Patent

No patent for Bristol’s infant formula at the IPO: 4807/CHENP/2006


This post illustrates the current patent office view on claim amendments after national phase entry but before examination.  Claim amendments that ensure compliance with jurisdictional norms before the issuance of an office action/FER are not acceptable. Edit: To be clear, no amendment is allowed at the time of filing the application, but amendments are allowed after filing. However, this view (claim amendments that ensure compliance with jurisdictional norms not acceptable before issuance of an office action/FER), in my opinion, is not correct because of two very specific reasons, both involving money.  1.  An applicant pays for, and gets claims to demarcate the metes and bounds of his rights.  In an infringement actions, it is the claims that matter. Claim amendment is therefore a right, and one that is limited to the disclosure originally made; (2) The applicant has an option of including claim language that complies with various  laws in the PCT application.  This choice may lead to an increase in the pages but the patent offices worldwide make a lot of money from those extra pages in the form of additional fees/page.  

The patent office may, therefore, reject an application because of no support in originally filed complete application, but it cannot reject an application merely because claims have been suitably amended to comply with jurisdictional norms.  Claim amendments that comply with jurisdictional norms must, in my view, be encouraged.  Warning: Long post follows:
Bristol-Myers Squibb (“Applicant”) filed a national phase (“NP”) application for, a “Therapeutically effective amount of Bb-12 and LGG in the preparation of a medicament for preventing or treating respiratory infections and acute otitis media in infants.” This NP application was for an application number PCT/US2005/023330, filed July 1, 2005 and claimed prioirty to a US provisional application 60/584830, of July 1, 2004.  The Controller’s decision can be accessed here.
Procedural History
At the time of filing the Indian application (NP), Swiss style claiming was used.  Claim 1 was:  Use of a therapeutically effective amount of Bb-12 and LGG in the preparation of a medicament for preventing or treating respiratory infections in an infant.
To contrast, the claim style in the PCT application was entirely different in the NP application. Claim 1 in the PCT application was: A method of preventing or treating respiratory infections in an infant, the method comprising administering to the infant a therapeutically effective amount of Bb-12 and LGG.
The Controller took objection to the change in the NP application and cited to the relevant provision in the Patent Cooperation Treaty (Article 19).  
The date of a NP application is reckoned from the date of international application filed in PCT. Therefore, the contents of the complete specification in PCT and the Indian National Phase application.  No amendment is allowed at the time of filing the application, but the same is allowed after filing the application. 
According to the Controller, applicant filed NP application with amended claims where there is no provision to do so.  An amendment to the specification is possible under the Indian patent laws and rules after the application has been filed in India (under section 57 and 59).
After the First Examination Report (FER), the applicant amended the claims again into composition claims.  Claim 1 after amendment read:
A nutritional formula, comprising an infant formula which comprises:
a lipid or fat;
a protein source selected from the group consisting of whey protein, casein, casein protein, non-fat milk, hydrolyzed protein, and combinations thereof;
one or more Bifidobacterium species which comprises Bifidobacterium lactis Bb-12; and
one or more bacterial species which comprises Lactobacillus rhamnosus GG.
At this stage, the Controller noted: [T]he applicant changed the entire scope of the initital 10 claims into 19 compositions to meet the objections of the FER. There was not a single composition claim at the time of filing the NP application, and hence application needed further examination, and a hearing was done.
After the hearing the applicant amended claims again.  This time the claim read:
An infant formula comprising:
3g to 7g of a lipid per 100kcal of infant formula;
1g to 5g of a protein source selected from the group of whey protein, casein, casein protein, non-fat milk, hydrolyzed protein, and combinations thereof per 100kcal of infant formula;
between 10^5 and 10^11 cfu of Bifidobacterium lactis Bb-12 and Lactobacillus rhamnosus GG.
The Controller then pointed to the the object of the invention and marked several statements from the complete specification.  For example, the Controller noted: “[A]ll the embodiments described in the description are related to method for preventing or treating respiratory infections and AOM in infants.  Interestingly, the claims at the international phase and NP entry are also related to the use of Bb-12 and LGG in the preparation of a medicament for preventing or treating respiratory infections in an infant by administering a therapeutically effective amount of Bifidobacterium lactis (Bb-12) and Lactobacillus rhamnosus GG (LGG), respectively.
...I wonder how different types of claims are possible for a single description which related to single invention in different jurisdictions.  Claims allowed in some countries are use/method (of treating and preventing) claims, but those are non-patentable in India.
Then the Controller discussed various prior art documents and their application to the claims and concluded that the subject matter of the claims did not involve an inventive step under section 2(1)(ja).
The Controller then cited to various tables in the complete specification and concluded: “Thus the present invention confidently related to a method of preventing or treating respiratory infections in an infant but the applicant amended from ‘use’ to ‘infant formula’ through method for preventing or treating respiratory infections in an infant claims.  Use or method of treating claims is not considered as an invention and/or non-patentable inventions under the provision of the Act in India.  Therefore the applicant willfully amended claims into infant formula to obtain a patent for a non-patentable subject matter.

