Breaking News: Pegasys Patent Invalidated by IPAB

In a major victory for public health advocates and patient groups, the IPAB (Intellectual Property Appellate Board) revoked the famous Pegasys patent (covering a new form of pegylated interferon) at the best of Sankalp Rehabilitation Trust, a patient group represented by leading counsel and renowned health activist, Anand Grover along with this associates Julie George and Pratibha Siva.

As I'd noted in an earlier post:

"Pegasus is an important case in many ways, not least of which is the fact that it scores two firsts in the annals of Indian patent history. It is India's first granted pharmaceutical product patent. It is also India's first post grant opposition case, with the Controller (Madhusudhanan) upholding the validity of the patent after reviewing more than 50 pieces of prior art! While one may disagree with his analysis and conclusions, his decision cannot be faulted for being a non speaking one.

As with most other patented drugs, Pegasus raises stark issues of pricing and access. From most accounts, Pegasys (Pegylated interferon alfa-2a), a drug used to treat Hepatitis C costs about Rs 4.36 lakh (available at a discounted price of Rs 3,14,496) for a 6 month treatment. It is usually taken in combination with Ribavarin, which costs another Rs 47,160.

One wonders why pharmaceutical patentees refuse to drop prices, despite being at the receiving end of high court orders (Roche vs Cipla, where Justice Bhat refused to grant an injunction on the grounds of the excessive price differential between the patented drug and the allegedly infringing generic) and compulsory licensing decisions. However, this issue should not concern the IPAB which is limited to examining the technological proficiency of the invention: whether or not it is patentable.

Pegasus offers considerable scope for the IPAB to place our patent jurisprudence on firmer legal moorings and resuscitate it from a more fanciful past."

Our IPAB judges have done precisely this! In a well reasoned and persuasive judgment, the bench (consisting of Justice Prabha Sridevan (the Chairman) and Justice DPS Parmar (the technical member)) invalidated Roche's patent on the ground that it is "obvious" and that it flunks the section 3(d) test. 

Sample this paragraph which goes to the root of their obviousness finding:

  

"Once the Court has the facts, it has to put the clock back to the date of the invention and see if this ordinary man would have found it obvious to put this invention together. In the present case, Interferon had already been used to treat hepatitis C. There were problems in the use of this protein as such. PEGylation was known from 1970s. Pegylation of proteins was known to improve the activity of the proteins. There was intense activity in the field of PEG chemistry and the person skilled in the art will be acquainted with it, if not directly involved in it. Linear conjugates of Protein showed improvement over unconjugated protein.

...The Person of Skill In The art takes a look at Monfardini and also at the other exhibits. He knows that the activity of Interferon has to be improved for Hepatitis C cases. He knows that linear pegylation will improve it a bit. He knows that branched pegylation has shown marked improvement over linear conjugates in the case of superoxide dismutase and three enzymes. He is confident that branched PEGylation of Interferon will work; it has worked in Monfardini with enzymes. Monfardini gives him the structure on a platter. He also knows that he can work with molecular weight range of 5000-40,000 daltons to strike oil. He has reason to believe that higher may be better. Why would [he] not be willing to make trial and error experiments and see if it works as Synthon said?"

And on section 3(d), the judges held as below:

"...The examples in the Complete Specification show improvement over unconjugated interferon, but the inventor claims surprising activity when compared to other conjugated interferon which is not shown. Hence the evidence for the “surprising activity “ is not adequate. Annexures A and C are without the supporting affidavits of the authors. The authors must present themselves as witnesses either in person or through proof affidavits for only then the evidence can be admitted. They are also documents published after the priority date .We have already held against the respondent on obviousness. With regards to S.3(d), we find that the respondent has not discharged the burden of proof."

And lastly, the decision also very rightly states that patient groups are certainly "persons interested" who can challenge patents within the meaning of the Act, for patents are not mere private rights alone, but have a significant "public interest" dimension as well.

In the tribunals' words:

"The Patents Act, 1970 defines the words ‘person interested’ in S.2 (1) (t) and the definition “include a person engaged in or in promoting research in the same field as that to which the invention relates”. S.25 (1) which deals with the pre-grant opposition uses the words ‘any person’. S.25 (2) deals with post-grant opposition and uses the words ‘any person interested’. The grant of a patent does not guarantee the validity of the patent. In Ajay Industrial Corpn. v. Shiro Kanao [AIR 1983 Delhi 496], the Delhi High Court held that“In our opinion, a ‘person interested’ within the meaning of section 64 must be a person who has a direct, present and tangible commercial interest or public interest which is injured or affected by the continuance of the patent on the register”.

Further public interest is a persistent presence in intellectual property law and will not melt into thin air, nor dissolve. We therefore hold that the appellant who works for a community which needs the medicine is definitely a ‘person interested” The locus standi objection is rejected."

Apart from the niceties of the law, articulated in a conceptually sound manner, Justice Srideva's judgments are a delight to read for another reason. They are infused with a fair sprinkling of wit. Sample these nuggets where the tribunal deals with the concept of the person skilled in the art:

"In KSR, the US Supreme Court held that the analysis of obviousness must be made explicit, and the reasoning to support the conclusion of obviousness must be articulated with rational underpinnings, the Court may have to look at the inter-related teachings of the multiple patents, the effect of demands known to the design community and the background knowledge possessed by a person having ordinary skill in the art. So the determination on obviousness is a legal one. 

The Court has to see a) what is the prior art b) the differences between the prior art and the invention and c) the skill of the imaginary ordinary man. This man has skill but until KSR came along he had no inventive or creative capacity. Such a person is hard to find, but we had to conjure this man in our mind as we do the man on the Clapham omnibus. By way of diversion, it seems he is referred by the acronym Mr.PHOSITA or just PHOSITA, the preferred acronym could be POSIT it sounds better or POSITA if you please. 

Getting back to the track, as KSR says this man is “A person of ordinary skill is also a person of ordinary creativity not an automaton.” So an automaton- like unimaginative but skilled man has now been allowed to have a modicum of creativity and imagination by the grace of the U.S.Supreme Court! 

We must remember that this ordinary man has skill in this art. He is not ignorant of its basics, nor is he ignorant of the activities in the particular field. He is also not ignorant of the demand on this art. “He is just an average man........ Well... just an ordinary man.” But he is no dullard."

I'm reminded of a Canadian judgment (Beloit Canada) which dealt with this concept in a similarly interesting manner:

"The classical touchstone for obviousness is the technician skilled in the art but having no scintilla of inventiveness or imagination; a paragon of deduction and dexterity, wholly devoid of intuition; a triumph of the left hemisphere over the right. The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent. It is a very difficult test to satisfy."