Category Archives: Patents

Teva held responsible for Induced Infringement of Eli Lilly’s Blockbuster drug ALITMA

In Teva Parenteral Medicines, Inc.; APP Pharmaceuticals LLC; Pliva Hrvatska D.O.O.; Teva Pharmaceuticals USA, Inc.; and Barr Laboratories, Inc. (hereinafter referred to be as Defendants/Appellants/Teva) Vs. Eli Lilly & Co. (hereinafter referred to as Plaintiff/Appelle/Eli Lilly) decided by United States Court of Appeals for the Federal Circuit (CAFC) on January 12, 2017, Plaintiff had filed Hatch Waxman suit against defendant to prevent them from launching generic version of the lung cancer drug whose rights are reserved with the plaintiff. The decision from CAFC came after an appeal from the United States District Court for the Southern District of Indiana in No. 1:10-cv-01376-TWPDKL, Judge Tanya Walton Pratt.

Eli Lilly owns a patent US 7772209 (hereinafter referred to as US‘209) issued in 2010, relating to method of treatment administering the chemotherapy drug pemetrexed disodium (hereinafter referred to as “pemetrexed”) (used to treat certain types of lung cancer and mesothelioma) after pretreatment with two common vitamins—folic acid and vitamin B12 (reduce the toxicity of pemetrexed in patients). Eli Lilly markets pemetrexed under the brand name ALIMTA®.

In 2008-2009, Defendants notified Eli Lilly that they had submitted ANDA seeking approval to market generic version of ALIMTA®. After issuance of US’209 patent, Teva sent additional notice that they had filed Para IV certifications, declaring that US’209 patent was invalid, unenforceable, or would not be infringed. Subsequent to which Eli Lilly alleged Teva of induced infringement. Eli Lilly asserted that Teva’s generic drug would be administered with folic acid and vitamin B12 pretreatments and thus will result in infringement of the 209 patent.

Eli Lilly asserted claims 9, 10 (dependent on claim 1), Independent claim 12, and its dependent claims 14, 15, 18, 19, and 21 of the US’209 patent at trial.

Independent claims 1 and 12 have been reproduced below for reference:

Claim 1:

A method of administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

Claim 12:

An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:

  1. a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;
  2. b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and
  3. c) administration of pemetrexed disodium.

It is important to note that current case involves issue of induced infringement i.e. a type of indirect infringement that may be committed under section 271 (b) (dealing with infringement of Patents).

In June 2013, Defendants conditionally conceded induced infringement under then-current law set forth in Akamai Technologies, Inc. v. Limelight Networks, Inc. (Akamai II) which at that time was the subject of a petition to the Supreme Court for a writ of certiorari. The parties’ stipulation included a provision reserving Defendants’ right to litigate infringement if the Supreme Court reversed or vacated Akamai II.

District court had rejected contentions of the defendant that Patent was invalid for obviousness or obviousness-type double patenting and also due to indefiniteness of the term vitamin B12.

Defendants filed an appeal on invalidity. While that appeal was pending, the Supreme Court reversed Akamai II, holding that liability for inducement cannot be found without direct infringement, and remanding for CAFC court to possibly reconsider the standards for direct infringement. In view of that development, the parties in this case filed a joint motion to remand the matter to the district court for the limited purpose of litigating infringement. CAFC granted the motion.

The district court held a second bench trial in May 2015 and concluded in a decision issued on August 25, 2015 that Defendants would induce infringement of the US’209 patent. This was after considering the effect of Akamai V decision, which had broadened the circumstances in which others’ acts may be attributed to a single actor to support direct infringement liability in cases of divided infringement.

Defendants appealed.

Below given factors are taken into consideration while deciding cases of induced infringement:

  • Whoever actively induces infringement of a patent shall be liable as an

Infringer;

  • There cannot be indirect infringement without direct infringement;
  • Patentee needs to prove alleged infringer knew or should have known his actions would induce actual infringements; and
  • Standard of proof required by Patentee to claim relief under induced infringement is ‘preponderance of the evidence’.

It was agreed by parties that Defendants’ proposed product labeling would be materially the same as the ALIMTA® product labeling and consists of two documents: the Physician Prescribing Information and the Patient Information. District court found that both the documents included instructions regarding the administration of folic acid—the step that the district court found would be performed by patients but attributable to physicians.

According to Akamai V, where no single actor performs all steps of a method claim, direct infringement only occurs if the acts of one are attributable to the other such that a single entity is responsible for the infringement. The performance of method steps is attributable to a single entity in two types of circumstances:

  • when that entity “directs or controls” others’ performance, or

 

  • when the actors “form a joint enterprise.”

In Akamai V, CAFC had held that directing or controlling others’ performance includes circumstances in which an actor:

(1) “conditions participation in an activity or receipt of a benefit” upon others’ performance of one or more steps of a patented method, and

(2) “establishes the manner or timing of that performance.”

District court found taking folic acid in the manner recited by the asserted claims is a critical and necessary step to reduce potentially life threatening toxicities caused by the Pemetrexed amounts to receive the benefit of the patented method.

Regarding first of the two pronged test, the court found, based on the product labeling, that taking folic acid in the manner specified is a condition of the patient’s participation in the Pemetrexed treatment. Regarding the second prong, the court found that physicians would prescribe an exact dose of folic acid and direct that it be ingested daily. Hence court held all steps of the asserted claims would be attributable to physicians.

Court further observed that the mere existence of direct infringement by physicians, while necessary to find liability for induced infringement, is not sufficient for inducement but there has to be also specific intent and action to induce infringement. Court went on to find intent on the part of physician for the inducement and held that there was no error in district court’s decision. Some important observations of court have been mentioned below.

CAFC made two important observations as below:

  • The intent for inducement must be with respect to the actions of the underlying direct infringer, here physicians.

 

  • Second, it is not required to show evidence regarding the general prevalence of the induced activity. When the alleged inducement relies on a drug label’s instructions, the question is not just whether those instructions describe the infringing mode,..but whether the instructions teach an infringing use such that we are willing to infer from those instructions an affirmative intent to infringe the patent. Court further observed that the label must encourage, recommend, or promote infringement and it is irrelevant that some users may ignore the warnings in the proposed label.

Court went on to observe a label that instructed users to follow the instructions in an infringing manner was sufficient even though some users would not follow the instructions, but vague instructions that require one to look outside the label to understand the alleged implicit encouragement do not, without more, induce infringement.

