The Mayo v. Prometheus event hosted at George Washington School of Law with the Biotechnology Industry Organization created an opportunity for a panel of thought leaders to distill meaning from the case, the impact on personalized medicine, and possible solutions to the Court created problem.*

Is the decision a game-changer?

Photo Credit: www.zooboing.com

Judge Paul R. Michel, former Chief Judge of the Court of Appeals for the Federal Circuit handling patent cases, concluded that the Mayo v. Prometheus represents a “shift in attitude between the Supreme Court and Federal Circuit.  There’s a certain amount of trust, a certain amount of respect, a certain amount of suspicion that there might be some deeper immersion, deeper familiarity, harder thinking and greater exposure [to patent law] at the Federal Circuit than the Supreme Court itself can offer,” he said. “The game changer I see here is the Supreme Court is effectively saying ‘We’re done with the Federal Circuit.’ They don’t get any credit for greater immersion, greater expertise, harder thinking or anything of the sort.”  While many of the panelists disagreed on what exactly the Supreme Court concluded in the Mayo v. Prometheus decision, it was clear that all the panelists shared in the concern expressed by Judge Michel.

Some might think that a 9-0 decision represents a shared consensus of opinion on how to handle the “law of nature” exemption for patents.  Not so according to former Solicitor General to the United States, Seth Waxman.  Waxman asserted that when this Supreme Court rules unanimously “its language cannot be taken at face value.”  This court rarely suggests edits or withholds their votes unless certain language is included.  “But in the end, there is no way that all nine justices thought that this opinion has the broad consequences that people are catastrophizing.  I do not believe that every single justice on the Supreme Court thought that the entire field of molecular diagnostics, everything in personalized medicine, that’s over. There’s just no way that there was that level of consensus about how the patent laws have to be reasonably read.”

How will Prometheus affect the Myriad case?

The panelists expressed disagreement over how Prometheus would impact Myriad with some asserting a clear difference between the abstract idea claims in Mayo versus the tangible molecules in Myriad.  However, Donald Dunner from Finnegan indicated that future litigants are going to take Prometheus to the ultimate extreme until district courts agree and the federal circuits have to disagree and until the Supreme Court disagrees again.

However, all panelists agreed that the Courts and the Department of Justice were unclear on the science.  Professor Christopher Holman stated that no rigorous claim construction had occurred in the District Court.  As a result, there is as lot of misperception of what exactly the patent covers in the Myriad case.  Professor Holman argued that the Court created distinctions between isolated cDNA and gDNA that do not make any scientific sense.  Seth Waxman added that the considerable challenge for articulating the science and what the patent covers in the remand of Myriad is to correct the “unfortunate formulation conceived immaculately.”

How will these decisions affect businesses?

Paul Yasger, head of IP for Abbott Laboratories, stated that while the Prometheus decision may be good for litigators and patent office fees, it is not good for business because of the uncertainty it creates.  Phil Johnson, Chief Intellectual Property Counsel at Johnson & Johnson, pointed out that “capital is hard to come by these days and people are reluctant.”  Johnson and Johnson can invest money in R&D projects involving shampoo instead of biomarker research.  He said investors “have other things they can invest in but I don’t think we, and I mean mankind, can afford it.”

Michael Walker, Chief Intellectual Property Counsel at Dupont pointed out that these decisions have an impact beyond personalized medicine.  60% of Dupont’s R&D is in Ag and Food research and industrial biosciences such as biofuels.  Mr. Walker concluded that businesses have large settled business expectations in this technology and they look at Prometheus and Myriad and wonder if their technologies are just natural phenomena.

What are the solutions going forward?

Phil Johnson at J&J concluded that making it hard to get patent protection cannot help innovation because who will fund that work.  In this day and age, government sources of additional money are unlikely.  Chief Judge Michel pointed out that this is exactly the problem when the Court makes assumptions about patents stifling innovation without providing any convincing evidence that it was so.  Michel pointed out that the articles cited “don’t prove the point that the Court is assuming.  The preemption problem is all hypothesized as far as I can tell.”  Finally, Michel concluded it is dangerous to have unelected judges with no expertise in measuring the retarding effects compared to the beneficial effects make these kinds of decisions.

Hal Wagner, partner at Foley & Lardner, argued that in spite of the lack of evidence of the stifling effect of patents on research, the rest of the world allows for an exemption for experimental use.  It does not hurt the patent owners and it gets rid of the stifling argument.  Dr. Sauer pointed out that Judge Newman, among other Judges on the Federal Circuit has expressed frustration on the lack of cases on this issue as researchers are not being sued and so the court cannot explore the U.S. exemption.

