THE REMICADE PATENT: ANOTHER ATTACK ON PATENT RIGHTS

After reading commentary about the Remicade patent, I was ready to write a post about obviousness-type double patenting (ODP), why restriction requirements are your friend, and why there is no place for continuations-in-part (CIPs) in modern society.  However, after looking at U.S. Patent No. 6,284,471, it appears that what we really need is a history lesson about the development of ODP, and an understanding that the USPTO (and apparently the Federal Circuit) has no interest in maintaining “pre-GATT” patents (or any patent for that matter).  The Remicade decision puts form over substance, a concept the Supreme Court determined robs statutes of their purpose in 1935, denying J&J legally obtained patent term, and generally, weakening property rights for all patent holders.   

So, we’re all on the same page: Last week the Federal Circuit court effectively killed the Remicade patent stating the it violates obviousness-type double patenting (ODP).  ODP is complicated.  In a nut-shell, a patent that claims an obvious variation of an invention described by the inventor in an earlier patent can be found invalid for obviousness-double patenting.  For example, if a predecessor patent claims “meat,” later filed patents that claim “pork” or “beef” violate ODP.  This was actually the issue in In re Vogel, an early decision laying out ODP jurisprudence.  ODP resulted from patentees attempting to extend patent protection beyond the statutory patent term by claiming obvious variations, or subsets of the earlier patented invention. 

As anyone who knows patent prosecution will tell you, obviousness is a very fluid concept.  When it comes to ODP, patent examiners generally apply obviousness doctrine extremely liberally.  For most patent applications, a terminal disclaimer, a document that causes both patents to expire on the same day, can be filed to overcome the OPD rejection.  Easy peazy, you file some paperwork, lose a little term in some cases, and everyone is more or less happy.  In the Remicade patent’s case, filing a terminal disclaimer was not an option, since the patent identified in the ODP rejection was already expired.  Filing a terminal disclaimer would automatically cause the Remicade patent to be expired as well.  The attorneys representing J&J, the Remicade patent licensor, had no option other than arguing against ODP, which is a hard row to hoe.  

The Remicade patent was filed as CIP of a patent application that was under a five-way restriction.  A CIP is a patent application that contains subject matter in addition to the subject matter described in the predecessor patent to which it claims priority.  Old subject matter is given the early filing date of the predecessor patent and any new subject matter is given the later filing date of the CIP.  It’s kind of confusing. 

In 2017, no patent attorney in the U.S. would advise a client to file a CIP in the face of a restriction requirement (I hope).  However, things were different in 1995.  On June 8, 1995, the Uruguay Round of the General Agreement on Tariffs and Trade agreement (GATT) went into effect, which changed the term of U.S. Patents from 17 years from the day the patent is granted to 20 years from the issue date.  The Remicade patent, having been filed in 1994, preceded the GATT agreement (i.e. is “pre-GATT”) and is entitled to a patent term of 17 years from its grant date.  The Remicade patent claims priority to a patent application filed in 2001.  If the post-GATT term applied to the Remicade patent, it would likely have expired in 2011.  Instead, the Remicade patent, which issued in 2001, would have expired in 2018.  Remicade generated $4 billion in revenue last year, so the additional 7 years patent term is a big deal. 

Filing a CIP was common practice before 1995.  Patent term was calculated from the end of prosecution rather than the filing date of the application, so it didn’t matter when new matter was added.  Additionally, the Request for Continued Examination (RCE), which allows prosecution of a patent application to continue after the Examiner issues a Final Office Action (for a fee), was not introduced into U.S. patent law until 1997.  For applications filed before 1997, patentees had two choices when an Examiner issued a final rejection: (1) Amend the claims to take what the Examiner gives you or (2) abandon the application.  The choice to abandon was usually lead to the filing a File Wrapper Continuation pursuing the same or similar claims.  The result of this practice is patent families with, for example, 30 applications many of which are abandoned.  The Remicade patent “family” follows this pattern out of necessity not gamesmanship.   

The decision to file the Remicade patent as a CIP rather than a divisional application is raising the most criticism.  J&J lost the case on arguments that the Remicade patent was a divisional that was incorrectly identified as a CIP when It was filed.  A divisional application is a type of continuation that pursues claims to an invention that were identified in a restriction requirement.  A restriction requirement is issued when the Examiner believes the claims of a patent application are directed to different inventions.  Under U.S. law, an inventor can obtain “a [one] patent” for any new and useful invention.  If a patent claims more than one invention, the patent must be restricted to one invention and the claims directed to different inventions must be divided into separate applications (aka, divisional applications).  By calling a patent application a divisional and pursuing claims that were restricted out of the predecessor patent, the patentee can rely on the Examiner’s decision that the restricted claims define a separate invention from the predecessor patent.  This was codified as the “safe harbor” created by 35 U.S.C. §121.  Hence, the Examiner cannot argue that the divisional invention is an obvious variation of the predecessor invention and reject the divisional claims for ODP.  The result: Had the Remicade patent been called a divisional when it was filed rather than a divisional, the ODP rejection that caused its demise could not have been made.  Remicade would still be protected, making investors around the world happy.   

ODP has been a hot topic lately.  In 2014, the Federal Circuit made several extremely questionable decisions about ODP, that are supper complex and set reactionary patent lawyer blogs around the country ablaze.  Calling the application, a CIP instead of a divisional was certainly a questionable decision in 1995; however, I’m fairly certain ODP was much less of an issue in 1995.  Moreover, U.S. Patent law allows for “correction” of the relationship between non-provisional patent applications for a fee.  Applications filed as, for example, a continuation or CIP are reclassified as divisionals during prosecution all the time.   

Regardless, shouldn’t the subject matter of the claims dictate how the patent is classified?  The Federal Circuit’s decision is clearly based on form over substance.  The Supreme Court dealt with this issue in the context of tax law in Gregory v. Helvering, 293 U.S. 465 (1935), and determined that putting form over substance “exalt[s] artifice above reality and [deprives] the statutory provision in question of all serious purpose.”  The USPTO and Federal Circuit deprived J&J of a legally derived patent right, in my opinion, because they have decided that pre-GATT patents have enjoyed too much term.  My experience prosecuting the appeal of a pre-GATT patent that was held under secrecy order for 30 years taught me just how little fairness (and clear evidence of commercial success) informs PTAB (Patent Trial and Appeal Board) decisions when the patent under evaluation was filed before June 8, 1995. 

Decisions like the Remicade decision, the 2014 cases I mentioned above, and chaos created by recent patentability decisions (Alice, Myriad, and Mayo), continue to weaken patent rights, make patent prosecution more onerous and expensive, and create a barrier to start-ups and small businesses protecting their technology.