On the issue of invalidity on the indefiniteness of the term “vitamin B12”, CAFC hold that a person of ordinary skill in the art would understand the scope of the claim term “vitamin B12” with reasonable certainty. Applying Nautilus (outcome of this decision) in this case did not lead CAFC to a different result from the district court’s conclusion on the question of indefiniteness.

Regarding issue of invalidity due to obviousness, CAFC was not convinced that the district court committed clear error in concluding that Defendants failed to carry their burden of proving that it would have been obvious to a person of ordinary skill to use vitamin B12 pretreatment to reduce Pemetrexed toxicities.

Thus CAFC affirmed district court decision.

About the Author :  Ms. Rashmi Goswami, WOS-C at TIFAC, intern at Khurana and Khurana, Advocates and IP Attorneys and can be reached at swapnil@khuranaandkhurana.com

NEPAL’S IP LAW: AN ENCAPSULATION

Intellectual property law in Nepal is comparatively new and it enjoys the extension provided for under the TRIPS agreement to the least developed country. The Patents, Designs and Trademarks are protected under one head, and the governing act/ legislation is known as “The Patent, Design and Trade Mark Act, 2022 (1965)” (hereinafter referred to as “Act”).

Trademarks

Section 2: Definitions: Unless the subject or the context otherwise requires in this Act:

“Trade-mark” means word, symbol, or picture or a combination thereof to be used by any firm, company or individual in its products or services to distinguish them with the product or services of others.

FILING PROCEDURE:

Step 1: Filing

  • Who may apply: Section 17:
  • Any person desirous to register the trademark of his business shall submit an application to the Department in the format specified in Schedule 1(C).
  • Document: Four specimens of the Trade Mark sought to be registered.
  • Fees: NPR 2000.

Trademark Application in Nepal can be filed in a single class only. Mutli-class Application cannot be filed.

Step 2: Investigation:

  • Section 18: When an application is received by the department, it conducts necessary investigation/examination and provides an opportunity of being heard to the applicant in case of any concerns/objections.
  • Examination is done with regard to distinctiveness, possibility of distinctiveness and conflicting trademarks.

Step 3: Grant/ Refusal:

  • If the department is satisfied with the application for registration, it shall register the trademark in the name of the applicant and grant him a certificate. Registration fees: NPR 5000.
  • It may conduct further inquiry/ investigation.
  • The mark shall not be registered/ registration is liable to be cancelled when the subject mark:
  • Hurt the prestige of individual/ institution
  • Adversely affect public conduct or morality
  • Undermine the national interest
  • Undermine the reputation of another’s trademark
  • Found to have already been registered in the name of another person.
  • If the registered trademark is not used within 1 year from the date of registration, the department may cancel the registration after conducting necessary inquiries.
  • The term of the registered trademark shall be 7 years from the date of registration.

Step 4: Publication:

  • Section 21A: The department shall publish the trademarks registered under section 18. Such publication is made in the Trademark Journal.
  • Anyone who has any objection to the same shall file a complaint to the department within 3 months from the date of such publication in Trademark Journal.
  • Necessary actions shall be taken by the department after conducting inquiries.

Step 5: Renewal and Cancellation

  • Renewal: Section 23B:
  • A trademark holder needs to renew the registration within a period of 35 days from the date of expiration of the term for which he is entitled to use the same.
  • The prescribed form is Schedule 2(F) and the fee is NPR 500 each time.
  • When the time limit of renewal expires, renewal may be done within 6 months from the date of expiry of the time limit for the same along with a fee of NPR 1000.
  • A trademark can be renewed indefinitely for a period of 7 years each time after a payment of renewal fee.

 

Patents

Section 2: “Patent” means any useful invention relating to a new method of process or manufacture, operation or transmission of any material or a combination of materials, or that made on the basis of a new theory or formula.

FILING PROCEDURE:

Step 1: Filing:

  • Who may apply: Section 3 and 4:
  • Any person desirous of having any patent registered in his name shall submit an application to the Department in the format prescribed in Schedule 1(A) containing the following particulars, along with all evidences related to the same in his possession:
  • Name, address and occupation of the inventor (person inventing the patentable subject matter)
  • If the applicant is not the inventor, then information as to how and in what manner has he acquired title thereto from the inventor
  • Process of manufacturing, operating or using the patent
  • If the patent is based on any theory or formula, then the same needs to be mentioned.
  • Maps or drawings, if any.
  • Application fees: NPR 2000

Step 2: Investigation:

  • Section 5: On receipt of an application for registration, the Department shall conduct all investigation or study to ascertain two things:

(a)  Whether the patent claimed in the application is a new invention or not

(b)  Whether it is useful to the general public or not.

 

  • Section 6: The Department shall not register any patent under this Act in the following circumstances:

(a) In case the patent is already registered in the name of any other person, or

(b) In case the applicant him/herself is not the inventor of the patent sought to be so registered nor has acquired rights over it from the original inventor, or

(c) In case the patent sought to be registered is likely to adversely effect the public health, conduct or morality or the national interest, or

(d) In case it is contradictory to the prevailing laws (the registration of the patent) will constitute a contravention of existing Nepal law.

The Examination/Investigation is of two kinds namely;

  1. Formality Examination- It is done to determine whether the application for patent fulfills the requirements of the same.
  2. Substantive Examination- It is done to determine the patentability of the invention, whether;

–  The claimed product/process is patentable or not.

–  The claimed invention is new i.e passes the test of Novelty.

–  The claimed invention is capable of Industrial Application.

– The invention involves a ‘innovative step’

Step 3: Grant/ Refusal:

  • If the Department is satisfied with the findings under Section 5, it shall register the patent in the name of the applicant.
  • In case, the Application does not fulfill the statutory requirements, a notice to the applicant is sent regarding the Rejection of Application.
  • Section 7: Issue of registration certificate:
  • When the registration of the patent is granted, the Department shall issue a certificate of registration in the name of the applicant in the format prescribed in Schedule 2(A).
  • The fee for the same is NPR 10,000.
  • Section 8: The term of the patent granted shall be 7 years from the date of registration.

Grounds of refusal/ cancellation of registration: Section 6:

  • The patent is already registered in the name of other person
  • The applicant is not the inventor of the subject matter of the patent and has not acquired rights over it from the original inventor
  • The patent sought adversely affects public health, conduct or morality, or national interest
  • The patent sought is contradictory to existing Nepalese laws.
  • The applicant will be provided a reasonable opportunity of being heard before the department cancels the registration of the patent.