Chief Judge Michel closed the meeting by suggesting that participants focus their energy and attention on the federal circuit panels and district courts dealing with 101 issues over the next 12 months.  If at the end of the year it is a terrible mess then go to Congress for a solution.

*Comments by the panelists should not be taken to bind the clients, companies, law firms, or other organizations with which they are affiliated.

Patent-Eligible Subject Matter after Mayo v. Prometheus: Exploring the Path Forward is a public round-table event hosted by the Biotechnology Industry Organization and the George Washington University Law School. Guest speakers at the round-table will discuss implementation of the Prometheus decision in patent prosecution practice, in examination guidance in the United States Patent Office, and in patent litigation.  Speakers will also discuss the implications of the decision on personalized medicine and possible ways forward.  Speakers include:

• The Hon. Paul R. Michel
• Richard P. Bress, Latham & Watkins
• Donald R. Dunner, Finnegan
• Raymond T. Chen, USPTO (invited)
• Q. Todd Dickinson, AIPLA (invited)
• Prof. Christopher Holman, UMKC
• Philip S. Johnson, Johnson & Johnson
• Seth P. Waxman, WilmerHale
• Hal Wegner and Andrew S. Baluch, Foley & Lardner
• Paul D. Yasger and Anat Hakim, Abbott Laboratories

Join us on May 16th from 2-5 PM at the Faculty Conference Center, Burns 5th Floor, George Washington University Law School, 716 20th Street NW, Washington, DC 20052.  A reception will follow the program.  For more information and to RSVP please email iplaw@law.gwu.edu with “BIO” in the subject line.

By David Saravitz, Alston + Bird

Day 2 of the 2012 BIO Intellectual Property Counsels’ Committee (IPCC) Spring Conference kicked off with a panel on the America Invents Act (AIA).  The panel focused on how practitioners and the U.S. Patent & Trademark Office (USPTO) are dealing with various provisions of this new patent act.

Mr. Ira Finkelstein, Senior Patent Counsel with Baxter Healthcare, led off the session initially discussing the first-inventor-to-file provision of the AIA (§ 3) which becomes effective on March 16, 2013, and the interplay of its one-year grace period for public disclosures by an inventor.  Mr. Finkelstein reminded the audience that in most foreign countries a pre-filing, public disclosure by the first inventor would be disqualifying prior art.  Thus, Mr. Finkelstein concluded that his strategy is: “Don’t rely on the grace period. File early, and file often!”

Mr. Finkelstein also discussed the best mode requirement of 35 U.S.C. § 112, first paragraph.  Mr. Finkelstein pointed out that § 112 still requires an applicant for a patent to disclose the best mode contemplated by the inventors and that he will continue to require his inventors to disclose the best mode in patent applications. According to Mr. Finkelstein, it is likely that this information will need to be in the disclosure anyway, to support claims to narrow, dependent claims.

Dr. Murray Spruill, Leader of the Alston & Bird’s Biotechnology, Chemical and Pharmaceutical Patents Group, took the podium next to discuss “Post-Grant Proceedings.”  Dr. Spruill pointed out that a defendant in an infringement lawsuit older than 1 year after the patent owner files a complaint alleging infringement of a patent needs to decide whether to bring an inter-partes challenge against the patent in USPTO before September 16, 2011 because the defendant would be barred from requesting the new inter partes review proceeding in such a circumstance.  Finally Dr. Spruill reviewed similarities and differences between the new post-grant review and inter partes review proceedings

The third and final speaker was Dr. Remy Yucel, Director, Central Reexamination Unit (CRU), U.S. Patent & Trademark Office.  Dr. Yucel indicated that since the inception of reexamination proceedings at the USPTO the number of reexamination filings per year has generally trended upward.  She indicated that, although there has been a sharp increase in number of reexamination filings per year since 2002, the CRU had reduced the time from filing to the issuance of a reexamination certificate from about 40 months in 2006 to about 22 months in 2011.

Regarding reexamination and the AIA, Dr. Yucel pointed to three key changes that would impact the CRU: the change in the standard for granting an inter partes reexamination (IPR) effective September 16, 2011; the transition from inter partes reexamination to inter partes review at PTAB effective September 16, 2012; and the commencement of supplemental examination on September 16, 2012.  Dr. Yucel indicated that the new, AIA-mandated “reasonable likelihood” standard for instituting an IPR does not require that the requester establish a prima facie case. And, unlike the prior standard of the “substantial new question,” the AIA-mandated standard does not require that a legal question be “new.”

