Generic Drugs and Branded Drugs - Details about the FDA Process

Drugs Manufacturers are required by the Food and Drug Administration (FDA) to submit details of the scope of their patents when they submit a New Drug Application (NDA). The details, along with the patent number and expiration date of each patent are published in “Orange Book”. The details, among other things, correspond to information about the drug’s components, clinical data and the intended uses for which the drug will be marketed. This information is called “use codes”. After the submission, FDA may approve the NDA for multiple “methods of use”. The “methods of use” roughly translates into treatment of different conditions or treatment of the same condition in different manners. Thus, the patentee has rights either on the drug compound itself or on a specific method of using the drug.

After an NDA has been approved, a generic company can consult the details of Orange Book and subsequently file an Abbreviated New Drug Application (ANDA), put simply, an application for manufacturing the generic version of the patented drug. The company filing the ANDA needs to show to the FDA that the generic drug will not infringe the patentee’s patent. The FDA evaluates the ANDA application to assess whether the proposed drug would infringe the patent on the basis of the information present in the Orange Book. A unique aspect about the entire cycle is that the FDA does not validate the information (use codes) entered in the orange book and “assumes” the information to be accurate. Thus, the use codes become the deciding factor in the approval or denial of the ANDA application.

In situations where no patents exist in the orange book and where the relevant patents will expire before the ANDA application is approved by the FDA, there is not much cause for concern. In situations where patents exist and are active, the generic company has two options. The first option is to file a “Section viii” statement and the second option is to file a “Paragraph iv” certification. Under the first option, the generic company markets the drug for one or more “methods of use” not covered in the patentee’s patent. This option differentiates the generic company’s intended method of use from the patentee’s (brand company) method of use and allows the generic company to manufacture and market the generic only under the “method of use” approved by the FDA. Under the second option, the generic company, by filing “Paragraph iv” certification, states that a listed patent in the orange book will not be infringed or is invalid. “Paragraph iv” certification provides more options to the generic company as it does not have to differentiate its method of use from the brand company’s method of use and allows the generic to market the drug for all uses. A peculiar thing about “Paragraph iv” filing is that under the statutes, “Paragraph iv” filing is considered as an act of infringement and the patentee has the right to drag the generic to the court of law. The approval of the ANDA in such cases is stalled for 30 months or until the court decides on the validity or infringement of the patent.

Date of Enforcement and Patent Amendments

The Indian Patents Act, 1970 has been amended in the years 1999, 2002, 2005 and 2006 to harmonize the patent laws and to make them more relevant to the new technologies. Some of the major changes have been allowance of product patents in drugs and chemicals, introduction of pre-grant opposition and changes in timeline and fee structure. Every amendment that is made is associated with a date of enforcement that tells us when the old provisions /act cease to exist and new provisions are enforced. 

This post deals with the apparent confusion that prevailed with respect to date of enforcement of patent amendments and interpretation of patent laws when scope of the laws is not easy to decode. The parties in contention are Philips Electronics India Limited (appellant), Asian Electronics Limited (respondent 1) and Controller General of Patents & Designs (respondent 2).  The appellant had filed an appeal in the High Court of Mumbai against the order of respondent 2 for granting of patent number 193436 (Application No. 545/BOM/1999) belonging to respondent 1. The matter was thereafter transferred by the High Court of Mumbai to the IPAB for hearing. 

Background of the case:

The patent application was accepted and notified in the Gazette of India Part III Section 2 dated July 17, 2004 under Patent Application No. 193436. The notice of opposition to the grant of patent under section 25 and Rule 55 was filed by the appellant on December 14, 2004(prior to the coming into force of the Patents (Amendment) Act, 2005). The opposition was filed on the grounds of non-compliance of section 8 by respondent 1. According to the appellant, respondent 1 has failed to disclose information about the status of foreign filing of the same application to the controller and as a result has failed to fulfill the statutory obligations. Failure to disclose the information about foreign filing has therefore established the grounds of section 25(1) and thus the patent application should not be granted.

