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patent

With the issue of data exclusivity for novel biologics re-emerging in the news, I’d like to present two arguments that will be published in the upcoming issue of the Journal of Commercial Biotechnology:

Why data exclusivity is the new patent protection
Peter J Pitts, Center for medicine in the public interest

Follow-on biologic drug competition – No need for new marketing exclusivities
Michael S Wroblewski(a) and Elizabeth A Jex(b)
a) Office of Policy Planning, Federal Trade Commission
b) FTC Office of Policy Planning

Novartis cancels Indian investments over patent dispute

Novartis cancels Indian investments over patent dispute
Source: Building Biotechnology

In 2005 India mostly strengthened their patent laws to meet international norms, with the distinct requirement that new drug products must “differ significantly in properties with regard to efficacy.” This requirement for a significant improvement in efficacy only applies to drugs — not to other patentable inventions like pens, car engines, etc., and is of concern for drug companies seeking to protect their inventions in India.

In 2007, Novartis received a first-hand demonstration of the limitations of patents under these new rules. They failed to receive patent protection for Glivec (sold as Gleevec in the U.S.). In response, Novartis opted to redirect hundreds of millions of dollars of R&D to other countries — essentially voting with their feet.

A recent partnership between Merck and India’s Nicholas Piramal (NPIL), potentially worth more than $300mm, suggests that Merck is unfazed. In this partnership, NPIL is responsible for essentially the entire drug discovery chain, from candidate identification through pre-clinical and early-stage clinical trials.So, one may ask the question: Have Novartis’ experiences affected other companies, and is Novartis actually redirecting their investments?

Pfizer is also investing strongly in India, announcing their intentions to develop drugs for conditions endemic to India.

Novartis, on the other hand, is keeping their word. Whie they did recently announce plans to dramatically increase the headcount at their India Development Centre, the company reiterated that these were not R&D jobs: “This is not a high-end work and the nature of job is similar to business process outsourcing. We will think of doing high-end R&D work in India only when the patent laws are made totally compatible with WTO norms”

So it appears that Novartis isn’t influencing the activities of others. The question remains: who will bend first? Novartis or the Indian Government?

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in November 2008

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent NumberPatent Expiration
ALKERANGlaxosmithklinemelphalan hydrochloride4,997,651Nov 18, 2008
BREVIBLOCBaxter Hlthcare Corpesmolol hydrochloride5,017,609Nov 21, 2008
BUSPARBristol Myers Squibbbuspirone hydrochloride5,015,646Nov 14, 2008
COVERA-HSGd Searle Llcverapamil hydrochloride5,030,456Nov 7, 2008
DYNACIRC CRSmithkline Beechamisradipine5,030,456Nov 7, 2008
NEUROLITELantheus Medcltechnetium tc-99m bicisate kit5,279,811Nov 23, 2008
NEURONTINParke Davisgabapentin4,894,476Nov 2, 2008
NEURONTINPfizer Pharmsgabapentin4,894,476Nov 2, 2008
NUVIGILCephalonarmodafinil4,927,855Nov 22, 2008
PRELAYSankyotroglitazone4,572,912Nov 9, 2008
REZULINPfizer Pharmstroglitazone4,572,912Nov 9, 2008

Courtesy of DrugPatentWatch.com

Guest content from John Avellanet, managing director and principal of Cerulean Associates:

Intellectual Property Theft on the Rise

John Avellanet

By John Avellanet, Managing Director and Principal of Cerulean Associates LLC

Reprinted with permission from SMARTERCOMPLIANCE™ 2(9): p 1-2 (September 2008)

Nine out of ten companies do not have appropriate policies and controls in place to stop employees, contractors or partners from walking out the door with intellectual property and trade secrets.

For those of us who’ve spent much of our careers helping prevent corporate espionage, the July report by the not-for-profit IT Policy Compliance consortium comes as little surprise.

Protecting Information

Passwords and patents do not make your company’s information and discoveries any more secure than locks and labels make your home and its belongings safe from theft.

Carnegie Mellon University’s CERT research think tank has followed information theft for decades and has come to two eye-opening conclusions:

  • · Most confidential information theft comes from people you know—employees, contractors, suppliers or even partners (especially for co-developed products); and
  • · More than 30% of this type of theft comes from people working in your computer department (IT/ICT).

Given all the security efforts around stopping outsiders when the real risk lies within, is it any wonder that 90% of businesses do not have any way to stop—much less even detect—intellectual property (IP) and trade secret theft?

Improving Your Chances

Before we even get down to work on reasonable trade secret controls, I give my clients a brief set of “yes/no” questions to answer on their own.

These questions are straightforward and easily answered in less than 30 minutes. For instance, “Do you have a ‘clean desk’ policy for sensitive or confidential information?”

The goal of these questions is to help my clients quickly outline their weaknesses—and their strengths. In this way, we can quickly shift into discussing solutions.