Next, Dr. Yucel turned the focus to Supplement Examination.  Some of the proposed rules that she discussed provide that the request must be filed by owner of the entire right, title, and interest in the patent, that third party participation is prohibited, that the number of items of information is limited to 10 per request, and that an unlimited number of requests may be filed at any time.  Dr. Yucel also discussed proposed rule 610 which indicates that the request must include: a list of each item of information and its publication date; identification of each issue raised by each item of information; explanation for each identified issue; identification of how each item of information is relevant to each aspect of the patent to be examination and how each item of information raises each identified issue; a copy of each item of information; and a summary of each document over 50 pages in length.

Dr. Yucel discussed  the equitable conduct immunization of supplemental examination but later indicated that if Director learns of “material fraud” committed in connection with the patent subject to supplemental exam, the Director has authority to confidentially refer the matter to the Attorney General and may take other action pursuant to § 257(e).  She indicated that the Office regards “material fraud” to be narrower in scope than inequitable conduct as defined in Therasense.  77 Fed. Reg. at 3667.  Before concluding her presentation, Dr. Yucel discussed some additional non-AIA-related changes to streamline the reexamination practice before yielding the podium to permit the audience to ask her and her fellow panelists some questions.

By John W. Cox, Counsel at Alston+Bird LLP

The Spring 2012 BIO Intellectual Property Counsels’ Committee (IPCC) Conference, held in Austin, Texas, provided an excellent forum for intellectual property (IP) practitioners in the biotech industry to socialize, network, and participate in panel discussions focusing on the dynamic developments in the patent laws.  The conference began for the general participants over margaritas and Tex-Mex fare, where attendees were already discussing recent Supreme Court and Federal Circuit decisions impacting the industry.  By the final panel on Wednesday morning, the Supreme Court had handed down two more opinions impacting the biotech industry.

Patent practitioners have been monitoring the guidance provided by the Federal Circuit since its creation almost 30 years ago.  The patent laws for biotech inventions have evolved over much the same time period, stemming from Diamond v. Chakrabarty in 1980.  But in the past few years, more cases involving biological arts have not only reached the Federal Circuit but been taken up by the Supreme Court.  Indeed, it appears that the Supreme Court has been more active in the patent field related to the biotech industry since the Fall 2011 BIO IPCC meeting than any similar time period.  Moreover, two new acts of Congress impacting the industry have come into play, namely the America Invents Act and the Biologics Price Competition and Innovation Act.

The first of two panels discussing case law focused on Prometheus and the guidance – or lack thereof – provided therein.  The panel, including Richard P. Bress of Latham & Watkins and Raymond Chen of the U.S. Patent & Trademark Office (PTO), provided insight into the Supreme Court’s opinion, describing the new frontier for biotech IP.

The final panel took up the mantel to update the conference on a wide range of case law that will impact the practice of IP in biotech.  Four of the most talked about cases in patent law happen to impact the biotech industry, and they are either currently active or were recently decided.  Deepro Mukerjee, of Alston & Bird, led a discussion of Novo Nordisk, the case decided by the Supreme Court just the previous day.  Dr. Jitty Malik, also of Alston & Bird, presented the Therasense case, which, until Prometheus, was the main case IP practitioners had been talking about.  Steve Reese, of Olswang in London, provided the European perspective on the standards to obtain or avoid injunctions in patent cases and compared that with the recent Kimberly-Clark decision.  Any one of these cases could have spurred discussion on the Supreme Court’s recent interest in patent cases.  Together, they signal both danger and opportunity to patent practitioners in this industry and have BIO member companies and IP practitioners alike looking to the Supreme Court and Federal Circuit together for guidance.

To close out the conference, Dr. Judy Jarecki-Black of Merial returned us to the Myriad Genetics case, which the Supreme Court vacated and remanded back to the Federal Circuit in view of Prometheus.  Dr. Jarecki-Black raised a myriad of issues associated with the case—from ethical considerations to the scope of patentable subject matter in the biotech industry and what is necessary to save claims directed to genetic diagnostic testing—leading a dynamic discussion to formerly close out the conference.

