Monthly Archives: December 2011

Form 3 – Some Reflections

Lately, we have been receiving a number of queries from our International clients related to the submission of Form 3 at the Indian Patent Office. The queries range from timing, frequency, content and information included in the Form 3. The aim of this article is to quickly put forth salient features of the Section 8, bring some light on the procedure and formulate some general guidelines which should be adhered to.

Form 3 is a Statement and Undertaking regarding Foreign Applications which is required to be submitted to the Indian Patent Office under Section 8. Section 8 is defined as:

8 (1) Where an applicant for a patent under this Act is prosecuting either alone or jointly with any other person an application for a patent in any country outside India in respect of the same or substantially the same invention, or where to his knowledge such an application is being prosecuted by some person through whom he claims or by some person deriving title from him, he shall file along with his application-

(a) a statement setting out the name of the country where the application is being prosecuted, the serial number and date of filing of the application and such other particulars as may be prescribed; and

(b) an undertaking that, up to the date of the acceptance of his complete specification filed in India, he would keep the Controller informed in writing, from time to time, of details of the nature referred to in clause (a) in respect of every other application relating to the same or substantially the same invention, if any, filed in any country outside India subsequently to the filing of the statement referred to in the aforesaid clause, within the prescribed time.

8 (2) The Controller may also require the applicant to furnish, as far as may be available to the applicant, details relating to the objections, if any, taken to any such application as is referred to in sub-section (1) on the ground that the invention is lacking in novelty or patentability, the amendments effected in the specifications, the claims allowed in respect thereof and such other particulars as he may require.

In simple words Form 3 is submitted to furnish information/actions/status relating to the patent applications filed in other countries for a particular Indian Patent Application. Further, Section 8 requires that the Applicant will keep the patent office informed (in Form 3) up to the date of grant of patent in India in writing the details regarding corresponding applications for patents filed outside India from time to time.

The Proper and timely submission of the Form 3 has gained all the more importance following a famous Chemtura Case when interim injunction was revoked against Chemtura Corporation by a Division Bench of Delhi High Court in a patent infringement suit involving one reason as the Non–compliance with Section 8(1) and 8 (2). In brief, Chemtura Corporation filed first Form 3 while filing Indian National Phase Application on 21st June 2001. After that, in spite of the changes in the status of the Applications in other countries particularly in US and Europe where Rejection Letters were issued and claims were narrowed down, no further Form 3 updating the status was submitted in accordance with Section 8(1). Further in accordance with Section 8(2), the Controller asked to furnish the details of the Examination Reports of countries like US, EP and JP, which Chemtura failed to comply with.

Though Indian Patent Act has defined the Section 8 mentioning the details regarding the submission of Form, the utmost clarity on the frequency, timing and the content/information relating to the subsequent Form 3 is required. We, at our Firm Khurana & Khurana, typically follow the general guidelines to adhere to the requirements of Section 8(1) and 8(2) as follows:

Timing, Frequency and Content of Form 3

  • First Form 3 is filed along with Filing the Application in India mentioning the countries, Application Nos., Publication nos. (if applicable) and the current status of the Application in respective countries.
  • Next within six months of filing the Application, the second and updated Form 3 mentioning the changes in the status if any is filed.  The status can be “Published”, “Awaiting Publication”, “Undergoing Examination”, “First Examination Report Received”, “Withdrawal of Application”, “Granted” etc and the same is updated from time to time up to the date of grant. Writing “Pending” as the Status of an application should be avoided as the decision of the Chemtura Case holds that “status” does not mean “pending” or “dismissed”. “
  • Then, we advise our clients to inform us the updated status of the Application in any country within six months of that status change. If desired, we also follow up with clients six months after their previous Form 3 submission date.
  • We also strongly advise our clients to submit the copies of the Examination Reports, Responses to the Objections, Amendments etc.

Information of which Countries

  • We submit information of all Foreign Applications whether they are PCT National Phase Applications or the Convention Applications based on Paris Convention taking priority within 12 months.

In conclusion, submission of Form 3 should not be held lightly as little delay or any missing status can cost the patent rights in India, as one of the grounds of the Revocation, Pre- & Post- Opposition of the Patent/Patent Application is non-compliance with the Section 8 of the Indian Patent Act.

