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April 24, 2014

Section 8 of the Indian Patents Act and a Comparison with the Disclosure Requirements in Canada, Israel and the U.S.

Section 8 of the India Patents Act, 1970 (the Act) requires an Applicant to submit certain bibliographic and prosecution details to the Controller of Patents & Designs (Controller) for any corresponding foreign patent applications filed outside of India that relate to the same or substantially the same invention as filed in India. First, under Section 8(1), an Applicant is required to voluntarily submit information regarding the status details for any corresponding foreign patent applications that relate to the same or substantially the same invention as the patent application filed in India by submitting a duly filled in “Form 3” at the Indian Patent Office (IPO). The details that must be provided in Form 3 include the name of the country the corresponding foreign patent application is filed in, the application/serial number, national filing date in the each respective country, status of the application, date of publication and the date of grant.

For any corresponding foreign patent applications filed before the filing of the Indian patent application, the bibliographic information must be provided within six months of the filing of the Indian application. Alternatively, for any corresponding foreign patent applications filed after the filing of the Indian patent application, the bibliographic information must be filed at the IPO within six months from any update in status of the filing of any such corresponding foreign patent application. An Applicant is required to inform the Controller of any status updates that occur in any corresponding foreign patent application such as publication, grant, rejection, opposition, appeal, abandonment, divisional or continuation filing, etc., from the date of filing up until the date of the grant of the Indian patent application. Information regarding status updates must be disclosed to the Controller within six months of the update (namely, within six months of publication, grant, rejection, opposition, etc.).

If an Applicant fails to comply with the requirements of Section 8(1), the application will be considered to be in default (namely, there shall be considered a procedural lapse on the part of the Applicant). However, an Applicant can rectify such a default by filing a petition under Rule 137 (which is a Petition for Obviating an Irregularity) requesting the Controller “to condone” the delay in filing the particulars under Section 8(1) of the Act.

Second, under Section 8(2) of the Act, the Controller, upon issuance of a first Office Action, shall call upon the Applicant (by way of an objection) to file the foreign prosecution history details from any corresponding foreign patent application related to the same or substantially the same invention. When requested to provide such information, an Applicant may be required to provide examination reports (both adverse and favorable), objections/rejections raised on the ground of novelty, inventive step and/or other grounds of rejection, claim amendments, divisional applications filed, etc. Additionally, the Examiner can request that an Applicant provide a translation of the relevant documents, if necessary. An Applicant has six months from the date an objection is communicated by the Controller to the Applicant to submit the details of the prosecution history of any such corresponding foreign patent application.

The Controller may require an Applicant to furnish such prosecution details up to the date the patent is granted. Non-compliance with Section 8(2) puts a patent granted at risk of facing an opposition or revocation proceedings (pursuant under Sections 25 and 64 of the Act, respectively). However, an Applicant can rectify such a default by filing a petition under Rule 137 before the grant of a patent (which is a Petition for Obviating an Irregularity) requesting the Controller “to condone” the delay in filing the particulars under Section 8(2).

Within the last 3-4 weeks, the Intellectual Property Appellate Board (Board) has issued four opinions which have discussed the object and importance of compliance with Section 8. These cases provide clarity and highlight the dangers in store for Applicants who do not timely comply with Section 8. These decisions are:

1.  Fresenius Kabi Oncology Limited v. Glaxo Group Limited and The Controller of Patents (Fresenius I  and Fresenius II); and

2.  Ajantha Pharma Limited v. Allergan Inc., Allergan India PVT. LTD.  (Allergan I and Allergan II).

Fresenius Kabi Oncology Limited v. Glaxo Group Limited and The Controller of Patents

On July 27, 2013, the Board issued two decisions relating to two Indian Patents owned by Glaxo Group Limited (Glaxo). In the first decision, the Board revoked Indian Patent No. 221171 entitled “Quinazoline Ditosylate Salt Compounds” for obviousness and for failing to qualify as an invention under Section 3(d) of the Indian Patents Act. Specifically, Fresenius Kabi Oncology Limited (Fresenius) filed a revocation action against Glaxo’s patent arguing that the patent should be revoked for obviousness, insufficiency of description, failing to comply with the requirements of Section 8 and falling under the purview of Section 3(d) of the Act (Fresenius I).

