Patent Baristas

In India, a team of doctors is reviewing ancient Indian medical texts and putting this information into a 30-million-page electronic encyclopedia of India’s traditional medical knowledge, the first of its kind. As practitioners of ayurveda, unani and siddha, ancient Indian medical systems that date back thousands of years, these doctors are trying to put an end to Biopiracy.

‘Biopiracy’ describes a process in which living resources or traditional knowledge and practices are patented, thus applying intellectual property restrictions to their use. The resources in question are predominantly from developing countries, and are the subject of patent applications by companies in developed countries. An important criticism in this context relates to foreigners obtaining patents based on biological materials, and the pharmacopeias and oral knowledge, such as that of the Indian Ayurveda and other traditional systems of medicine. However, it is difficult to precisely define Biopiracy. One countries folk medicine is another countries recent find.

The project, called the “Traditional Knowledge Digital Library,” will put together an encyclopedia of the country’s traditional medicine in five languages in an effort to stop people from claiming them as their own and patenting them. The electronic encyclopedia, which will be made available next year, will contain information on the traditional medicines, including exhaustive references, photographs of the plants and scans from the original texts.

This is an especially difficult task in that the ayurvedic texts are in Sanskrit and Hindi, unani texts are in Arabic and Persian and siddha material is in Tamil language. Material from these texts is being translated into five international languages, using sophisticated software coding. Currently, there are nearly 150,000 recorded ayurvedic, unani and siddha medicines. Under normal circumstances, a patent application is rejected if there is prior existing knowledge about the product but this generally must be published in a journal or available on-line and not just an oral tradition.

When the USPTO granted a patent on the wound-healing properties of turmeric, Indian scientists protested and fought to get the patent revoked. And, as we reported earlier, after patent was awarded to the U.S. Department of Agriculture and the multinational company WR Grace & Co. in 1995 for the fungicidal properties of seeds extracted from the neem tree, native to India, the European Parliament’s Green Party, India’s Research Foundation for Science, Technology and Ecology, and the International Federation of Organic Agriculture Movements fought to have it revoked on the grounds of biopiracy.

The basis of the challenge to the patent was that the fungicide qualities of the neem tree and its use had been known in India for over 2,000 years. The neem derivatives have also been used traditionally to make insect repellents, soaps, cosmetics, tooth cleaners and contraceptives. In 1995, WR Grace patented neem-based bio pesticides, including Neemix, for use on food crops. Neemix suppresses insect feeding behavior and growth in more than 200 species of insects. But the EPO agreed that the process for which the patent had been granted had actually been in use in India for many years.

While patents should not be granted on known materials, many developing countries want to deny patents for new uses of a known product or process, including second use of a medicine. The fear is this could stall research into new areas for these known starting materials. There is the view that the TRIPS Agreement is aiding the exploitation of biodiversity by privatizing biodiversity expressed in life forms and knowledge but patents are granted under national patent laws and have territorial application only. But, the TRIPS Agreement merely provides minimum standards of protection for intellectual property rights including patents, while WTO Members are free to grant a higher level of protection under their national laws.

Thus, India and other countries are free to deny patents on life forms, except on micro-organisms and micro-biological and non-biological processes, as per the provisions of the TRIPS Agreement. However, if the U.S. chooses to grant patents on plants or other life forms, other nations cannot object. Nevertheless, such patents will have force only in the U.S. and cannot be enforced elsewhere.

The World Trade Organization (WTO) members approved measures to make it easier for developing countries to get cheaper generic versions of medicines for communicable diseases like AIDS. Changes to the WTO’s intellectual property agreement would make permanent a waiver currently in place to allow poor countries without their own pharmaceutical manufacturing capacities to import cheaper copies of patented medicines for humanitarian purposes.

Its general council has agreed to make permanent a 2003 waiver that allows poorer nations to import generic drugs to treat serious diseases such as Aids. WTO members have set Dec. 1, 2007, as a deadline to ratify the amendment, the organization said. It would need to be approved by two-thirds of the 148 members. The waiver remains in force until then.

The World Trade Organization (WTO) is an international rules-based and member driven organization which oversees a large number of agreements defining the “rules of trade” between its member states and is the successor to the General Agreement on Tariffs and Trade (GATT) that was set up in 1947, and operates with the broad goal of reducing or abolishing international trade barriers. It ensures trade among nations operates smoothly, freely and orderly.

As of August 19, 2005, there are 148 members in which most of them are developing countries in the organization. All WTO members are required to grant one another most favored nation status, such that (with some exceptions) trade concessions granted by a WTO member to another country must be granted to all WTO members.

