Thanks bengster for your reply. I admire your optimism about BIG .. but I must say I am abit concerned about this whole patent issue. I don’t think it is a case of JNJ unable to sue BIG for patent infringement … but I would rather think that BIG is probably not a major threat to JNJ at the moment. It is loss making and only starting to make in roads to Asia. Besides, JNJ perhaps feel that by using its patent threat later, it could get BIG to submit to them in case of a takeover. Off course, this is still my desired wish for BIG ….. to be taken over at the Target Price that we are all dreaming about. I am including several articles here to show you why this is serious…

<< Mar 12 2008, Wyeth, J&J Sue Medtronic Over Stent Patents

Less than a month after the FDA approved Medtronic’s Endeavor drug-eluting stent, both Wyeth and Johnson & Johnson (J&J) filed suit over the product. The companies filed a patent infringement suit in the U.S. District Court for the District of New Jersey last month alleging the zotarolimus-eluting stent infringes on the claims of three patents owned by Wyeth and licensed to J&J — the ’781, ’146 and ’728 patents. These patents relate to the use of rapamycin, or sirolimus, and its analogues — including zotarolimus. The ’781 patent describes a method of treating restenosis in humans undergoing a percutaneous transluminal angioplasty procedure with an effective amount of rapamycin. The ’146 and ’728 patents both describe a method of preventing or treating hyperproliferative vascular disease by administering rapamycin. This lawsuit may not threaten Medtronic’s stent profits immediately. RBC Capital Markets analysts predicted the case “will probably take many years to work its way through the federal court system.” The plaintiffs have asked the court to enjoin Medtronic from selling the stent in the U.S. While injunction requests are standard in such cases, they are rarely granted, RBC said. >> I am including the first claims from patent ‘781 (issued in the 1996), which is owned by Wyeth, for easy reference… What is claimed is:

1. A method of treating restenosis in a mammal resulting from said mammal undergoing a percutaneous transluminal coronary angioplasty procedure which comprises administering an antirestenosis effective amount of rapamycin to said mammal orally, parenterally, intravascularly, intranasally, intrabronchially, transdermally, rectally, or via a vascular stent impregnated with rapamycin.

<<Nov 2007, J&J sues Abbott to block new stent

Apparently, Johnson & Johnson didn't want to wait and see what the FDA's expert advisors think of Abbott Laboratories' Xience stent. The company filed suit against Abbott for patent infringement instead. It's the fourth time this year that J&J has gone after Abbott in court in an attempt to keep Xience off the market. The new suit claims that Xience tramples on a patent for the use of rapamycin and related meds on stents. Rapamycin is the drug that coats J&J's Cypher stent; Xience uses everolimus, which J&J claims is a related drug. The suit was filed Tuesday, the same day J&J's Cordis unit got the patent in question.>> I am including the claims from the Wright family (issued in 2003 but related to this 2007 patent above) of patent owned by Cordis.. What is claimed is:

1. A stent having a coating containing rapamycin, said coating formed from a polymer mixed carrier containing the rapamycin; and said coating applied to said stent.
4. A stent having a coating containing rapamycin or its analogs, wherein said rapamycin or said analogs are contained in the coating at a weight percentage of 0.0001% to 30%.
5. The stent of claim 4 wherein a polymer is mixed to the rapamycin or its analogs.
6. The stent of claim 4 wherein a polymer is bound to the rapamycin or its analogs.

Note that these two patent above are all granted before BIG’s key patent. As you can see from the highlighted parts above, the claims are so broad that it covers all the analogs of Rapamycin. Biolimus is also an analog of Rapamycin. Most of the known stents (Taxus, Xience, Endeavour) today appears to be using a Rapamycin derivative on polymer (permanent or biodegradable). That is why I said earlier that this case between JNJ and Abbott is monumental to BIG. Of course I also did some homework to see if there could be some exceptions in all these patent lawsuits that might be in favour of BIG if they get sued. The following case is interesting and relevant. Hope this case gets cited in future litigation proceedings..!!