Step 4: Publication:

  • Section 7A: All patents registered under the Act, except those that are kept secret in the national interest, shall be published in the Nepalese Gazette by the department.
  • In case of objections, the complaint may be filed within 35 days from the date of seeing or copying the Patent, and thereafter, the Department shall conduct necessary inquiries and take further action. The fee for complaints and objections is NPR 1000.
  • In case anyone wants to see or copy the particulars, maps or drawings of a patent, he can do so by paying the prescribed fee of NPR 750.

Step 5: Renewal

  • Section 23B: Renewal:
  • A patent holder shall renew the registration within a period of 35 days from the date of expiration of the term for which he is entitled to use the same.
  • The prescribed form is Schedule 2(D) and the fee for
  1. First time: NPR 5000
  2. Second time: NPR 7500.
  • When the time limit of renewal expires, it may be done within 6 months from the date of expiry of the time limit for the same along with a fee of NPR 1000.
  • A patent can only be renewed twice for a period of 7 years at a time.

 

FILING CONVENTION PATENT APPLICATIONS IN NEPAL:

Nepal being party to Paris Convention since June 2001, an applicant desirous of filing patent application in Nepal claiming priority from one or more convention countries based on same invention may file such application within 12 months from the date of earliest priority. Pertinently, Nepal is not a member of PCT (Patent Cooperation Treaty).

 

Designs

Section 2:

“Design” means the form or shape of any material manufactured in any manner.

FILING PROCEDURE:

Step 1: Filing:

  • Who may apply: Section 12 and 13:
  • A person desirous to register the design of any article manufactured or caused to be manufactured, shall submit an application in the format specified in Schedule 1 (B) to the Department.
  • The applicant shall also furnish four copies of such design and maps, and drawings and particulars thereof.
  • Fees: NPR 1000.

Step 2: Examination

This involves “Formality check” and “Substanstive check” –

  1. Formality Check- An application is submitted to check if the statutory formalities and procedural requirements are fulfilled.
  2. Substantive Check- After the formality check, a substantive examination is carried out, weather ;

–  There is existence of a prior application or registration of the same.

–  Such design will hurt the prestige or interest of an individual or institution or conduct of public or morality of undermines national interest.

If either of the above mentioned points are

Step 3: Grant/ Refusal:

  • Section 14: On receipt of the application filed by any person under Section 13, the Department shall register the design in the applicant’s name and issue a certificate of registration in the format specified in Schedule 2(A). i.e If it has passed the stage of Examination.
  • In case, the Application is rejected, a Notice of Rejection is sent to the Applicant.
  • Registration fees: NPR 7000.
  • The term of a registered design is five years from the date of registration.
  • Renewal: Section 23B:
  • A design holder shall renew the registration within a period of 35 days from the date of expiration of the term for which he is entitled to use the same.
  • The prescribed form is Schedule 2(E) and the fee for
  1. First time: NPR 1000
  2. Second time: NPR 2000.
  • When the time limit of renewal expires, it may be done within 6 months from the date of expiry of the time limit for the same along with a fee of NPR 1000.
  • A design can only be renewed twice for a period of 5 years at a time.

Step 4: Publication:

  • Section 21A: The department shall publish the designs registered under section 14, along with their particulars of renewal or cancellation.
  • Anyone who has any objection to the same need to file a complaint to the department within 35 days from the date of such publication.
  • Post receiving the complaint, Department takes necessary actions after conducting inquiries.

Step 5: Renewal/ Cancellation

Grounds of refusal/ cancellation: Design is liable to be refused or cancelled, if the design or design registration, as the case may be:

  • Hurt the prestige of individual/ institution
  • Adversely affect public conduct or morality
  • Undermine the national interest
  • Found to have already been registered in the name of another person.
  • The design holder will also get an opportunity to show cause as to why his registration must not be cancelled.

REVOCATION OF PATENTS ACCORDING TO INDIAN PATENT ACT, 1970: INSIGHT

This article focuses on the revocation proceedings which is one of the mechanisms available for annulations of Patents in India.

  1. What is revocation of a patent?

When a patent has been sealed or granted, it is not always the case that the patent shall stay unhindered by any third party till the life of the patent. The patent can be challenged by certain people on different grounds, and a method to cause the same is by filing a revocation petition/ post-grant opposition proceedings. This article focuses on the revocation proceedings.

  1. Why does one file a revocation petition?

As the Patent Act does not presume Patents granted to be valid, rights granted on such Patents cannot be absolute. Third parties which are required to seek permission from Patentee for practicing any of the exclusive rights bestowed upon him are also given a chance to challenge the validity of the Patents. This challenge can be instituted on own as well as on Patentee asserting infringement of Patent rights.

  1. Who can file a revocation petition?

As per Section 64 of the Patent Act, 1970, the following persons can file the petition in the High Court:

  • any person interested[1];
  • the Central Government
  • the person making the counter-claim in a suit for the infringement of a patent
  1. Where can a revocation petition be filed?

Thus, a revocation petition can be filed in the Intellectual Property Appellate Board by the interested person or the Central Government, or it can be filed as a counter-claim in a suit for infringement at the High Court.

To bring in the aspect about jurisdiction of suits of infringement and the corresponding revocation petitions, Section 104 of the Patents Act, 1970 states that no suit of infringement can be brought before a court inferior to the District Court having jurisdiction to try the suit and in the event of a counter-claim for revocation of the patent made by the defendant, such suit for infringement and the said counter-claim must be transferred to the High Court.

  1. What are the grounds under which a revocation petition can be brought?

Under Section 64, the following are the said grounds:

