• CalendarMarch 20, 2018 – "How to Secure and Exploit Patents for Combination Therapies" (J A Kemp) – 3:30 to 4:30 pm (GMT)

    March 20, 2018 – Technology Center 1700 Customer Partnership meeting (U.S. Patent and Trademark Office) – 12:00 to 2:00 pm (ET), Alexandria, VA

    March 20, 2018 – "USPTO Examiner Interview Strategies: Preparing for and Conducting Interviews to Advance Patent Prosecution" (Strafford) – 1:00 to 2:30 pm (EDT)

    March 22, 2018 – Biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office) – Alexandria, VA

    March 28, 2018 – "Patent Infringement: Structuring Opinions of Counsel — Leveraging Opinion Letters to Reduce the Risks of Liability and Enhanced Damages" (Strafford) – 1:00 to 2:30 pm (EDT)

    March 29, 2018 – "The Evolving Scope of IPR Estoppel" (Federal Circuit Bar Association) – 1:00 pm to 2:00 pm (EST), Washington, DC

    March 29, 2018 – "Patent Prosecution Estoppel from PTAB Proceedings" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    April 5, 2018 – "Paragraph IV Litigation and IPRs — Interplay Between Paragraph IV Litigation and IPRs, Multiple Generic Challengers, Key Issues in IPRs" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 6, 2018 – "Are Patents Under Attack?" (Federal Circuit Bar Association and Center for Innovation Policy at Duke Law) – 8:00 am to 4:45 pm (ET), Duke University School of Law, Durham, NC

    April 7, 2018 – "Court of Appeals for the Federal Circuit Practice & Procedure" (John Marshall Law School Center for Intellectual Property, Information & Privacy Law) – 9:00 am to 4:30 pm (CT), John Marshall Law School, Chicago, IL

    April 9, 2018 – "The Patent System: Transformative Times" (Federal Circuit Bar Association and Boston Patent Law Association) – 2:30 pm to 5:30 pm (ET), Northeastern University, Boston, MA

    April 10, 2018 – "Federal Circuit Practice & Insights: A Townhall with Federal Circuit Judge Kara Stoll" (Federal Circuit Bar Association and Michigan IP Inn of Court) – 4:30 pm to 6:30 pm (ET), University of Detroit Mercy School of Law, Detroit, MI

    April 12, 2018 – "Protecting Software as a Medical Device With Patents, Design Patents and Trade Secrets" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 14, 2018 – "Court of Appeals for the Federal Circuit Practice & Procedure" (John Marshall Law School Center for Intellectual Property, Information & Privacy Law) – 9:00 am to 4:30 pm (CT), John Marshall Law School, Chicago, IL

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Patent Prosecution Estoppel from PTAB Proceedings" on March 29, 2018 from 2:00 to 3:00 pm ET.  Jeff Hohenshell of Medtronic, Inc., Stephen Kunin of Oblon, and Scott McKeown of Ropes & Gray LLP will discuss why patent prosecutors should be worried about estoppel arising from PTAB proceedings.  Such concern was made clear in the latest version of the USPTO's Manual of Patent Examining Procedure, which states that, "[PTAB] trial proceedings yield information that may be considered material to pending related patent applications . . . .  [An] example of such material information is any assertion that is made during litigation and/or trial proceeding which is contradictory to assertions made to the examiner."  This sweeping requirement for additional disclosure signals a big change that can create issues for those prosecuting patent applications.  The panel will discuss:

    • The USPTO program run every two weeks that creates links between filed petitions for AIA trials and the related applications, which is not accessible to the public or to the attorney of record.
    • How standard operating procedure for patent prosecutors must now change. The MPEP states that the prosecutor is in danger of violating his or her duty of disclosure if anything in the PTAB record known to be material to the patentability of any claim in an application is not submitted to the USPTO. What are the patent prosecutor's responsibilities and how should they be fulfilled?
    • Some commenters have questioned whether the PTAB has authority to issue its estoppel rule, 37 CFR § 42.73(d)(3)(i). Should this have any impact on prosecutors' behavior?

    The registration fee for the webinar is $135 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Federal Circuit Bar AssociationThe Federal Circuit Bar Association and Michigan IP Inn of Court will be hosting a program entitled "Federal Circuit Practice & Insights: A Townhall with Federal Circuit Judge Kara Stoll" from 4:30 pm to 6:30 pm ET on April 10, 2018 at the University of Detroit Mercy School of Law in Detroit, MI.  Attendees will be able to gain new insights and enhance their advocacy skills in patent appeals by hearing directly from Judge Kara Stoll of the U.S. Court of Appeals for the Federal Circuit, and also learn best practices for presenting argument in briefs and at oral argument and how to avoid the most common mistakes and pitfalls that hinder the likelihood of success.

