Patent Baristas

The United States Patent and Trademark Office (Office) is adopting new rules governing the conduct of disciplinary investigations, issuing warnings when closing such investigations, disciplinary proceedings, non-disciplinary transfer to disability inactive status and reinstatement to practice before the Office. See Changes to Representation of Others Before the United States Patent and Trademark Office; Final Rule (14Aug2008).The Office is adopting a new rule regarding recognition to practice before the Office in trademark cases. The Office also is adopting a new rule to address a practitioner’s signature and certificate for correspondence filed in the Office.

Included in the rules for part 11 are rules governing the conduct of investigations, disciplinary proceedings, issuing warnings, disciplinary proceedings, reinstatement, recognition to practice before the Office in trademark cases, and a practitioner’s signature and certificate for correspondence filed in the Office.

The primary purposes for adopting procedures for disciplining practitioners who fail to conform to adopted standards and non-disciplinary procedures for transferring practitioners to disability inactive status include affording practitioners due process, protecting the public, preserving the integrity of the Office, and maintaining high professional standards. The final rules will be applied only prospectively, not retroactively.

Included in the rules is a clarification under Subsection 11.5(b) of practice before the Office as including a law-related service that comprehends any matter connected with the presentation to the Office or any of its officers or employees relating to a client’s rights, privileges, duties, or responsibilities under the laws or regulations administered by the Office for the grant of a patent or registration of a trademark, or for enrollment or disciplinary matters.

The section provides that nothing in § 11.5 prohibits a practitioner from employing or retaining non-practitioner assistants under the supervision of the practitioner to assist the practitioner in matters pending or contemplated to be presented before the Office.

Section 11.5(b)(1) provides a definition of practice before the Office in patent matters, which includes preparing and prosecuting any patent application, consulting with or giving advice to a client in contemplation of filing a patent application or other document with the Office, drafting the specification or claims of a patent application; drafting an amendment or reply to a communication from the Office that may require written argument to establish the patentability of a claimed invention; and drafting a communication for a public use, interference, reexamination proceeding, petition, appeal to the Board of Patent Appeals and Interferences, or other proceeding. This section also provides that registration to practice before the Office in patent cases sanctions the performance of those services which are reasonably necessary and incident to the preparation and prosecution of patent applications or other proceeding before the Office involving a patent application or patent in which the practitioner is authorized to participate. The services are identified as including consideration of the advisability of relying upon alternative forms of protection which may be available under state law, and drafting an assignment or causing an assignment to be executed in contemplation of filing or prosecution of a patent application if the practitioner is filing or prosecuting the patent application, and assignment does no more than replicate the terms of a previously existing oral or written obligation of assignment from one person or party to another person or party.

Section 11.5(b)(2) provides a definition of practice before the Office in trademark matters which includes consulting with or giving advice to a client in contemplation of filing a trademark application or other document with the Office; preparing and prosecuting an application for trademark registration; preparing an amendment or response which may require written argument to establish the registrability of the mark; and conducting an opposition, cancellation, or concurrent use proceeding; or conducting an appeal to the Trademark Trial and Appeal Board.

With regard to § 11.5, the final rule will be applied only prospectively to assignments and licenses written on or after the effective date of the final rules.

The Office of Enrollment and Discipline can be found here.

See also the Invent Blog.

Today’s Washington Post features a story on Ismed’s efforts to promote a follow-on biologics approval pathway here in Washington.  The article outlines the campaign by Insmed’s chief exec, Geoffrey Allan, to give Congress a lesson in biotechnology.

The sudden outpouring of educational efforts on protein structures and drug pharmacology has to do with the fact that Insmed is looking to be the first U.S. company to develop biotech generics — a/k/a follow-on biologics (FOB), sometimes called biosimilars or biogenerics.

