Last week, several newspapers ran an AP article on so-called “small-time” inventors and the pending patent reform proposals.  The story can be accessed at this Washington Post link.

The Professional Inventors Alliance, an interest group for independent and small entity  inventors (I don’t think the term “small-time” is accurate),  is spotlighted in the article.

A money quote from the article (and representative of the independent/small entity viewpoint on the proposed patent reform):

“I honestly feel that if we don’t stop what the big companies are trying to do, there won’t be any opportunity for us,” said Ronald J. Riley, the Professional Inventors Alliance’s president. “What they call patent reform is all about making it virtually impossible to enforce the patents.”

Thanks to George Margolin, independent inventor extraordinaire, for the link.

Representative Sherrod Brown from the great State of Ohio has introduced a bill “to provide for compulsory licensing of certain patented inventions relating to health care emergencies.” (H.R. 4131).

Are compulsory licenses an issue in the United States?  You better believe it.  Remember, following 9–11 and the subsequent Anthrax scares, the Bush administration considered invoking an existing compulsory license provision of federal law for Ciprofloxacin, the Bayer antibiotic that is approved for treatment of Anthrax infections.

The Board of Patent Appeals and Interferences at the United States Patent and Trademark Office recently issued a precedential opinion holding that there is no separate “technological arts” test when determining whether a claimed invention meets the subject matter requirement of 35 U.S.C. s. 101 (Ex Parte Lundgren, BPAI 2003–2088; view and/or download a .pdf of the opinion here).

The Board distinguished a 1970 decision of the Court of Customs and Patent Appeals (a predecessor of today’s Court of Appeals for the Federal Circuit) that says that Section 101 only requires that a claimed process be “in the technological arts.”  In Lundgren, the Board rejected this earlier case as establishing a general test for patentable subject matter.

The Lundgren opinion casts a critical eye on the scope of patentable processes despite its holding, particularly business methods.  One Administrative Patent Judge expresses a belief that Section 101 is not satisfied by a process unless the human physical actions involved in the process transform some physical subject matter to a different state.

When considering Section 101 issues, I often wonder if the real issue is accessibility to prior art.  What if Examiners had perfect accessibility to prior art when examining claims to a process?  I wonder if that would change any beliefs on what lies within Section 101 and what does not.

Is the question really one of access to prior art rather than one of what should and should not be considered patentable?

Consider one of the examples discussed in the opinion — the “patented” move of an athlete.  Sportscasters often use the phrase “…and there’s his patented move…” to describe an athletic move for which an athlete is known.  But, as described in the opinion, the PTO has tried to resist patenting such human performed subject matter* (because there is no transformation of physical matter?).

What if an athlete submitting a claim for a “method of [entertaining][performing in an athletic event][etc.]” that covered his “move” AND the Examiner had absolute perfect access to the relevant prior art (e.g., it is relatively easy for the Examiner to review video footage of athletes performing similar moves).

Would this change things?

Of course, perfect access to relevant prior art cannot be achieved.  Maybe Section 101 can/should/is/will be used as a gatekeeper of this deficiency.

* I have never seen nor heard of an issued patent or an application claiming an athletic move.  If you have, I’d appreciate a reference by e-mail (jmbesq AT gmail DOT com).

by J. Matthew Buchanan.

The Korean Food and Drug administration is considering whether it should invoke a compulsory license on Roche’s anti-flu medication, Tamiflu.  The agency has sought input from Korean drug manufacturers to determine if any would be capable of making the drug.

This Korean approach, in which a governmental agency appears to be taking the lead role on the issue, stands in stark contrast to the approach seen thus far in India, where a generic drug manufacturing firm is advancing the issue.

Roche has estimated that it would take nearly a year for a company to be ready to manufacture Tamiflu if it were starting from scratch.

See this article for more information on the Korean situation.

Cipla, an Indian pharmaceutical company, made headlines last week when Dr. Yusuf K. Hamied, the chairman of Cipla of Bombay, announced that the company was nearly ready to begin production of a generic version of Tamiflu, Roche’s popular influenza medication.  The Roche drug is reportedly protected by patents in India (and elsewhere).  The clincher for this story — Dr. Hamied says Cipla will make the drug despite any patent concerns.

(stories here, here, and here)

Indian drug companies have been making knock-off versions of patented medicines for decades.  So why is this story such a big deal?

Timing.  It’s everything.

The current flu scare comes just 10 months after the effective date for changes made to Indian patent law to allow patents to cover pharmaceutical compositions.  The Indian system changed dramatically on January 1, 2005, and many industrial sectors were not pleased with the changes — especially the generic drug manufacturing sector of the pharmaceutical industry.  After all, these companies grew by legally making knock-offs, and the new patent system begins to put an end to that practice.