  1. the invention, so far as claimed in any claim of the complete specification, was claimed in a valid claim of earlier priority date contained in the complete specification of another patent granted in India;
  2. the patent was granted on the application of a person not entitled to apply therefor;
  3. the patent was obtained wrongfully in contravention of the rights or the petitioner or any person under or through whom he claims;
  4. the subject of any claim of the complete specification is not an invention;
  5. the invention so far as claimed in any claim of the complete specification is not new, having regard to what was publicly known to publicly used in India before the priority date of the claim or to what was published in India or elsewhere in any of the documents referred to in Section 13;
  6. the invention so far as claimed in any claim of the complete specification is obvious or does not involve any inventive step, having regard to what was publicly known or publicly used in India or what was published in India or elsewhere before the priority date of the claim;
  7. the invention, so far as claimed in any claim of the complete specification, is not useful;
  8. the complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed, that is to say, that the description of the method or the instructions for the working of the invention as contained in the complete specification are not by themselves sufficient to enable a person in India possessing average skill in, and average knowledge of the art to which the invention relates, to work the invention, or that it does not disclose the best method of performing it which was known to the applicant for the patent and for which he was entitled to claim protection;
  9. that the scope of any claim of the complete specification is not sufficiently and clearly defined or that any claim of the complete specification is not fairly based on the matter disclosed in the specification;
  10. that the patent was obtained on a false suggestion or representation;
  11. that the subject of any claim of the complete specification is not patentable under this Act;
  12. that the invention so far as claimed in any claim of the complete specification was secretly used in India, otherwise than as mentioned in sub-section (3), before the priority date of the claim;
  13. that the applicant for the patent has failed to disclose to the Controller the information required by section 8 or has furnished information which in any material particular was false to his knowledge;
  14. that the applicant contravened any direction for secrecy passed under section 35
  15. that leave to amend the complete specification under section 57 or section 58 was obtained by fraud.
  16. that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention;
  17. that the invention so far as claimed in any claim of the complete specification was anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere.
  1. Does revocation restrict itself to Section 64?

It is important to note that section 64 does not restrict grounds to be used in revocation to only those provided in section 64 whereas section 25 (2) setting out grounds used in post-grant opposition proceedings is restrictive in nature.

  1. What are the other provisions concerning revocation?

Under Section 65, if a patent is claimed to be related to atomic energy, a revocation petition can be filed against it. Such patent shall not be granted under the Atomic Energy Act, 1962 and shall be revoked. Under Section 66, if the Central Government is of the opinion that a patent or the mode in which it is exercised was mischievous to the State or prejudicial to the public, after giving an opportunity to the patentee to be heard, it may make such declaration in the Official Gazette and the patent shall stand revoked.

Moreover in the Enercon (India) Ltd and Ors. v Enercon Gmbh (2014) 5 SCC 1 , it was laid down by the Supreme Court that when post grant opposition proceedings are instituted by a party, he cannot institute a revocation petition or counter-claim of revocation proceeding against the same patent.

  1. “‘Person interested’ under Section 64 would mean a person who has a direct, present and tangible commercial interest which is injured or affected by the continuance of the patent on the register. (Ajay Industrial Corporation v Shiro Kanao of Ibaraki City AIR 1983 Del 496)”

About the Author :  Ms. Anjana Mohan, Symbiosis Law School, Pune, intern at Khurana and Khurana, Advocates and IP Attorneys. Views expressed in this article are solely of the intern and do not reflect the views of either of any of the employees or employers. Queries regarding this may be directed to swapnil@khuranaandkhurana.com or swapnils@khuranaandkhurana.com.

India: Do we need Patent Term Extension and Non-Patent Exclusivities for Pharmaceuticals?

India, though in a phase of rapid economic development, still has the bane of poverty. In this country, around 22% of the population is Below the Poverty Line [1], and hence most of the nation’s policies are oriented towards the poor. India’s IP Policy is no different, as the IP legislature in India is mostly oriented towards giving the general public an easy and inexpensive access to medicines. Indian IP policy drafters have used every flexibility in the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS), to which India is a signatory, for this purpose.

The curious case of drug development

The process of development of the drugs to treat the diseases and ailments is pretty much painstaking. A drug regulatory authority, (e.g. The US Food and Drug Administration-US FDA; Central Drugs Standard Control Organization-CDSCO in India) monitors and governs the testing of the New Chemical Entities (NCEs) through pre-clinical and clinical trials to prove their safety and efficacy to treat an ailment. Several NCEs fail at some or the other stage, rendering all the money and efforts in vain. The amount of money invested in each NCE is of the order of billions of dollars. [2] The time period it takes for the development of the NCEs as approved ‘Drugs’ typically ranges from 10-15 years [2]. The chances of a candidate making it through this whole of the process, to the desk of the pharmacy, are merely 2% [2]. So, in this precarious situation, the 20 years of patent protection granted to the drug products is not sufficient to recover the huge investment made in the R&D of the product. So, the pharma companies usually demand the extension of the protection of their monopoly over the drug product. This Patent Term Extension (PTE) is granted by the Patent Office of the region or country.

Now, these clinical trials generate data regarding the therapeutic activity and safety of the drug. So, if a generic player wants to launch the same drug, it will need this data to prove that its generic version of the drug is ‘equivalent’ to the innovator’s product. Since the innovator companies invest huge amounts of time, money and efforts into generating this data, they demand exclusivity of this data. This Clinical Trial Data Exclusivity is under the discretion of the drug regulatory authority and regardless of the existence of a valid patent on the subject matter. If granted, it gives an additional layer of protection to the innovator drug product.

In the following paragraphs, we will discuss the Patent Term Extension and Clinical Trial Data Exclusivity provisions present in the US and European, legislature, in comparison with the Indian scenario. Several other countries also provide these provisions, but we will limit our discussion to these three jurisdictions.

 

Patent Term Extension

In the US, according to the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, 1984 [3], the patent term can be extended up to 5 years, however, the total patent term (including extension) should not be more than 14 years after the date of approval of the product by FDA. This period may be extended by a period of another six months of Pediatric Exclusivity.

The European Patent Office similarly provides an extension of protection in this regards, by giving the Supplementary Protection Certificate (SPC). [4] The SPC allows extending the Patent term by 5 years. however, the total patent term (including extension) should not be more than 15 years after the date of approval of the product by the European Medicines Agency. Additional 6 months’ protection is given to medicinal preparation to treat children (Pediatric Formulations). This extension is not applicable to orphan drugs [11]

Non-Patent Exclusivities:

The US FDA grants different types of Non-Patent Exclusivities [5] [6]

  1. 5 years for a New Chemical Exclusivity (NCE) for the Active Ingredient approved for the first time
  2. 180 days exclusivity for the generic player who first files and maintain an ANDA (Abbreviated New Drug Application) with Paragraph IV certification, which requires the applicant to prove either that he will not be infringing the innovator’s patent or that the innovator’s patent is invalid/not enforceable.
  • 3 years of New Clinical Study Exclusivity for submission of “reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application [or the supplemental application] and conducted or sponsored by the applicant”. For example, in case of preparation of a drug previously approved, which differs in the route of administration, drug delivery system, dosing regimen, modification of the drug such as salt or ester, which won’t affect the pharmacological actions of the drug. The exclusivity period would start from the date of NDA approval of the same drug. This is for the Active Ingredient has been approved before in another application.
  1. 5 additional years in case of antibiotics that treat some serious condition, for products that have obtained Qualified Infectious Disease Products (QIDP) designation under the Generating Antibiotics Incentives Now (GAIN) Act.
  2. 7 years for an orphan drug, i.e. the drug for the treatment of the rare diseases
  3. 6 months of Pediatric Exclusivity which gets added to the existing Patents and exclusivities.