About the Author: Ms. Gopanjali Singh, Patent Associate at Khurana & Khurana and can be reached at: Gopanjali@khuranaandkhurana.com

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E-Filing of Trade Mark Application and Related Documents with Indian Trade Marks Registry to be made mandatory

Indian Trade Marks Registry has on 03rd November 2011, published on their website Gazette Notification dated October 13,2011 which states that after expiry of forty five days from the date (which falls on 18 Dec 2011) on which this notification is published, the e-filing of trade marks applications and related documents will be made mandatory after considerations of objections and suggestions received from public in this regard. As an impact of this, if one files a Trade Mark application online, he/she will:

• Receive a trade mark application number immediately

• Receive an On-line verification to assure error-free filing and obtain the filing date

• Speed up the registration process

• Print the completed application data and receive fee acknowledgement

• Save the data locally onto the PC

• Be able to recall the contact details for subsequent applications

 

About the Author: Mr. Sagar Gupta, a Trade Mark Associate at Khurana & Khurana, IP Attorneys and can be reached: Sagar@khuranaandkhurana.com.

Technology Transfer Opportunities for Pharma/Biotech/Diagnostic Companies in the SME Sector

IIPRD (IIPRD) is among the leading Indian IP Consulting Firms focusing on Technology Transfer and Licensing for numerous Indian and Global Corporates and Research Institutes. IIPRD is highly active in the Technology Transfer and Licensing of Patent Backed Technologies/IP’s in the domains of Pharmaceutical, Life Sciences, Diagnostics, Telecommunications, Software and Medical Devices among others.

IKP Knowledge Park: IKP Knowledge Park (formerly known as ICICI Knowledge Park) is a non-profit Science and Technology Park based in Hyderabad, and is recognized as the premier biotech park in India. It is playing an active role in developing the biotechnology and pharmaceutical industries.

Foundation for MSME Clusters: Also known as FMC, the body is a non-profit registered Trust conceived by the Entrepreneurship Development Institute of India (EDII), Ahmedabad, India with technical support from the United Nations Industrial Development Organization’s Cluster Development Program in India. FMC strives towards making cluster initiatives inclusive with the help of a pool of distinguished national and International experts.

IIPRD is happy to announce its association with IKP Knowledge Park and The Foundation of MSME Clusters for being its Official Partner for scouting for new and innovative technologies (preferably backed by a strong Patent Portfolio) Technology Transfer opportunities for Small-Medium Size Pharmaceutical Companies. The ultimate aim is to accelerate the development of innovative companies in biotech, pharma, diagnostics and medical device areas through cluster development, technology acquisition and innovation fostering.

It is an excellent opportunity for the Indian/ Foreign companies, universities and Institutes for technology transfer/out-licensing/commercialization of their technologies in the following technology areas.

Technology Areas:

  1.  Therapeutics & vaccines in phase 1 clinical trials (infectious diseases, cancer)
  2. Biosimilars with significant data for regulatory approval (MAbs, therapeutic proteins)
  3. Point of care diagnostics that can be low priced
  4. Molecular PCR diagnostics – infectious diseases, genetic diseases
  5. ELISA based diagnostics – infectious diseases, genetic diseases
  6. Rapid diagnostics (paper strip tests)
  7. Enzymes for diagnostics biochemical tests (GOD, POD, etc)
  8. Enzymes with industrial applications
  9. Economic and green production of pharmaceutical intermediates and API’s
  10. Cardiac stents improvements, designs
  11. Inexpensive medical devices

In brief, the mandate of the exercise is to identify technologies in one or more of the above highlighted technology verticals and present them to established and interested group of In-Licensees/Buyers of the technologies. Product or process Technologies of potential out-licensees/sellers, which are either Corporates or Individuals, having adequately supporting clinical data or commercial use data relating to the respective technology, are welcome to send their technologies to us for brief evaluation post which we would be sharing these technologies with potential in-licensees/buyers in India.

The potential technologies would be showcased in January 2012 in Hyderabad and Ahmedabad, India and we therefore request all interested companies having technologies in the above mentioned categories to write to us at Dayanand@iiprd.com or iiprd@iiprd.com or contact Dayanand Reddy at 0120-2342010.