In the second decision, the Board dismissed a revocation action brought against Indian Patent No. 221017 entitled “Bicyclic Heteroaromatic Compounds” that is also owned by Glaxo. Specifically, Fresenius filed a revocation action against Glaxo’s patent arguing that the patent should be revoked for obviousness, insufficiency of description, failing to comply with the requirements of Section 8 and falling under the purview of Section 3(d) of the Act (Fresenius II).

The quinazoline ditosylate salt compounds that were the subject of Glaxo’s patent in Fresenius I were protein tyrosine kinase inhibitors (PTKs) belonging to the ErbB family, which has been implicated in a variety of disorders, including psoriasis and cancer. In Fresenius II, Glaxo’s application disclosed and claimed Lapatinib, a synthetic, orally-active quinazoline compound having antineoplastic activity. Lapatinib blocks phosphorylation of the growth factor receptors EGFR and ErbBs which have been implicated in the growth of various types of tumors. Glaxo markets Lapatinib (in the form of ditosylate monohydrate) under the names TYKERB® (in the U.S. and in certain international markets such as India) and TYVERB® (in the European Union and in other European countries).

In Fresenius I, Fresenius argued that Glaxo failed to disclose a Korean Patent application, certain U.S., European, Australian, Canadian and New Zealand divisional applications, a U.S. final rejection as well as details regarding certain counterpart U.S. and European patents.

In Fresenius II, Fresenius argued that Glaxo failed to disclose a counterpart published PCT application as well as certain European and U.S. patents.

In both proceedings, Fresenius simply argued that the Section 8 requirements were not complied with and did not provide any specific proof or details as to how Glaxo failed to comply with the requirements of this section. In response, Glaxo argued that it had furnished all the necessary information required under Section 8. In addition, Glaxo further argued that while Section 8 might have been necessary at a time when there was no infrastructure or technical support available to the IPO to learn of corresponding foreign applications, today with search engines and information available from the internet, Section 8 must be balanced and raised in context.

The Board noted that Section 8 destroys a patent which is otherwise patentable on a ground that has nothing to do with the invention, but instead only with an inventor’s lapse during the grant proceedings. Thus, according to the Board, Section 8 must be carefully applied and it was never intended to be a “bonanza for all those who want an inconvenient patent removed.” The Board referred to the Ayyangar Committee Report {which was submitted in 1959 and formed the basis of the Patents Bill of 1965 (which eventually lapsed)} which stated that:

“[I]t would be of [an] advantage therefore if the applicant is required to state whether he has made any application for a patent for the same or substantially the same invention as in India in any foreign country or countries, the objections, if any, raised by the Patent offices of such countries on the ground of novelty or unpatentability or otherwise and the amendments directed to be made or actually made to the specification or claims in the foreign country or countries.”

The Board further noted that the Ayyanger Report made it clear that the purpose of Section 8 was to allow the Indian Patent Office to know “the objections raised by the patent offices outside India regarding the patentability of the invention and the amendment[s] if any [were] made or [were] to be made.” Interestingly, the Board referred to the Therasense decision from the U.S. Federal Circuit noting that the materiality required to establish inequitable conduct was a but-for materiality and that when assessing the materiality of a withheld reference, a Court “must determine whether the Patent Office would have allowed the claim if it had been aware of the undisclosed reference.”

The Board also made it clear that the object of Section 8 was to ensure disclosure. Specifically, the Board also noted that this section had been introduced to make sure that a person given an exclusive monopoly was “candid and fair” in his conduct and disclosed all the official actions regarding patent filings made outside India with respect to the same or substantially the same invention.

