Amendments of the standing requirement solves the case and avoids the Trolls DA.
Alex Jurisch 18. J.D. magna cum laude, 2017 from the Seattle University School of Law. “A Prescription for Biopharmaceutical Patents: A Cure for Inter Partes Review Ailments.” Seattle University Law Review. 2018. https://heinonline.org/HOL/LandingPage?handle=hein.journals/sealr41&div=53&id=&page=
Inter partes reviews were surely not meant to be abused for financial gain and were not designed to help invalidate otherwise valid patent claims. Unfortunately, this has been the result, and while there is consensus that the system is broken, there seems to be little consensus on how to fix it. A recent proposal raised in the House Judiciary Committee was designed to shield pharma patents from IPR review; however, it never made it out of committee.84 Other attempts have been made to contest the constitutionality of post-issuance reviews, though they too have been largely unsuccessful. 8 'Although the Supreme Court has been deliberating the constitutionality of IPRs in the Oil States case, the consensus among patent professionals is that the Court will likely uphold IPRs as constitutional.8 6 Other legislative attempts have focused on amending patent litigation laws, but because the issues arise during IPRs-not litigation-such reforms are unlikely to be of any help.87
In light of the lack of solutions to the current problem, I endeavor to put forward a novel approach to improve IPRs by borrowing from other procedures in order to cure the most egregious defects of the IPR process: the standing requirement is too low, the amendment procedure is too draconian, and the claim interpretation is too biased towards the patent challenger.
One of the greatest criticisms for IPRs is that, unlike cases in Article III courts, there is no standing requirement to initiate an IPR. Anyone who has unearthed allegedly invalidating prior art may file a review with the PTAB." Because the Supreme Court has largely avoided any challenges of IPRs on constitutional grounds, 89 the duty to solve the standing issue must fall upon Congress. Abuse of IPRs in meritless cases can be addressed most simply by creating a requirement that those who intend to initiate an IPR must either be defendants in an infringement suit or must have been sent a cease-and-desist order by the patentee, similar to a CBM. This keeps the process of invalidating unworthy patents relatively inexpensive but assures that only parties with some legitimate interest in the validity of the patent can move forward with an IPR.
Another harsh aspect of the current IPR proceedings is the difficulty of getting a challenged claim amended. Although statutes permit patentees to cancel a challenged claim and make a reasonable number of amendments, 90 the amount of amendments that the PTAB has granted is incredibly low-around seven percent of amended claims have been allowed by the PTAB.91 In oppositions with the EPO, however, amendments are looked at more favorably, leading some companies to attempt amendments with the EPO in order to discern which amendments to bring with the PTAB. 92 Compared to the "kill rate" of over seventy-five percent of claims challenged in IPRs at the PTAB, 93 seventy-one percent of opposition claims survived in either the original or amended form.94
The major distinction between the two proceedings is who has the burden of showing the validity of amendments. In the United States, the patentee making the amended claims bears the burden of proving validity,95 whereas in Europe, the opposition has the burden of proving invalidity. 96 The trade-off is that in oppositions there is no estoppel barring arguments that the challenger could have made in later challenges like there is in IPRs. 9 7 In the interest of making amendments easier, it is reasonable to trade off the possibility of having to defend further actions in order to keep a claim from being invalidated, and it would go a long way in preventing the death of legitimate patents if instituted
The last amendment that should be made to biotech IPR proceedings, and really to every post-issuance challenge proceeding, is to have consistent claim interpretation for trials and post-issuance reviews. Though this viewpoint is neither novel nor unique, it is simply good common sense to give a patent that has been issued the presumption of validity. 98 When the PTAB construes claim language, it gives the terms the "broadest reasonable construction." 99 However, in ordinary court proceedings, claim terms are given the "ordinary meaning ... as understood by a person of skill in the art."1oo This discrepancy allows a much lower bar to invalidate patents at the PTAB than at trial because when terms are given a broader construction there is a greater chance that prior art will cover the claims, thus invalidating them.
Most recently at the Supreme Court, Cuozzo argued that IPRs are meant to be "mini-trials" and should therefore use the same construction standard as at trial,"o' but the Court ultimately rejected this argument claiming public policy concerns about stifling innovation.1 02 However, to promote innovation there has to be a reasonable assurance of a return on investment, and a presumption of validity creates a solid investment.
Making an IPR less of an unknown risk would make IPRs far less desirable to opportunists looking to bring meritless challenges without chilling parties looking to challenge truly suspect patents.