The controller heard the matter on June 28, 2006 and ordered the grant of patent on July 24, 2006. The controller based his decision on section 15 of the Patents Act, 1970 as amended by the Patent Amendment Act 2002 (emphasis added), (hereinafter, “Old Act") rather than section 25. Aggrieved by the actions of the controller, the appellant alleged that the controller erred in construing that he could decide an opposition (that was filed under Section 25(1)) under Section 15 of the Patents Act. 

The counsel for the appellant argued that as the opposition was filed under section 25(1) of the Old Act, the decision on opposition should have been taken under the Old Act and not based on Patents Act 1970, as amended by Patent Amendment Act 2005 (emphasis added)(hereinafter, “Current Act”). According to the counsel, section 15 of the Current Act has no application in opposition proceedings and by considering section 15 rather than section 25, the appellant has been denied a statutory remedy by the controller thereby negatively affecting the outcome of the proceedings. 

The counsel based his reasoning on section 162(5) of the Current Act, the General Clauses Act and paragraph 7 of the Circular dated 14th March 2005 of the Controller General of Patents & Designs. Section 162(5) reads:

Notwithstanding anything contained in this Act, any suit for infringement of a patent or any proceeding for revocation of a patent, pending in any court at the commencement of this Act, may be continued and disposed of, as if this Act had not been passed.

In response to the allegations from the counsel of the appellant, the counsel for respondent 1 submitted that the provisions for continuing proceedings as described in section 162(5) cannot be extended and made applicable to all pending proceedings and were only applicable to specific pending proceedings. 

Decision of the IPAB Board:

After hearing the arguments of both the parties, the board observed that the opposition was filed on December 14, 2004 under the then existing section 25(1) and the matter was heard by respondent 2 on September 18, 2006. The board pointed out that before the matter was heard by respondent 2, the Patents (Amendment) Ordinance, 2004 had come into force amending the Patents Act, 1970 with effect from January 1, 2005 which was later replaced by the patents (Amendment) Act, 2005. The board brought to the attention of the parties the instructions given by the Controller General through office instruction dated January 14, 2005 on how to deal with the pending oppositions under section 25(1). 

The instruction read:

“The cases which have been accepted and notified in the Gazette for inviting opposition u/s 25(1) of the Act, before this Patents (Amendment) Ordinance, 2004 came into force, the opposition if any will be dealt with as per the old Act and rules and if no opposition is filed, the application shall directly proceed to grant.”

Further, sub-section 2 of section 1 of the Ordinance number 4 of 2004 stated:

“Sub-clause (ii) of clause (a), and clause (b), of section 37, sections 41, 42, 47, 58 to 62 (both inclusive) and 73 shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint; and the remaining provisions shall come into force on the 1st day of January, 2005.”

Moreover, the board specified that the appellant has got a right to go for appeal before the Honorable High Court as per the provisions available under section 116 (2) of the principal Act that were operative and in force when the impugned order was passed.

Section 116(2) reads:

“116 (2) Save as otherwise expressly provided in sub-section (1), an appeal shall lie to a High Court from any decision, order or direction of the Controller under any of the following provisions, that is to say, section 15, section 16, section 17, section 18, section 19, section 20, section 25, section 27, section 28, section 51, section 54, section 57, section 60, section 61, section 63, sub-section (3) of section 69, section 78, section 84, section 86, section 88 (3), section 89, section 93, section 96 and section 97.”

 The board concluded that the respondent 2 wrongly applied section 15 and ignored the Office instruction 1/2005 dated January 14, 2005 because of which respondent 2 failed to notice the date of enforcement of the amendments. Consequently, the decision of the respondent 2 is erroneous as instead of referring to section 25, the respondent 2 has referred to section 15 to decide the proceedings. The board has directed the order to be amended and asked the controller to base his decision under section 8 and section 25 of the old act as applicable on the date of filing of the opposition and not on section 15.  For further information, please refer to the IPAB site.