In one portion of the decision, the Board reminded the Controllers at the Patent Office of their role and responsibilities in enforcing Section 8. Specifically, the Board stated that Controllers cannot ignore the requirements of Section 8 just because information relating to the corresponding foreign applications is available on the Internet. In particular, the Board stated:

“For good reasons, S. 8 is there in the Act. The Controllers cannot ignore it and condone the breach. The patentee cannot tell the Examiners, ‘We are filing applications nineteen to the dozen, compliance is very difficult, and in any case there is the Super Kamadhenu, the Internet which will give you what you want.’ We cannot wish S.8 a relieved farewell. Tough for Inventors, but they must comply with requirements of S. 8. When George Mallory was asked ‘Why do you want to climb Mount Everest?’ he is supposed to have replied, ‘Because it is there.’ To the question ‘Why should we comply with S.8?’ The answer is ‘Because it is there.’

Having said that, we must also insist that the IPO shall have a consistent stand with regard to S. 8. It cannot be East West Who is best. We request the Controller General to educate and instruct the officers regarding the requirements of the law. We must remember what the Supreme Court said in the Novartis case, ’29. In order to understand what the law really is, it is essential to know the ‘why’ and ‘how’ of the law. Why the law is what it is and how it came to its present form? The adage is more true in case of the law of patents in India than perhaps any other law.’ The ‘why’ of S. 8 is clear from the Ayyangar report. The office must remember it.

It is unfortunate that the office has failed to understand the importance of the S. 8 requirement and leaves it to the Patentee to decide what he will give. We earnestly hope that this practice has died a natural death. It is important that the Patentee furnishes details of those search reports where there are objections like obviousness objections and shall not suppress them. If one of the major Patent offices alone has raised an obviousness objection, it is the duty of the Patentee to disclose it, considering the Object of the Act” (emphasis in original).

Thereupon, the Board emphasized the point that a party seeking to revoke a patent based on Section 8 is required to do more than allege that Section 8 had not been complied with. Instead, at the time of filing a revocation action, a party alleging Section 8 non-compliance will have to:

1. Provide the specific corresponding filing particulars and/or foreign office actions, claim amendments, prior art and other information that was not submitted to the Patent Office; and

2. Demonstrate that the foreign office actions, claim amendments, prior art and other information not furnished relates to the same or the substantially the same invention as that in the patent for which revocation is being sought.

With respect to demonstrating whether foreign office actions and other information relate to the “same or substantially the same” invention, the Board noted that a divisional application would be considered to be the “same invention or substantially the same invention” and that information relating to such a divisional application or an amendment in such a divisional application would be information that should be submitted pursuant to Section 8.

Thereupon, the Board rejected Fresenius’ argument that Section 8 non-compliance had occurred in connection with both of Glaxo’s patents because Fresenius had failed to plead any facts sufficient to support that such non-compliance had occurred. According to the Board, “[A] bald statement will not suffice by merely reproducing the language of the section. The facts have to be pleaded and the applicant must state how the particular undisclosed application was for the same or substantially the same invention. It is also not enough to just file the documents along with an affidavit. The least that the deponent shall state is how it is the same or substantially the same.”

Ajanta Pharma Limited v. Allergan Inc., Allergan India PVT. LTD.

On August 8, the Board issued two decisions relating to two Indian Patents owned by Allergan Inc. (Allergan). In the first decision, the Board revoked Indian Patent No. 212695 entitled, “Hypotensive Lipid (prostaglandin derivatives) and Timolol Composition and Methods of Using Same.” Specifically, Ajanta Pharma Limited (Ajanta) filed a revocation action against Allergan’s patent arguing that the patent should be revoked for obviousness and for failing to comply with the requirements set out under Section 8 of the Act (Allergan I).

In the second decision, the Board revoked Indian Patent No. 219504 entitled “Combination of Brimonidine and Timolol.” Specifically Ajanta filed a revocation action against Allergan’s patent arguing that the patent should be revoked for obviousness and for failing to comply with the requirements of Section 8 of the Act (Allergan II).