All of the attendees, panelists included, are now figuring out what to do in view of Prometheus.  The PTO recently provided guidelines to its examiners based on that opinion, though the impact of the 9-0 decision has yet to make itself heard in other cases.  That, however, is not the situation for the industry itself.  BIO member companies are considering how to pursue their research and protect their IP, aware that the Supreme Court has moved the boundaries of the frontier for patentable subject matter in this field.

Despite the clock signaling the end of the Spring 2012 BIO IPCC program, the attendees once again returned to the Prometheus and Myriad Genetics cases.  The venerable Driskill Hotel heard musings about what will happen as Myriad Genetics moves up and down the appellate ladder.  The conference provided a forum at which IP practitioners came together to see old friends and meet new ones, enjoy some Texas hospitality, and get briefed on the hot topics in IP currently impacting the industry.  At its close, instead of scattering to the south Texas winds, we departed with renewed interest in considering, together, what dangers and opportunities this new frontier holds.

The House Judiciary Committee conducted a hearing on World IP Day on “International Patent Issues: Promoting a Level Playing Field for American Industry Abroad.”  BIO submitted written comments for the record highlighting the unique patenting challenges that biotechnology companies face around the world.

“To fully understand what is needed to level the playing field for the biotechnology sector in international markets, one must understand the intellectual property (IP) needs of the biotechnology sector.  Biotechnology innovation requires predictable and effective upstream (early stage) and downstream (product) IP protection.  Biotechnology innovation generally starts with an early laboratory discovery, and thus upstream protection helps to generate investment and interest in the further, applied research and development of the invention.  Upstream protection includes broad patent eligibility for biotech innovations, consistent patent term, flexible licensing practices, and effective patent enforcement.

Downstream protection is just as important.  As mentioned above, the research and development of a biological product can take decades and cost more than a billion dollars to complete.  A significant portion of this time and money goes towards developing the regulatory data package that is required by the U.S. FDA, USDA, or similar foreign regulatory offices to approve the biotech product.   Therefore, downstream protection for biotech products must include sufficient protection against foreign and domestic competitors relying on the innovator’s data package to secure abbreviated approval of competitive products in such markets. “

Read the Full Comments

Recent court decisions and ongoing implementation of the America Invents Act are certain to impact the life sciences industry. The 2012 BIO International Convention will feature an educational track devoted to Biotech Patenting and Tech Transfer to discuss legal and legislative developments and how they are likely to impact biotech companies.   This year’s global event for biotechnology will take place June 18-21, 2012 at the Boston Convention and Exhibition Center in Boston, MA.

Recent Developments in Patentability: Prometheus, Myriad, Classen, and the Patentability of Diagnostic Methods

Gain insights on major court cases—and the decision-making behind them—from a distinguished panel of patent law experts, attorneys and practitioners.

American Invents Act Comes to Campus: the Impact on Commercialization and Technology Transfer Offices

Panelists will discuss how the AIA affects universities and non-profit research institutions and what new strategies they can use to secure and enforce U.S. patents.  Learn pragmatic approaches to satisfy the AIA’s new requirements for patent procurement while improving your goals of timely technological disclosures.

IP Issues Affecting Biomarker Diagnostics and Personalized Medicine

A lively panel of international attorneys will get you up to speed on the impact that recent court cases, legislation and scientific issues—specific to inventions in the field of biomarkers and PM—have on patent procurement and protection. Have your questions ready for the audience Q&A!

Prior User Rights and Trade Secrets: A New IP Option Replacing Patents to Secure Freedom-to-Operate for Internally-Used Innovations in Biotechnology

Deciding whether it’s worth the trouble to patent internally-used technology? We will help you consider whether Prior User Rights, which serve as a defense against infringement of a later patent, might be a better option in your situation.

Academic Medical Centers: The New Pharma R&D Engine and Beyond

Developing 10% of all FDA-approved drug applications, AMCs are indispensible to life sciences. But academia-pharma partnerships are challenging. Looking at case studies of successful collaborations, we’ll uncover new pharma/biotech R&D strategies for partnering directly with AMCs to develop IP.

Challenges and Opportunities of Protecting and Managing IP Assets in Emerging Markets

How can you better protect your IP assets in emerging markets such as Brazil, Russia, India and China—or will enforce IP at all? Gain a handle on the issues involved to determine what you want—and need—to do.

Measuring The Impacts of Innovation: What Is The Future of Tech Transfer?

Tech transfer metrics that focus on activity—rather than impact—are a case of the tail wagging the dog. Join a vibrant roundtable discussion on initiatives to create more meaningful metrics, ones that will be useful in developing strategies for future transfers.