    Additional information regarding the program can be found here.  The program is complimentary for FCBA members and students, and $150 for non-members.  Those interested in registering for the conference can do so here.

  • JMLSThe John Marshall Law School Center for Intellectual Property, Information & Privacy Law will be hosting Donald Dunner of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, who will be presenting a CLE course entitled "Court of Appeals for the Federal Circuit Practice & Procedure" from 9:00 am to 4:30 pm on April 7, 2018 and April 14, 2018 at the John Marshall Law School in Chicago, IL.  The course will provide a comprehensive study of the U.S. Court of Appeals for the Federal Circuit (CAFC) and its jurisdiction over patent cases from the perspective of an appellate practitioner.  The course will also cover litigation strategies and the process of guiding a client through an appeal.

    Tuition for the course is $1,565.  Those interested in registering for the conference can do so here.

  • Duke LawThe Federal Circuit Bar Association and Center for Innovation Policy at Duke Law will be hosting a program focusing on important patent law issues affecting the protection of cutting-edge technology.  The program, entitled "Are Patents Under Attack?" will take place from 8:00 am to 4:45 pm ET on April 6, 2018 at Duke University School of Law in Durham, NC.  The program will include sessions on the following topics:

    • Women in IP Breakfast
    • The Impact of Recent Section 101 Patent Eligibility Cases on U.S. Innovation
    • Hot Topics in PTAB Proceedings.
    • Moderated Discussion with The Honorable Todd M. Hughes, Judge, U.S. Court of Appeals for the Federal Circuit
    • Supreme Court Review of Federal Circuit Decisions
    • A View from the Bench
    • Diversity in Courts, Agencies, Corporations and Law Firms

    Additional information regarding the program can be found here.  The program is complimentary for FCBA members and students and $150 for non-members.  Those interested in registering for the conference can do so here.

  • BPLAThe Federal Circuit Bar Association and Boston Patent Law Association will be hosting a discussion about the evolution of the patent system and the biggest issues facing patent policy and litigation today.  The program, entitled "The Patent System: Transformative Times," will take place from 2:30 pm to 5:30 pm ET on April 9, 2018 at Northeastern University in Boston, MA.  The program will include sessions on the following topics:

    • Fireside Chat with Circuit Judge Alan Lourie, U.S. Court of Appeals for the Federal Circuit
    • In-House Counsel Panel: "Perspectives on Decision-Making and Strategy"
    • Fireside Chat with Chief Judge David Ruschke, U.S. Patent and Trademark Office

    Additional information regarding the program can be found here.  The program is complimentary for FCBA members, $145 for BLPA members, and $285 for non-members.  Those interested in registering for the conference can do so here.

  • Strafford #1Strafford will be offering a webinar entitled "Protecting Software as a Medical Device With Patents, Design Patents and Trade Secrets" on April 12, 2018 from 1:00 to 2:30 pm EDT.  Cory C. Bell, Elizabeth D. Ferrill, and Susan Y. Tull of Finnegan Henderson Farabow Garrett & Dunner will guide counsel for companies in the medical device industry on protecting software as a medical device (SaMD), and also discuss the new FDA rules regulating SaMD and how to leverage IP law to protect SaMD.  The webinar will review the following issues:

    • What are the hurdles for patent counsel to demonstrate a software-related claim is not abstract?
    • What factors should counsel consider when determining what type of IP protection to seek?
    • What guidance have the courts provided in recent decisions concerning patent eligibility for software-related inventions?

    The registration fee for the webcast is $297.  Those interested in registering for the webinar, can do so here.

