Feroz Ali, INDIAN INSTITUTE OF TECHNOLOGY MADRAS

Lead Author: Feroz Ali
Organization: Indian Institute of Technology Madras
Country: India

Abstract

Patents are unilateral declarations by an inventor which when approved by the patent office stand unchallenged for the remainder of its life. The only way by which its credibility or truth can be questioned, is by putting forward a challenge before a court of law. This is a hugely expensive and inefficient way to find the truth about patents. Open prosecution offers an ex ante opportunity to test the validity of patents. By transposing the point at which the validity can be challenged (usually the courts) and placing it within the patent office within the grant process at the patent office (for e.g. by the introduction of pre-grant opposition), open prosecution brings in the much needed peer-scrutiny of patents. This is not an alien thing to do. Open prosecution is similar to the re-examination procedure in the United States. The new patent law in the United States, the America Invents Act also allows for post-grant review of a patent. This recognizes the fact that it is primarily the competitors who are empowered to challenge the patent. By making the analysis ex ante, open prosecution not only empowers a resource-crunched patent office but it also saves on future litigation time and costs. The evidence from 10 years of pre-grant opposition procedure in India, which can be regarded as the first step towards open prosecution, demonstrates the high rate of success of pre-grant opposition in invalidating patents could be a boon for improving access to medicines.

Submission

Open Prosecution: Towards Ex Ante Validation of Patents

Impact on remedying policy incoherence

The Role of the Public in the Patent System
Democracy plays a key role in having a patent system, a system that encourages its citizens to invent. Democratic governance relies upon participatory action. In a democratic set up, it is hard to envisage a system creating exclusive rights without some form of consultation with the public, especially when such rights have an impact on the public. Even from a procedural perspective, patent law is a misfit. Audi alteram partem, one of the foundational principles of natural justice on which Common Law stands, does not find a place in patent granting process. Modern patents can be filed in secrecy, kept unpublished until grant and used stealthily to stop the business activities of others without hearing the parties who would be affected by the grant of such patents. The absence of public participation in the patent system remains an unsolvable puzzle, which everyone has learned to live with.

Historically though this did not appear to be the case. In the early days of patent law where the demonstration of inventions was through working models, we notice a time when the public were poised to play a participatory role. Though patent law developed in a secretive manner with minimal public participation, this period was a bright spot in history where things seemed to move towards greater public participation. However, the hopes of having a participative patent system crashed when the representation of the invention became textualized ⎯ a move that arguably added the ‘intellectual’ bent to intellectual property law ⎯ to enable the description of the invention in words and figures as opposed to its material embodiment by working models. While working models allowed for the immediate ascertainment of the value of the invention, giving the impetus to the public to see these models, the textual representation allowed the public to know about the invention only upon the publication of the patent specification. This abstract, interpretational description of the invention embodied in modern patent specifications by its very design left very little room for public participation.

Patent Prosecution as a Closed Process

Traditionally prosecution of patents involves interactions between the patent applicant and the patent office. Patent prosecution, the process of examination of patent applications, is neither open nor adversarial. Most patent systems allow for a deferred publication of the patent application. In some cases, patent applications can be kept unpublished until the grant offering no means for the public to participate in patent prosecution. Non-participation by the public in the prosecution process has several drawbacks. Some of them, like, inadequacy of the notice function, the practice of endless amendments, and the grant of frivolous and abstract patents can be curbed to some extent by effective public participation. Ideally the public should participate in the patent prosecution process as the rights granted by a patent can affect the public at large. One of the ways the patent system promotes participation is by having a procedure for the opposition of patents before their grant.

Opposition procedures at the patent office may either be before the grant of a patent (pre-grant) or after the grant (post-grant). Much of the problems in the prosecution pertain to the information asymmetry that affects the patent office. The introduction of opposition procedures at the patent office is premised on the idea that knowledge embodied in a patent application is likely to be at the hands of the competitor than the patent office. The patent office, in itself, is not competent in many of the streams of technology where applications contain cutting-edge research and its application. Moreover, the patent office suffers from a troubling attrition rate, which make it hard to retain good talent. Research shows that the patent office would spend on an average eighteen hours on the examination of a patent application, which by some accounts, is grossly inadequate for scrutinizing applications covering high-technology. Despite the shortcomings in the manner in which the patent office works, the patent system has not encouraged peer-review mechanism for scrutinizing patents. The Common Law system is built on the adversarial process for bringing out facts. The introduction of peer-review in patent prosecution will not only alleviate the burden of the patent office but will also be significant to addressing quality issues in the grant.