US Trade Representative Rob Portman said that the U.S. was fully behind the move. The European Union (EU) and the UK has also backed the change. Under the rule, poorer nations will be allowed to import the generic drugs for humanitarian reasons and not for commercial purposes. Some of the larger developing countries, like India, hope that they will be able to sell antiretroviral Aids drugs to Africa under the deal.

Flexibilities such as “compulsory licensing” are written into the TRIPS Agreement — governments can issue compulsory licenses to allow other companies to make a patented product or use a patented process under license without the consent of the patent owner, but only under certain conditions aimed at safeguarding the legitimate interests of the patent holder.

But some governments were unsure of how these flexibilities would be interpreted, and how far their right to use them would be respected. The African Group (all the African members of the WTO) was among the members pushing for clarification. A large part of this was settled at the Doha Ministerial Conference in November 2001.

In the main Doha Ministerial Declaration of November 2001, ministers stressed that it is important to implement and interpret the TRIPS Agreement in a way that supports public health — by promoting both access to existing medicines and the creation of new medicines.

“TRIPS” stands for Trade-Related aspects of Intellectual Property Rights. It is an Agreement drawn up by the World Trade Organization between 1986 and 1994 to ensure intellectual property rights are respected within international trade. It came into force on 1st January 1995, although implementation dates vary from country to country.

Governments can issue a compulsory license if a patent owner abuses their rights by, for example, failing to offer their product on the market, or offering it at a price that is too high for potential buyers to afford. Competitors can then produce the product or use the process under government license without fear of prosecution. In the case of generic drugs, compulsory licenses can be issued because of the high (and for developing nations, often unaffordable) prices charged by the major pharmaceutical companies for their products.

Article 31(f) of the TRIPS Agreement says that production under compulsory licensing must be predominantly for the domestic market. The concern was that this could limit the ability of countries that cannot make pharmaceutical products from importing cheaper generics from countries where pharmaceuticals are patented. As with the 2003 waiver, the permanent amendment will allow any member country to export pharmaceutical products made under a compulsory license for this purpose.

Now, the amendment itself is in three parts. Five paragraphs come under Article 31 “bis” (i.e., an additional article after Article 31). The first allows pharmaceutical products made under compulsory licenses to be exported to countries lacking production capacity. Other paragraphs deal with avoiding double remuneration to the patent-owner, regional trade agreements involving least-developed countries, “non-violation” and retaining all existing flexibilities under the TRIPS Agreement.

A further seven paragraphs are in a new annex to the TRIPS Agreement. These set out terms for using the system, and cover such issues as definitions, notification, avoiding the pharmaceuticals being diverted to the wrong markets, developing regional systems to allow economies of scale, and annual reviews in the TRIPS Council. An “appendix” to the annex deals with assessing lack of manufacturing capability in the importing country. This was originally an annex to the 2003 decision.

The new Article 31 “bis” and annex of the TRIPS Agreement are attached to a protocol of amendment. This in turn is attached to a General Council decision, which adopts the Protocol and opens it for members to accept it by 1 December 2007.

See a Draft Text of the Changes here.

I received a letter from a reader asking about the current status of the reexamination request on Pfizer’s Viagra (sildenafil citrate) patent (U.S. Pat. No. 6,469,012). I always appreciate hearing from readers and don’t mind trying to answer questions (when I can) so I reviewed the file history. The proceedings are now merged (consolidated into one) and the actions to date are summarized below.

In October 2002, Pfizer Inc., Pfizer Limited, and Pfizer Ireland Pharmaceuticals filed a patent infringement lawsuit against ICOS, Lilly ICOS, and Lilly in the United States District Court for the District of Delaware. Pfizer contends that the use, offering for sale, selling, manufacture, or importing into the United States of Cialis for the treatment of erectile dysfunction by any of the defendants infringes claim 24 of Pfizer’s U.S. Patent No. 6,469,012, and seeks a declaratory judgment to that effect. Pfizer also seeks a permanent injunction, attorneys’ fees, costs, and expenses.

The USPTO subsequently ordered the reexamination of the Pfizer Patent (Reexam. C.N. 90/007,478). Under the reexamination process, the PTO is required to reconsider the validity of a patent if substantial new questions of patentability are raised by any party including by the PTO itself. The District Court stayed, or suspended, the patent infringement lawsuit, pending the outcome of the reexamination. Subsequently, Lilly ICOS and other parties filed several reexamination requests regarding the Pfizer Patent, which were merged with the USPTO-ordered reexamination. The first office action issued by the PTO rejected claim 24 of the Pfizer Patent. Claim 24 reads:

A method of treating erectile dysfunction in a male human, comprising orally administering to a male human in need of such treatment an effective amount of a selective cGMP PDEv inhibitor, or a pharmaceutically acceptable salt thereof, of a pharmaceutical composition containing either entity.