  • By Andrew Williams

    USPTO SealPharmaceutical patent owners have been one of the more vocal groups decrying the creation and existence of inter partes reviews and other PTAB post-issuance proceedings.  And for good reason.  Congress enacted the Hatch-Waxman statute to create an abbreviated approval pathway for generic small molecule drugs.  In so doing, it crafted a fine balance between the interests of branded pharmaceutical NDA holders and generic drug-product manufacturers.  As part of this balance, Congress established a procedure by which ANDA filers could challenge the validity of patents that cover the drug product and methods of its use in district court without needing to launch at risk.  This included the creation of the Orange Book, which listed all such patents.  An ANDA filer wishing to challenge these patents files a Paragraph IV certification for each patent that it believes is not infringed, is invalid, or is unenforceable.  Technically, however, it is the filing of the ANDA that is the act of infringement regardless of whether the patent is Orange Book listed or not.  Nevertheless, with the introduction of IPRs and related proceedings, ANDA filers have a new mechanism to challenge the validity of these patents outside the carefully balanced patent-resolution scheme of the Hatch-Waxman statute.  Correspondingly, the new PTAB proceedings have the potential to shift the balance away from patent and NDA holders and towards generic drug manufacturers.

    Likely in response to these concerns, Chief Judge Ruschke announced the results of an Orange Book-listed Patent Study during his "Chat with the Chief" on March 13, 2018.  The meeting presentation slides can be found here.  During the chat, the Chief Judge also revealed the results of an expanded panel study, which we will analyze in a future post.  For the Orange Book study, the PTAB classified a petition as challenging an Orange Book-listed patent if, unsurprisingly, the patent was listed in the Orange Book when the petition was filed.  The data provided was through the end of the fiscal year 2017, which ended on September 31, 2017.  We will look at three of the questions asked by the Office in this study.

    What Are the Filing Trends for Petitions Challenging Orange Book-listed Patents?

    The PTAB has been releasing filing trends for the various technology centers since at least April, 2015.  For fiscal year 2015, Bio/Pharma patents from TC 1600 accounted for 9% of all petitions filed.  For fiscal year 2017, that number was 11%.  However, it is important to keep in mind that this is a relative number, and that the total number of Bio/Pharma petitions has risen every year (despite the relative number hovering around 10%).  The current study broke down the numbers in this technology center by whether it was an Orange Book-listed patent or a miscellaneous Bio/Pharma patent.  The results since September 16, 2012, and the results for fiscal year 2017 are reproduced below.

    Figure 1

    Figure 2
    The picture that emerges is that, overall, Orange Book-listed patents have accounted for about half of all Bio/Pharma petitions, but that this ratio has recently shifted away from such patents.  This could be due to the rise in the use of IPRs and other post-grant proceedings in the BPCIA context.  The Patent Office also included the actual number of petitions that fell into the Orange Book-listed category, and it appears that such petitions peaked in FY15, with the number of petitions filed in FY17 being about 2/3 of the numbers filed in FY16 (80 versus 127).

    How Does the Institution Rate on Petitions Challenging Orange Book-listed Patents Compare to Those of Other Technologies?

    The Patent Office highlighted the fact that the cumulative institution rate of Orange Book petitions was essentially the same as the cumulative overall rate (66% versus 68%).  Interestingly, the institution rate of the miscellaneous Bio/Pharma patents was 60%, lower than both.  Moreover, whereas it would have made the study more complicated, it would have been interesting to break out the institution rate number by whether the patents contained composition-of-matter claims or method-of-use claims.

    What Are the Outcomes of Challenges to Orange Book-listed Patents?

    When looking at the 82 total final written decisions for Orange Book-listed patents, the Office found that more than 50% retained all claims as patentable.  This is an extraordinary number, considering the number for all other technologies was 17%.  The charts are reproduced below:

    Figure 3
    Nevertheless, the number one "number" highlighted by the study was that 83% of all such petitions resulted in the patent being unchanged.  This is represented in the below reproduced graphic:

    Figure 4
    Touting this number seems suspect, however.  The Patent Office considered a patent as being unchanged when it survived final written decision, when the parties settled, when the case was dismissed, and when the case was not instituted in the first place.  In addition to the aforementioned success of such patents at the final written decision stage, there are unique factors intrinsic to Orange Book-listed patents that may help explain this number.  For example, Orange Book-listed patent holders may be more motivated to settle with parties in order to retain the listing (and thereby prevent the flood-gates of ANDA filers from opening).  In addition, many petitioners are not the first ANDA filers, and the NDA holder may have already settled with the first filer.  In such cases, there may be less of a barrier to settle with follow-on challengers.  Importantly, the patent holder in such situations may not consider a settlement a positive outcome.