Towards Open Prosecution
Pre-grant opposition is unique as it is the only procedure which allows for an ex ante validation of patents. It is definitely the first step a country can take to incorporate a culture of open prosecution of patents. Open prosecution can be defined as an approach where patent offices use external and internal expertise in the prosecution of patent applications. Open prosecution refers to a participatory, decentralized approach to prosecution of patents recognizing the fact that cutting-edge knowledge that is described in patent applications is widely distributed and no patent office can have access to all of it. Open prosecution can reduce costs and improve the time taken to grant a patent. It is the antithesis of traditional prosecution where the patent office relies on internal expertise in prosecuting patents.

Pre-grant opposition refers to the first challenge a third party gets to make while the patent application is pending before the patent office. This procedure has some distinct advantages when compared to other revocation methods. First, it allows the challenge to be made before the authority that grants the patent, i.e., the patent office, the institution within the patent system where technical arguments on the subject matter are most likely to be appreciated. Second, it allows the challenge by peers who could bring vital knowledge about the invention to the patent office. Third, the time-bound nature of pre-grant opposition allows challenges to be made before the grant of the patent, unlike validity challenges, which could be made at any point in time during the life of a patent. Fourth, compared to the cost involved in patent litigation, pre-grant opposition is cost-effective.

The Absence of Peer-review
The patent system evolved without a provision for peer-review of patents. Peer review makes the patent prosecution process participative and benefits the patent office by bringing external expertise into the prosecution process. Incorporating the peer review into the patent prosecution process will enhance the quality of patents by introducing an additional level of scrutiny.
As a peer stands in a better position than the examiner to prove the invalidity of a patent, there have been calls to include a third party review mechanism into the patent law. Some scholars have called for a peer-review mechanism for patents. Those supportive of peer-review, advocate it at an early stage of the application. Others have pointed that a peer-review system may not be feasible for patents. They argue that the way a patent is drafted does not suit them for peer-review. Much of the critique against the peer review mechanism emerges from the failure of disclosure function of patents. Since patents with inadequate disclosure result from not complying with the existing standards of disclosure, peer review can be seen as a tool for enhancing the disclosure requirements.


Impact on public health

Pre-grant opposition and Access to Medicines
Generally, opposition proceedings serve as an opportunity for a competitor to oppose unjustified protective rights. Pre-grant opposition, as a procedure exercisable before the grant of a patent, offers the earliest opportunity to challenge a patent. The significance of pre-grant opposition grew with a steady increase in the number of patent applications filed before the Indian Patent Office after the post-TRIPS amendment to the Indian Patents Act which allowed for product patents for pharmaceutical products. In 2006, 28,940 patent applications were filed—19 % increase over the previous year. That year witnessed 44 pre-grant oppositions. In the year 2007, 64 oppositions were filed, and in the following year the number grew to 153. The year 2009 saw 103 oppositions and the following year witnessed 294 oppositions. In 2011 there were 193 oppositions. The following year saw 262 oppositions. One can see that the rate of filing oppositions has been increasing steadily over the years.

The low number of oppositions initiated in comparison to the applications filed is not an indication of its ineffectiveness. Rather there is evidence to suggest that only the commercially valuable patent applications get opposed and litigated. In fact, some of the best-selling drugs in recent history have been victims of pre-grant opposition in India. They include, Novartis’ Glivec and Exforge, Eli Lilly’s Forteo and Cialis, AstraZeneca’s Iressa and Nexium, Gilead’s Viread, Pfizer’s Caduet, Tibotec’s Prezista, Glaxo SmithKline’s Hepsera and Roche’s Tamiflu. Recently, the patent application covering Gilead’s blockbuster drug Sovaldi (sofosbuvir) for the treatment of Hepatitis C was rejected by the Indian Patent Office noting the pre-grant oppositions filed by a generic company.

