Tag Archives: Examination

Modification in procedure regarding examination of patent applications involving the use of biological material

The Biological Diversity Act (the BD Act) was enacted with the goal to provide for conservation of Biological Diversity, sustainable use of its components and fair and equitable sharing of the benefits arising out of the utilization of biological resources. One of the provisions under the BD Act (section 6) relates to seeking prior permission from National Biodiversity Authority (NBA) before applying for any intellectual property right, if the invention is based on any research or information on a biological resource obtained from India. In the event of an intellectual property right (patent application) being filed without prior NBA permission, NBA permission may be obtained after the acceptance of the patent but before patent grant by the patent authority concerned.

It has been witnessed in a few recent Indian Patent Office (IPO) decisions that patent applications involving use of biological materials, not procured from India and sourced from commercial sources in countries like Switzerland, Spain, Japan and China, were rejected. In light of such IPO decisions, stakeholders at Mumbai and Delhi held meetings to put forward certain issues regularly faced by patent applicants regarding unwarranted objections raised by the IPO concerning requirement of permission from NBA and further delay in obtaining NBA approval.

In view of the submissions made by stakeholders, this issue has been considered by Indian Patent office and instructions/guidelines for NBA permission have been streamlined by way of the following:

S. No. Issue Modified procedure to be followed
1 Where the invention does not relate to a biological resource defined under the Biological Diversity Act 2002, such as:

(a)    Value-added   product

(b)       Bio- wastes

(c)        Synthetically prepared biological material

(a) Value Added Product:

Section 2 of Biological Diversity Act 2002 explicitly excludes value added products from the purview of “Biological resources”.

As per Biological Diversity Act, 2002:

Section 2 (c): “biological resources” means plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value, but does not include human genetic material;

Section 2 (p): “value added products” means products which may contain portions or extracts of plants and animals in unrecognizable and physically inseparable form.

Examiners/Controllers shall verify from    the   disclosure in patent specification if the claimed invention resides in the biological resource or value-added product. If the invention resides in a value-added product, then they shall avoid

2 Where the biological resource/material used in invention is not obtained /sourced from India. Section 6 (1) of the Biological Diversity Act, 2002 states,

“No person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without

obtaining   the    previous   approval   of  the    National
Biodiversity Authority before making such application.

Provided that if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned; and,

Provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.”

Thus, no    approval from   NBA   is  necessary when the invention is based on any research or information on a biological resource not obtained from India.Therefore, when an applicant makes unequivocal
declaration in application for patent (Form 1) that the
biological material used in the invention is neither
obtained from India nor sourced from India, then

Examiners/Controllers shall duly consider such
declaration before issuing FER and shall avoid raising an objection with respect to the requirements of NBA approval.

3. Marking of applications in the module regarding requirement of NBA approvals.
While examining the applications involving use of biological
resource, Examiners should mark these applications as
“NBA approval application” in the examination module
before sending the examination report to the Controller for
approval.
However, if the Controller is not satisfied with
requirement regarding NBA approval, he shall unmark the
application by giving reasons thereof.
4 Cases held up for grant
of patents only due to
non-submission of
NBA permission.
Where the applicant has complied with all the objections,
except submission of NBA approval, the Controller shall
mark the application in the examination module by remark
that “NBA approval pending, but in order for grant” and,
the System Administrator shall put a tag on such cases so
that these applications can be treated as if disposed of
the Controller.

IPO has further clearly stated that any false declaration on behalf of the applicant makes him liable for revocation of patent under section 64 (1) (j)/ 64(1) (p) of the Patents Act
1970 (as amended). Further, as per provisions in section 55(1) of Biological Diversity Act 2002, if the applicant contravenes or attempts to contravene or abets the contravention of the provision
of section 6 of the Biological Diversity Act 2002, he shall be liable for penal action under section 55(1) of the Act’.

With the streamlining of instructions/guidelines for NBA permission, the patent applicants can now effectively deal with the unwarranted objections raised by the IPO concerning the requirement of permission from NBA. Henceforth, the patent applicants can question the unjustifiable extension of applicability of Section 6 of the BD Act by IPO to reject patent applications even when the invention is not based on Indian biological resource and/or when the invention is one of a value-added product, bio-waste or a synthetically prepared biological material and hence, does not relate to a biological resource defined under the Biological Diversity Act 2002.