Mr. Dayanand Reddy

IIPRD

IFAIA Centre, S/20-22,
Greater Noida Shopping Plaza
UPSIDC Site – IV,
Plot No. S-7/2, Kasna Road
Greater Noida – 201 308, UP,
National Capital Region, India.

Specific Requirements:

API and intermediate production:

  1. Few intermediates which are imported from China. Indian companies are interested in cost-effective methods of manufacture that can be in-licensed. Examples: 2,4-Dichloroflurobenzene (Intermediate for Ciprofloxacin), 6 – AminoPenicilic Acid (6-APA; intermediate for Peninicillin),  Erythromycin (fermentation intermediate)Vitamin C, Difluorobenzene(Intermediate for Flucanazole).
  2. Biocatalysis for stereoselective reduction.
  3. Chiral synthesis, enzymatic stereoreduction, Novel catalysts to make process more efficient, Stoichiometric yield improvement (theoretic/atom yields).
  4. Cheaper process, green processes, more efficiency. Raw materials. Want to enter new markets-open to new APIs.
  5. Custom synthesis of Impurity/metabolite: Cost effective synthesis, novel methods of synthesis.
  6. Process improvements, Intermediate manufacture.
  7. Open to considering new synthesis pathways. Open to making new analogs of APIs.
  8. Open to new processes that are more economical. Reduction, chloromethylation and bromination green technologies, Methylation of phenols, Water based methylation using methanol and phase transfer catalysts.
  9. Ketone and amine technology for statins.

Formulations and drug delivery:

  1. NDDS, Novel formulations, production technologies (Directly Compressable Granulation technology; Dissolution Technology (key requirement))
  2. Gastric retentive technology (GRT). Transdermal patches-HRTs, hypertension. Liquid orals technologies. Solid oral- controlled release, Intra rumenal capsules. Dry powder inhalation products
  3. NDDS for asthma drugs, for respiratory delivery
  4. Mouth dissolving tablets

Biotechnology:

  1. High value, low volume.  Energy, probiotics, waste water treatment etc.
  2. Childhood vaccines/ candidates, adult vaccines, novel vaccines, novel fermentation technology, adjuvants, vaccine delivery, cold chain breaking technologies..novel formulations
  3. Want microbial identification techniques
  4. High yield vectors to produce monoclonal antibodies, better production techniques. Similar techs for biosims
  5. Most robust technological systems for manufacturing, processing and analytical advantages(HPLC, PCR, etc-fewer steps). Methods for increasing yields, or reducing down-stream processing costs. Antibodies for purification: product specific. Raw materials too high-disposable bioreactors, plastics, pipettes, etc.New vaccine candidates, novel adjuvants, novel expression systems, Bacterial or yeast expression systems for influenza antigens, HPV antigens, MAbs, etc
  6. Monoclonal antibodies-biosimiliar. Open to acquiring new area (oncology focus, TuMabs). Surface resonance frequence meters for testing Mabs.
  7. Genetically modified organism for yielding DHA, less expensive raw materials
  8. Effluent treatment.
  9. Fermentation based technologies, technologies that can improve conjugation of vaccines, anything that can increase yields, etc.better vaccines that. Better adjuvants, better stability appearance, etc
  10. Fermentation based technology for pharma – Immuno-surpressions. Seretiopeptidase, Nattokinase, Fungal-destase, acitic protease, Lectase (enzymes), Improved versions. They have 40,000 litre fermentation capacity, which is ready, which they want to use. Sub-merge biotechnology. Good vaccine technology, like polyvalent, penta-valent. They don’t want to be disease specific. Open for multiple disease areas
  11. Vertical integration. Biofuels: Jatropha seed to oil. Value added technologies. (for e.g. decrease toxicity in seed cake). Anything that adds value to any step in the biodiesel production. Any clean energy technology- algae, etc. Resin column technologies, hydrodynamic conversion, catalytic depolymerization. Nutraceuticals:  innovative herbal extraction, low- value, high value plant based products.