The ophthalmic composition that was the subject of Allergan I related to a fixed combination of a hypertensive lipid (such as BIMATOPROST) and a Timolo component. According to the specification, this composition provided enhanced treatment of ocular hypertension with reduced side effects.

The ophthalmic composition that was the subject of Allergan II related to a combination of a certain weight percentage of each of Brimonidine and Timolol as well as a pharmaceutically acceptable carrier. This composition was sold commercially as Combigan®.

In Allergan I, Ajanta argued that the Allergan failed to provide the application numbers for corresponding applications filed in Korea, New Zealand, Canada, China and Japan as well as any information regarding the prosecution of the European and U.S. counterpart applications.

The Board found that Allergan failed to comply with Section 8(2) because no information relating to the prosecution of a same or substantially the same patent application in any corresponding foreign countries was provided to the Patent Office, (despite the fact that Allergan had agreed to provide such information). Although Allergan filed a petition under Rule 137 for condonation of the delay and irregularity with respect to certain “foreign filing particulars,” Allergan failed to disclose information relating to a certain published PCT application, a U.S. and European patent application and certain Office Actions in corresponding U.S. and Europe patent applications. In revoking the patent for non-compliance with Section 8, the Board said:

“We have indicated the principles behind the S. 8 objection, how it should be raised, defended and decided. The Act says failure to disclose the information required by S. 8 is a ground for revocation. It does not qualify it by saying that the failure must be deliberate nor are there any words to indicate that the failure must be in regard to material particulars.”

In Allergan II, Ajanta argued that Allergan failed to:

1.  Indicate in Form 3 the existence of three issued U.S. Patents; and

2. Furnish details of the proceedings in the U.S. Patent Office, the European Patent Office or the Japanese Patent Office (both the U.S. and European Patent Offices had rejected the requisite corresponding patent application).

In its decision, the Board reminded the appellants and respondents that with respect to Section 8 the following should be remembered:

1.  Section 8 must be complied with.

2. Non-compliance of Section 8 must be plead and proven with respect to patent applications that disclose the same or substantially the same invention.

3. Documents that prove such non-compliance must be filed early in the proceeding (if such documents are filed belatedly, costs might be imposed).

4. The failure to provide Section 8 particulars does not have to be deliberate and willful or with respect to material particulars.

5. A Patentee must be candid and fair in order to pursue the object behind the requirement laid under Section 8.

6. The Controller cannot deal with the Section 8 requirements casually. The Controller must adhere to the law and should not dilute it.

7. The Patentee has a statutory duty under Section 8 which cannot be satisfied by stating that the filing particulars for corresponding foreign applications are available on a website.

8. The Controller will not condone the non-disclosure of filing particulars of corresponding foreign applications under Section 8 by arguing that such information is available on a website.

9. Section 8 is not a penal provision and the object of the law is to provide clear disclosure to the Patent Office.

10. Once the Section 8(1) detailed particulars are given, the Controller may ask for details relating to “a” country. This can mean any country.

In revoking the patent, the Board held:

 …“that but for the fact that the EP office action and/or U.S. office action were kept away from the Controller, the patent may not have been granted.

…The Controller did not know of the adverse office actions, had the Controller known, the consequence may have been otherwise. It is no response to say that the standard must be more lax today because information is available on the internet. It is no defence to say that if the patent is valid otherwise then discretion should be exercised in the respondent’s favour.”

Disclosure Requirements in Other Countries

Given the rather strict disclosure requirements in India, we thought it would be useful to review the disclosure requirements in three other jurisdictions, specifically, Canada, Israel and the U.S.

Canada

In Canada, an Applicant has no duty to disclose prior art to the Canadian Intellectual Property Office (CIPO) but is permitted to voluntarily submit prior art to CIPO. Such voluntary submissions are at the discretion of the Applicant, but are recommended to support the prima facie validity of a patent. A Canadian Examiner, however, may require an Applicant to submit prior art that has been cited in corresponding patent applications filed in other countries, especially Europe and the U.S. If the Applicant fails to make a good faith response to the Canadian Examiner’s requisition for prior art in the allotted time, the application is deemed abandoned and CIPO sends the Applicant a notice starting a one-year period for making the good faith response and reinstating the application.