About the author: Tanu Goyal, Patent Associate at IIPRD and can be reached at: tanu@khuranaandkhurana.com

Advertisements

A Simplified Account of Patenting Procedure in India

Well, this is something for which we have been getting queries on regular basis from individual inventors, universities and companies in India as well as outside India. This article comprehensively addresses all the procedural issues which normally applicant faces while patenting invention in India. Though this article focuses on the procedural aspects, it is always a good idea to start a discussion with basics. Patents are territorial rights which mean to secure invention in India, one has to get it patented in India. No regional patent applies to India. It is to be noted that patent does not confer on the patentee positive rights rather it confers on the patentee negative right i.e. right to exclude other from doing certain acts (see section 48 of The Patents act, 1970 (hereinafter referred to as ‘act’)).

We will address all the procedural aspects in Question and Answer format.

  1. Who may apply for patent?

True and first inventor, his assignee or legal representative of either of them after their death (According to section 6 of act)

  1. Where to apply?

Kolkata (Head Office), Mumbai, Delhi or Chennai depending on the jurisdiction of which applicant resides, has domicile or place of business in India (first applicant in case of joint applicants) or  the place where invention originated or patent attorney’s office is situated (in case of foreign applications). When applicant does not have a place of business or domicile in India, address for service in India needs to be submitted.

  1. Types of application:
  1. Provisional application: This is to be filed when inventor is not ready with the complete details of the invention but wants to secure the priority date. Claims may be filed with (though we at Khurana & Khurana do not recommend it) provisional application.
  2. Complete specification: It has to be filed within 12 months from the date of filing of provisional specification, failing of which will cause application to be abandoned.  It may be filed directly (without filing provisional specification) when the applicant is ready with the complete details of the invention. Every convention application, application filed under Patent Cooperation Treaty, divisional application has to be filed with complete specification. According to section 135 of the act, for same or substantially same application (s) for patent filed in convention countries, application for patent may be filed in India by the same person who has filed application in convention country or his legal representative or his assignee, which is known as convention application within 12 months from the date of priority of the application filed in convention country. National phase application under Patent Cooperation Treaty may be filed designating India within 31 months of the date of priority. This period of 31 months and period of 48 months within which request for examination has to be filed are non-extendable. As one application for patent can only be filed for a single invention or a group of closely related invention, if claims of the complete specification relate to more than one invention, applicant if he so desires or with a remedy the objection raised by the controller, may file a further application known as divisional application at any time before the grant of the patent. For filing complete specification, applicant needs to submit form 1 (application for grant of patent), 2 (provisional/complete specification), 3 (statement and undertaking u/s 8), form 5 (declaration of inventorship), form 26 (form of authorization of patent agent), and form 28 (to be submitted by small entity) along with other documents. Form 9 needs to be filed if early publication is desired. Form 18 needs to be filed for examination or express request for examination. These forms need to be filed either with the application or within prescribed time period.
  1. What is patent of addition?

It is the application made by the applicant or patentee of the main invention for any improvement in or modification of the invention disclosed in the complete specification therefor.  Reader is further advised to click here for an interesting and knowledgeable article on patent of addition.

  1. Is there any period during which pre-grant can be filed for sure?

Pre-grant opposition can be filed any time after the publication of the application till the grant of the patent. According to rule 55 (2003 rules), no patent shall be granted before the expiry of a period of 6 months from the date of publication so during this period pre-grant opposition can be filed for sure.

  1. Who may file request for examination and what is time allowed for putting application in condition of grant?

It may be filed by the applicant or any other interested person but examination report is sent to the applicant only. In case request for examination was made by the any other interested person then intimation of examination is sent to such other interested person. The time for putting an application in order for grant is twelve months from the date on which first examination report is issued to the applicant.

  1. Is it possible to file pre-grant opposition even though there is no request for examination filed?

Yes, it is possible to file representation for pre-grant opposition even though no request for examination has been filed. However, the representation will be considered only when a request for examination is received within the prescribed period. As representation for pre-grant will be considered only when a request for examination is received within the prescribed period, one can choose to file request for examination as ‘any other interested person’ so that one does not need to wait till applicant files request for examination. This will help to expedite the process and decide the fate of patent application.

  1. What is the relevant date from the infringement perspective?

Though suit for infringement can only be instituted after the grant of patent, patentee shall have privileges as if it is patent was granted on the date of publication of application.

