the new energy sector thanks to General Electric, Siemens and Nissan.

Just as the eco-party is getting started, China and India have hinted at turning off the music by suggesting that new green technology should be subject to compulsory licensing (where a government forces the holder of a patent or other exclusive right to grant use to the state or others usually with some royalties set by law or determined through some form of arbitration).  China and India claim that developed countries are primarily responsible for climate change so the EU and US should support poorer nations by providing them with clean technologies.

According to Inside US Trade, the US chamber of commerce is gearing up for a fight to limit the access of developing countries to environmentally sound technologies (ESTs). They fear that international climate change negotiations taking place under the United Nations, will erode the position of corporations holding patents on existing and future technologies.

As you can imagine, deciding which technologies could be shared and on what terms is pretty contentious.  Especially since many green technologies and innovations have dual use, if not more.  Just what is green technology?  Greener than what?  Does it include greenwashing technologies?

The idea of breaking patents is not new but compulsory licensing has to date only been used in emergency (or pseudo-emergency) situations where patent-protected pharmaceuticals were seen as prohibitively expensive. The Brazil government used the system to break the patent on the HIV drug Storcrin (the brand name for efavirenz) after Brazil’s President signed a compulsory license for efavirenz under provisions permitted by World Trade Organization rules.  This year, Brazil agreed to buy five French submarines, one of them with nuclear propulsion, and 50 helicopters for about $12 billion.

The Group of 77, the largest intergovernmental organization of developing states in the United Nations — and really covering 130 countries since originally forming in 1964, tries to promote economic interests within the United Nations system.  The Group of 77, mainly through China as a spokesperson, wants to apply this same principle to energy efficiency.

The Coalition for Innovation, Employment and Development (CIED), a think-tank strongly in favor of intellectual property rights, has published a report showing that ending patent protection on clean technologies poses a great threat to European industry and jobs.  The Clean Technology and European Jobs Study shows a strong intellectual property (IP) system will support the development of green technologies and the creation of over 2 million jobs in the European Union (EU) over the next 20 years.

Climate change will be top of the agenda when leaders meet at the 12th EU-China Summit in Nanjing on November 20.

In a case highlighting the importance of ensuring a correct chain of title when filing a patent application, the UK High Court addressed the issues of loss of priority due to an incomplete assignment, as well as the credibility of expert witnesses.  In particular, it is important to transfer rights to interests initially owned by consultant inventors as soon as possible — especially before the declaration in respect of the claim to priority needs to be made, i.e.,  within 12 months of the date of filing of the priority application.  See, Edwards Lifesciences AG v Cook Biotech Incorporated [2009] EWHC 1304 (Pat) (12 June 2009).

Edwards manufactures the SAPIEN artificial heart valve designed to be compressed onto a balloon catheter for percutaneous delivery via the femoral artery. It can also be delivered transapically through the side of the chest and into the apex (the bottom of the left ventricle) of the heart in patients with severe aortic stenosis. It is primarily used to replace the aortic valve but is also suitable for replacement of the pulmonary valve.

Cook alleged the SAPIEN infringes its patent and Edwards denied infringement and challenged the validity for lack of novelty, obviousness, insufficiency and added new matter. That is, Edwards said the matter disclosed in the specification of the European Patent as granted was extended beyond the original disclosure in the application for the patent as filed.

The international application which led to Cook’s European patent was filed on January 31, 2001, claiming priority from a US patent application filed on January 31, 2000. The claim to priority is disputed by Edwards, a matter of some importance because, if priority is lost, Pavcnik, published later in 2000, is relevant prior art.

The US application was filed in the names of Joe Obermiller, Francisco Osse and Patricia Thorpe, all as joint inventors. Mr Obermiller was an employee of Cook at the time the invention was made. Mr Osse and Ms Thorpe were not. The PCT application was filed in the name of Cook but at that time the only interest it had in the invention was via Mr Obermiller’s contract of employment. It is accepted that Mr Obermiller’s interest, such as it was, belonged to Cook. The interests of Mr Osse and Ms Thorpe were not assigned to Cook until September 2002, that is to say 21 months after Cook filed the PCT application but before the grant of the Patent.

Cook argued that the claim to priority is a good one because it had acquired all rights in the invention before the date of grant of the Patent and in any event always owned Mr Obermiller’s interest. Edwards says the claim is misconceived because the right of priority may only be enjoyed by the person who filed the priority application or his successor in title as at the date the right to priority is claimed, and on 31 January 2001 that was Mr Osse, Ms Thorpe and Cook, not Cook alone.

According to Article 4 of the Paris Convention, a person is to enjoy a right of priority if he has filed a relevant application for a patent or if he is the successor in title (in respect of the invention) to such a person. Furthermore any person wishing to take advantage of the right of priority is required to make an appropriate declaration. Article 4 is implemented by section 5 Patents Act 1977, which requires a declaration made by the applicant which complies with the relevant rules and specifies one or more earlier relevant applications made by the applicant or a predecessor in title.