Taken from

 http://www.aipla.org/Template.cfm?Section=Committee_Reports&template=/ContentManagement/ContentDisplay.cfm&ContentID=5433 <<In American Home Products, et al v. Novartis, [2000] RPC 547, claimed a new use for rapamycin, a known antifungal antibiotic, as an immunosuppressant.  The claim was written in second medical use format and recited “use of rapamycin for the preparation for a medicament for inhibiting organ or tissue transplant rejection in a mammal in need thereof.”  In the specification, the invention was described as including the use of natural and synthetic rapamycin, genetically engineered rapamycin and all of its derivatives and prodrugs of rapamycin. At issue during litigation was whether the claim covered the defendants compounds, which was a derivative of rapamycin and if so whether the patent was invalid as lacking a sufficient disclosure for the scope of the claimed compounds.  A third issue was whether there is a distinction between ordinary claims and “second medical use” claims.  The patent was ultimately held to be valid with sufficient disclosure as to the rapamycin compound.  However, the court rejected arguments that the claims covered all rapamycin derivatives and therefore no infringement was found. In conclusion, overbroad claims should be avoided and participation from chemists, biologists and molecular modelers could be helpful in formulating claims that cover the broadest possible scope that is scientifically supportable based on established structure/activity relationships that can be used as a basis for rational prediction.  Further, it is important to claim the disclosed compounds individually as well as within the genus because the claims to the individual compounds may be the only valid claims.>>

Note that the patent above claimed (mainly in the specification part) the use of derivatives/analogs … but their claims were seen as too broad and not specific. Also analogs that have not been created yet cannot be claimed. The District court in Hague ruled in favour of Novartis. So this is why I said we have to keep our fingers crossed. Hope Abbott wins the case above. I am in favour of an open competition between stent companies without all these patent litigations. BIG shall prevail with its superior technology..

Thats what Terumo did. They use NOBORI (biomatrix) as the leading product to sell their own in-house delivery system. Can make $ on 2 medical devices at one go as both are used together during the angioplasty ops. STJ tried to get into the DES market but failed. They signed exclusive distributorship for Conor's Costar DES in many countries but Costar DES flopped clinical trials. BIG should approach a "virgin" to DES program to license Biomatrix to avoid political problems with the licensee company.  

Approaching older DES players like JNJ, BSX, MDT or ABT for licensing of Biomatrix USA market will face many political problems with the MNC company itself. These MNCs will ask their Chief DES Technology Scientists to evaluate Biomatrix and Biomatrix will not be able to cross that politics hurdle. If the Chief DES Scientist say Biomatrix is the best he has seen so far, then the CEO will ask him way is he burning so much money on their own programs and cannot come out with something better? How come you didn't spend enough on R&D on biodegradable polymer? How come an unknown company can have a much better drug like BiolimusA9? WTF have you been doing all these years R&Ding on some inferior DES we are having now? These are very real internal politics problems BIG will face if they look for existing DES major players for USA licensing.           

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Taken from recent Annual Report of Abbott..

 

CASE 1 – Medtronic sues Abbott

 

A case is pending in the U.S. District Court for the Northern District of California in which Medtronic Vascular, Inc., Medtronic USA, Inc., and Medtronic Vascular Galway, Ltd. (collectively Medtronic) and Evysio Medical Devices ULC(Evysio) claim that Abbott's Multi-Link Vision®, Multi-Link Penta™, Multi-Link Zeta®, and Xience V™ Coronary stent systems infringe certain Evysio stent design patents. Medtronic and Evysio seek damages, an injunction, and other relief. Abbott has filed its response denying the infringement claims and asserting that the patents are invalid and/or unenforceable. Evysio has also brought lawsuits in France, Ireland (in which Medtronic is also a plaintiff) and Germany claiming that the Multi-Link Vision, Multi-Link Penta, and/or Xience V infringe the European counterparts of these patents. In France, a court enjoined the launch of the Xience V stent as designed as of 2006. Abbott appealed this decision and filed responses in each of these European courts denying the infringement claims and asserting that the patents are invalid. In the United Kingdom, Abbott filed an action seeking a declaration that its stents do not infringe Evysio's patents and that the patents are invalid. Evysio filed a counterclaim that accuses Abbott's stents of infringement and seeks a declaration of validity.