And while many executives need the more detailed audit with its prioritized recommendations, keep in mind that a half-dozen quick-fixes implemented now can stop today’s disgruntled employee or frustrated contractor from sabotaging your work.

Two Quick Fixes to Take Today

Ask yourself, What documented proof do we have that our policies are being followed?

For instance, a typical “clear desk” policy requires personnel to clear their desk and office area of confidential information before they leave for the day, locking it in a file cabinet, turning it back over to the document specialist for filing and so on.

When companies state they do this, my reaction is always to be skeptical. How do you know this is actually being followed?

If your people turn sensitive material over to an archivist, that individual should have log files that can be reviewed.

However, what proof do you have that people are clearing their desk and securing their office area?

A simple way to test this is to simply stay late one evening and walk around, from cubicle to cubicle, office to office. How many documents do you see labeled “confidential” or “private” or “trade secret” sitting out? How many documents do you quickly recognize that should be labeled “confidential” or “trade secret” (such as product drawings or formulations) but that aren’t labeled and aren’t put away?

Then, take the next step. Ask your internal auditors (or hire an outside independent auditor) to include this in their regular audit routine. Assuming no other extenuating circumstances, I usually suggest my clients audit this once or twice a year (perhaps more for habitual “offender” departments).

Final Thoughts

I’ve made a free version of my intellectual property and trade secret security checklist available for download. You can use this to quickly assess your strengths and opportunities for improvement.

You can get your free PDF copy here: http://www.ceruleanllc.com/biotechblog

Are you ready?

About the Author

John Avellanet is a former Fortune 50 subsidiary C-level medical device and biotechnology executive where he created, developed and ran his firm’s Records Management and IT departments, and was directly accountable for trade secret protection. In 2006, he founded his independent consulting firm, Cerulean Associates LLC (www.ceruleanllc.com) and has since become one of the leading experts on trade secret and corporate espionage protection for biotech, pharmaceutical and device companies.

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in October2008

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent NumberPatent Expiration
CASODEXAstrazenecabicalutamide4,636,505Oct 1, 2008
CONDYLOXWatson Pharmspodofilox5,057,616Oct 15, 2008
COSOPTMerckdorzolamide hydrochloride; timolol maleate4,797,413Oct 28, 2008
ELIGARDQlt Usaleuprolide acetate4,938,763Oct 3, 2008
ELIGARDQlt Usaleuprolide acetate5,733,950Oct 3, 2008
ELIGARDQlt Usaleuprolide acetate5,739,176Oct 3, 2008
ELIGARDQlt Usaleuprolide acetateRE37950Oct 3, 2008
FERIDEX I.V.Amag Pharms Incferumoxides5,055,288Oct 8, 2008
GASTROMARKAmag Pharms Incferumoxsil5,055,288Oct 8, 2008
IONSYSAlzafentanyl hydrochloride5,232,438Oct 3, 2008
MIRCETTEDurameddesogestrel; ethinyl estradiolRE35724Oct 20, 2008
TRUSOPTMerckdorzolamide hydrochloride4,797,413Oct 28, 2008
ZEMURONOrganon Usa Incrocuronium bromide4,894,369Oct 13, 2008

Courtesy of DrugPatentWatch.com

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in September 2008

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent NumberPatent Expiration
ANDRODERMWatson Labstestosterone4,855,294Sep 6, 2008
AVITAMylan Bertektretinoin5,045,317Sep 3, 2008
DDAVPSanofi Aventis Usdesmopressin acetate5,047,398Sep 10, 2008
OPANA EREndo Pharmsoxymorphone hydrochloride5,128,143Sep 19, 2008
RESCULAR Tech Ueno Ltdunoprostone isopropyl5,001,153Sep 19, 2008