The Court held that the priority claim was invalid because at the date of filing of the PCT application the right to claim priority belonged jointly to Cook and the two non-employee inventors, and not to Cook alone:

In my judgment the effect of Article 4 of the Paris Convention and section 5 of the Act is clear. A person who files a patent application for an invention is afforded the privilege of claiming priority only if he himself filed the earlier application from which priority is claimed or if he is the successor in title to the person who filed that earlier application. If he is neither the person who filed the earlier application nor his successor in title then he is denied the privilege. Moreover, his position is not improved if he subsequently acquires title to the invention. It remains the case that he was not entitled to the privilege when he filed the later application and made his claim. Any other interpretation would introduce uncertainty and the risk of unfairness to third parties. In reaching this conclusion I derive a measure of comfort from the fact that the Board of Appeal of the EPO has adopted the same approach to the interpretation of Article 87 EPC in two cases: J 0019/87 and T 0062/05.

Therefore, the acquisition by Cook of all rights in the invention in September 2002 did not permit it to claim priority from the US application. Since Cook’s patent was not entitled to its priority date, a document published between the priority and the filing dates was citable as prior art.  The Court held that several claims of the patent were obvious in light of this document.

A question was also raised regarding the credibility of an expert witness and specifically whether an expert changing his opinion undermined his value as an expert.  One expert witness appearing in the case had also appeared as an expert in an earlier decision of the UK High Court involving Edwards and another party.  It was noted that the opinions of the expert differed in material respects between the two cases.  However, the Court decided that opinions may change during the courts of a case, particularly after cross examination and further consideration as to the abilities of the ordinary skilled person.  The expert’s opinions were found to be “cogent and reasonable” rather than partisan.

I aim to shed light on the extent to which advance in the life sciences was directed by the profit motive and the availability of the patent system … and on the ways that the patent ‘institution’ evolved in response to science and to interest groups, mainly business ones, but also legal practitioners associated with business.
~ Graham Dutfield

In Intellectual Property Rights and the Life Science Industries: Past, Present and Future, Graham Dutfield presents a perspective on how we got to where we are in life sciences patenting — and where we are likely headed —  through the co-evolution of the patent system and the life science industries since the mid-19th century. This book follows the origins of the pharmaceutical industries in advances in synthetic chemistry and in natural products research and how these approaches to drug discovery and business have shaped patent law.

Seven Tales of a Patent

Dutfield reviews the past invention f pharmaceuticals to show the co-development of patents and pharma.  Dutfield describes specific businesses, products and technologies, including Bayer, Pfizer, and GlaxoSmithKline.  He writes of the true stories of the development of mauve dye, aspirin, warfarin, streptomycin, and omeprazole, polymerase chain reaction and the oncomouse.

In one story, we learn that insulin is a natural product that was named, patented and made available for therapeutic use in the 1920s, four decades before its structure was worked out.  Often drugs were patented long before they knew how they worked (see aspirin).  The patents on hormones that the Reich [German] patent office accepted in the 1920s and 1930s established precedents that were used to consolidate the notion that purified biological products in general should become proprietary.

Drugs Past, Present and Future

Historically, it was common to exclude medicines from patentability ostensibly because it was deemed immoral, though it was often really to protect domestic infant industries.

The bulk of the book is a thorough historical grounding of the development of patented drugs.  The middle section then details the growth of Big Pharma, Small Biotech.  Following developments since Watson and Crick discovered the double helix structure of DNA in 1953, Dutfiled leads us through the intertwining workings of genomics and money.

In showing the business of biotechnology, we see that the biotechnology revolution is rooted in the recombinant DNA  invention by Stanley Cohen and Herbert Boyer.  The technique, which enables foreign DNA to be inserted into a genome and passed along subsequent cell divisions was patented by Stanford, bringing in over $200 million in licensing royalties between 1975 and 1997, when the patent expired.

This second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology.  As the patent system has been modified to accommodate biotechnological inventions, it brought with it an opposition from those who felt that “patenting life” as they would call it, was wrong and immoral.

The book ends with the perennial question of “would we have got where we are today without patents?” Dutfield points out that it almost goes without saying both that the pharmaceutical industry is crucially important for human welfare since it produces cures (among other things), and that it is considered to be the most dependent of all industries on patents.

This should remind us of two things that a new institutionalist approach leads us to expect.  First, changes in property rights structures can never make winners out of everybody.  Second, the differences between the gains for some and the losses for others are bound to be great when the biggest right holders have, as they often do, such a firm grip on the regulatory system to the partial or total exclusion of other holders, users and those representing consumer interests.

We highly recommend you read this thought-provoking treatise on the pharmaceutical-patent collaborative.

About the Author

Graham Dutfield is Professor of International Governance at the University of Leeds, United Kingdom. He was formerly Herchel Smith Senior Research Fellow at Queen Mary, University of London. He was also Academic Director of the UNCTAD-ICTSD Capacity-building Project on Intellectual Property Rights and Development.

“Intellectual Property Rights and the Life Science Industries: Past, Present and Future (2nd Edition)” by Graham Dutfield (428 pages; World Scientific Publishing Co.)  is available through Amazon.

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