The question is whether the FDA should approve generic biotech drugs the way generic small molecule pharmaceuticals are approved.  Unlike with small-molecule drugs, there’s no mechanism for generic-drug makers to gain approval for follow-on biologics.   For some companies, an approval process could be a matter of survival.

The Public Health Service Act, under which biologics are licensed, does not contain any type of shortcut or abbreviated approval pathway analogous to the process used under the Food, Drug, and Cosmetic Act for generic drug approvals, according to the FDA.  However, the agency has approved some follow-on biologics under the FD&C Act, such as GlucaGen, Hydase, Fortical and Omnitrope.

Under any new law, a follow-on biologic applicant will be required to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the brand product in order for the FDA to approve a follow-on biologic as interchangeable. However, the applicant must provide evidence that its product will produce the same clinical result as the brand product in any given patient and that it presents no additional safety risks or diminished efficacy if a patient alternates or is switched between products.  This will be a tough road to travel.

A recent Congressional Budget Office analysis found that biosimilar competition would reduce expenditures on biologics by about $200 million by 2013 and about $25 billion by 2018. With savings amounting to about 0.5 percent of national spending on prescription drugs over the next decade, why isn’t Congress all over this idea? The main problem is the length of data exclusivity, which can run during and longer than the period of patent protection.

Earlier, the Senate Health, Education, Labor and Pensions Committee passed the Biologics Price Competition and Innovation Act, S. 1695, which would have established a way for the FDA to approve products as biosimilar to existing biologics. As a compromise, S. 1695 would have granted 12 years of data exclusivity to innovator biologic drugs.  Congress abandoned its efforts to include follow-on legislation in the PDUFA bill and has said it will address biogenerics in a separate bill.

Insmed, along with consumer groups such as AARP and the National Organization for Rare Disorders, are lobbying for five years, the same length as chemical drug data exclusivity, while the Biotechnology Industry Organization supports a 14-year period.  Hence, the intense efforts to educate Congress on protein chemistry.

Amgen’s biologic drug Neupogen, which stimulates white blood cell growth, generated $1.3 billion in worldwide sales last year.  Insmed, who would like a peice of that marker, has now demonstrated that its biosimilar version of Neupogen was equivalent in 32 healthy volunteers to the original product. But, for now Insmed’s version will have to wait.

Billed as the ONE AND ONLY course where you will learn how to add value to your practice by drilling into the complex nuances of pharmaceutical and biotech patent opinion writing to reveal the strategies, solutions, and tactics for successfully tackling the issues, ACI’s Intensive Course in Pharmaceutical and Biotech Patent Opinion Writing will bring you an exceptional faculty with deep expertise in this complex area of patent law.

An evolving impact of In Re Seagate, conflicting views on the necessity of a patent opinion, and the massive cost factor combine with other issues to create critical, timely, and multidimensional considerations for pharmaceutical and biotech patent attorneys.

To break through these considerations, you must have a thorough understanding of the diverse approaches that the experts use in counseling their clients.

In the course, you will learn how to master the new challenges in the dynamic labyrinth of patent opinion writing in this exclusive course. This course is the ONE place where you will find patent attorneys with the passion, reputation, and resource of knowledge required to give you crucial insights on:

• What to put in writing, what to leave out
• Determining whether the client needs a patent opinion
• Mastering the core complexities of writing validity and non-infringement opinions
• Defining the elements of an effective FTO search
• Measuring the scope of the patent opinion
• Clarifying, incorporating, and forecasting the impact of In Re Seagate in your analysis

American Conference Institute’s Pharmaceutical and Biotech Patent Opinion Writing will be held in three choice locations:

1. November 17-18, 2008, Boston, MA,
2. December 8-9, 2008, Atlanta, GA
3. January 12-13, 2009, San Diego, CA

Get all of the details here.

Patent Baristas is a Media Partner for this Event.

In a notice labeled “Clarification of Patent Regulations Currently in Effect, and Revision in Applicability Date of Provisions Relating to Patent Applications Containing Patentably Indistinct Claim,” the US Patent and Trademark Office (USPTO) published a notice to “clarify” just which patent-related regulations are currently in effect.