The table below summarizes these exclusivities in relation to whether innovator and/or generic players can avail them.

Table 1. Scheme of Exclusivities granted by the US FDA

Sr. No. Description  NDA Applicant  ANDA Applicants
1 New Chemical Entity (NCE) 5 years NA
2 New Clinical Investigation (NCI) (Same drug, different route of administration or another form of the same drug, e.g. salt form) 3 years NA
3 First Abbreviated New Drug Application, under Para (IV), with applicant successfully proving the innovators patent invalid, or not infringing, or in case the infringement suit is not filed within 45 days of application NA 6 months
4 Antibiotics with Qualified Infectious Disease Product (QIDP) designation to treat serious conditions 5 additional years NA
5 Drugs to treat rare disease (Orphan Drugs) 7 years NA
6 Pediatric preparation 6 additional months NA

The European Medicines Agency, after 2005,started the 8+2(+1) formula which dictates that the innovator will be getting 8 years’ data exclusivity, and 2 years of market protection, during which no generic can be placed on the market, and an additional 1 year exclusivity for the new indication which shows significant clinical benefit (same as NCI in the US). Prior to this rule, there was a distinction for nationalized procedure and centralized procedure. The following table indicates the exclusivity period based on the application date and type.

Date of submission of application For Centralized Procedure For Nationalized Procedure
Before

20.11.2005 (CP)

30.10.2005 (NP)

10 years’ data exclusivity 6a or 10b years’ data exclusivity
After

20.11.2005 (CP)

30.10.2005 (NP)

8 years data exclusivity

+2 years market protection

(+1 year market protection for the new indication showing significant clinical benefit)

a – Austria, Denmark, Finland, Ireland, Portugal, Spain, Greece, Poland, Czech Republic, Hungary, Lithuania, Latvia, Sweden, Slovakia, Malta, Estonia, Cyprus, Bulgaria, Romania, Norway, Iceland, and Liechtenstein. (‘6-year countries’)

b – Belgium, Germany, France, Italy, Netherlands, Sweden, United Kingdom, Luxembourg. (’10 year countries’)

In addition to this, the orphan drugs get 2 more years of exclusivity. [7], [11]

India

India has not, as of yet, implemented such provisions, because-

  1. Granting of the PTE and Non-Patent Exclusivities would require the establishment of the Patent Linkage system in effect, which is not there at present, and India is not planning to do it in the near future, because India has not, as of yet, entered into any trade agreement which requires such provisions.
  2. The TRIPS agreement also does not require members to grant such benefits to the innovators, this means that India is in no obligations to grant PTE and Non-Patent Exclusivities. [8] Whatever pressure is there on Indian policymakers to implement such benefits, are there due to the Trade Agreements like the Trans-Pacific Partnership (TPP), Regional Comprehensive Economic Partnership (RCEP). These agreements constitute to a new regime called as TRIPS Plus, which is lobbied by the big pharma companies of the developed countries. Currently, India is not signatory to any of such agreements.
  3. If at all these provisions are implemented, they would severely delay the entry of generic versions of the drugs into the market. India, being a developing country, simply cannot afford granting PTE and DE to every request, at the expense of access to the poor.
  4. On the same lines, the Indian Pharma sector is largely thriving on the generic players, so the industry is hardly affected by the absence of provisions for PTE and DE.

These provisions have long been sought by the Big Pharma lobby of the developed nations, by criticizing India’s ‘weak’ IP policies. Companies like Bayer, Novartis have tried to tweak with the legislature for the same purpose. [9] Several generic pharma companies and access-to-medicines activists like Médecins Sans Frontières (Doctors without Borders) have constantly warned India about the effects of such provisions, saying that India will no longer remain the ‘Pharmacy of the world’. [10]

Implementing these would be advantageous only to the innovator companies, and millions will be stripped off their right to live a healthy life. This is being sugarcoated to say that these provisions will boost the trade and innovation in India. On the other hand, if these provisions are not introduced, India will be under constant pressure to do so at the earliest, but it won’t kill anyone. Now it is up to the policy makers whom they are going to put first.

About the Author: Mr. Swapnil Chandwade intern at Khurana and Khurana, Advocates and IP Attorneys. In case of any queries, feel free to reach on swapnil@khuranaandkhurana.com.

References:

  1. http://data.worldbank.org/country/india
  2. http://www.nature.com/nrd/journal/v9/n3/full/nrd3078.html
  3. http://www.fda.gov/newsevents/testimony/ucm115033.htm
  4. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31992R1768
  5. http://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm447307.pdf
  6. http://www.orangebookblog.com/files/nonpatent_exclusivity.pdf
  7. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/05/WC500143122.pdf
  8. https://indiankanoon.org/doc/1123372/
  9. https://iiprd.wordpress.com/2010/05/17/bayer-vs-cipla/
  10. http://www.thehindu.com/sci-tech/health/If-India-signs-RCEP-it-will-not-be-the-pharmacy-of-the-world-MSF/article14422200.ece
  11. Chakrabarti, G., 2014. Need of data exclusivity: Impact on access to medicine. Journal of Intellectual Property Rights, 19(5), pp.325-336.

Analysis of the rejection of Lumacaftor (Polymorph) patent application in India

We have been receiving requests from our Pharma clients/readers of the blog for the analysis of the decision/ facts that led to rejection of Lumacaftor (Polymorph) patent application in India since last year.

Here is our take:

Details of the Patent Application and important dates:

Patent application number in India 2056/KOLNP/2010
Title of the invention SOLID FORMS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID
Applicant VERTEX PHARMACEUTICALS INCORPORATED
International application number/ International filing date PCT/US2008/08545/

 

04/12/2008

Priority Application Number/ Priority date US61/012,162

 

07/12/2007

National phase Filing date 04/12/2008
Publication date 03/09/2010
Request for examination date 25/11/2010
Pre-Grant Opposition under section 25 (1) 19/02/2011
First examination report Date 20/08/2014
Date of communication of outstanding objections 01/03/2016
Date of hearing after failure to put the application in condition of allowance 18/03/2016
Date of decision of rejection 31/03/2016

Application Area:

Lumacaftor is given with another active ingredient Ivacaftor in the treatment of cystic fibrosis which is caused by F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Facts of the case:

First Examination Report (FER) was issued on 20/08/2014 which not only objected claims based on the prior arts cited in International Preliminary Report on Patentability (IPRP) corresponding to PCT application but also used section 3 (d), 3 (i), 3 (n) of the Patents Act, 1970, and procedural grounds for objection.

