Tags Posts tagged with "patent"

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

Tradename Applicant Generic Name Patent Number Patent Expiration
ALKERAN Glaxosmithkline melphalan hydrochloride 4,997,651 Nov 18, 2008
BREVIBLOC Baxter Hlthcare Corp esmolol hydrochloride 5,017,609 Nov 21, 2008
BUSPAR Bristol Myers Squibb buspirone hydrochloride 5,015,646 Nov 14, 2008
COVERA-HS Gd Searle Llc verapamil hydrochloride 5,030,456 Nov 7, 2008
DYNACIRC CR Smithkline Beecham isradipine 5,030,456 Nov 7, 2008
NEUROLITE Lantheus Medcl technetium tc-99m bicisate kit 5,279,811 Nov 23, 2008
NEURONTIN Parke Davis gabapentin 4,894,476 Nov 2, 2008
NEURONTIN Pfizer Pharms gabapentin 4,894,476 Nov 2, 2008
NUVIGIL Cephalon armodafinil 4,927,855 Nov 22, 2008
PRELAY Sankyo troglitazone 4,572,912 Nov 9, 2008
REZULIN Pfizer Pharms troglitazone 4,572,912 Nov 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

Tradename Applicant Generic Name Patent Number Patent Expiration
CASODEX Astrazeneca bicalutamide 4,636,505 Oct 1, 2008
CONDYLOX Watson Pharms podofilox 5,057,616 Oct 15, 2008
COSOPT Merck dorzolamide hydrochloride; timolol maleate 4,797,413 Oct 28, 2008
ELIGARD Qlt Usa leuprolide acetate 4,938,763 Oct 3, 2008
ELIGARD Qlt Usa leuprolide acetate 5,733,950 Oct 3, 2008
ELIGARD Qlt Usa leuprolide acetate 5,739,176 Oct 3, 2008
ELIGARD Qlt Usa leuprolide acetate RE37950 Oct 3, 2008
FERIDEX I.V. Amag Pharms Inc ferumoxides 5,055,288 Oct 8, 2008
GASTROMARK Amag Pharms Inc ferumoxsil 5,055,288 Oct 8, 2008
IONSYS Alza fentanyl hydrochloride 5,232,438 Oct 3, 2008
MIRCETTE Duramed desogestrel; ethinyl estradiol RE35724 Oct 20, 2008
TRUSOPT Merck dorzolamide hydrochloride 4,797,413 Oct 28, 2008
ZEMURON Organon Usa Inc rocuronium bromide 4,894,369 Oct 13, 2008

Courtesy of DrugPatentWatch.com

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in September 2008

*Drugs may be covered by multiple patents

Tradename Applicant Generic Name Patent Number Patent Expiration
ANDRODERM Watson Labs testosterone 4,855,294 Sep 6, 2008
AVITA Mylan Bertek tretinoin 5,045,317 Sep 3, 2008
DDAVP Sanofi Aventis Us desmopressin acetate 5,047,398 Sep 10, 2008
OPANA ER Endo Pharms oxymorphone hydrochloride 5,128,143 Sep 19, 2008
RESCULA R Tech Ueno Ltd unoprostone isopropyl 5,001,153 Sep 19, 2008