The earlier proposed changes in the Claims and Continuations Final Rule were permanently enjoined by the district court in Tafas v. Dudas. That decision is currently on appeal to the U.S. Court of Appeals for the Federal Circuit.  The provisions of the Claims and Continuations Final Rule are not in effect.

The USPTO now just seemingly wants to appear helpful and generous to applicants by pointing out that those regulatory provisions relating to applications containing patentably indistinct claims which are enjoined in Tafas v. Dudas — should the injunction be lifted — will apply only to applications filed on or after any new effective date that would be published by the USPTO in the future.

In a nod that the Patent Office intends to fight on longer than Hideki Tojo, the USPTO noted that it “anticipates that it will be some time before the litigation concerning the Claims and Continuations Final Rule is finally resolved.”

They have therefore provided the following helpful guidelines:

The USPTO is concerned that some applicants may be taking preparatory action anticipating the new requirements of 37 CFR 1.78(f)(1) and (2), as added by the Claims and Continuations Final Rule, due to the possibility that the injunction by the district court in Tafas will be removed. The purpose of this notice is to aid applicants who might otherwise feel the need to take such preparatory actions by identifying the applicability date of the provisions of 37 CFR 1.78(f) in the event that the injunction by the district court in Tafas is removed.

Specifically, the changes in 37 CFR 1.78(f)(1) and (f)(2) will only apply to applications filed on or after any new effective date that would be published by the USPTO after the removal of the injunction. Thus, in the event the referenced injunction is lifted, applicants will only need to comply with the identification requirements of 37 CFR 1.78(f)(1) in applications having an actual filing date on or after this new effective date. Likewise applicants will only have to identify other commonly owned applications that satisfy the conditions set forth in 37 CFR 1.78(f)(1)(i) in applications that have a filing date on or after this new effective date.

Similarly, the rebuttable presumption of 37 CFR 1.78(f)(2) will only apply to applications having an actual filing date on or after the effective date. Furthermore, the rebuttable presumption will only exist with respect to an application that satisfies the conditions set forth in 37 CFR 1.78(f)(2)(i) and also has a filing date on or after this new effective date.

As pointed out by others, when the PTO WANTS you to know about a Federal Register notice, they can post it on the USPTO web site, and even make phone calls to reporters to let them know about it.   When the PTO does NOT want you to know about a Notice (like the Paperwork Reduction Act comment period, two months ago), they somehow “forget” to let anyone know.

This Federal Register Notice states that the PTO will not apply Rules 78(f)(1) and (2) (the presumption of double patenting and requirement to rebut) retroactively, even if the Tafas v Dudas injunction is lifted.

We’ll have to wait to see if the court is moved by this new-found generosity.   See the full Notice here.

More here

Tafas v. Dudas: The Continuation Wars
No Joke, Court Smacks Down New Patent Rules
Oops, They Did It Again — Patent Office has “Typographical Error”
Sides Line Up in Impending Patent Continuations Fight

In a bit of shameless self-promotion, we find that the Patent Baristas were ranked (once again!) in the 2008 Edition of Chambers and Partners, a guide to the legal profession that rates attorneys and their practices based upon peer and client review.

Chambers USA touts the Intellectual Property Department as known for their “exceptional” attention to detail and impeccable biomedical knowledge. Frost Brown Todd LLC is said to boast one of the top Intellectual Property practices in the region. Clients use adjectives such as “impeccable”, “genius”, “simply superb”, and “quite excellent” in describing Stephen Albainy-Jenei, Karlyn Schnapp, Steven Goldstein and David Schmit.

