navigating the patent maze

Several pharmaceutical companies (Abbott, Merck, and Gilead Science) have apparently received a letter from the Health Minister of Brazil, Humberto Costa, giving them 21 days to grant a voluntary license for the productions of some anti-retroviral drugs.  If the companies aren’t forthcoming, the Brazilian Government is set to grant licenses under a compulsary licensing mechanism. 

(From a newsletter sent by Daniel Advogados as reported in the newpaper O GLOBO). 

In November 2004, I reported the conclusion of a long running dispute in the U.S. Patent Office on who first invented Agrobacterium-mediated transformation technology (previous post).  A few weeks ago, a joint press release from Bayer CropScience, Max Planck Society, and Monsanto announced that the interference ended by settlement among these parties.  Under the agreement, the organizations will cross-license their respective Agrobacterium-mediated transformation technologies; Bayer (the exclusive licensee of Max Planck’s technology) and Monsanto will provide each other non-exclusive licenses related to R&D and sale of transgenic crops; Monsanto will give Max Planck a license in the U.S. for research purposes.  No other details of the agreement are disclosed.

The chutzpah of the parties is revealed. 

From Bayer CropScience:  "This agreement secures freedom for the involved parties in the field of Agrobacterium-mediated transformation technology, thereby ensuring present and future market access for their respective technologies in the United States and Canada,"

From Monsanto:  "This is a positive development for agricultural biotechnology as a whole. This agreement enables their [MaxPlanck and Monsanto] respective agricultural innovations to reach consumers and farmers without hindrance."

If the technology is not licensed to anyone else - neither of these companies is known to widely license technology - then they are able to effectively stifle other companies from entering the transgenic plant field.  Agrobacterium is the most widely used method for transforming plants; there are very few other means of transformation, only bombardment (owned by Cornell and licensed to duPont) is frequently used.  With luck new transformation technology developed at CAMBIA using non-Agrobacterium strains will break the stranglehold. 

When it comes to patentability, my working theory is "the most damaging prior art is your own."  It makes sense though - whose work is more like your own than your own?  Dr Crish fell victim this way and lost his chance for a patent as a result (In re Crish, Fed. Cir., No. 04-1075, 12/21/04). 

The patent application claimed purified DNA molecules having promoter activity for the human involucrin gene (hINV).  Involucrin is a protein that interacts with keratin along with other intracellular proteins to form a cross-linked structure within dead cells and strengthens the plasma membrane.  Skin cells, which are mostly dead cells, benefit from this.  The hINV promoter was sequenced from a plasmid that was the subject of an article authored by Dr Crish and others. 

Crish tried to distinguish the claims from the damaging effect of his publication first by asserting that the rejected claims did not encompass the whole plasmid, and second, by asserting that the publication did not disclose any nucleotide sequence of the promoter.  The Court did not buy either of these arguments because (1) the use of "comprising" in the claim language meant that the whole plasmid was encompassed by the claim, and (2) the sequence conferred indentification and characterization of a prior art material and "one cannot establish novelty by claiming a known material by its properties." 

The following shows how I think Crish could have successfully claimed the promoter sequence. 

(more…)

Like a good lawyer I’ll tell you that the answer "depends".  Depends on the country, depends on how long ago the patent issued, depends on the basis for the challenge. 

The United States has never had very good ways to challenge a patent unless you have lots of money and willing to take your chances in court.  Reexamination of the patent in the Patent Office has been available, is not costly, but was never really highly favored because the procedure basically excluded third parties after placing a request for reexam and also greatly favored the patent owner.  In an effort to correct the perceived imbalance, Congress amended the Patent Act in 1999 to allow greater participation of third parties in reexams; this new procedure is called inter partes reexaminations.  It was immediately clear that certain provisions of the law - especially the limitation of the requester to appeal the outcome - meant no patent lawyer would recommend the procedure.  Some of the problems in the law were fixed in amendments enacted by Congress in 2002, but not the provision limiting the scope of appeal by the third-party requester. 

Sure enough, the Patent Office’s report evaluating the reexamination proceedings confirm the sorry picture of a good idea enacted into bad law.  In a gross understatement of the problem, the report noted that "the number of [reexamination] filings did not increase at the rate anticipated.  Take a look at the chart below to see just how far off the mark of predicted use this procedure falls. 

After 5 years, the intra partes reexam had been used only a total of 53 times!!!!  Based on this dismal performance, the Patent Office solicited comments from the public and has now made 3 recommendations for improving the current system.  Let’s hope that Congress fixes it and gets it right, finally. 

In a summary of IP law updates from the Far East Committee of AIPLA, comes this unusual news item:  a recent Taiwan decision holds that the grant of a patent in Taiwan carries with it the right to practice the claims.  As published though, the patent statute of Taiwan grants exclusionary rights - thus, the court decision would seem to be at odds with statutory law. 

In the U.S. and most, if not all, other countries, the patent right is exclusionary, that is, the rights holder can exclude others from making, using, selling, etc. but has no rights to practice.  While newcomers to patent law may find exclusionary rights difficult to grasp, it actually makes really good sense. 

Consider this scenario:  Joe has a patent for expression vectors that can be used to transform plants; Sally has a patent claiming the method of transformation of plants using Agrobacterium containing vectors, such as Joe’s expression vectors.  In an exclusionary patent system, Joe needs permission (e.g., license) from Sally to transform plants with his vectors; Sally needs Joe’s permission to transform plants using Joe’s vectors.  Both inventors gain economic benefit this way.  (Critics of patent systems would contend that Sally could block Joe from practicing his invention, which is not a good thing in their view.) 

In a non-exclusionary system, I assume that it means either Joe or Sally can transform plants and moreover Sally could use Joe’s vectors.  While this is boon for Sally, and some would argue is not bad for Joe because under the exclusionary system he might be blocked, Joe does not appear to get any benefit from his patent.  To me, it appears to remove any incentive Joe - or Sally - has for patenting and becomes a world of compulsary licenses (with .  In a non-exclusionary system, is there even such a thing as infringement?  Does anyone know more about this seemingly confusing and confused situation in Taiwan?

Astute readers may remember that I’ve said this before.  Other legal bloggers will (hopefully) sympathize, knowing that do post an entry takes about 3-4 times the amount of reading plus typing time.  When I find an interesting item, I typically research it for accuracy, additional facts and info, and consider how it fits into the patent (and PBR or PVPC) world.  As another IP blogger said, "kiss those billable hours goodbye."  Well, yes, he was right - I will attest to it. 

During my absence of the last month, I have finally finished assembling and launching my work web site:  Cougar Patent Law.  For a non-web designer and HTML language neophyte, this task, while made easier by the purchase of the template, still took an inordinate amount of time.  Additionally, my economist mate (we are both Aussies in fact) rose to the level of my "worst nightmare" and enlisted my assistance in drafting a chapter for an economics handbook.  All I can say to him is payback is a b—-.  On top of this, I got a request to help an agency pro bono - through PIIPA (link on sidebar).  Lucky for me, the issue was quite easy to research and answer.  Needless to say, my work-related reading has suffered in the last month or so. 

While these are reasons for the dearth of posts, they are not excuses.  I have caught up a bit on reading, formed some ideas for posts, and ready to get going again.  Meanwhile, I hope that I haven’t lost too many readers.  Cheers to all.

P.S. For you Mac users out there, I have fixed the post "About Me" so it doesn’t look like gibberish to you.  Please let me know if there is still a problem.