Is lack of communication at patent office hampering your patent application?

This post deals with a recent application that was filed at the IPAB and highlights the importance of timely communication on all matters at the patent office. The journey of a patent application from filing to its grant is time bound. Every action comes with a deadline and failures to meet the deadlines have their own consequences.  This is what happened when a patentee was not informed about the grant of his patent by the patent office and the patentee subsequently filed for amendments in the patent application. Thus, the question that needs to be answered is whether the amendments that were filed by the patentee (without having information on the grant of his patent) correspond to amendments for the pre-grant application or for the post-grant application?

B. Braun Melsungen AG, a German medical and pharmaceutical company, had filed an application (1857/MAS/1998) for a patent titled “AN I. V. CATHETER” on August 18, 1998 at the Indian Patent Office. On May 27, 2005, the agents of the patentee were intimidated that the application was in order to grant but the letters would be issued after the disposal of pre-grant opposition. Form 13 was filed on September 10, 2007 for changing the counsel by the patentee and the counsel was informed on December 19, 2007 that patent has been granted on the application and the grant of patent has been recorded in the Register of Patent Office on December 3, 2007 (Ref: Patent No. 210062 (1857/MAS/1998), dated August 18, 1998 granted on September 17, 2007”).

The situation gets tricky on September 19, 2007 (see image) when the counsel for the patentee filed another Form 13, this time for amending the claims in the patent application. The patentee cancelled all the original 54 claims and replaced the claims with new set of 28 claims. The required payment for form 13 was made on September 21, 2007 because of which the date of filing of form 13 was considered as September 21, 2007. The examiner allowed the amended claims stating that the allowed claims were well within the scope of the claims of the specification before the amendments. What makes matter even more interesting is the fact that the patentee had filed another application under rule 137 and rule 138 for condonation of delay under section 8(1)(b). Section 8(1) (b) deals with the filing date for international application under PCT where India has been designated.   Rule 137 and rule 138 deal with specials powers given to the controller on matters where no special provisions are made in the patent act.

Suru International, an Indian company that manufactures syringes, catheter and cannulas, had raised a pre-grant opposition for 1857/MAS/1998 on the grounds that the invention was not novel and that the patentee had not only failed to comply with section 8 (1) (b) but also the fact that the patent office was treating the amendments as pre-grant amendments.

Upon examination of patent records, it was revealed that 1857/MAS/1998 was allotted number 210062 on September 17, 2007. Further, it was revealed that notice of allotment of a patent number to an application under rule 37 of patent rules 2003 is not communicated to the officers at the patent office. Based on the above information, the IPAB has asked the patent office to consider the matter afresh from September 21, 2007. As form 13 was filed after grant of patent, the IPAB has decided that the responses filed after date of grant will be dealt in accordance with provisions on post-grant applications. 

The IPAB has gone one step ahead and called for greater transparency and communication at the patent office so that examiners are aware of when Form 13 are filed, when the patent is granted and when the number has been allotted. IPAB also placed importance on the availability of information and requested that once a patent number is allotted, it should be made immediately available on the patent office website so that the patentee’s are well informed about the status of their applications.

Recent IPAB Decision - A hotchpotch of arguments

What happens when a pre-grant opposition is filed for an Indian patent application and the following happens:

• The pre-grant opposition application is withdrawn by the respondent on the grounds that the party (respondent) is no longer interested in pursuing the matter.
• The documents cited as prior art in the pre-grant opposition belong to the inventor of the current application and has been abandoned.
• The most important cited document is not from the same technology area.
• There is no agreement between the experts testifying on the matter of novelty and inventive step.

This is what happened in a recent IPAB decision in which the patent application was not allowed for grant. The patent in suit is 40/2007/PT/MUM, titled “NOVEL AGRICULTURAL COMPOSITION”. The patent application discloses an agricultural composition comprising an effective amount of a sulphur active ingredient and a dispersing agent. According to the appellant (patentee), the novel feature of the invention was the ability to instantly convert sulphur to its sulphate form so that desired quantity of sulphur is made available for assimilation by plants. The composition was in the form of grains (0.1 mm to 2.5 mm) that were soluble in water and ranged from 2 to 12 microns in particle size. 