And now comes H5N1, the avian flu strain responsible for the current scare.  Conveniently, the current scare provides a worldwide stage for the generic drug manufacturers to reassert their agenda that met defeat during debate surrounding the January changes to the law.

I didn’t expect this to come so quickly after the changes were put in place, but the tipping point may be here for the Indian patent system.

Having the right laws on the books is one thing.  Industry and governmental behavior under those laws is quite another.  How is the Indian pharmaceutical industry going to behave in light of the new laws?  How is the government going to respond to the industry’s behavior?

Take this example — Roche apparently filed a patent application for the flu medication about two months after India began accepting applications under what is called the “mail box rule,” which allowed companies to secure priority dates after January 1, 1995 even though the respective applications could not be examined until this year (when the final TRIPs amendments were made to Indian law).  This New York Times article reports that Dr. Hamied said that he thought the Indian government would be unlikely to fight over a 10–year-old difference of two months.

If deadlines are not respected in the law, they are meaningless.  Dates are everything, especially in patent law.  It doesn’t matter if it’s two months or two days – Roche apparently did what it had to do, under the law, to secure its patent rights.

Here’s another twist on this story.  Indian patent law allows for compulsory licenses under certain circumstances.  It even allows drug manufacturers to sell drugs made under such a license to underdeveloped countries that meet certain undefined criteria and that have also granted such a license.  Theoretically, if an Indian company secures the proper Indian compulsory license, it could legally make a generic version of a drug in India and supply it to India and other underdeveloped countries.

Interestingly, the news stories out thus far make no mention of an application for a compulsory license to manufacture Tamiflu.  Is Cipla simply going to ignore the patent and manufacture a knock-off?

The Indian system is indeed at a fork in the road.  It’s only been 10 months since the final TRIPs changes were put in place, but, nevertheless, it is time for India to determine its patent fate.

Here are a few tipping point questions I have:

• Will the Indian generic manufacturers play by the new rules and respect the Roche patent?
• If they do wish to manufacture a generic drug, will they seek to do so legally (i.e., apply for a compulsory license)?
• If an application for compulsory license is made, what standard will emerge?
• If they don’t apply for a compulsory license and simply begin manufacturing the drug, how will the Indian system respond?
• If Roche has to use the Indian court system to enforce its rights, how will the Indian court handle such a high profile case?  How will it apply the new laws?
• What price, if any, will the generic manufacturers have to pay for ignoring the new rules, if indeed they do?

The most interesting questions to me are these — if the generic manufacturers are allowed to manufacture a knock-off and disregard Roche’s patent rights and the compulsory license provisions altogether, without significant ramifications, how will the global pharmaceutical industry treat India – the country –  in the future?  Will pioneering drug companies begin to see the recent changes to the law much like the generic manufacturers apparently do – meaningless?

That’s a multi-billion dollar question…and only time will tell.

Well, that didn’t take long.  On the heels of Brazil’s successful threat to assert TRIPs-backed compulsory licenses for popular AIDS drugs, many people are now claiming that the avian flu scare might warrant the issuance of compulsory licenses:

 “It makes sense to do something along the lines of what was done with AIDS drugs.” – Ira Longini, Emory University professor (avian flu pandemic modeling)

“If patents are in the way, the WHO should ask the manufacturing country to issue the appropriate compulsory licenses. The patent owner will receive royalties, but we will have the stockpiles.” – James love, director of the Consumer Project on Technology in Washington

Roche, the rights-holder for the drug at issue, Tamiflu, isn’t budging just yet:

“Roche … fully intends to remain the sole manufacturer of Tamiflu.” – company spokesman Terry Hurley.

Compulsory licenses under TRIPs, which have yet to be issued or tested, are certainly a controversial issue in intellectual property and health policy, and stand to become even more so as medicine advances and disease continues to affect people around the globe.  When these difficult issues are addressed, it will be essential to keep politics in the background to allow proper focus on the complex legal and scientific issues at hand.

All quotes are from this article.

My good friends at LexThink, Matt Homann and Dennis Kennedy, are at it again.  They’re applying their LexThink model of the re-imagined conference* to legal blogging.

The result — BlawgThink! 2005.

Have a legal blog and want to learn more about blogging and the blogosphere?  Want to learn how to do more with your legal blog?  Just have a general interest in legal blogs and want to learn more about them?