The Examiner rejected claim 24 on the basis that certain prior art rendered the claimed invention not new, and therefore unpatentable under 35 U.S.C. §102(b), and obvious and unpatentable under the judicially created doctrine of obviousness-type double patenting. This broad claim would cover treatment by any cGMP PDEv inhibitor (read: Cialis) and was rejected over the references Korenmann, 41 J. Am Geriatrics Soc. 363 (1993) and Yin et al., 10(6) Yunnan J. Traditional Chinese Medicine 13 (1989).

On September 15, 2005, the USPTO issued a second office action that rejected Pfizer’s arguments made in response to the first office action, reaffirmed the initial rejection of claim 24, and entered new grounds for rejecting claim 24. The second office action also maintained the obviousness-type double patenting rejection of the other claims. Pfizer’s response to the second office action was due by November 15, 2005. The time for taking any action by a patent owner in an ex parte reexamination proceeding can be extended only for sufficient cause and for a reasonable time specified. Any request for such extension must be filed on or before the day on which action by the patent owner is due, but in no case will the mere filing of a request effect any extension.

Therefore, the time for response has passed but it is possible that Pfizer will file with an extension of time or that the response has just not made it to the file wrapper as yet. If a response has been filed, the USPTO could issue a further action, which may finalize the rejections of claim 24, withdraw the rejections of that claim, or allow an amended claim to be entered. In any event, Pfizer may challenge the result of a final office action within the PTO and subsequently in court.

ICOS and Lilly also have initiated or are defending lawsuits and/or administrative proceedings against Pfizer in other jurisdictions around the world regarding patents corresponding to Pfizer’s U.S. “method of use” patent. The corresponding patent in the UK was found invalid as obvious by the Court of Appeal in Lilly ICOS Ltd v. Pfizer Ltd. (2002) EWCA Civ 1 and Civ 2 and in Australia in Eli Lilly v. Pfizer (2005) FCA 67.

UPDATE: Dr. Vivien Santer, a patent attorney with Griffith Hack in Australia, sent a note pointing out that the case was litigated in Australia, and at first instance claim 10 was held by the Federal Court of Australia to be invalid for lack of inventive step and for lack of fair basis (analogous to lack of support in the specification under US Section 112). Claim 10 is the equivalent of US claim 24, and would have encompassed Cialis. However, the Full Federal Court held on appeal that the invention as claimed was novel and not obvious, but then it upheld the finding of invalidity of claim 10 on the ground of lack of fair basis. A case of winning the battle but losing the war. The appeal decision can be found here.

We’ll keep you posted on any further actions on this matter.

See the Nonfinal Office Action here.

Colin Samuels brings on Blawg Review #35 in the Nine Circles of Hell from Dante’s Inferno. Samuel’s Infamy or Praise review provides an overview law blawgs within the concept of a hell unworthy of Hell — one filled with those who, as Dante observes, “made through cowardice the great refusal.”

Samuel shows his desire to be of consequence and not to be one of the inconsequential souls — those whom Dante noted in passing as “[t]hese miscreants, who were never alive” — is in many ways more damning than to exist in any of the nine circles of Hell through which Dante and Virgil subsequently journey.

We especially like David Gulbransen of the Preaching to the Perverted blog distilling the law school experience of 1L down to a few bullet points, e.g., Torts: “Accidents happen, but someone’s gonna have to pay for that.”

Academics at Cambridge University are divided over a new proposal by the university to tighten its control over intellectual property created by faculty by managing patent applications and taking a stake in spin-out companies. Under the current regulations, the university has no effective control over intellectual property created by the majority of its staff.

The university says that the new rules will bring Cambridge in line with other universities; and that it is only right that the whole of the university benefits. The university says it is concerned that the current system penalizes junior staff who contribute to research but sometimes miss out while distinguished heads of departments can make millions.

Cambridge now owns the right to patent ideas arising from externally funded research by charities, research bodies or companies, which accounts for 70 per cent of the output. Faculty retain ownership of the intellectual property in other work they do. The inventor would receive about a third of the proceeds, with the rest going to the university. Academics would continue to be free to decide to publish their work rather than seek commercial development. Faculty will also be able to demand that the university assign back to them the relevant intellectual property rights so they can seek commercial sponsors, with the university claiming a proportion of the profits.