Additionally, the validity of an issued Canadian patent may not be challenged for failure to make a good faith response to an Examiner’s requisition for prior art during prosecution of the same patent. The appellate decision inCorlac Inc. v. Weatherford Canada Inc. effectively eliminated in Canada such challenges to the validity of a patent by indicating that courts should not retroactively examine an Applicant’s submission(s) that was deemed acceptable by CIPO. The validity of an issued Canadian patent may still be challenged, however, for willfully misleading statements or omissions to CIPO concerning the invention, for example, failure to adequately disclose how to implement the invention and improper statements with regards to the Applicant and/or inventor(s) that are material to patentability.

Israel

According to Section 18(1) of the Israeli Patent Law, the Israeli Patent Office is entitled to require an Applicant to submit a list of references relied upon by the Examining Authorities in all other countries in which an Applicant has filed an application on the same invention, including references cited and/or submitted by an Applicant to other Examining Authorities (such as the U.S. Patent Office, the European Patent Office, the Japanese Patent Office, etc.). According to Section 18(2) of the Israeli Patent Law, an Examiner is entitled to request that an Applicant provide any prior art references known to the Applicant and which were published before the priority date of the application that are directly applicable to the invention.

As such, the Israeli Patent Office issues a notification prior to examination directing the Applicant’s attention to the need to submit information under Section 18 (a “Section 18 Notification”). The Applicant must then disclose to the Israeli Patent Office all known information that may be related to the invention.

The requirement is ongoing up to allowance of the application. The requirement also applies to all references, including references cited by patent offices, references considered by the Applicant to be relevant to patentability of the claimed invention (even if not relied upon by another patent office when examining a foreign counterpart application), and references cited during various proceedings, such as oppositions, patent nullifications, and other court proceedings. Furthermore, according to an Israeli Patent Office directive, the Applicant is required to submit a list of the corresponding patent applications filed in other countries as well as electronic copies of all non-patent references disclosed under Sections 18(1) and 18(2). It is important to note that these requirements are not explicitly stated in the statute, but are included in the Section 18 Notification. The requirement for “copies of any references the Examiner requests” is covered by the statute; however, the actual Israeli Patent Office requirement has recently changed from providing “X (novelty) and Y (inventive step/obviousness) references” to “all non-patent references disclosed under Sections 18(1) and 18(2).”

The requirements under Section 18 may be fulfilled by providing a cumulative list of the references cited in search reports, such as the International Search Report, a supplementary European Search Report, a U.S. Notice of References Cited {U.S. PTO form PTO-892 for Section 18(1)}, and a separate list of additional references known to the Applicant, such as those listed in an Information Disclosure Statement (IDS) submitted to the U.S. PTO for a corresponding United States patent application {for Section 18(2)}. Please note that the statutory requirement and Israeli Patent Office directive is for separate lists, thus supplying copies of IDS’ submitted to the U.S. PTO does not fully comply with the requirement.

A recent amendment to Section 18 now allows third parties to submit prior art in a pending patent application on a limited basis. Specifically, any prior art submitted by a third party must be filed within two months of the Applicant’s initial Section 18 response.

If an Applicant fails to file an initial Section 18 response, the application will not proceed to substantive examination and the application will be deemed to be abandoned.

If an Applicant knowingly fails to fully comply with Section 18, such as, for example, by not updating the Israeli Patent Office regarding any new citations, or by not disclosing a relevant reference, and the application is allowed or granted, then in a proceeding before the Registrar (such as in an opposition against the allowed application) or before the Court (such as in a request for cancellation of the patent), the Registrar or Court is entitled to carry out one or more of the following: (1) cancel or not grant the patent; (2) grant a compulsory license to a third party (under conditions agreed to among the parties, or in the absence of an agreement, as deemed by the Registrar or Court); and/or (3) shorten the term of the patent. In addition, the Court may also impose a fine in accordance with the Penal Code (1977) on the party responsible for failing to comply with the Section 18 requirement.