From Chambers:

The Firm: [Frost Brown Todd] undertakes a substantial amount of transactional and prosecution work in patents, and litigates trademark, trades secrets and patent matters. Team members have particular expertise in the life sciences, Internet and computer technology sectors, and recently advised AOI Medical on the IP aspects of its IPO on the LSE.  The team also acted for Caudill Seed in obtaining declaratory judgment for non-infringement of patents related to a new product line of nutritional supplements.

The Lawyers: The “extraordinarily intelligent” Stephen Albainy-Jenei “knows the practice area inside out.” “Well-reasoned and never hasty,” he is active in life sciences and patent prosecution, and is responsible for the influential Patent Baristas blog. “Excellent attorney” Steven Goldstein has stepped down as department chair, to be replaced by Ann Schoen, and has now taken on the role of vice-chair. His practice takes in patent prosecution and transactional work, largely in the life sciences. David Schmit receives enthusiastic praise, which depicts him as “a genius who is extraordinarily formidable on the other side.” He is the group’s litigation expert and undertakes patent, trademark, copyright and trade secret cases. Interviewees also “think the world of” senior associate Karlyn Schnapp, a life sciences specialist with a PhD in chemistry.

The qualities on which rankings are based include technical legal ability, professional conduct, client service, commercial awareness/astuteness, diligence, commitment, and other qualities valued by the client. Editorial comment is also derived from the research, with quotations used when they sum up the prevailing opinion of the market. The rankings and editorial comment about attorneys are independent and objective. Inclusion in the guide is based solely on the research team’s findings. For the current Global directory, over 6,500 of these interviews were conducted covering 170 countries. They were carried out by a team of 30 full-time researchers over a period of 12 months.

Now, if only we could win a Webby…

See more in the Frost Brown Todd LLC Profile

Yali Friedman announced the new, Third Edition of Building Biotechnology, known as the definitive primer and leading textbook on the business of biotechnology is now available in its third edition.We have not read the newest edition but it promises to be better than ever.

This new edition is a whopper containing 20 Chapters, 460 pages 44 figures, 25 Tables, and 63 Boxes — over 100 pages longer than the second edition with new chapters, new figures and tables, and additional case examples.

Building Biotechnology builds a foundation by providing a comprehensive fundamentals-based overview of the broad variety of elements influencing the commercialization of biotechnology.  You can get a taste of this guide by downloading the Introduction to Molecular Biology (PDF).

Expanding on this foundation to ensure a practical appreciation of operational issues in the biotechnology industry, Building Biotechnology adds real-world examples on topics such as the hidden pitfalls of common operational decisions, practical considerations in selecting business models and funding options, strategies to overcome developmental failures, and methods to leverage options to strengthen development plans.

You can purchase the texct at Amazon here: Building Biotechnology 3d Edition. 

Author Yali Friedman is also the editor of Best Practices in Biotechnology Business Development.  His other projects include the Biotech Blog and Drug Patent Watch.

The phosita® blog notes perhaps the first dismissal of a declaratory judgment action following the Supreme Court’s decision in MedImmune.  In a dispute over U.S. Pat. No. 5,247,356, a patent involving photogrammetry*, a court in Minneapolis dismissed two counts seeking declaratory judgment of non-infringement and invalidity (Case 08–cv-00816).

[*Apparently, photogrammetry is the science of making reliable measurements by the use of photographs, espeially useful in aerial photography.]

Pictometry tried to get the case dismissed for lack of subject-matter jurisdiction arguing that Geospan has failed to state a case or controversy under Article III of the Constitution.  Geospan hit back saying that MedImmune and subsequent case law made the standard for declaratory judgment jurisdiction a very low hurdle to get over.