Opponents claim that the new rules will discourage entrepreneurs and damage growth in the region, which is home to more than 900 high-tech firms. Cambridge faculty are also worried that the university will try to strike a deal similar to the 2001 venture where IP2IPO, an investment vehicle, gave £20m to Oxford University in return for a stake in any companies that were spun out of its chemistry department over the following 15 years. Faculty have now forced a vote of all members of the university, which can over-rule the management’s decision. Previous attempts by the university authorities to revise the rules on ownership of intellectual property have failed.

David Norwood, chief executive of IP2IPO, described the reforms as essential. “These academics are happy to take the money and use the university’s infrastructure,” he said. “The idea that the intellectual property belongs to them is ridiculous. UK taxpayers are paying for this. We expect returns for the investment in them.”

Enactment of the Bayh-Dole Act (P.L. 96-517) in the U.S. created a uniform patent policy among the many federal agencies that fund research. Bayh-Dole gave U.S. universities control of their inventions by placing few restrictions on the universities’ licensing activities. The success of Bayh-Dole in expediting the commercialization of federally funded university patents is seen by the fact that prior to 1981, fewer than 250 patents were issued to universities per year. Slightly over a decade later, almost 1,600 were issued each year. Of those, nearly 80% stemmed from federally funded research. The ability to retain title to and license their inventions has been a healthy incentive for universities.

See the details here.

Visit Cambridge Enterprise here.

The Intellectual Property Department of Frost Brown Todd LLC has beefed up its trademark and copyright practice Jones Day attorney Joseph Dreitler has joined the firm as Chair of the Trademark & Copyright Practice Group, along with his colleagues Mary True and Brian Downey. Dreitler’s group has represented top clients such as Elizabeth Arden, K-Mart, R.J. Reynolds, Burberry, Kate Spade, Coors Brewing, The Ohio State University, Nationwide Mutual Insurance Company and Dell Computer in trademark, copyright and domain name litigation, prosecution and transactional matters. This past spring Dreitler’s group obtained both a temporary restraining order and product recall against a knock-off trade dress of Elizabeth Arden’s “curious Britney Spears” perfume.

Member Joseph Dreitler has more than 25 years of experience in all aspects of U.S. and international trademark law, from litigation to counseling to business transactions. In addition to his practice in the courts and administrative agencies, his practice focuses on brand development, global trademark clearance, prosecution and portfolio management, and licensing. Dreitler’s business transaction practice focuses on trademark, copyright, and domain name issues, including due diligence and drafting of agreements for mergers, acquisitions, divestitures and bankruptcies, licensing of joint ventures, and the establishing and operation of intellectual property holding companies.

Counsel Mary True has extensive and varied trademark litigation experience. She has successfully represented clients in federal courts on a wide variety of trademark, unfair competition, copyright and Internet matters, including expedited TRO and preliminary injunction proceedings. She has also represented clients in various oppositions before the TTAB, and has counseled clients on issues ranging from trade dress protection to counterfeiting.

Counsel Brian Downey has practiced exclusively in the trademark, trade secret, copyright, and Internet area for a number of years. He routinely handles intellectual property matters, including searching, licensing, the prosecution of applications, transactional negotiations as well as counseling. In addition, Downey has litigated numerous trademark and unfair competition cases in federal court and has successfully obtained the transfer of several domains under the Uniform Domain Name Dispute Resolution Policy.

While we’re on the subject of patent re-exam lately, I received a letter from a plucky individual that has decided to file a request for ex parte reexamination of Amazon’s “One-Click” patent (US Patent 5,960,411), using some prior art that he found.

It turns out that New Zealander Peter Calveley is one of the actors who provided the motions for computer-generated elves and orcs in Two Towers. He also has been laid up of late due to an accident (I can relate). He has now put his free time to use taking on a David and Goliath effort against Amazon.

From his web site, the sequence of events appears to be as follows:

October 04, 2005: Ordered a book from Amazon and it never arrived.

October 09, 2005: Got out of hospital and the book finally arrived (very late).

November 13, 2005: Mailed a request for re-examination for the Amazon “One-Click” patent.

You can view the request in PDF form here and, as you’ll see, it is very impressive and quite thorough. Clearly not the average work of a pro se litigant (i.e., not in crayon).