Background: Seven documents were cited in the first examination report, the response to which was filed by the appellant by limiting and modifying the initial set of 15 claims to 13 claims. Thereafter, the pre-grant opposition was filed by the respondent. The most important document from a prior art view disclosed all the elements of the current application. However, the difference lay in the fact that the document was targeted towards fungicides whereas the current application targeted the easy assimilation of sulphur in its sulphate form by plants. Further, the percentage by weight of each ingredient was different in the cited document and the current application.  Even though the respondent withdrew their appeal and did not go ahead with the opposition, the board nonetheless stressed on the fact that it was the duty of the board to not allow an application to go forth to the public merely because the opposition is withdrawn.

For deciding the novelty and inventive steps, the board relied on the fact that the process of assimilation of sulphur in sulphate form was known in the art and the main area of contention was with respect to the particle size and the speed at which the sulphur containing composition gets oxidized and becomes sulphate. In order to throw light on the novelty and inventive step, the board agreed with the findings of the controller who had concluded that agricultural composition included both fungicidal composition and nutrients required for the plants. As a result of this, the cited document acted as deciding prior art for the current application. The board stated “The use of sulphur as a nutrient is a known use, the rapid oxidation by change in particle size is known, there are prior arts which feature economic advantage of the composition as also sustained release.” The above argument was also used while considering the testimony of 10 experts in the field of horticulture and sulphur. There was difference of opinions with respect to what the experts thought of the novelty and inventive steps of the invention with one expert going as far as stating in his testimony that the claims (as filed) did not do justice to the invention and only dependent claims 12 and 13 in combination with examples in the specification brought out the novelty of the invention. Further details can be found on the IPAB site.

Declaratory Judgment - A preemptive action!

In a typical patent infringement lawsuit, the patentee enjoys the convenience of bringing the lawsuit at his/her own will. In other words, when the patentee is made aware of an infringer, the patentee has the liberty of waiting for the “right time” to file a lawsuit against the infringer in order to claim maximum damages.  What happens when the so called “alleged infringer” has made an honest mistake and was unaware of patents mentioned in the lawsuit? Are there any provisions or preemptive actions present in the patent laws that can be exploited by people who have invested a substantial amount of capital, efforts and time in manufacturing and launching their products and subsequently feel that they may become targets of potential patent infringement lawsuits?

Declaratory judgment is one such provision that can be used by the “alleged infringer” as a preemptive action to clear any uncertainty about their products. As the name implies, Declaratory Judgment is merely declarative where the court provides its opinion on an issue. Thus, when a patentee sends a Cease and Desist letter to the alleged infringer stating that certain products or services of the alleged infringer are infringing or potentially infringing patents owned by the patentee, the “alleged infringer” can file for a Declaratory Judgment in their own jurisdiction or a “favorable jurisdiction”.  Although the patentee has the option to file a motion for transfer of the jurisdiction, the selection of a favorable jurisdiction by the alleged infringer acts as a great tool to control the venue and time of future trials.

The alleged infringer can file for a Declaratory Judgment on the following grounds, namely, non-infringement, invalidity, and unenforceability. Further, while filing for Declaratory Judgment, the alleged infringer has to prove that controversy exists over the patents and the products in order to persuade the court to grant the Declaratory Judgment.  

Some advantages of Declaratory Judgment:

• A strong pre-emptive action that can be used by alleged infringers
• Increases expenses of the patentee by forcing the patentee to continue proceedings in the jurisdiction where the Declaratory Judgment is filed by the alleged infringer
• Less expensive as it does not involve a trial and the court provides opinion on the controversy
• Get an idea on the likely outcome of a future trial and accordingly take appropriate corrective actions (such as out of court settlements).