As the FER was issued on 20/08/2014 (before 16/05/2016), period of twelve months was allowed to put the application in condition of allowance. Controller found the application not to be in condition of allowance even after 12 months and communicated the objections on 01/03/2016. Finally, hearing was held on 18/03/2016.

As reported in the decision of controller dated 31/03/2016, “There were nine (09) objections mentioned in the hearing letter including major technical objections on the grounds of novelty, inventive step and non-patentability of the claimed subject matter u/s 3(d) of the ‘Act’.”

Section 3 (d) has been reproduced below for the reference:

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

Analysis of the rejection decision:

Dr. I. S. Bhattacharya, attorney of the applicant, who attended the hearing, relied on the technical data filed as affidavit along with reply statement in respect of pre-grant opposition already filed under section 25(1) for the instant application to argue that form 1 of Lumacaftor ought to be considered be Novel and Inventive. She asserted that better pharmacokinetic properties / superior bioavailability of the formulation of claimed polymorphic Form I compared to the hydrochloride salt of the compound were enough to win the Patent.

Controller in response declined to accept the arguments on the ground ‘Anything beyond the disclosure of complete specification is not acceptable’ as the technical data was not part of the complete specification yet. The technical details were also rebuffed on the ground that different pharmacokinetic properties / superior bioavailability results were natural results of comparison of Form I (free solid) with hydrochloride salt of the same compound. He further opined that better bioavailability does not necessarily lead to better efficacy.

Based on these grounds, controller went on to reject the Patent Application under section 15.

Controller also took into consideration the pre-grant opposition that had also been filed under section 25(1) by Indian Pharmaceuticals Alliance, Mumbai for the instant application. Controller did not conduct a separate hearing under section 25 (1) as the grounds and prior arts were incorporated in the hearing letter and were heard on 18/03/2016. Controller accepted the petition under section 25 (1) while refusing the grant of the patent application no. 2056/KOLNP/2010.

Reference:

http://ipindiaservices.gov.in/decision/2056-KOLNP-2010-16971/2056-KOLNP-2010.pdf

Merk’s patent valid but Teva’s Nasonex generic non-infringing

In Merck Sharp & Dohme Corp.  (hereinafter referred to be as “Merck”) v. Teva Pharms. United States, Inc. (hereinafter referred to be as “Teva”) decided on November 16, 2016, Teva’s application of Abbreviated New Drug Application (hereinafter referred to as “ANDA”) no. 205149 had triggered Merck to file infringement suit against Teva in respect of US patent number 6127353 (hereinafter referred to be as “353” patent) which is currently listed against NDA number of New Drug Application (hereinafter referred to as “NDA”) number 020762. The‘353 patent is set out to expire in April 03, 2018 with Pediatric Exclusivity. NDA 020762 was approved for ‘NASONEX’ having MOMETASONE FUROATE (hereinafter referred to as “MMF”) as active ingredient in the dosage form EQ 0.05MG BASE/SPRAY. Merck further stated in its complaint that Teva’s ANDA application contained certification (PARA IV) that US patent no. 6127353 is invalid and unenforceable and will not be infringed by Teva producing its generic, the complaint also stated that Teva refused to allow Merck access to its ANDA application or samples.

Anhydrous Mometasone Furoate (“MFA”) was earlier patented by Merck in the early 1980s. MFA and MFM are the polymorphs. On July 3, 2014, plaintiff i.e. Merck brought this action alleging infringement. Merck filed an amended complaint on August 17, 2015, which Teva answered on August 31, 2015. Independent claims 1 and 6 and dependent claims 9-12 of the ‘353 patent titled ‘Mometasone furoate monohydrate, process for making same and pharmaceutical compositions’ were asserted by Merck.

Independent claim 1 and claim 6 have been reproduced below for the reference:

Claim 1:

9.alpha.,21-dichloro-16α-methyl-1,4-pregnadiene-11β,17α-diol-3,20-dione-17-(2′-furoate) monohydrate.

Claim 6:

A pharmaceutical composition comprising mometasone furoate monohydrate in a carrier consisting essentially of water.

Teva’s ANDA contains MFA as the active ingredient and has shelf life of 2 years. Merck did not allege the inclusion of MFM in the pre-formulation active ingredient of Teva’s formulation.

Teva had challenged the ‘353 patent on the grounds of double patenting with U.S. Patent 6,180,781 (hereinafter referred to be as ‘781’) and lack of subject matter description. Court rejected both the arguments and found the Patent to be valid. To ascertain whether Teva’s ANDA product contains any MFM during shelf life, Teva presented six different batches of its product to Merck. Merck’s expert, Dr. Victor Young (“Dr. Young”), testified in favor of Merck by placing a high premium on his ability to visually distinguish between MFM and MFA using a microscope. Teva’s expert, Dr. Leonard Chyall (Dr. Chyall), however, contended that protocol required visual observation to be paired with a more accurate method of measurement. Court observed that “Dr. Chyall has offered up a reasonable criticism of such findings. At bar, Dr. Chyall’s testimony is more credible and consistent”. Finally the court ordered in favor of Merck for the issues of validity but declared Teva’s product to be non-infringing the ‘353 patent. In the form 10K submitted with Securities and Exchange Commission on February 26, 2016, Merck apprehended decline the sale of Nasonex after the entry of generics. Here is their take ‘For example, a court has ruled that a proposed generic form of Nasonex does not infringe the Company’s U.S. patent for Nasonex. If the generic form of Nasonex receives marketing approval in the United States, the Company will experience a loss of Nasonex sales.’

About the Author :  Ms. Rashmi, intern at Khurana and Khurana, Advocates and IP Attorneys. For any queries, please write to swapnil@khuranaandkhurana.com.

Foreign Filing Permission: Indian Patent System Perspective

Different countries having regard to National Security Considerations and with the intent of having a check on the defence and atomic energy related inventions, have different restrictions in place. While some countries make it mandatory to file Patent Applications in their country before applying in any other country, some countries require only prior permission before applying in other countries.  Here is the link for a quick overview of the requirements of different countries.