  1. We have summarized below important timelines and also compared and contrasted different procedures involved in the patenting in India.procedure_patenting

A graphical representation of the procedure of patenting in India

Notes:

  1. In case, secrecy directions have been given in respect of any application, then application shall be published after the expiry of 18 months or the expiry of such directions, whichever is later.
  2. If request for examination is not made within applicable time limit, then application is treated as withdrawn by the applicant.
  3. In case, secrecy directions have been given in respect of any application, then request for examination has to be made within 48 months from the date of priority or date of filing of the application, or 6 months from the date of revocation of the secrecy direction, whichever is later.
  4. In case of divisional application, request for examination has to be filed within 48 months from date of filing or priority of first mentioned application, or within 6 months from date of filing of further application, whichever expires later.

Table 1: Comparison of procedures for publication and Examination of patent application

procedure_publication_examination

* Request is compulsory for early publication and needs to be made in form 9.

**The patent office does not commence the processing of an application filed corresponding to international application designating India before the expiry of 31 months from the date of priority, unless express request is made in form 18.

Table 2: Comparison of procedures for Pre-Grant and Post-Grant opposition to patent application

procedure_pre_grant_post_grant

While filing for pre-grant opposition has no charges, post grant opposition can be done only on charges.

  1. Payment of annuity:

No annuity/maintenance/renewal fees needs to be paid for first 2 years out of 20 years of term of patent. According to section 53 (2) of the act, renewal fees needs to be paid in order to keep patent in force at the expiration of 2 years or subsequent years from the date of patent which shall be renewal fees for the third year or subsequent year. It means that maintenance fees needs to be paid in nth year in respect of nth plus 1 year. According to section 142 (4) of the act, where a principal patent is granted later than 2 years from the date of the filing of the application, the fees which have become due in the meantime may be paid within a term of three months from the date of the recording of the patent in the register or within the extended period not later than nine months from the date of recording. Renewal fees due in respect of 2 or more years may be paid in advance. Extension of period to pay fees up to 6 months can be sought in form 4. This period of six months is not extendable.

  1. Costs involved in the patenting in India:

They can be divided into statutory fees and attorney fees.

Statutory fees:

Statutory fees as revised by the patent (amendment) rules 2014can be accessed here. For physical filing, 10% additional fees have to be paid more than e-filing. In other than natural person(s) category, fees for small entity fees are half to those entities which are not small entities.

Attorney fees:

These charges vary from attorney to attorney and task to be done. Attorneys also vary charge depending on whether client is Indian or foreign. For Indian client, generally charges by attorneys for preparing patent application are INR 20 to 50 K,  for patent searches are INR 15-20 K, for responding to examination reports are INR 15-20 K,  for filing pre-grant opposition are INR 25-30 K.

For foreign client, generally charges by attorneys for preparing patent application are US$ 450-500, for filing reply to objection raised by patent office are US$ 600-800, for attending hearing and replying to hearing notice are US$ 600-800, for drafting and filing opposition are US$ 600-800.  It is to be noted that quoted charges are just for general idea and actual charges may vary. Khurana and Khurana also helps clients with other patent related tasks than those mentioned above for quoting charges. Quoted tasks and charges are just exemplary. To know the charges of our firm, please contact us at the contact details given at our site.

Khurana and Khurana has on board patent agents who are experienced, are qualified to practice before patent office and are well versed with all the procedures of patenting. Khurana and Khurana would be obliged to help you with any patenting issues.

It is to be noted that patent (amendment) rules 2015 are not taken into consideration as said rules are still into draft stage.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com.

Revised Draft Guidelines for Examination of Pharma Patent Applications

We have earlier reported the release of Draft Guidelines for Examination of Pharma Patent Applications. The Patent office has now released revised draft guidelines and in continuation of our earlier article here, we explain herein what those revisions are and impact of the guidelines in general. The revised guidelines are available here.

The revised guidelines of 12th August 2014 are not much different from the earlier guidelines of 28th February 2014 with only some clarity provided at certain places. For example, the scope of the guidelines is clarified by inserting that “Examiners are requested to examine applications on a case-to-case basis, without being prejudiced by the specific illustrations being provided herein.”  Some other clarifications/changes include:

  1. On carrying out a prior art search for pharmaceutical products, if the applicant does not inform the INN even on the request, the examiner should try to find out the INN and use the same in the search strategy.
  2. Further clarity on identification of prior art documents pertaining to Markush formula is provided wherein it is emphasized that “If a markush formula covers innumerable compounds and certain other compounds fall within another prior art, in such cases all these prior art documents are to be cited. A generic disclosure in the prior art may not necessarily take away the novelty of a specific disclosure. A specific disclosure in the prior art takes away the novelty of a generic disclosure”
  3. On the discussion of “skilled person” in section 8.6, the revised guidelines add new IPAB order on Enercon vs alloys Wobbens, ‘We do not intend to visualize a person who has super skills, but we do not think we should make this person skilled in the art to be incapable of carrying out anything but basic instructions”.
  4. On sufficiency of disclosure requirements pertaining to biological materials, the new guidelines add disclosure requirements pertaining to depositing the material to an International Depository Authority (IDA) under the Budapest Treaty.