…The infant formula as claimed in claim 1 of the present invention neither prepared so far nor imagined till receiving the FER in 2009.  The birth of claim 1 took place only after FER.  The applicant misleads patent administration by manipulating the information disclosed in the description in a different way to acquire patent for infant formula which was not at all prepared as a product.  ….Thus the claims of the present invention lack support in the description and not complied with the requirement under section 10(4) of the Act.

Therefore the Controller refused to allow the application.

Rajiv Kr. Choudhry

Rajiv did his engineering from Nagpur University in 2000 in electronics design technology. He has completed his LL.B. from Delhi University, Law Center II in 2006, while working as an engineer at ST Microelectronics in NOIDA. After his LL.B., he went on to The George Washington Univeristy, Washington DC to do his LL.M. in 2007. After his LL.M., he has worked in the US at a prestigious IP law firm based out of Philadelphia. Till 2014, he was Of-Counsel to a Noida based IP law firm where he specialized in advising clients on wireless, telecommunication, and high technology. Rajiv is the founder of Tech Law Associates, a New Delhi based law firm specializing in IP law, with a focus on high - technology, and patent law. His core IP interest areas are the intersection of technology and IP, Indian IP policy, innovation, and telecommunications patents. He is also an inventor with pending applications in machine-to-machine communications domain (WO2015029061).

10 comments.

  1. Kshitij

    Rajiv,

    Please clarify. Is the patent office saying that voluntary (preliminary) amendments before examination of a national phase patent application can not be ipso facto taken on record?

    I do not think so there is any ground of construing the law this way. Once a NP patent application is made into India, then the patent applicant made is just like domestic applications. Section 57 is applicable, of course, with the regulation of section 59. If the patent office says that no amendments can be made “ipso facto”, I believe it is totally erroneous. Yes, if amendments are made contrary to spirit of section 59, then the patent office has all the rights to object.

    Also, I do not find any grounds why article 19 has relied upon by the patent office? Article 19 no where says that voluntary amendments can not be filed after the deadline for filing of article 19 amendments lapses?

    I look forward to your views.

    Thanks,
    K

    Reply
  2. Rajiv Kr. Choudhry

    Kshitij: I had specifically mentioned that, “Claim amendment is therefore a right, and one that is limited to the disclosure originally made.” It is not that claim amendments cannot be taken on record. In this case, the objection was that because the claims were “manipulated” to comply with jurisdictional norms, i.e. patent for infant formula-not as a product, they were not acceptable.

    Additionally, the Controller has clearly stated that no amendment is allowed at the time of filing the application, but amendments are allowed after filing.

    So claim amendments are allowed, but only after NP entry.

    The point I was making is that if the applicant can include language in the application at the time of filing (say PCT), then there is nothing that stops the applicant from inserting claims that comply with jurisdictional norms as was done here. India does not give patents for method of use for treating or preventing, but it does give a patent on a product.
    The patent office should not object to the fact that claims have been amended to comply with jurisdictional norms because it can reject those claims later.

    I agree with the Controller on all other grounds except for the one listed in the post.

    The Controller pointed to Article 19 to indicate the last opportunity to amend claims. It is these amended claims (if the applicants amends claims) that enter into NP.