If you’ve answered yes to any of these questions, mark BlawgThink on your calendar for November 11 and 12, 2005.

Matt and Dennis have assembled a great list of leading legal bloggers that will speak on a variety of topics ranging from the basics to advanced material.

There will be plenty of real world applications too…the Rethink(IP) team will speak on collaboration and group blogging.

You can contact Matt and Dennis here to request an invite.  Also, as speakers, Steve, Doug and I have a number of invites to give out….we’d love to have some of our readers in attendance.  You can contact me by e-mail here.

* If you’re wondering about the “re-imagined conference” and what it means or what it’s good for, read the LexThink description here and then read my recent Law Practice Today article on improving customer service by professional service providers…this article is a direct result of the creative thinking that occurred at the inaugural LexThink last year, which focused on improving professional practices.

Brazil has been the focus of a fair bit of intellectual property drama in recent months.  The Brazilian government has done quite a bit of saber-rattling lately on intellectual property issues, using its willingness to violate intellectual property rights as a sword in its international policy efforts.

A major development that appears to represent an end to some of the drama was announced yesterday. 

Before tackling that, though, it helps to review a little history.  Several recent acts by the Brazilian government have placed it in the IP hot seat:

• earlier this year, government officials threatened to invoke the compulsory licensing provisions of the TRIPs agreement to break the patents of several US companies on drugs the country distributes to AIDS patients for free.
• officials threatened to “suspend” the intellectual property rights of all American products if the US government didn’t address a WTO deadline to change its cotton subsidy practices.
• Brazil is leading an opposition charge in WIPO against the patent law harmonization agenda of the United States, Japan, and some European countries while attempting to advance its own development agenda in that organization.

Yesterday, a deal was announced between the Brazilian government and Abbott Laboratories that requires the drug maker to cut the price of Kaletra, the company’s popular protease inhibitor and AIDS treatment, nearly in half.  Abbott claims that the deal is a success for the company, a difficult position to defend in light of earlier claims that the company was selling Kaletra for a loss at the pre-discount price.  Perhaps Abbott sees the deal as a success because it successfully avoided a patent battle with the country that would likely have resulted in a dispute over the meaning of the language of the compulsory licensing provisions of TRIPs which, to date, has not been defined or tested.  Perhaps even the US government sees that result as a success.

Is this really an end to the drama, though?  I don’t think so.  I think it more resembles a beginning.

The threats by Brazil to violate intellectual property rights is a bold an unprecedented use of intellectual property in international policy.  The United States, of course, uses intellectual property in its policy efforts — seeking better protections for rights-holders based in the country — all the time.  But Brazil has done the opposite –– using its willingness to ignore intellectual property rights to accomplish its policy objectives.

And it succeeded. Abbott cut its price in half in response to the threats.

The country is also negotiating with Merck and Gilead Sciences over the price of their AIDS drugs.  What deal will these companies strike with Brazil?  What will happen two years from now when Brazil needs higher volumes of the medicines?

This issue will grow in importance for the medical-related industries considering the language of the TRIPs agreement and the WTO Doha Declaration in particular.  Brazil and other countries are likely to be emboldened by the Abbott deal.  When will Brazil or another country raise the TRIPs medical-emergency sword again?  Hard to predict, of course, but considering the success Brazil had in the Abbott deal, one thing is certain — it will happen.

But its not just the medical industries that should be interested in this issue.  Remember that Brazil also threatened to suspend the intellectual property rights of all American products in an effort to force the United States to take action on a WTO dispute over cotton subsidies, of all things.  This action was quite likely a simple posturing move, but it also provides clear evidence of the Brazilian government’s willingness to use the active violation of intellectual property rights as a sword.  And this threat was made before the Abbott deal.

All companies with investment and/or customers in Brazil, or thoughts of making such investments or building such a customer base, should carefully consider these actions of Brazil and keep a close eye on its actions in the future.

The House Subcommittee on Courts, the Internet, and Intellectual Property has scheduled an oversight hearing, Improving Federal Court Adjudication of Patent Cases, for Thursday, October 6, 2005 at 4:30 PM Eastern.

Is this a patent reform hearing?

Little information is available at this time — there is no agenda or witness list available yet.  If it is a reform hearing, it’s probably safe to guess that the hearing will focus on the proposed litigation-based reforms, including elimination of the best mode requirement, modification and/or elimination of willfulness, and changes to the standard and process for inequitable conduct.

Considering the content of the draft amendment and the Coalition Print and the discussion from the last hearing, apportionment of damages may also be discussed.

I’ll post more as information becomes available.

You can view a live webcast of the hearing here.