GlaxoSmithKline (GSK) has scored a decisive victory in its efforts to head off new US patent rules that would strike at the heart of the way the drug industry goes about protecting its inventions.
The US District Court for the Eastern District of Virginia granted GSK a summary judgment in its challenge to the final rule on continuation applications issued by the US Patent and Trademark Office (PTO) last August.
This has restricted the number of amendments inventors can make to existing filings and the number of permissible claims in these 'continuation' applications.
The ruling was on the technical grounds that the proposed rules were "substantive in nature" and the PTO had therefore exceeded its rule-making authority, which did not extend to making substantive rule changes. GSK had already obtained a preliminary injunction blocking the rule changes from the District Court at the end of October 2007, just one day before the revisions were due to take effect.
The proposed revisions to the rules of practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications had also been challenged by Triantafyllos Tafas, a Connecticut inventor and co-founder of Ikonisys, which develops cell-based diagnostics for women's health and oncology.
GSK's lawsuit was supported by the industry associations Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO), as well as the American Intellectual Property Law Association.
However, not all of industry objected to the PTO's attempt to streamline the patent examination process and whittle down a growing backlog of continuation filings that the Office said was having a "crippling effect" on its ability to examine 'new' applications.
For example, semiconductor giant Intel had strongly backed the PTO's proposals to curb what the company termed as "abuses by those outliers who unnecessarily delay prosecution of their applications with multiple continuation filings".
As an illustration of how much the situation was getting out of hand, the PTO said in its final rule that the volume of continued examination filings (including both continuing applications and requests for continued examination) had increased from about 11.4 per cent of overall patent filings in fiscal year 1980 to around 18.9 per cent in FY 1990, 21.9 per cent in FY 2000 and 29.4 percent in FY 2006.
The cumulative effect was "too often to divert patent examining resources from the examination of new applications disclosing new technology and innovations, to the examination of applications that are a repetition of prior applications that have already been examined and have either issued as patents or become abandoned", the Office commented.
Moreover, it noted, "when the continued examination process fails to reach a final resolution, and when multiple applications containing claims to patentably indistinct inventions are filed, the public is left with an uncertainty as to what the set of patents resulting from the initial application will cover."
Consequently, the PTO argued, "these practices impose a burden on innovation both by retarding the Office's ability to examine new applications and by undermining the function of claims to notify the public as to what technology is or is not available for use".
What specifically concerned GlaxoSmithKline and the broader biopharmaceutical industry was how the new rules would affect the practice of filing broad patent claims as soon as a new drug candidate is discovered and then following up with continuation applications and additional claims (e.g., for new indications) as more information emerges about the compound.
There were particular fears about the impact of the final rule on the always challenging realm of intellectual property for biotechnology products.
As BIO argued in an amicus brief filed in support of GSK's lawsuit, the final rule would "affect biotechnology more than other technology areas because biotechnology applications and the associated patentability issues are often more complex, which results in a longer and more involved examination process requiring more continuing applications and requests for continued examination".
Biotech companies developing large-molecule biologics often had to make substantial investment decisions early in the development process, the association pointed out, adding: "Biologics are produced using cell culture facilities that, on average, take three to five years to construct, cost between $250 million and $450 million, and must often be constructed during clinical testing."
To make these kinds of investments, BIO said, "the company must have a clear prospect
of adequately protecting all aspects of the invention, including those aspects that become important during the development process and are amenable to protection through continuation or continuation-in-part applications".
The final rule would have been retroactive. GSK said it had more than 100 applications pending and another 30 planned that would have been caught by the more restrictive requirements.
Under the final rule, patent applicants would have been allowed two continuing
applications (either continuation or continuation-in-part applications) and one request for
continued examination without any further justification. Anything above that threshold would have required a petition "showing why the amendment, argument, or evidence sough to be entered could not have been previously submitted".
The new rules also have called for support document covering all of the claims in a patent application if the application contained more than five independent claims or more than 25 claims in total. This was seen as a particularly low ceiling for biotechnology products, given their inherent complexity and the need to patent early to stimulate interest and draw in investment.
The final rule incorporated other changes, such as requiring that all "patentably indistinct" claims in multiple applications with a common assignee be filed in a single application, or that the multiple applications should effectively be treated as a single application.
The patent office has not decided yet whether to appeal against the District Court's ruling. In a statement, the PTO said it was "disappointed with this court's decision, which rejects our view that the USPTO has the authority to implement the proposed rules about claims and continuations. The USPTO believes that these rules are consistent with existing statutes and will strengthen the US patent system for all stakeholders".
"While considering next steps, our goal remains the same as it has always been: to improve the quality of the intellectual property system for the benefit of all," it added.
For GSK, the District Court's verdict is "a judgment in support of innovation across all industries. It reaffirms that all who want to patent their inventions in the United States will be allowed to seek protection on the full scope of their discoveries".
BIO also welcomed the outcome, claiming the final rule would have "inhibited the ability of biotechnology innovators to obtain adequate patent protection on their technologies, significantly decreasing their ability to attract the financing necessary to bring innovative, life-enhancing and live-saving products to market".
The judgment also underlined the need to develop a "viable and workable solution to the legitimate workload challenge at the PTO", the association commented, one that "fairly allocates responsibility for patent quality between patent applicants and patent examiners and enhances the strength and integrity of the American patent system, while not stifling innovation or placing a disproportionate burden on any one industry".