    Reply
  3. Kshitij

    Thank you Rajiv for the clarification. I agree with you, there are no grounds to believe that an applicant can not make amendments in the patent application after the date of filing of the NP entry into India. In fact, I believe that there are no grounds to believe that amendments can not be made at the time of making the NP entry into India? Please correct me if I am wrong.

    Regarding the view of controller on the scope of amendments, I agree with the view taken by the controller on the amendments. IMHO, section 59 suggests a two prong test for amendments, these are:

    1. Scope of specification: The subject matter added in amended claims should not go beyond the scope of the specification.

    2. Scope of claims: Scope of the amended claims should not go beyond the scope of the initial set of claims.

    As to scope of specification, in the instant case enough reliance can be place by converting the use claim into a product claim. Of course, the elements disclosed in the Swiss type use claim should have been described somewhere in the specification.

    With regard to the second test, i.e., scope of initial claims, I believe the patent office is correct. When I change a use claim into a product claim to meet the jurisdictional requirement, then the scope of the amended claims are totally changed. Therefore, the objections taken by the patent office are valid.

    However, I also believe that section 59 somehow creates unnecessary problems for applicants in NP entries. India is unique with respect to claim amendments. Such rule is not followed in EPO, where the main test still are the new matter test and generalization test.Thank you Rajiv for the clarification. I agree with you, there are no grounds to believe that an applicant can not make amendments in the patent application after the date of filing of the NP entry into India. In fact, I believe that there are no grounds to believe that amendments can not be made at the time of making the NP entry into India? Please correct me if I am wrong.

    Regarding the view of controller on the scope of amendments, I agree with the view taken by the controller on the amendments. IMHO, section 59 suggests a two prong test for amendments, these are:

    1. Scope of specification: The subject matter added in amended claims should not go beyond the scope of the specification.

    2. Scope of claims: Scope of the amended claims should not go beyond the scope of the initial set of claims.

    As to scope of specification, in the instant case enough reliance can be place by converting the use claim into a product claim. Of course, the elements disclosed in the Swiss type use claim should have been described somewhere in the specification.

    With regard to the second test, i.e., scope of initial claims, I believe the patent office is correct. When I change a use claim into a product claim to meet the jurisdictional requirement, then the scope of the amended claims are totally changed. Therefore, the objections taken by the patent office are valid.

    However, I also believe that section 59 somehow creates unnecessary problems for applicants in NP entries. India is unique with respect to claim amendments. Such rule is not followed in EPO, where the main test still are the new matter test and generalization test.

    Reply
  4. Anonymous

    What I have beleived so far is that the amendments are allowed at the time of national phase entry..but we have to file Form 13 for the same. The examiner just can not reject the patent application merely on the ground of amendments. In this case, if swiss type claims are not allowed then there is no point in filing in India…hence we can file the claim amendments as per the Indian Act & Rules and simultaneously file Form 13.

    Further, patent office has started taking fees for claims filed in PCT application. say if I have 100 claims in PCT application directed to composition, method of treatment and use. Then I have to pay the fees for claims which are not patentable in India. This is too much to expect from the applicants.

    Any comments on this ?

    Reply
  5. rajeev

    Dear sir,
    The prime argument in this post is that applicant may be rightfully allowed to amend his claims to bring it in line with jurisdictional norms.The patent is perfectly right in pointing out the abject misuse of this in this case. The basic premise of ant procedural system is the depedibility and predictibility. To say that amended claims can later on be rejected is inviting abuse of the system. To me the Controller is very logical and correct.Not playing by the rules leads to free for all.
    R.K.jain
    Patent agent

    Reply
  6. Anonymous

    Dear Patent Agent

    In my opinion the applicant has in this case a right to amend the claims in any way as long as they are within the scope of the specification. If my claims are dirdetd to swiss claims and I later on change them to compoistion claims to make them confirm to the Indian Practise then there is no harm as long as my specification covers the composition.

    regards

    Reply
  7. Shankar

    The applicant has every right to have the amended claims examined. If the examiner feels the claims were not part of the original specification, he can recommend filing of a divisional carrying these claims, that are well supported by the specification. “applicant misleads patent application…” is not tenable.

    Reply

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