Courtesy of DrugPatentWatch.com

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in August 2008

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent NumberPatent Expiration
ADVAIR DISKUS 100/50Glaxosmithklinefluticasone propionate; salmeterol xinafoate4,992,474Aug 12, 2008
ADVAIR DISKUS 100/50Glaxosmithklinefluticasone propionate; salmeterol xinafoate5,126,375Aug 12, 2008
ADVAIR DISKUS 100/50Glaxosmithklinefluticasone propionate; salmeterol xinafoate5,225,445Aug 12, 2008
ADVAIR DISKUS 250/50Glaxosmithklinefluticasone propionate; salmeterol xinafoate4,992,474Aug 12, 2008
ADVAIR DISKUS 250/50Glaxosmithklinefluticasone propionate; salmeterol xinafoate5,126,375Aug 12, 2008
ADVAIR DISKUS 250/50Glaxosmithklinefluticasone propionate; salmeterol xinafoate5,225,445Aug 12, 2008
ADVAIR DISKUS 500/50Glaxosmithklinefluticasone propionate; salmeterol xinafoate4,992,474Aug 12, 2008
ADVAIR DISKUS 500/50Glaxosmithklinefluticasone propionate; salmeterol xinafoate5,126,375Aug 12, 2008
ADVAIR DISKUS 500/50Glaxosmithklinefluticasone propionate; salmeterol xinafoate5,225,445Aug 12, 2008
ADVAIR HFAGlaxosmithklinefluticasone propionate; salmeterol xinafoate4,992,474Aug 12, 2008
ADVAIR HFAGlaxosmithklinefluticasone propionate; salmeterol xinafoate5,126,375Aug 12, 2008
ADVAIR HFAGlaxosmithklinefluticasone propionate; salmeterol xinafoate5,225,445Aug 12, 2008
ETOPOPHOS PRESERVATIVE FREEBristol Myers Squibbetoposide phosphate5,041,424Aug 20, 2008
HECTOROLGenzymedoxercalciferol5,861,386Aug 2, 2008
HECTOROLGenzymedoxercalciferol5,869,473Aug 2, 2008
IMPLANONOrganon Usa Incetonogestrel4,957,119Aug 5, 2008
SEREVENTGlaxo Grp Ltdsalmeterol xinafoate4,992,474Aug 12, 2008
SEREVENTGlaxo Grp Ltdsalmeterol xinafoate5,126,375Aug 12, 2008
SEREVENTGlaxo Grp Ltdsalmeterol xinafoate5,225,445Aug 12, 2008
SEREVENTGlaxosmithklinesalmeterol xinafoate4,992,474Aug 12, 2008
SEREVENTGlaxosmithklinesalmeterol xinafoate5,126,375Aug 12, 2008
SEREVENTGlaxosmithklinesalmeterol xinafoate5,225,445Aug 12, 2008
TREXIMETGlaxosmithklinenaproxen sodium; sumatriptan succinate5,037,845Aug 6, 2008

Courtesy of DrugPatentWatch.com

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in July 2008

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent NumberPatent Expiration
CARDIOLITEBristol Myers Squibbtechnetium tc-99m sestamibi kit4,988,827Jul 29, 2008
DEPAKOTEAbbottdivalproex sodium4,988,731Jul 29, 2008
DEPAKOTEAbbottdivalproex sodium5,212,326Jul 29, 2008
DEPAKOTE CPAbbottdivalproex sodium4,988,731Jul 29, 2008
DEPAKOTE CPAbbottdivalproex sodium5,212,326Jul 29, 2008
DEPAKOTE ERAbbottdivalproex sodium4,988,731Jul 29, 2008
DEPAKOTE ERAbbottdivalproex sodium5,212,326Jul 29, 2008
GLUCOTROL XLPfizerglipizide5,545,413Jul 2, 2008
HIVIDRochezalcitabine5,028,595Jul 2, 2008
RESTORILTyco Hlthcaretemazepam5,030,632Jul 9, 2008
RESTORILTyco Hlthcaretemazepam5,326,758Jul 9, 2008
UVADEXTherakosmethoxsalen5,036,102Jul 30, 2008
VEXOLAlconrimexolone4,686,214Jul 22, 2008

Courtesy of DrugPatentWatch.com

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in June 2008

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent NumberPatent Expiration
ADALAT CCBayer Pharmsnifedipine4,892,741Jun 8, 2008
CAVERJECT IMPULSEPharmacia And Upjohnalprostadil4,968,299Jun 28, 2008
EFFEXORWyeth Pharms Incvenlafaxine hydrochloride4,535,186Jun 13, 2008
EFFEXOR XRWyeth Pharms Incvenlafaxine hydrochloride4,535,186Jun 13, 2008
GENOTROPINPharmacia And Upjohnsomatropin recombinant4,968,299Jun 28, 2008
GENOTROPIN PRESERVATIVE FREEPharmacia And Upjohnsomatropin recombinant4,968,299Jun 28, 2008
NICODERM CQSanofi Aventis Usnicotine5,004,610Jun 14, 2008
NICODERM CQSanofi Aventis Usnicotine5,342,623Jun 14, 2008
NICODERM CQSanofi Aventis Usnicotine5,344,656Jun 14, 2008
NICODERM CQSanofi Aventis Usnicotine5,364,630Jun 14, 2008
NICODERM CQSanofi Aventis Usnicotine5,462,745Jun 14, 2008
NICODERM CQSanofi Aventis Usnicotine5,633,008Jun 14, 2008
NICODERM CQSanofi Aventis Usnicotine6,165,497Jun 14, 2008
PREVACIDTap Pharmlansoprazole5,026,560Jun 25, 2008
RISPERDALJanssen Pharmarisperidone4,804,663Jun 29, 2008
RISPERDAL CONSTAJanssen Pharmarisperidone4,804,663Jun 29, 2008
SONATAKing Pharmszaleplon4,626,538Jun 6, 2008
SULARSciele Pharma Incnisoldipine4,892,741Jun 8, 2008
TESTIMAuxilium Pharmstestosterone5,023,252Jun 11, 2008

Courtesy of DrugPatentWatch.com