Diagnostics:

  1. Access to good quality MAbs. Immunoturbidometry techniques.Open to sub-licensing. Enzymes such as Glucose oxidase-GOD , peroxidise-POD, Urease, cholesterol oxidase and cholesterol esterase : can enter these verticals.
  2. R&D Equipments is a major problem, bio-equipment is a major opportunity area (No/very few people operate)…..Following areas they are interested in: Novel Rapid diagnostics technologies, markers,  Glucometer, Hb-meter, molecular diagnostics…..POCT .
  3. Better, less expensive instrumentation technologies. Enzymes for biochemical tests. Rapid test technologies-list- pregnancy then HIV, HBV, tropinin, etc. (See website of Association of Diagnostic Manufacturers of India :www.admi.org).
  4. Smart-phones: Android (google) based solutions for diagnostics…to ally with Elisa reader/spectrophotometer. MAbs for Diabetic markers (C-peptide, HA1C): CVD markers. Check with ATCC. Rapid test technologies. All hand held diagnostics
  5. Its only through innovative technologies we can penetrate the market nationally and internationally and create a brand value for ourself. Like for example you see most of the products in diagnostics sectors are not stable above say 37 °C, if we have a products which are stable at even 45 °C and above then there is huge potential. Say insulin oral delivery  again has good potential market. Biosimilars stable at 40°C might sound good.

Medical devices:

  1. Drug-delivery, elution kinetics. Novel alloys for stent systems, biocompatible material in stents. Also entering oncology drug delivery material. Stents in non-cardiac areas (peripheral stents). Self-expanding or shape memory stents.
  2. Anything that optimizes/miniaturizes the controller components or iontophoresis. Sumatriptan succinate, GNRH, etc. Formulations for transdermal patch-friendly drugs.
  3. Implant and fixator grade SS steel and titanium manufacture technologies. Forging of titanium and cobalt-chrome.
  4. Hydroxy-apatite, ceramic and other biocompatible coatings for implants
  5. Tech transfer of design.

Stem Cells Unpatentable on destruction of Embryos

On 18 October 2011, the European Court of Justice (ECJ) gave its decision in Brustle v Greenpeace (C-34/10) regarding the patentability of human embryonic stem cells (hESCs) in Europe. This Decision is largely in view with the Opinion of the ECJ Advocate General issued in March this year.

European Court of Justice (ECJ) stated;

“A process which involves removal of a stem cell from a human embryo at the blastocyst stage, causing the destruction of that embryo, cannot be patented.

The use of human embryos for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not patentable”.

ECJ issued a judgment in the case of Brustle v Greenpeace e.V (Case C 34/10) in which it prohibits the use of human embryonic stem cells in drug formulation and banned issuing patents for the same:

Background:

An invalidity suit was filed by Greenpeace on 2004, in the German Federal Patent Court against a German patent DE 197568664 assigned to Dr Oliver Brustle of the University of Bonn. The patent DE 197568664 was filed on 19th December 1997, disclosing a treatment against Parkinson’s disease. The treatment involved the use of embryonic stem cells for five days after fertilization. The product was obtained from embryonic stem cells at the Blastocyst stage of neural progenitor cells, isolated and purified, and was able to fight against Parkinson’s disease.

The ECJ referral originated from an appeal brought by Dr Oliver Brustle against the decision of the German Federal Patent Court that his patent was invalid.

In Europe, the Biotechnology Directive (98/44/EC) (the Directive) rules out patentability for certain inventions, including “uses of human embryos for industrial or commercial purposes”. Accordingly, the ECJ was asked by the German Federal Court of Justice for its interpretation of the concept of a “human embryo”, which is not defined in the Directive, under European law in order to determine whether Dr Brustle’s patent should be excluded from patentability.

The European Court of Justice viewed the term ‘’human embryo” in a wide sense. It considered that any human ovum being fertilised, be regarded as a “human embryo” if that fertilisation involves the process of development of a human being. The term “human embryo” also covers those artificially stimulated or manipulated (but unfertilised) cells which are capable of multiplying and developing into human being through parthenogenesis. In general, the development from conception begins with a few totipotent cells, wherein cell has the capacity to develop into a complete human being. The Court viewed totipotent cells as representing the first stage of the human body and must therefore be legally categorized as embryos.

Additionally, the Court felt that it would be wrong to characterize a totipotent cell as an embryo because an embryo quickly develops into a blastocyst made up of pluripotent cells, which further develops into all kinds of cells to form different organs of the human body, as disclosed in the invention covered in Dr Brustle’s patent.