There are some other minor changes for clarity purposes for example:

  1. Deletion of the following examples: “2) Use of compound A in the process of preparing B. and 3) Use of compound A in the composition of ————– ” from illustrations depicting use claims (non-product and non-process claims)
  2. Deletion of the following one illustration on implicit disclosure: “For example, the invention claims halide salts of a compound whereas the prior art teaches the chloride salts of the same compound but does not explicitly disclose the other halide salts. However, it may be noted that the question of implicit disclosure is often a mixed issue of novelty and inventive step.
  3. Deletion of a following sentence from “8.8 Reasonable expectation of success”:In other words enhanced effects cannot be adduced as evidence of inventive step if they emerge from obvious tests.
  4. Addition of a new illustrative example for section 3(j).
  5. Deletion of one paragraph (para 11.15 in earlier version) on sufficiency of description
  6. Addition of Structures for clarity in the illustrative example for Unity of invention in para 12.13

These guidelines are released with an objective to provide clarity and understanding on various patentability criteria to the Examiners/Controllers so that a uniform standard of examination can be achieved in pharmaceutical inventions. There have been several instances where certain type of claims are allowed by one examiner and rejected by others. For example, even though it is statutorily mentioned that method of treatment claims are not patentable under section 3(i) but still such claims are sometimes filed as use claims for example as “use of compound X in treatment of disease Y…” or compound claims for example as “compound X for use in treatment of disease Y..” which claims have been allowed by some Examiners in the past. These guidelines now clarify that only products or processes will be patentable and no such use claims will be patentable. This strives to provide much needed uniformity in examination standards. Another highlight of the guidelines is that these include recent IPAB and court decisions for providing further clarity. For example, section 3d has been well explained w.r.t Supreme Court’s Novartis decision. Obviousness criteria is well explained giving various illustrations, particularly defining “skilled person”, “reasonable expectation of success” “motivation” w.r.t various IPAB/court decisions. Product by process claims are clearly defined explaining that they are patentable only when the product is novel and non-obvious. Claims containing Markush structures are specifically well-explained w.r.t various patentability criteria. Since all these explanations available in these guidelines on various types of pharmaceutical claims are not explicitly present in the Patent Act, so releasing these guidelines should prove to be a boon to Examiners/Controllers especially in view of inconsistent examination standards seen in the past.

In sum, these guidelines will help Examiners establishing patentability of pharmaceutical inventions with much ease and clarity now avoiding inconsistency in examination standards.

Now Responses to Examination Reports can be filed online too!

As per the notification of 07th July 2013 at the Indian Patent Office, the responses to Examination Reports can now be also filed online.

The online database of Indian Patent Office has been significantly automated over the last couple of months causing much convenience to the Applicants and Agents as well as speeding processes at the Patent Office. Now, every form from Form 1 to 27 including Petitions and every request including application for post-dating, alteration in patent register, entry of additional address of service, correction of clerical errors etc., can be filed online.

Online Filing of responses to Examination Reports will considerably reduce the time and increase the efficiency resulting in speedy disposal of applications.

fer1

 

fer2

 

Follow us on Twitter: @KnKIPLaw.

Examination Guidelines/Standards – Indian Patent Office

This article relates to a recent judgment of IPAB for a patent application 2254/DELNP/2005 which was refused to proceed further by the Indian patent office. The judgment illustrates the mode in which decisions are established by the patent office during the examination/prosecution phase. Copy of the decision can be accessed here.

Brief summary of the case

The patent application relates to “A New Crystal Form of Adefovir Dipivoxil and its Composition” and was filed by Tianjin Kinsly Pharmaceutical Co., Ltd, China on 26th May 2005 bearing patent application number 2254/DELNP/2005. The application claimed a new crystal form of Adefovir dipivoxil {9-[2-[[bis[(neovaleroxy)-methoxy] phosphinyl] methoxy] ethyl] adenine} and its composition, and the method to prepare the crystal. However, the patent office refused to proceed further on the basis that the claims were not allowed on account of section 3(d) of Patent act, 1970 and inability of the Applicant to provide evidence showing enhanced efficacy. Furthermore, the patent office held that the claims 4-7 were not allowable under section 3(e) of Patent act 1970 while claims 7-10 were beyond scope of limit.

