Mock Trial at Delhi University
Under the aegis of the 5th India Project Intellectual Property Rights Summit jointly organised by George Washington University Law School (GWU Law), Confederation of Indian Industry (CII) and Intellectual Property Owners Association (IPO), a mock trial is scheduled to be held on 25th February, 2008 in the Convention Hall at Delhi University. The Summit itself will be held from 24th February- 1st March 2008. The past editions of this Summit have boasted of the who’s-who in the US and Indian IP Industry and this year’s edition too promises to be bring together a galaxy of legal luminaries. To obtain the brochure of the Summit, visit www.ipo.org.
The broad objectives of the Mock Trial are to understand the nuances of winning a patent case both at the trial and appellate fora. The case itself deals with what has become the symbol of vibrant IP litigation in India- s.3 (d) of the Patents Act. Following is the statement of facts of the Mock Trial: FACT PATTERN OF MOCK COURT AT DELHI UNIVERSITY, FEB 25 2008
1. Form I of paroxetine hydrochloride anhydrate was launched as drug LIPAX1 by BigPharma in 1995 in the US and India.
a. Form I contains no water and is relatively unstable when it absorbs water.
2. Form I of paroxetine hydrochloride anhydrate is disclosed in BigPharma’s ‘001 patent obtained in many countries including the US. There is no patent for Form 1 in India.
3. Form II (paroxetine hydrochloride hemihydrate) is claimed in BigPharma’s ‘002 patents that issued in 2005 in the US and in India under the Patents (Amendment) Act, 2005.
a. The ‘002 patents in the US and India contain only one claim — “Paroxetine hydrochloride hemihydrate.”
b. Form II contains one molecule of water for every two molecules of paroxetine hydrochloride; Form II is easier to handle than Form I. Form II is both stable up to 120°F (thus can be stored at room temperature) as well as has 50 percent faster absorption in the body so that it becomes active within an hour instead of 1.5 hours for Form I.
c. The ‘002 patent is active in 2008 in the US and India.
4. BigPharma launched Form II as drug LIPAX2 in the US and India in January, 2006, at about the same time as the expiration of BigPharma’s ‘001 Form I patent in the US.
5. Tests conducted by GenEric in 2006 using new equipment developed after BigPharma ‘002 patent issued in 2005 showed that small amounts of Form I (1 part per 1000) convert to Form II when Form I is stored above 40°F for a period of one week or more.
6. No one knew or suspected that Form I could convert to Form II prior to the grant of BigPharma’s ‘002 patent.
7. GenEric obtains invalidity and non-infringement opinions regarding the ‘002 Form II patents in the US and India.
8. In 2007, GenEric notifies BigPharma that:
a. GenEric would make generic LIPAX2 in the US and India; the generic LIPAX2 would contain pure Form II as the primary active ingredient.
b. GenEric does not infringe BigPharma’s ‘002 patents in the US and in India because the ‘002 Form II patent claim is non-patentable subject matter and/or invalid.
9. GenEric launches generic version of LIPAX2 called GENPAX2 in the US and India in January 2008. GENPAX2 contains Form II as the primary active ingredient.
10. Most LIPAX1, LIPAX2 and GENPAX2 storage facilities in the US and India are maintained at temperatures below about 32°F. Though, the storage facilities in Delhi could sometimes reach temperatures above 40°F in summer. There is no evidence that the temperature of any storage facility did in fact reach above 40°F.
11. BigPharma files lawsuit against GenEric in the US and India, alleging infringement of the ‘002 Form II patent.
12. GenEric files a motion for summary judgment of non-patentable subject matter and/or invalidity. Issue to be decided:
Is the ‘002 Form II patent claim non-patentable subject matter and/or invalid?
Under the aegis of the 5th India Project Intellectual Property Rights Summit jointly organised by George Washington University Law School (GWU Law), Confederation of Indian Industry (CII) and Intellectual Property Owners Association (IPO), a mock trial is scheduled to be held on 25th February, 2008 in the Convention Hall at Delhi University. The Summit itself will be held from 24th February- 1st March 2008. The past editions of this Summit have boasted of the who’s-who in the US and Indian IP Industry and this year’s edition too promises to be bring together a galaxy of legal luminaries. To obtain the brochure of the Summit, visit www.ipo.org.
The broad objectives of the Mock Trial are to understand the nuances of winning a patent case both at the trial and appellate fora. The case itself deals with what has become the symbol of vibrant IP litigation in India- s.3 (d) of the Patents Act. Following is the statement of facts of the Mock Trial: FACT PATTERN OF MOCK COURT AT DELHI UNIVERSITY, FEB 25 2008
1. Form I of paroxetine hydrochloride anhydrate was launched as drug LIPAX1 by BigPharma in 1995 in the US and India.
a. Form I contains no water and is relatively unstable when it absorbs water.
2. Form I of paroxetine hydrochloride anhydrate is disclosed in BigPharma’s ‘001 patent obtained in many countries including the US. There is no patent for Form 1 in India.
3. Form II (paroxetine hydrochloride hemihydrate) is claimed in BigPharma’s ‘002 patents that issued in 2005 in the US and in India under the Patents (Amendment) Act, 2005.
a. The ‘002 patents in the US and India contain only one claim — “Paroxetine hydrochloride hemihydrate.”
b. Form II contains one molecule of water for every two molecules of paroxetine hydrochloride; Form II is easier to handle than Form I. Form II is both stable up to 120°F (thus can be stored at room temperature) as well as has 50 percent faster absorption in the body so that it becomes active within an hour instead of 1.5 hours for Form I.
c. The ‘002 patent is active in 2008 in the US and India.
4. BigPharma launched Form II as drug LIPAX2 in the US and India in January, 2006, at about the same time as the expiration of BigPharma’s ‘001 Form I patent in the US.
5. Tests conducted by GenEric in 2006 using new equipment developed after BigPharma ‘002 patent issued in 2005 showed that small amounts of Form I (1 part per 1000) convert to Form II when Form I is stored above 40°F for a period of one week or more.
6. No one knew or suspected that Form I could convert to Form II prior to the grant of BigPharma’s ‘002 patent.
7. GenEric obtains invalidity and non-infringement opinions regarding the ‘002 Form II patents in the US and India.
8. In 2007, GenEric notifies BigPharma that:
a. GenEric would make generic LIPAX2 in the US and India; the generic LIPAX2 would contain pure Form II as the primary active ingredient.
b. GenEric does not infringe BigPharma’s ‘002 patents in the US and in India because the ‘002 Form II patent claim is non-patentable subject matter and/or invalid.
9. GenEric launches generic version of LIPAX2 called GENPAX2 in the US and India in January 2008. GENPAX2 contains Form II as the primary active ingredient.
10. Most LIPAX1, LIPAX2 and GENPAX2 storage facilities in the US and India are maintained at temperatures below about 32°F. Though, the storage facilities in Delhi could sometimes reach temperatures above 40°F in summer. There is no evidence that the temperature of any storage facility did in fact reach above 40°F.
11. BigPharma files lawsuit against GenEric in the US and India, alleging infringement of the ‘002 Form II patent.
12. GenEric files a motion for summary judgment of non-patentable subject matter and/or invalidity. Issue to be decided:
Is the ‘002 Form II patent claim non-patentable subject matter and/or invalid?