While filing Patent application outside India for the invention conceived by Indian resident, it is not compulsory to first file Patent Application in India. However, it’s important to note that if Patent Application is not to be first filed in India, written permission is to be sought in form 25 from the Indian Patent Office. It’s also important that mandate of seeking permission for foreign filing remains there even after filing Indian application for six weeks.

Attention of the readers is also sought to the language of the governing section (reproduced below) of the Patent Act, 1970 which uses the word ‘resident’ and not the citizen. Therefore if the invention has been conceived by citizen/national of any country while he was residing in India, section 39 has to be complied with before applying for foreign Patent Applications.

Official fee for form 25 is as follows:

Natural person(s) and/ or Startup:

E-filing- 1600

Physical filing: 1750

Small entity, alone or with natural person(s) and/ or Startup:

E-filing- 4000

Physical filing: 4400

Others, alone or with natural person(s) and/ or Startup and/ or small entity                        

E-filing- 8000

Physical filing: 8800

 

Regarding timeline, Indian Patent Office has to dispose of such request within 21 days of receipt of such request. However, this timeline changes for the inventions related to defence or atomic energy, where the period of twenty-one days starts from the date of receipt of consent from the Central Government.

Related sections and rules have been reproduced below. Sections dealing punishments in case of failure to comply with relevant sections have also been reproduced.

Section 39. Residents not to apply for patents outside India without prior permission.—
(1) No person resident in India shall, except under the authority of a written permit sought in the manner prescribed and granted by or on behalf of the Controller, make or cause to be made any application outside India for the grant of a patent for an invention unless— (a) an application for a patent for the same invention has been made in India, not less than six weeks before the application outside India; and (b) either no direction has been given under sub-section (1) of section 35 in relation to the application in India, or all such directions have been revoked.

(2) The Controller shall dispose of every such application within such period as may be prescribed: Provided that if the invention is relevant for defence purpose or atomic energy, the Controller shall not grant permit without the prior consent of the Central Government.

(3) This section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India.

Rule 71: Permission for making patent application outside India under section 39.—

(1) The request for permission for making patent application outside India shall be made in Form 25.

(2) The Controller shall dispose of the request made under sub-rule (1) within a period of twenty-one days from the date of filing of such request:
Provided that in case of inventions relating to defence or atomic energy, the period of twenty-one days shall be counted from the date of receipt of consent from the Central Government.

Below given sections deals with the penalties for not complying with section 39:

Section 40:

Liability for contravention of section 35 or section 39.—Without prejudice to the provisions contained in Chapter XX, if in respect of an application for a patent any person contravenes any direction as to secrecy given by the Controller under section 35 or makes or causes to be made an application for grant of a patent outside India in contravention of section 39 the application for patent under this Act shall be deemed to have been abandoned and the patent granted, if any, shall be liable to be revoked under section 64.

Section 118: Contravention of secrecy provisions relating to certain inventions.—If any person fails to comply with any direction given under section 35 or makes or causes to be made an application for the grant of a patent in contravention of section 39 he shall be punishable with imprisonment for a’ term which may extend to two years, or with fine, or with both.

Hetero’s Subsidiaries not infringing Roxane’s patent on PhosLo

In Roxane Laboratories, Inc. (hereinafter referred to be as “Roxane”) v. Camber Pharmaceuticals Inc., et al. (hereinafter referred to as “Camber”) decided by United States Court of Appeals for the Federal Circuit on November 17, 2016, Roxane had appealed against decision of district court in an infringement suit against Camber and Invagen Pharmaceuticals Inc (collectively referred to as “appellees”), both of which are subsidiaries of Hetero Drugs Ltd. (hereinafter referred to as “Hetero”). The infringement suit was in respect of US patent number 8563032 (hereinafter referred to be as “032” patent). This appeal was from  the  United  States  District  Court  for  the  District  of  New  Jersey  in  No.  2:14-cv-04042-SRC-CLW, Judge Stanley R. Chesler. In March, 2014 appellant i.e. Roxane had filed suit for infringement against the appellees in the district of Ohio. The case was later (in June 2014) transferred to state of New jersey on the basis of convenience of  the parties  and  witnesses  as  a  whole  and  the  balance  of public and private interests.

Appellees manufacture and  sell  calcium  acetate  products  in  elongated  size  00  (“size  00el”)  capsules which are same in diameter and but have a greater length and  a larger fill volume. Calcium acetate is used to treat patients suffering from end-stage kidney failure who have abnormally high serum phosphorous levels. When taken orally, calcium acetate binds to phosphorous in foods and prevents its absorption through the gastrointestinal tract.

Roxane filed a patent on 6 Dec, 2006, the ’032 patent, for a capsule formulation of calcium acetate granules. The ‘032 patent titled ‘Formulation and manufacturing process for calcium acetate capsules’ was asserted by Roxane. This patent has only one independent claim.

In July 2015, the district  court  in  New  Jersey  issued an order construing the claim limitation “size 00 or less.” In favor of appelles. The district court held that the ’032 patent does not clearly state that size 00 also includes family of size 00 including 00el.

Appellant not only challenged construction of claims by court of New Jersey but also challenged transfer of case from state of Ohio to the state of New Jersey.

Independent claim 1 has been reproduced below for the reference:

Claim 1:

A calcium acetate capsule formulation comprising flowable granules comprised of a pharmaceutically acceptable amount of calcium acetate along with other pharmaceutically acceptable adjuvants, wherein said granules are filled into and contained within a pharmaceutically acceptable capsule such that 667 mg of said calcium acetate on an anhydrous basis are present in said capsule that is size 00 or less.

Decision of the Federal Circuit on the transfer of case:

Federal circuit observed that district court had not abused the discretion while transferring the case from Ohio to New Jersey. Federal Circuit observed that district court has wide discretions on transferring the jurisdiction and in the current case, the transfer was well within the powers of the district court.

 Decision of the Federal Circuit on the construction of claim:

Roxane argued that the court made a mistake in interpreting claims as excluding size 00el capsules. According to Roxane, “size 00” refers to either non-elongated or elongated size 00. Roxane maintains that capsule “size” only designates capsule diameter, not length or volume. Hetero responded that court correctly construed “size 00” as designating a capsule of one specific size i.e., one specific diameter, length, and fill volume not a family of capsules and that the limitation “size 00 or less” thus excludes the larger elongated size 00 capsules from the scope of the claims and further the written description, examples and the prosecution history supports the fact that “size 00” refers to standard, non-elongated size 00 capsules as they clearly mention size 00 capsule containing 667 mg of calcium acetate, thus having particular fill capacity. Federal Circuit concluded that 032’ patent and its prosecution history clearly indicates that size 00 refers to standard, non-elongated capsules and Hetero manufacturing and selling calcium acetate size 00el capsules does not infringe Roxane’s patent for capsule formulation of calcium acetate granules.