Apparently, the bar may be lower but not that low.  According to the ruling:

[A]lthough MedImmune lowers the bar for declaratory judgment jurisdiction, a substantial controversy is still required. In the post-MedImmune authorities relied on by [Plaintiff], a patentee has either demonstrated a preparedness to litigate against the prospective declaratory judgment plaintiff, accused the prospective declaratory judgment plaintiff of infringement, affirmatively asserted its rights to license fees, or engaged in some combination of all three. For example, in Micron Technology, Inc. v. MOSAID Technologies, Inc., 518 F.3d 897 (Fed. Cir. 2008), …

The instant case is distinguishable because [Defendant] has not demonstrated an intent to litigate against [Plaintiff], has not accused [Plaintiff] of infringement, and has not demanded licensing fees. There is no evidence that [Defendant] has pursued litigation against [Plaintiff].

It would appear that the court only needs to see a tiny hint of controversy, i.e., any one of the following:

1. Patentee is ready to litigate;
2. Accused the plaintiff of infringement; and/or
3. Asserted its rights to license fees.

Despite the fact that this particular plaintiff failed in its quest to avoid declaratory judgment, there requirements seem to be quite thin for showing a substantial controversy exists and, hence, gaining subject matter jurisdiction.

See more here:

Despite the fact that this particular plaintiff failed in its quest to avoid declaratory judgment, the requirements seem to be quite thin for showing a substantial controversy exists and, hence, gaining subject matter jurisdiction.  Look for further clarification to come down the pike.

See more here:

MedImmune and Genentech Settle, Lawyers Look For New Topic of Discussion
Practical Implications of MedImmune
Supreme Court High-Fives MedImmune
MedImmune Asks: What’s A Patent Lawsuit Among Friends?

In a nonprecedential opinion, the U.S. Court of Appeals for the Federal Circuit gave the thumbs up to a district court decision that Plaintiff-Appellant Novo Nordisk A/S wasn’t getting a preliminary injunction out of Sanofi-Aventis after alleging that Sanofi’s SoloStar product infringed claims of Novo’s U.S. Patent No. 7,241,278.  Novo Nordisk A/S v. Sanofi-Aventis (08-1225).

In order to obtain a preliminary injunction, a patentee must show: “(1) reasonable likelihood of success on the merits; (2) irreparable harm; (3) that the balance of hardships tips in its favor; and (4) the impact of the injunction on the public interest.”  The denial of a preliminary injunction pursuant to 35 U.S.C. § 283 is within a district court’s discretion.

In this case, the district court denied the preliminary injunction because Novo failed to show a reasonable likelihood of success on the merits.  The district court reasoned that Sanofi “raised substantial questions regarding whether the specification read as a whole suggests that the very character of the invention.  These substantial questions included whether:

1. the embodiments of the invention set forth in the specification as “the invention” constitute the invention itself despite claim language that could be interpreted more broadly,
2. the specification expressly disclaims injection pens with rotating piston rods or gearing other than direct gearing,
3. the specification suggests the need to narrowly construe the claims because it distinguishes prior art or clearly expresses an intention to limit the invention’s structure, and
4. Novo’s amendment of the ’278 patent’s claims to import language from the DCA Application affects this Court’s use of the specification, which was not amended, in construing such claims.

The district court ultimately found that these substantial questions precluded a finding that Novo has a likelihood of success on the merits and, accordingly, denied Novo’s motion for a preliminary injunction.

Novo appealed, arguing that the district court’s claim construction is legal error because the claim language is clear, the specification contains no disclaimer, the prosecution history makes clear that Novo abandoned these requirements, and the doctrine of claim differentiation supports Novo’s proposed construction.

The federal Circuit felt that the lower court was well within its discretion:

[N]otwithstanding Novo’s arguments to the contrary, we read the district court’s opinion as generally addressing whether Sanofi raised “substantial questions,” rather than specifically articulating a claim construction.  While it is true that many of the substantial questions identified by the district court would ultimately be analyzed in the context of construing the claims, some might more appropriately be analyzed in the context of validity (i.e., written description and enablement).

At the preliminary injunction stage, however, it is irrelevant whether this case presents greater issues of claim construction or validity—the existence of one or both of these issues is sufficient to justify the district court’s decision to deny a preliminary injunction.