But Advocate General did not agree that pluripotent embryonic stem cells not regarded as “human embryos” because they do not in themselves have the capacity to develop into a human being, but that inventions relating to pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo, whether its destruction or its modification. Article 6(2)(c) of Directive 98/44 must be interpreted as meaning that: “any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’”. Hence the Court held that a “human embryo” should be considered from the fertilization stage to the initial totipotent cells and to the entire process of the development and formation of the human body, which includes the blastocyst.

The second objection for patentability of Brutle’s invention was:

“The use of human embryos for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not patentable.”

The Court examines whether the concept of ‘uses of human embryos for industrial or commercial purposes’, not patentable, also covers the use of human embryos for purposes of scientific research. The Court notes that the grant of a patent for an invention implies, in principle, its industrial or commercial application. Although the aim of scientific research must be distinguished from industrial or commercial purposes, the use of human embryos for the purposes of research which is the subject-matter of a patent application should not devoid from scope of patentability. In that regard, the use of human embryos for purposes of scientific research which is the subject-matter of a patent application cannot be distinguished from industrial and commercial use and, thus, avoid exclusion from patentability. Consequently, the Court concludes that scientific research entailing the use of human embryos cannot access the protection of patent law. In addition to it, the Court also points out that the patentability of using human embryos for industrial or commercial purposes is not prohibited under the Directive where it concerns the use for therapeutic or diagnostic purposes.

Finally, the Court answers the third question on the patentability of an invention involving the production of Dr Brustle’s neural/neurological precursor cells. In this case a patent specification may not necessarily mention the use of human embryos, however there is a supposition that firstly, stem cells are obtained from a human embryo at the blastocyst stage and, secondly, that the removal of a stem cell entails the destruction of that embryo. In conclusion, the Court holds that an invention is excluded from patentability where the implementation of the process requires either the prior destruction of human embryos or their prior use as base material, even if, in the patent application, the description of that process, as in Brüstle case, does not refer to the use of human embryos.

Conclusion

In conclusion we find that the decision is related to the patentability of products which could be prepared exclusively by a method which involved the destruction of human embryos. In this decision, the German Federal Court decided that if production of a claimed product necessarily involved the destruction of a human embryo, its patentability was to be denied. However, induced pluripotent cells (iPS cells), which are not obtained by the destruction of a human embryo, appear to remain patentable in Europe.

But finally it is upto the German Federal Court to decide whether pluripotent stem cells should be excluded from patentability or not, keeping in view the responses given/stated by ECJ. However, if the German Federal Court follows the Opinion of the Advocate General, then it is likely that inventions relating to pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo, whether its destruction or its modification.

The ECJ’s ruling also implies on other National Courts including India, hearing similar cases in the field of biotechnology. However, due to differences between the laws of the National Courts, it is unlikely that other national courts would follow this ECJ Decision in this area of patent law. Recently, applicants for patents in places such as the countries of India, Japan, Peru, and Brazil have been facing patenting issues in relation to inventions involving human embryonic stem cells (raising morality concerns) and illegally obtained genetic resources. Now considering the present scenario on stem cells patent in India, it has been noted that Indian Patent Office has granted many patents on embryonic stem cells. In a previous Patent draft manual of 2008, it was stated that embryonic stem cell patents are against public order and morality. But latest Manual of 2011 on Patent laws does not highlight obligations/rules about stem cell patentability. Hence, in the absence of any such objections or law prohibition on stem cells, it can be considered that India can give way to embryonic stem cells Patentability.

Lastly, in regards to the case of Brustle’s patent, “The International Society for Stem Cell Research” (ISSCR) along with worldwide research scholars, express their views stating that such objections over patentability of stem cells can adversely affect the development of new therapies from human embryonic stem cell research and related issues of medical research. Scientists urge all countries to permit human embryonic stem cell research conducted under rigorous and transparent ethical oversight to accelerate progress toward understanding disease and identifying new treatments. It has been recognized that protections of intellectual property rights are critical to all branches of medical research including human embryonic stem cell research. Protection of intellectual property is crucial to the development of techniques, drugs and devices for the better understanding, detection and treatment of disease.

About the Author: Ms. Minusmita, Patent Associate at IIPRD and can be reached at: minusmita@iiprd.com