Successful IP Strategies for Biotech Platform Technologies

Many standard IP strategies are a poor fit for companies like yours. We’ll share real-world strategies that are better tailored to your needs and can evolve with your company as it grows more product-driven.

Patenting Under the America Invents Act in Comparison with European Patent Practice

Get the inside scoop—and gain international perspective—as representatives from the European Patent Office and U.S. Patent and Trademark Office discuss First to File, Prior Art and Opposition Proceedings in the two systems.

The New World: Post-Grant Review In the United States–What Can We Learn From Past Experiences In Europe, Japan, India and Australia

Hot Topic! Explore the important changes AIA has brought to U.S. patent laws. In this interactive session, a panel of international experts will take you through other countries’ histories and the growing pains they experienced in developing their post-grant review systems.

IP Challenges to Personalized Medicine & Diagnostics (Personalized Medicine and Diagnostics Track)

Hot Topic! How might recent court decisions (e.g., Myriad, Classen, and Prometheus) and emotionally charged public perception affect the obtainability of personalized medicine patents? More broadly, what are the ramifications for other technologies—perhaps those of your company—if such inventions are deemed ineligible for patents?

New patented drugs actually save the United States and its citizens lots of money. In fact, new drugs save 7 times more in non-drug spending than they cost.  Those savings come as new drugs result in reduced hospital and nursing home admissions which far exceed the cost of using newer drugs.  New patented prescription drugs can also reduce the need for expensive surgeries and hospital stays. This data clearly articulates that the cost of treating illness with no or substandard medicine far outweigh the cost of new patented medicines which can better treat that same illness.

401K - Money and Savings

Newer drugs also save 9 times their estimated costs in value of increased workforce participation.  One example is that new drugs reduce lost work hours due to illness and hospitalization. We all know several people around us that have debilitating illnesses that costs them their sick leave, vacation time, and forces them to take leave without pay.  There are many others whose illness is so extreme that they cannot work and must look to family, community, and government to cover their expensive healthcare costs.

Finally, Medicare ultimately saves $2.06 for every additional dollar it spends on new patented drugs. You read that correctly, Medicare (and you the taxpayer who funds Medicare) actually save money when Medicare spends additional money on new patented drugs. One recent drug approval clearly portrays this principle.  Affymax recently received approval for Omontys which treats patients with chronic kidney disease on dialysis.  The drug is used only once a month versus the older drug which is used 3 times a week.  The article goes on to state that the new drug “may potentially save money for Medicare” and I think we can all understand why.

A new patented purple pill and a new patented antiviral had an enormous impact on my life.  Prior to taking those two pills, I was seriously ill dealing with chronic pain and making a couple of trips to the emergency room a year which was very costly for myself and my middle class military family.  The doctors followed protocol and tried several other older generic medications which did not work.  When I was finally prescribed the new patented pills, my health suddenly and remarkably improved.  I was finally able to go back to college, then law school, and then obtain employment and become a proud husband and father of three.

While these improvements to my quality of life are invaluable to me and my loved ones, some of the cost benefits to myself and society are easily understood.  First, my new patented pills helped me avoid the emergency room and hospital stays saving my family (and my insurance) lots of money.  Second, I was able to go back to school and on to law school where I now have much greater employment opportunities which provides for my family, results in increased tax revenues to Medicare and Medicaid funds, and increases my productivity (which also results in more tax revenues and funding for Medicare and Medicaid).

My story and the countless other stories of your family, neighbors, and friends clearly articulates the need for new medicines and the patents which provide necessary incentives for their research and commercialization.  There are many problems in our current health care system, many of which my family has personally faced.  However, pursuing solutions that address supposed ‘patent problems’ will likely cost us all more money and will only delay new and better medicines for those in dire need.

India recently issued a compulsory license on Bayer’s liver and kidney cancer drug (Sorafenib) with the stated goal of providing access to India’s poor. However, the Times of India recently ran the article Cheap generics drugs no panacea for India’s poorest, quickly dispelling this myth:

“The compulsory license system might not really work because poor people cannot even afford the discounted price,” said G. Balachandhran, former head of the National Pharmaceutical Pricing Authority (NPPA), India’s drug price watchdog regulator.

“Instead of dealing on a case-to-case basis, India needs to have a policy that will bring more and more people under medical cover … We need to increase the health insurance penetration, so that even poor people can afford treatment,” he added.