I have to admit, I was quite intrigued by the whole affair given that a Request for Re-Exam is not something average citizens take on in their spare time. After some correspondence, we spoke by telephone briefly — since I was unwilling to write about his efforts if this was all a scam. I found that Calveley is extremely bright and has his own inventions and understands computer patents and procedures quite well. He has the time and will to do this even if it won’t bring him a direct benefit.

The request focuses on one of the broadest claim in the patent, claim 11, along with the dependent claims 14, 15, 16, 17, 21 and 22, relying on two different groups of prior art:

1. United States Patent No. 5,729,594; and

2. A number of references (including pages from the Wayback Machine) referring to DigiCash.

Keep in mind that anyone can file a written request asking the USPTO to reexamine any claim of an issued patent on the basis of prior art consisting of patents or printed publications that the person believes had a bearing on the patentability of any claim of the issued patent. The USPTO reviews this submission and initially determines whether the submitted prior art raises a substantial new question of patentability. If yes, then the patent undergoes an ex parte reexamination. However, beyond the initial request, a third party’s involvement in the reexamination ends, and the patent goes through an examination process that is similar to the regular examination process for pending patent applications. Thus, ex parte reexamination has the risk for a third party of bringing to the USPTO’s attention a potentially damaging prior art document that the patent owner will survive the challenge and obtain new, stronger claims.

There is also the possibility of using inter partes reexamination provisions which apply to any patents issuing from original applications filed in the United States on or after November 29, 1999. Substantively, the inter partes reexamination procedure tracks the ex parte reexamination procedure, in that the reexamination request must set forth a “substantial new question of patentability” based on a prior art document. Further, as with ex parte reexamination, the patent owner cannot expand the scope of claims but can present narrower claims in view of any prior art cited in the reexamination. Under this reexamination procedure, however, third party requesters can participate in a much more meaningful way. For example, they can respond within 30 days to all papers filed by the patent owner and can comment on positions taken by the examiner in Office Actions.

Given that this is not his profession, Calveley is asking for donations to cover the filing fee with the USPTO. The fee for requesting reexamination is $2,520 and he has so far raised $62.92. Besides donations, he is soliciting comments and criticism.

Make donations and read more about the tale here.

The title to the Public Patent Foundation (“PUBPAT”) news release said it all: “PUBPAT Receives Substantial Victory in Lipitor Patent Challenge: Pfizer Concedes to Give Up Original Broad Patent Claims. Or, does it? PUBPAT touted that in the challenge it filed last year against Pfizer Inc.’s patent on Lipitor, “Pfizer has conceded to significantly narrow the patent to specifically exclude the form of atorvastatin tested in its early clinical trials for Lipitor.”

The press release goes on to state that “This is a substantial victory for the public,” said Dan Ravicher, PUBPAT’s Executive Director. “Pfizer has been caught with its hand in the cookie jar and is correctly giving up the undeserved breadth of the patent it was originally issued.” (See U.S. patent 5,969,156)

Well, the amendments clearly give up some subject matter (amorphous atorvastatin) so the claims are in fact narrower. However, I would argue that the real question is “Does this matter to Pfizer?” I would say the answer is “Probably not.”

For a different kind of patented invention (say, an electronic device), this getting your broad claim narrowed could be devastating since the disclaimed subject matter (product) could be easily marketed immediately as an equivalent. However, the present patent covers Form I crystalline atorvastatin calcium trihydrate, which is the active ingredient in the drug Lipitor, and the only form approved by the FDA.

Therefore, you could argue that competitors are now free to make, use and sell the amorphous solid form of atorvastatin but they would need to get FDA approval for that form in order to sell it in the U.S. But, FDA approval usually requires 10 to 12 years of development and 100 – 800 million dollars in development costs. And, this could all be for a drug that may not work as well. The FDA approval process thus creates a second layer of exclusive protection.

Competitors are not going to spend this type of time and money to effectively gain a “generic” version of the drug (as they would not have exclusivity). The best a competitor could hope for is that they could take some of the market share away from Pfizer but they could only gain that market share by cutting the price. However, this could effectively prevent them from recouping the R&D costs since the competitor would not have had the benefit of years of exclusivity. Companies would generally be better off waiting until the drug is off patent and then marketing a true generic.

It might be possible for a competitor to file an FDA application using the Abbreviated New Drug Approval (ANDA) process to gain approval but it requires a showing that the proposed drug is the same as, or bioequivalent to, the FDA approved drug (which seems unlikely given the declarations by Pfizer in this case that the drugs are indeed different).

I think Pfizer has come out pretty well in this re-exam.

See more by PUBPAT here.