The applicant for the said application challenged the order given by patent office in the Intellectual Property Appellate Board (IPAB).

We herein evaluate the decision given by the Patent office in a step wise manner as follows:

First paragraph of the order of the Patent Office:

“1. The present invention relates to a new crystalline form of a compound and its composition, and in particular, to a new crystalline form of adefovir dipivoxil with the nomenclature of 9- [2-[bis(pivaloyloxy)- methoxy] phosphinyl] methoxy) ethyl] adenine and a composition containing that new crystalline form.

“The claim 1-4 could not be allowable under section 3(d) of patent act 1970, and the agent have not able to prove enhance efficacy. There is no data submitted in the complete specification for clinical trial on human being, “for the support of therapeutical efficacy.  “The experimentation must be done with the human body, for testing a drug on a lion or a horse or monkey might not prove anything about its effect on man”””.

The applicant appealed before the board that the above order is a mere collection of lines taken from an extract of an article from internet. The article which was published by David W. TSCHANZ, MSPH, Ph.D. is cited below (can be accessed from here Page 16):

“Ibn Sina and Clinical Trials

Discussing Ibn Sina is like ………………………….. These principles still form the basis of modern clinical drug trials.

1. The drug must be free from any extraneous accidental quality…………………………………………………………..if this did not happen, it was an accidental effect. 7. The experimentation must be done with the human body, for testing a drug on a lion or a horse might not prove anything about its effect on man.

The board states that the order given by the patent office is a word to word copy from the above source provided as evidenced by the Applicant.

Second paragraph of the order of the Patent Office

“2. What is the clinical trial?

A clinical trial (also called a clinical study) is a medically supervised procedure in which investigational drugs are given to patients for a set period of time while changes in the patients’ disease and overall health are monitored through physical examinations and laboratory tests. Typically, during the time patients are taking a drug, they make periodic visits to the doctors in charge of the trial. On these visits, patients usually provide information about how they are feeling, undergo physical examinations, and are given diagnostic tests meant to measure how their condition is responding to the drug. Clinical trials can vary in length from days to years, depending on how long it takes to measure the effect of the investigational drug on the disease being treated.”

Counsel of the Applicant argued before the board that the order is a word by word copy from the extract from Procter & Gamble’s website with even the same font size and same spacing.

THIRD PARAGRAPH OF THE ORDER OF THE PATENT OFFICE

The 3rd paragraph of the order was:

“3. Five (5) different types classifying trials:

  • Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
  • Screening trials: test the best way to detect certain diseases or health conditions.
  • Diagnostic trials: conducted to find better tests or procedures for diagnosing a particular disease or condition.
  • Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
  • Quality of life trials: explore ways to improve comfort and the quality of life for individuals with a chronic illness (a.k.a. Supportive Care trials).”

The applicant submitted that the above statement was a word by word extraction from wikipedia under “Clinical Trial”. This can be accessed from here. The appellate board stated that the order was extracted from the said document under the heading “Types”.

Failed to submit Experimental Data

Furthermore, the order states that “The applicant failed to submit any experimental clinical data done on human being in support of therapeutic efficacy.” However, the counsel of the applicant stated that the experimental data was submitted before the patent office but was not considered. The counsel stated that the order was totally a copy-paste material from published articles from Internet without any further comments.

Finally, the appellate board after going through the arguments from the counsel of the applicant, ordered the patent office to reconsider the patent again independently. The board also blamed the patent office for the way the order was given by them. The board stated “This is not how an order shall be passed by the Patent Office.  The Controller has the duty to examine the claims and test them for patentability. This order must be set aside.  The application is sent back to the Controller who shall consider it independently.” The board further stated that the Controller shall re-examine each claim of the applicant independently and give reasoned order to the applicant.

Assuming that the examination standards continue to remain as exemplified above, the positive point to bring home for the Patentees is that any order from the Patent Office should not to be taken for granted or binding, and presence/availability of Appellate Boards such as IPAB should be fully exercised for accurate assessment of fulfillment of patentability requirements.

About the Author: Mr. Sitanshu Shekhar Singh, Patent Associate at Khurana & Khurana and can be reached at: sitanshu@khuranaandkhurana.com