    The other two conclusions reached by the study relate to the issue of serial petitions.  In general, the Office has been concerned about multiple petitioners filing against the same patent.  However, the problem seems more pronounced in the Orange Book context because of the potential for multiple ANDA filers for a particular drug product.  Nevertheless, the Office found that 80% of all challenged Orange Book-listed patents have only 1 or 2 petitions filed against it, as opposed to 87% for all challenged patents.  Moreover, 85% of all challenged Orange Book-listed patents have 1 or 2 petitioners, as opposed to 94% for all challenged patents.  These numbers are presented in such a way to suggest that the problem is not as significant as feared.  However, what isn't represented is that 1/3 of all Orange Book-listed patents are challenged by more than one petitioner (as compared to 15.6% for all challenged patents).  Moreover, according to this study, 1/3 of all patents are challenged by more than one petition, but for Orange Book-listed patents, the number is closer to 42%.  Therefore, there does seem to be a multiple-petition or multiple-petitioner problem with this subset of patents.

    In any event, this study by the Patent Office is certainly interesting.  It does go a long way to allaying the fears of NDA holders.  Nevertheless, considering that an IPR is a lose-or-draw proposition for any patent holder, and that Orange Book-listed patents are so valuable to NDA holders, this may come as little comfort to the community.  Instead, anything that disrupts the balance struck by Hatch-Waxman is not going to be seen as favorable, no matter how the actual numbers have been borne out.

  • By Kevin E. Noonan

    Senate SealIn a development that could moot (once and for all) the controversy over tribal sovereign immunity occasioned by the St. Regis Mohawk Tribe's ownership of patents relating to Allergan's Restasis formulation for treating disorders of the eye, a group of Senators including Tom Cotton (R-AK), Claire McCaskill (D-MO), Pat Toomey (R-PA), Joni Ernst (R-IA), and David Perdue (R-GA) introduced a bill to broadly abrogate assertion of tribal sovereign immunity in any patent-related proceeding.  The bill, entitled the Preserving Access to Cost Effective Drugs (PACED) Act, provides that tribal sovereign immunity cannot be asserted:

    • In derivation proceedings under 35 U.S.C. § 135 and judicial review of PTAB decisions thereunder;

    • In reexamination proceedings under 35 U.S.C. § 305 and both administrative and judicial review of PTAB decisions thereunder;

    • In inter partes review proceedings under 35 U.S.C. § 316 and judicial review of PTAB decisions thereunder;

    • In post-grant review proceedings under 35 U.S.C. § 326 and judicial review of PTAB decisions thereunder; or

    • In exclusion proceedings under 19 U.S.C. § 1337 and judicial review of International Trade Commission decisions thereunder.

    The bill also expands the abrogation of sovereign immunity under 35 U.S.C. § 296 to include Indian tribes and specifically to include biosimilars under 42 U.S.C. § 262.  Each of these provisions is expressly limited by the proviso that abrogation "shall apply only to the extent permitted under the 11th amendment to the Constitution of the United States."

    Curiously, when the patent owner is a foreign state, the bill gives the Patent Trial and Appeal Board the power to determine whether the state is immune from PTAB jurisdiction, applying the principles set forth in 28 U.S.C. Chapter 97 "as if the Patent Trial and Appeal Board were a court of the United States," blurring anew the lines between Article I and Article III courts that has produced a certain amount of mischief in the implementation of the Leahy-Smith America Invents Act.

    Statements from the Senators illustrate the political motivations behind the bill:  the belief that the assignment and license arrangement between Allergan and the tribe was a sham (despite the PTAB's strenuous avoidance of that conclusion) and that such arrangements are a misuse of the patent system that only serves to increase drug prices (or, more accurately, delay generic competition that could decrease drug prices):

    • Senator Cotton:  "It's far past time that we crack down on patent abuse, which is raising costs for our seniors.  This bill will make sure unscrupulous patent holders can't game the system and block their competitors from entering the market.  That'll go a long way to help seniors get the drugs they need,"

    • Senator McCaskill:  "We watched a company brazenly try to exploit a potential legal loophole to game the system in an effort to protect their bottom line-and keep Missourians from access to cheaper generic drug options in the process.  That should be illegal, and our bipartisan bill would make it so by ending this astounding assertion of sovereign immunity to avoid patent review, before any other companies follow suit."

    • Senator Toomey:  "Sham transactions involving the transfer of patent ownership from a pharmaceutical company to a tribe for the sole purpose of shielding the patent from challenges are a clear abuse of our patent system and set a dangerous precedent for other consumer products.  The PACED Act will improve our patent system and protect patients and consumers from higher drug prices by eliminating this egregious loophole."