U.S.

Under 37 C.F.R. § 1.56, an individual associated with the filing or prosecution of a patent application, such as an inventor, an attorney and/or an agent, has a duty to disclose to the U.S. Patent Office all information known to the individual to be material to patentability. Information is material to patentability when it establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim or it refutes or is inconsistent with, a position the Applicant takes in (i) opposing an argument of unpatentability relied on by the U.S. Patent Office or (ii) asserting an argument of patentability. Information that is material to patentability may include relevant patents, patent applications and other published information, information on enablement, possible prior public uses, sales, offers to sell, derived knowledge, prior invention by another, and inventorship conflicts.

The duty of disclosure is fulfilled by submitting the information relevant to an invention’s patentability on an Invention Disclosure Statement. The duty to disclose exists until the application becomes abandoned or a patent is granted on that application. Failure to comply with the disclosure requirement can result in a ruling by a court that the Applicant has engaged in inequitable conduct.  A ruling of inequitable conduct can lead to the invalidation of any patent that might issue from the application and possible disbarment of the attorney or agent.

The bar for proving inequitable conduct was set high in the Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011) an en banc decision, in which the Federal Circuit held that inequitable conduct must be shown with clear and convincing evidence that there was intent to withhold or misrepresent information and that the information was material. Specifically, clear and convincing evidence must show that the Applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it. The Court noted that proving that an Applicant knew of a reference, should have known of its materiality, and decided not to submit it to the U.S. Patent Office does not prove specific intent to deceive. However, the Court explained that intent can be inferred from indirect and circumstantial evidence, but that this inference must be the “single most reasonable inference able to be drawn from the evidence.” The Federal Circuit also adopted a new standard for materiality required to establish inequitable conduct. A reference is material if “there is a substantial likelihood that a reasonable examiner would consider it important in deciding whether to allow the application to issue as a patent”, i.e., the prior art is but-for material if the U.S. Patent Office would not have allowed a claim had it been aware of the undisclosed prior art.

Attorneys and patent agents at Chadha & Chadha, Gowlings and Dr. Shlomo Cohen & Co also contrubuted to this article.

© MICHAEL BEST & FRIEDRICH LLP

About the Author

Patent Agent

Julia Cox is a Patent Agent and a member of the Intellectual Property Practice Group in the Madison office. Dr. Cox has an extensive background in Chemistry, Biochemistry, and Molecular Biology, with broad experience in protein engineering, pharmaceuticals, genetic screening, and biotechnology. She has experience in all phases of foreign and domestic patent prosecution, including advising clients in contemplation of filing a patent, as well as writing and prosecuting patent applications. Dr. Cox focuses her practice on inventions in life science, pharmaceuticals, and biotechnology.

608-283-4429

About the Author

Laura J, Opperman Ph.D. Scientist Michael Best Friedrich LLP
Member

Laura Opperman is a Patent Scientist in the Intellectual Property Practice Group in the Madison office.

608-257-3061
Lisa L. Mueller, Michael Best Law Firm, Patent Attorney
Partner

Lisa Mueller is a partner in Michael Best’s Intellectual Property Practice Group and a member of the Life Sciences Industry Group. Ms. Mueller writes a blog found at http://bricwallblog.wordpress.com/. Ms. Mueller has extensive experience in the biotechnology and pharmaceutical areas. In her practice, Ms. Mueller regularly drafts and prosecutes patent applications involving genomics, proteomics, immunology, diagnostic assays, pharmaceuticals, green chemicals and bi-products, agricultural products,...

312-596-5812

About the Author

Associate

Sansun Yeh is a member of the firm’s Intellectual Property Practice Group in the Madison office. Dr. Yeh’s practice is focused on patent drafting and prosecution. She has also provided litigation support.

608-257-3055

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