 

CASE 2 – Abbott sues Medtronic

 

A case is pending in the U.S. District Court for Delaware brought by Advanced Cardiovascular Systems, Inc., now an Abbott subsidiary, against Arterial Vascular Engineering, Inc. (now known as Medtronic Vascular, Inc.) alleging that certain models of Medtronic's stents infringe four of Abbott's Lau patents, and seeking injunctive relief and damages. The court bifurcated the issues of liability and damages. In February 2005, a jury found that Abbott's Lau patents were valid and infringed by all of the Medtronic stents in question, including its Driver® coronary stent. The court denied Medtronic's post-trial motions asking the court to enter a judgment in Medtronic's favor and/or for a new trial. In June 2005, the court held a hearing on Medtronic's claim that Abbott's patents are unenforceable. The court rejected Medtronic's claims of inequitable conduct. In June 2007, Abbott filed a motion seeking to enjoin Medtronic from infringing activities relating to their stent designs, and Medtronic filed a motion to stay proceedings related to the injunction. Medtronic's motion to stay was denied with respect to the named bare metal stents, and was granted with respect to the Endeavor stent pending further determinations.

 

CASE 3 – JNJ sues Abbott

 

A case is pending in the U.S. District Court for New Jersey brought by Johnson & Johnson, Inc. and Cordis Corporation, a wholly owned subsidiary of Johnson & Johnson, (collectively Johnson & Johnson) against Abbott, in which Johnson & Johnson asserts infringement of certain of Johnson & Johnson's patents by Abbott's Xience V stent, and seeks an injunction, an award of damages, and a determination of willful infringement. The previously reported cases in the U.S. District Court of Delaware were dismissed after Johnson & Johnson's granting of a covenant not to sue Abbott with respect to certain other patents held by Johnson & Johnson. In January 2008, Cordis Corporation and Wyeth filed suit in New Jersey accusing the Xience V stent of infringement of three additional patents. Abbott denies all substantive allegations.

 

These are the three current legal cases involving Abbott, which are related to stents. It seems to me that this whole stent market is super complex and super litigious. Really not for the faint hearted investors :-). And BIG has to be extra cautious and tread the waters carefully. Just last year alone, JNJ tried to sue Abbott about 4 times. I find that case 3 above is the most serious one to Abbott. It could also affect BIG if the court rules in favour of JNJ. Actually, JNJ can already sue BIG for patent infringement judging on case 3. So don’t play play and say that BIG can sue JNJ for biodegradable polymer stent so easily. They can just turn around and sue BIG as well for infringement of their Wright family of patents!. I feel that the first two cases could cancel out each other.. if both parties agree. And this type of canceling out is what BIG should strive for in the long term to stay alive..

 

It is very important that BIG builds up its portfolio of patents so that it can be used in counter suing cases. Maybe, BIG staying clear of US for now is really a good idea. Do not step on the Big Boy’s toes yet! Just look at all the lawsuits involving the 4 big players. Start off small first and in other parts of the world, especially Asia. If BIG is infringing on other patents, BIG might need to let the big boys use similar technologies that might infringe on BIG’s patents… so that BIG could use them to cancel out lawsuits. I feel that the outcome of case 3 above is really monumental to BIG. So lets keep our fingers crossed…   

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One day you say you invest in BIG unlike "HappyDay", now you admit you're HE/SHE or HESHE liao! Shorting & making a lot...

In fact ALL FORUMERS & not only Newbies -- PLEASE BEWARE OF HIS POSTS. CERTAINLY NO INTEGRITY.

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apologise for the adv there....