    • Senator Ernst:  "Congress cannot look the other way as some pharmaceutical companies attempt to stifle competition and prevent Americans from accessing affordable generic drugs.  Failure to act could incentivize other industries to use similar tactics to block competitors.  Through the Preserving Access to Cost Effective Drugs Act, we can speed up the entry of safe and affordable generic drugs into the market while maintaining the integrity of the U.S. patent system."

    • Senator Perdue:  "Gaming the patent system is not good for consumers or businesses.  I'm disappointed this legislation even has to be offered due to a few bad actors trying to do an end run around the U.S. Patent and Trademark Office."

    According to Senator Cotton's webpage, the following groups support the PACED Act:

    R Street, The Electronic Frontier Foundation, Engine, American Consumer Institute Center for Citizen Research, Public Knowledge, America's Health Insurance Plans (AHIP), Association for Accessible Medicines, United for Patent Reform, High Tech Inventors Alliance, Patients for Affordable Drugs Now, BlueCross BlueShield Association, Blue Shield of California.

    Insofar as Congressional authority over tribal sovereign immunity is "plenary," United States v. Lara, 541 U.S. 193, 200 (2004) ("the Constitution grants Congress broad general powers to legislate in respect to Indian tribes, powers that we have consistently described as 'plenary and exclusive'"), and in view of the Senators' politic framing of the issue both as an abuse and a cause of higher drug prices, only the seeming inability of this Congress to pass anything other than tax "reform" is likely to stop the bill from being enacted into law.  Perhaps the Supreme Court will rule IPRs unconstitutional in Oil States Energy Services v. Greene's Energy Group, or the pharmaceutical industry or Native American tribes can arrange matters to have naysayers be the last group to speak with Mr. Trump before he is called upon to veto the bill.  Otherwise it is likely that this particular procedural gambit has run its course.

  • By Sophie Blake* —

    The Enlarged Board of Appeal has now released its written decision in respect of G 1/16 (T 0437/14).  This decision resolves the question regarding which standard is to be applied to determine whether an "undisclosed disclaimer" in a patent claim introduces added subject-matter (that is, it contravenes Article 123(2) EPC).

    Previously G 1/03 and G 2/10 have both addressed issues regarding added subject-matter of disclaimers; this is therefore the third Enlarged Board of Appeal decision to be issued in just over a decade on this subject, which perhaps gives an indication of how contentious an issue the allowability of introducing disclaimers into patent claims is seen to be at the EPO.

    Background — undisclosed v disclosed disclaimers

    In general, patent claims typically define the subject-matter for which protection is sought in terms of "positive" technical features of the claimed invention; meaning those technical features that define the elements and characteristics of the claimed subject-matter.

    In contrast, a "disclaimer" was defined in G 1/03 as meaning an amendment to a claim resulting in the incorporation of a "negative" technical feature, typically excluding from a generally defined subject-matter specific embodiments or areas.

    For example, a claim may define its subject-matter by the following positive features:
    "A composition comprising a metal".

    However, it is also possible to define the claimed subject-matter in terms of "negative features"; for example, by introducing the feature that "the metal is not tin".  This sort of amendment can be illustrated as shown below:

    Image
    This is known as a disclaimer since what is left in the claim is less than that before the introduction of the negative feature.

    An undisclosed disclaimer refers to a disclaimer which is not disclosed in the application as filed, and nor is there any disclosure of the subject-matter excluded by it in the as-filed application; it is a disclaimer that excludes subject-matter that is not specifically mentioned in the application as filed.  Using the above example of "metal – tin", this would be an undisclosed disclaimer in the case where there is simply no mention of tin anywhere in the application as filed.

    In contrast, a disclosed disclaimer refers to a disclaimer which may not itself have been disclosed in the application as filed, but the subject-matter excluded by it is disclosed in the application as filed; it is a disclaimer that excludes subject-matter that is specifically mentioned (disclosed) in the application as filed, such as in an embodiment or example.  Again, using the above example of "metal – tin", a situation in which there is an example in the application as filed of the metal being tin would constitute this disclaimer being a disclosed disclaimer.