Courtesy of DrugPatentWatch.com

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in August 2008

*Drugs may be covered by multiple patents

Tradename Applicant Generic Name Patent Number Patent Expiration
ADVAIR DISKUS 100/50 Glaxosmithkline fluticasone propionate; salmeterol xinafoate 4,992,474 Aug 12, 2008
ADVAIR DISKUS 100/50 Glaxosmithkline fluticasone propionate; salmeterol xinafoate 5,126,375 Aug 12, 2008
ADVAIR DISKUS 100/50 Glaxosmithkline fluticasone propionate; salmeterol xinafoate 5,225,445 Aug 12, 2008
ADVAIR DISKUS 250/50 Glaxosmithkline fluticasone propionate; salmeterol xinafoate 4,992,474 Aug 12, 2008
ADVAIR DISKUS 250/50 Glaxosmithkline fluticasone propionate; salmeterol xinafoate 5,126,375 Aug 12, 2008
ADVAIR DISKUS 250/50 Glaxosmithkline fluticasone propionate; salmeterol xinafoate 5,225,445 Aug 12, 2008
ADVAIR DISKUS 500/50 Glaxosmithkline fluticasone propionate; salmeterol xinafoate 4,992,474 Aug 12, 2008
ADVAIR DISKUS 500/50 Glaxosmithkline fluticasone propionate; salmeterol xinafoate 5,126,375 Aug 12, 2008
ADVAIR DISKUS 500/50 Glaxosmithkline fluticasone propionate; salmeterol xinafoate 5,225,445 Aug 12, 2008
ADVAIR HFA Glaxosmithkline fluticasone propionate; salmeterol xinafoate 4,992,474 Aug 12, 2008
ADVAIR HFA Glaxosmithkline fluticasone propionate; salmeterol xinafoate 5,126,375 Aug 12, 2008
ADVAIR HFA Glaxosmithkline fluticasone propionate; salmeterol xinafoate 5,225,445 Aug 12, 2008
ETOPOPHOS PRESERVATIVE FREE Bristol Myers Squibb etoposide phosphate 5,041,424 Aug 20, 2008
HECTOROL Genzyme doxercalciferol 5,861,386 Aug 2, 2008
HECTOROL Genzyme doxercalciferol 5,869,473 Aug 2, 2008
IMPLANON Organon Usa Inc etonogestrel 4,957,119 Aug 5, 2008
SEREVENT Glaxo Grp Ltd salmeterol xinafoate 4,992,474 Aug 12, 2008
SEREVENT Glaxo Grp Ltd salmeterol xinafoate 5,126,375 Aug 12, 2008
SEREVENT Glaxo Grp Ltd salmeterol xinafoate 5,225,445 Aug 12, 2008
SEREVENT Glaxosmithkline salmeterol xinafoate 4,992,474 Aug 12, 2008
SEREVENT Glaxosmithkline salmeterol xinafoate 5,126,375 Aug 12, 2008
SEREVENT Glaxosmithkline salmeterol xinafoate 5,225,445 Aug 12, 2008
TREXIMET Glaxosmithkline naproxen sodium; sumatriptan succinate 5,037,845 Aug 6, 2008

Courtesy of DrugPatentWatch.com

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in July 2008

*Drugs may be covered by multiple patents

Tradename Applicant Generic Name Patent Number Patent Expiration
CARDIOLITE Bristol Myers Squibb technetium tc-99m sestamibi kit 4,988,827 Jul 29, 2008
DEPAKOTE Abbott divalproex sodium 4,988,731 Jul 29, 2008
DEPAKOTE Abbott divalproex sodium 5,212,326 Jul 29, 2008
DEPAKOTE CP Abbott divalproex sodium 4,988,731 Jul 29, 2008
DEPAKOTE CP Abbott divalproex sodium 5,212,326 Jul 29, 2008
DEPAKOTE ER Abbott divalproex sodium 4,988,731 Jul 29, 2008
DEPAKOTE ER Abbott divalproex sodium 5,212,326 Jul 29, 2008
GLUCOTROL XL Pfizer glipizide 5,545,413 Jul 2, 2008
HIVID Roche zalcitabine 5,028,595 Jul 2, 2008
RESTORIL Tyco Hlthcare temazepam 5,030,632 Jul 9, 2008
RESTORIL Tyco Hlthcare temazepam 5,326,758 Jul 9, 2008
UVADEX Therakos methoxsalen 5,036,102 Jul 30, 2008
VEXOL Alcon rimexolone 4,686,214 Jul 22, 2008

Courtesy of DrugPatentWatch.com

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in June 2008

*Drugs may be covered by multiple patents

Tradename Applicant Generic Name Patent Number Patent Expiration
ADALAT CC Bayer Pharms nifedipine 4,892,741 Jun 8, 2008
CAVERJECT IMPULSE Pharmacia And Upjohn alprostadil 4,968,299 Jun 28, 2008
EFFEXOR Wyeth Pharms Inc venlafaxine hydrochloride 4,535,186 Jun 13, 2008
EFFEXOR XR Wyeth Pharms Inc venlafaxine hydrochloride 4,535,186 Jun 13, 2008
GENOTROPIN Pharmacia And Upjohn somatropin recombinant 4,968,299 Jun 28, 2008
GENOTROPIN PRESERVATIVE FREE Pharmacia And Upjohn somatropin recombinant 4,968,299 Jun 28, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,004,610 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,342,623 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,344,656 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,364,630 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,462,745 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,633,008 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 6,165,497 Jun 14, 2008
PREVACID Tap Pharm lansoprazole 5,026,560 Jun 25, 2008
RISPERDAL Janssen Pharma risperidone 4,804,663 Jun 29, 2008
RISPERDAL CONSTA Janssen Pharma risperidone 4,804,663 Jun 29, 2008
SONATA King Pharms zaleplon 4,626,538 Jun 6, 2008
SULAR Sciele Pharma Inc nisoldipine 4,892,741 Jun 8, 2008
TESTIM Auxilium Pharms testosterone 5,023,252 Jun 11, 2008

Courtesy of DrugPatentWatch.com