Federal circuit thus not only rejected the Appellant’s arguments on the transfer of case but also affirmed the construction of the claims by the district court.

About the Author : Ms. Rashmi Goswami, intern at Khurana and Khurana, Advocates and IP Attorneys. In case of any queries, feel free to reach on swapnil@khuranaandkhurana.com.

Inside Secure states, France Brevets licenses NFC Patents to HTC

Access to robust data and effective analytics are the must for today’s business world. But sometimes it can be difficult to acquire good data. That’s where near-field communication (hereinafter referred as “NFC”) technology comes in. NFC is a short-range high-frequency wireless communication technology which enables the exchange of data between devices when they’re touched together or brought within a few centimetres of each other by using magnetic field induction.

Reportedly, on November 14, 2016, Inside Secure (INSD.PA) has announced that France Brevets have granted to HTC (mobile phone Company) a worldwide patent license under their NFC Patent Licensing Program for use in HTC’s products. [1]

INSIDE Secure, is a leader in security solutions for mobile and connected devices, provides software, silicon IP, tools and know-how required to protect customers’ transactions, content, applications, and communications. With deep security expertise and experience, the company delivers products with advanced and distinguished technical capabilities to serve the gruelling markets of network security, IoT security, content & application protection, mobile payment & banking.

France Brevets leads the efforts under the NFC Licensing Program in Asia, Europe, South America and Africa. NFC Technology LLC, France Brevets’ affiliate, leads the NFC Licensing Program in the US. The Program provides NFC-enabled device manufacturers the right to use the patents of INSIDE Secure, the NFC patents of Orange and also other patents acquired by France Brevets and NFC Technology, LLC. The licensing program caters multiple categories of NFC device manufacturers, for example, those manufacturing smartphones, feature phones, tablets, laptops, desktop computers, TVs, and smart meters offering a wide range of services such as mobile payment, transit, access control, customer retention programs and also ticketing.

France Brevets, created in March 2011, jointly owned by the French government and the Caisse des Dépôts ET Consignations, is the number one patent monetisation and investment fund in Europe. France Brevets aims to create a coherent patent cluster by acquiring public and private patents, then executing licensing strategies that best serve the interests of the patent holders and partners of France Brevets. More simplified it is tasked with helping private and public research to best monetise its patent portfolios from an international perspective. The key focus areas of France Brevets is Information Technology and Communication at large, Aeronautics and Space, Alternative Energy, Chemistry, Materials, Life Sciences and the environment.

Enormous usage of artificial intelligence has made the internet of things (IoT) more ubiquitous giving ways for NFC to become a staple of networks everywhere. Though NFC has only been deployed recently but is grow rapidly in importance and with NFC Patent Licensing Program soon will become a part of everyone’s daily life might be through social interactions, commerce, and identification etc.

References:

China (SIPO) Proposed Amendments Patent Examination Guidelines

On October 27, 2016, the Chinese Patent Office – State Intellectual Property Office (SIPO) published Revised Patent Examination Guidelines draft to remove the software and business method patents hurdles in Chinese Jurisdiction. The published draft will be open for public comments till November 27, 2016.

Chinese Patent Law, under Article 25(2) mandates that patent rights shall not be granted for “rules and methods for mental activities”. Such provision under Article 25(2) is frequently resorted to by patent examiners during examination for rejecting computer implemented business method patents. SIPO spotted the concern that although many patents are related to technical subject matter but they are concluded as “rules and methods for mental activities”, and hence not a patent eligible subject matter. To address the concern, SIPO proposed to amend the patent examination guidelines that relates to software patents as well as business method patents.

  1. Proposed Amendment clause with respect to Business Method:

Proposed draft elucidates, “Claims related to business methods that contain both business rules and methods and technical characteristics, shall not be excluded from the possibilities of obtaining patent rights be Article 25 of the Patent Law.”.

This proposed amendment, if eventually accepted, will certainly elevates the ease to obtain business method patents as the amendment provides clear elucidation to the patent examiners that the claims would not be rejected under Article 25(2) barely on the basis of a business method or rule.

According to this proposed clause, if a claim contains both business method and technical characteristics, the examiner shall not reject the claim on the grounds that the claim relates to “rules and methods for mental activities” under Article 25.

  1. Proposed Amendment clause with respect to Computer Software:

Another proposed change is made in the second line of Part II, chapter IX, section 5.2, paragraph 1, the third sentence of the Patent Examination Guidelines are amended from, “and describe in detail which parts of the computer program are to be performed and how to perform them” to provide that “The components may not only include hardware, but may also include programs.” Another proposed clause of revised draft states that apparatus claim related to computer software program will be eligible for patent rights, if it includes both hardware features and features pertaining to computer software programs. Such programs feature will be considered equally to the hardware features and shall not be treated as merely features so as to bar for patent rights. Further, the guidelines also clarifies that software per se is not a patent eligible subject matter as they are rules and methods for mental activities.

These revised amendments substantiate that red flags generated by examiner indicating non-patentability only on the ground of business method and software will no more exist. The examiners who are more vigilant in treating the patents under business method and software per se are now being addressed by Chinese Patent Office. Amended draft itself explains that claims relating to a business method are not excluded from patentability if they contain sufficient technical features.

iii. With respect to amendment of granted claims:

The proposed revised draft also focuses on amendment of granted claims. As per the current scenario, applicant can only either delete or combine the granted claims, wherein the revised draft proposal allows the applicants to make amendments in granted patent claims. Now, patentees will be able to add limitations from another granted claim in the same patent, but such amendment must be under certain limits. Claim can be amended as far as it is supported by the specification. This amendment will especially benefit those patent assertion entities who mainly focuses on licensing their patent assets.

These amendments will certainly attract worldwide companies that are generating software to enforce and monetize their IP. As China market will become more hospitable in software patents, companies across the globe will certainly try to grab the opportunity in China market.

Also the patent examination guidelines are not to be construed as law but rules for patent examiners at China’s State Intellectual Property Office (SIPO) to get educated about how to appropriately examine the patent applications.

About the Author: Kumar Tushar Srivastava, Sr. Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at tushar@khuranaandkhurana.com