“Only 15 percent of India’s 1.2 billion population is covered by health insurance, according to business lobby group the Federation of Indian Chambers Commerce & Industry, meaning even at a lower price, Nexavar will be out of reach for many.

“Still, the head of Pfizer, the world’s largest drugmaker, told Reuters on March 12 that there were around 100 million people in India with “wealth equivalent to or greater than the average European or American, who don’t pay for innovation”.

While Natco will profit off someone else’s investment and innovation, it seems the company’s compulsory license gift from Indian regulators will do little to help India’s suffering masses.

By Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization

We are surprised and disappointed in the Court’s decision, which disregarded the considered judgment of the Executive Branch experts and numerous amici such as BIO, who warned about the unintended consequences of attempting to use patent eligibility as a basis to strike down these patents for biomarker-based diagnostic methods.

While we are still analyzing the opinion, we are concerned that it introduces new and confusing concepts into the traditional body of patent law, which patent examiners and lower courts will struggle to consistently and rationally implement.  While the opinion’s lack of guidance may limit its practical impact, we are troubled that the Court’s opinion fails to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases.

BIO will work with the Administration and the U.S. Patent and Trademark Office to ensure that the future application of this opinion does not irrationally restrict the ability of innovators to protect inventions that lead to cures, medical breakthroughs, and other technologies that make our lives and our environment cleaner, safer and healthier.

India’s ‘increased efficacy’ patentability requirement for medicines prevents an improved form of a known drug from receiving a patent unless the new form is significantly more effective than the previously-known form. This provision aims to accomplish one task: stop patent “ever-greening.”  This issue has risen to prominence lately as the New York Times reports on the Novartis suit challenging patent ever-greening requirements in India’s Supreme Court.

Globalism Pictures

So what is patent ever-greening?  Opponents claim that corporations pursue patenting strategies that involve ‘tweaking’ their medicines to apply for new patents which artificially extend their patent life.  This ‘tweaking’ subverts access to medicines for poor people.  India argues that Indian generic companies stand uniquely positioned to provide medicine to the poor and patent ever-greening directly threatens their ability to do so.  A compelling argument, if it was true or remotely based on fact.

Let me be clear.  Poor patients in the developing world face real access problems for medicines – patented or unpatented. BIO has been directly engaged in studying the problem and suggesting real answers.  However, patent ever-greening, if it is a real problem at all, in no way contributes to the access problem.

Restrictions on so called ‘patent ever-greening’ ignore the fundamental nature of invention and commercialization.  Patents exist to incentivize both invention and commercialization of that invention.  However, measuring the value of each invention is almost impossible to accomplish.  There are many inventions which represent a marginal increase but are in fact a huge innovation.  Imagine an improved jet engine that is “only” 5% more fuel- efficient. Would you be surprised if such an engine would quickly take a major market share? Now imagine an improved heat tolerant vaccine which is about as effective as the original vaccine, but no longer requires refrigeration.  An outright ban on incremental innovation through the use of patent ever-greening restrictions rejects all valuable incremental innovation, automatically deeming it not “patent-worthy.”

Other inventions seem clearly inventive to our society but have little commercial impact in the real world.  For example, wind power generation has only recently emerged when the economics (i.e. price and environmental costs) of oil production has created a market for alternative fuels.   India has become an innovative world leader in advanced wind turbine technology and its champion (Suzlon) captured 7.7% of the world market in 2006.  I find it odd that India’s efficacy requirement does not apply to their innovative wind turbine sector (here is an interesting story of patent intrigue in the wind turbine industry in India).

Finally, Incremental innovation patents do not extend the patent life of the underlying drug.  Any generic company can produce and market the earlier version of the branded drug when the original patent expires.  If the brand company ‘tweaks’ the drug and files for a new patent, the generic company only infringes the new patent if they produce the ‘tweaked’ drug.  However, after the original patent expires, the generic can still produce the earlier version.

Consider your own experience.  You go to the drug store to buy medication.  You can choose to pay more for a branded version which has an extended release mechanism or buy the generic version of the same drug which does not. If you think the patented extended-release formulation is a meaningless “tweak,” you will probably opt for the cheaper, generic version of the original drug. You have access to the drug regardless of the so called ‘patent ever-greening.’

So what does ‘patent ever-greening’ limit access to?  I don’t know.  Indian generics (and generic companies elsewhere) can still manufacture the original, off-patent drugs. And poor patients in developing countries can access the first generation of the drug.  Where is the ‘patent ever-greening’ problem?