Impact on human rights

Patents and Access to Life-Saving Medicines
Patents present one of the biggest barriers to the access of life-saving medicines. There is a growing concern that patent protection for pharmaceutical products has the effect of putting live-saving medicines beyond the reach of a very large section of world’s population. Despite the variety of remedies that exist, the strongest response to the issue of access has come by availing the flexibilities offered by the patent system. Two international responses, both of which occurred around the turn of this millennium, illustrate this. The events occurred when the debates in relation to access to live-saving medicines were being resolved in favor of lowering trade barriers to access. The first response happened when the members of the World Trade Organization (WTO) unanimously agreed upon the relevance of intellectual property rights on the price of live-saving drugs and passed the Doha Declaration allowing countries to control the patent rights in order to avoid any adverse impact on public health. The second response pertains to the reaction of Indian generic manufactures to the HIV/AIDS crisis when the high cost of anti-retroviral (ARV) drugs made them affordable to only a small segment of the people in the developing countries afflicted with AIDS. The supply of generic versions of the ARV combinations by Indian generics at a fraction of the cost at which the originator companies supplied brought the situation under control. The solution came about because of the different levels of patent protection offered for live-saving drugs around the world. The legal regime in India then allowed for manufacturing ARV drugs, as the TRIPS Agreement had not obligated India to offer patent protection for drugs until 2005.

The debate surrounding the impact of patents on access to essential medicines is stimulated by the differences in opinion on what “essential medicines” and “access to medicines” mean. Access could generally mean access to “essential medicines” as classified and updated frequently by the World Health Organization (WHO). The WHO List of Essential medicines (WHO-EML) enumerates the minimum needs for a basic-health care system detailing the most efficacious, safe and cost-effective medicines for priority conditions. By this yardstick, the problem of access may appear to be a minor one: patents for essential medicines are uncommon in poor countries and prevailing views attribute the lack of access of medicines more to poverty than to patents.

However, many medicines that are essential are not included in the WHO-EML as they are expensive or under patent protection. A more reasonable approach to determine the impact of patents on access would be to compare the number of persons in need of particular drugs who “would gain or lose access or would have their access to drugs unaffected if patents that did exist in their country were removed or modified.” Patents grant exclusivity on live-saving medicines and act as barriers to access. They allow pharmaceutical companies to practice monopoly pricing. Monopoly pricing is not the best way to incentivize research and development (R&D) and has often been criticized as the cause of lack of access to live-saving drugs.

Pharmaceutical companies who own the patented medicines cite the high cost of R&D as the reason for the high price. They also tend to follow a universal price for all the markets irrespective of the market’s ability to afford the medicines. In developing countries where majority of the population have a low per capita income and cannot afford health insurance, the high price of patented medicines on life-saving drugs hinders access. Resultantly, most of the population in developing countries do not have access to such medicines.

The measures to promote access to patented medicines can pertain to either non-legal or legal reforms. Some of the non-legal reforms include established initiatives like the direct purchase programs (like the US PEPFAR), bulk buying (like the program by Clinton Foundation), differential pricing, medical patent pools (like the one spun off from the UNITAID program), Priority Review Vouchers, Price Funds, Advance Market Commitments, and reform ideas such as the establishment of Health Impact Fund. Of the legal reforms that relate to making changes in an existing law, the provisions on compulsory licensing and price control of drugs are popular. Most of the proposals look at changing the existing regime or introducing a new program sometimes with radical measures. However, the approach of enhancing access to medicines by changing the patent laws is of recent origin.

Implementation

Pre-grant Opposition in India

In India, which has a novel pre-grant opposition in place, the results so far have been encouraging. Opposition procedures have helped examiners to identify suspect patents. Though India did provide for pre-grant opposition when the 1970 Act came into force, the procedural formalities did not make it a viable option and consequently only a few pre-grant oppositions were initiated. With the introduction of product patents for pharmaceuticals which saw a deluge of applications for pharmaceuticals and related inventions filed in the period between 1995 and 2005 and with the revisions made to the procedure of pre-grant opposition, the mechanism of pre-grant opposition used increasingly.