    G 1/03 – Allowability of undisclosed disclaimers under Article 123(2) EPC

    G 1/03 first dealt with the question of allowability under Article 123(2) EPC of undisclosed disclaimers.  In G 1/03, the Enlarged Board of Appeal held that an amendment to a claim by the introduction of a disclaimer may not be refused under Article 123(2) EPC for the sole reason that neither the disclaimer, nor the subject-matter excluded by it from the scope of the claim, have a basis in the application as filed.  However, such an undisclosed disclaimer is only allowable in certain, limited circumstances; namely, in order to:

    1.  Restore novelty against art under Article 54(3) EPC;

    2.  Restore novelty over an accidental anticipation; or

    3.  Disclaim subject-matter that is excluded from patentability for non-technical reasons under Articles 52 to 57 EPC.

    It was thus clear that undisclosed disclaimers could only be introduced if the limitation does not contribute to the invention — it must not become relevant for assessment of inventive step or sufficiency.  Furthermore, it was held that a disclaimer may only serve the purpose for which it is intended and nothing more; meaning it cannot disclaim more than is necessary to restore novelty or disclaim the non-technical subject-matter.

    G 2/10 – Allowability of disclosed disclaimers under Article 123(2) EPC

    Several years later, G 2/10 addressed a different question of whether a disclaimer infringes Article 123(2) EPC if its subject-matter was disclosed as an embodiment of the invention in the application as filed.  In other words, G 2/10 was concerned with the question of allowability of disclosed disclaimers.

    In G 2/10, the Enlarged Board of Appeal held that an amendment to a claim by the introduction of a disclosed disclaimer infringes Article 123(2) EPC if the subject-matter remaining in the claim after the introduction of the disclaimer is not, be it explicitly or implicitly, directly and unambiguously derivable from the application as filed.  This therefore confirmed that the application of the "gold standard" for assessing added matter (what the skilled person would directly and unambiguously derive from the application as filed) of disclosed disclaimers.  A number of commentators have considered that this was seemingly in conflict with the decision in G 1/03.  There followed a divergence in applicability of G 2/10 to undisclosed disclaimers:  in a number of decisions, Boards applied the gold standard test of G 2/10 to undisclosed disclaimers in addition to the criteria set out in G 1/03, whilst in some cases the allowability was primarily assessed on the basis of the gold standard alone.

    The question of which standard should be applied for undisclosed disclaimers was therefore referred to the Enlarged Board for consideration in G 1/16.

    G 1/16 decision

    In G 1/16, the Enlarged Board has confirmed that the criteria set out in G 1/03 are to be applied when considering whether a claim amended by the introduction of an undisclosed disclaimer is allowable under Article 123(2) EPC.  The gold standard test of G 2/10 is not the relevant test for examining whether an undisclosed disclaimer complies with Article 123(2) EPC

    Reasoning

    Fundamental to the Enlarged Board of Appeal's decision was the inherent conceptual differences which exist between disclosed and undisclosed disclaimers.  Indeed, the Enlarged Board of Appeal noted that, by virtue of what an undisclosed disclaimer is, when neither the disclaimer itself nor the subject-matter excluded by it is disclosed in the application as filed, it automatically follows that the subject-matter remaining in the claim after the introduction of such an undisclosed disclaimer can hardly have been considered to be derivable from the application as filed.  The Enlarged Board of Appeal held that:

    It follows from the above that the choice of the proper test . . . is determined by the fundamental distinction between disclosed and undisclosed disclaimers.  That distinction necessitates providing for each of the two classes of disclaimer a single specific test for assessing whether the introduction of a given disclaimer is in compliance with Article 123(2) EPC.  For undisclosed disclaimers, the proper test is whether the criteria of G 1/03 are fulfilled, and for disclosed disclaimers the proper test is the gold standard disclosure test of G 2/10.

    In arriving at this decision, the Enlarged Board of Appeal also noted that the idea underlying Article 123(2) EPC is that the applicant should not be given an unwarranted advantage, and precludes a new technical contribution being added by an amendment.  G 1/03 was considered not to be in contradiction with this premise.

    Conclusion

    This decision has clarified that the door is not being shut entirely on the use of undisclosed disclaimers.  This provides some relief as it will therefore still be possible for applicants to introduce undisclosed disclaimers where necessary in order to exclude prior art that is either an accidental anticipation or post-published, or in order to exclude non-technical features.

    Of course, it still needs to be borne in mind that the criteria for allowability of undisclosed disclaimers under Article 123(2) EPC is very restricted.  Applicants should therefore continue to draft applications with sufficient fall-back positions, preferably in terms of positive features, that allow for limitations to be made during prosecution without needing to rely on the introduction of such undisclosed disclaimers.  The introduction of such disclaimers should be relied on sparingly.

    * Ms. Blake is a patent attorney with D Young & Co

    This article was reprinted with permission from D Young & Co.