Despite its profitability, the Patent Office is burdened with issues relating to examination standards, transparency and unexpected growth arising out of an exponential increase in the number of new applications. Viewed in the light of the difficulties faced by the Indian Patent Office, the pre-grant opposition procedure offers hope to remedy some of these issues by supplying vital information into the Patent Office. Pre-grant opposition impacts the patent system in three significant ways: it can leverage information of third parties to help patent offices identify important and suspect patents; it can induce the applicant to give examiners information that may be relevant to patentability; and it can increase compliance costs for applicants.

Empirical Evidence
In an empirical study conducted surveying the pre-grant opposition decisions published between 2007 and 2014 on the Indian Patent Office website, it was found that pre-grant opposition procedures had a high rate of success.

Effectiveness of the Process
Out of the 155 decisions on section 25(1), oppositions had a success rate of 65.16% resulting in the rejection, withdrawal or abandonment of patent application in 101 cases. The impact of opposition proceedings were analyzed under 4 categories: (1) in 70 cases, the grounds of opposition raised were successful resulting in the rejection of the patent application; (2) in 17 cases, the grounds of opposition raised were successful resulting in the amendment of the patent application; (3) in 9 cases, though the grounds raised by the opposition were unsuccessful, the patent applications were eventually rejected possibly indicating a higher vigilance by the patent office in cases where oppositions are filed; and (4) in 5 exceptional cases, where the grounds of opposition were not considered as the patent applicant abandoned the application. I consider the patent opposition which leads to the amendment of the patent application as an effective one as amendment under the Indian Patents Act can be done either by way of a disclaimer, correction or explanation, or for the incorporation of an actual fact, and such amendment usually results in improving the notice function of the claim. Similarly, the cases where the Patent Office rejected the application despite the opposition not able to prove the grounds could be indicative of higher vigilance by the patent office in scrutinizing the application possibly prompted by the importance of the application highlighted by the opposition filed.
Conclusion

A case for ex ante validation of patents can be made within the structure of the contemporary patent system. By bringing out the importance of peer-review procedure for embodiments of technical knowledge, it should be possible to shift the point of validation of patents to the prosecution stage preferably through an inter partes proceeding, as opposed to its present position after the grant. If worked well, the process of ex ante validation could lead to improved quality in the grant. Some scholars regard patents are ‘probabilistic property rights’ and note as one of the reasons for the uncertainty, “the inability of third parties to participate effectively in determining whether a patent should issue.” Others have been more specific in linking patent’s unreliability with the lack of peer-review.

The proposal to introduce ex ante validation should not be seen as a move towards detailed examination of all patents. Peer review of every application will neither be possible nor efficient. The process of ex ante review should be an option which could be exercised in the case of valuable patents. Peer-review mechanism by way of inter partes opposition proceedings could “give the PTO greater access to relevant industry knowledge.” Peer review of patents may not eliminate all the problems in the patent system. To be sure, peer review did not do that for science. But the patent system could gain by emulating the scientific method as theoretically the standards of patenting and scientific publishing are the same.

Bibliography and References

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In the year 2007-2008, 64 pre-grant oppositions were filed. In 2008-2009, it increased to 153.
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The author conducted an empirical study of the patent office decisions rendered between 2007 and 2014 and made available at the Indian Patent Office website: http://ipindiaservices.gov.in/patentdecisionsearch/patentsearch.aspx. The study was confined to the decisions rendered under section 25 (1) of the Patent Act, 1970. The decisions are searchable by any of the 6 modes (Applicant Name, Opponent, Application Number, Section, Patent Number and Decision Date) as mentioned in the site. The results for the search term “25” under the category “Section” gave 212 decisions, out of which 155 decisions pertained to section 25(1), i.e., the provision relating to pre-grant opposition. The decisions that were not considered included those rendered under section 25 (2) relating to post-grant opposition and null entries which had to be excluded due to non-availability of documents on the website. Certain decisions though categorized under section 25 (2), were decisions rendered under section 25 (1) and hence they were looked into.
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